FrancophonIA/ELRC3.0 huggingface dataset:
English: Lumbar spine BMD at least 4% decrease
Croatian: Smanjenje BMD-a lumbalne kralježnice za najmanje 4%
English: (using MDRD equation).
Croatian: (doza u mg)
English: • softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells, • fatty liver.
Croatian: • omekšavanje kostiju (uz bol u kostima i ponekad s posljedičnim prijelomom kostiju), do kojega može doći zbog oštećenja stanica bubrežnih tubula
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.
Croatian: Devedeset pet posto bolesnika koji nisu prethodno primali nukleoz(t)idne lijekove, 84% bolesnika koji su primali nukleoz(t)idne lijekove i 83% bolesnika rezistentnih na lamivudin postiglo je HBV DNK < 400 kopija/ml u 72. tjednu.
English: HBV strains expressing the rtL180M, rtT184G, rtS202G/I, rtM204V and rtM250V mutations associated with resistance to entecavir showed a susceptibility to tenofovir ranging from 0.6- to 6.9-fold that of wild- type virus.
Croatian: Sojevi virusa HBV koji izražavaju mutacije rtL180M, rtT184G, rtS202G/I, rtM204V i rtM250V povezane s rezistencijom na entekavir pokazali za 0,6 do 6,9 puta veću osjetljivost na tenofovir od divljeg tipa virusa.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Croatian: Srednje vrijednosti promjene u 48. tjednu (na kraju randomizirane faze) iznosile su 0,032 odnosno 0,087 u BMD Z-rezultatu lumbalne kralježnice i -0,184 odnosno -0,027 u BMD Zrezultatu cijelog tijela u skupinama liječenima tenofovirdizoproksilom odnosno stavudinom ili zidovudinom.
English: Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Croatian: Hepatički recidiv može biti posebno ozbiljan u bolesnika s dekompenziranom bolešću jetre i ponekad imati smrtni ishod.
English: PLBtenofovir disoproxil
Croatian: PLBtenofovir dizoproksil
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil ( tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Croatian: Nakon 72 tjedna, održana je virološka supresija u bolesnika koji su primali dvostruko slijepo tenofovirdizoproksil nakon čega je slijedilo otvoreno liječenje tenofovirdizoproksilom (skupina tenofovirdizoproksil-tenofovirdizoproksil): 86,5% (45/52) bolesnika u skupini tenofovirdizoproksil-tenofovirdizoproksil imalo je HBV DNK < 400 kopija/ml u 192. tjednu.
English: If bone abnormalities are detected or suspected in paediatric patients, consultation with an endocrinologist and/or nephrologist should be obtained.
Croatian: Ako se u pedijatrijskih bolesnika otkrije ili posumnja da imaju abnormalnosti kostiju, potrebno je dobiti stručno mišljenje endokrinologa i/ili nefrologa.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Tenofovir disoproxil Zentiva treatment.
Croatian: Ako se otkriju ili se sumnja na abnormalnosti bubrega, potrebno dobit stručno mišljenje nefrologa da bi se razmotrio prekid liječenja lijekom Tenofovir disoproxil Zentiva.
English: Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes.
Croatian: Nakon toga konstitucijski izraženi stanični enzimi pretvaraju tenofovir u djelatni metabolit, tenofovir difosfat, koji obavezno završava lanac.
English: Tenofovir disoproxil Zentiva can cause dizziness.
Croatian: Tenofovir disoproxil Zentiva može uzrokovati omaglicu.
English: In study GS-US-104-0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Croatian: U ispitivanju GS-US-104-0352, 97 prethodno liječenih bolesnika u dobi od 2 do < 12 godina sa stabilnom virološkom supresijom koji su prethodno bili liječeni režimima koji su sadržavali stavudin ili zidovudin bilo je randomizirano u skupine kojima se stavudin ili zidovudin zamijenio tenofovirdizoproksilom (n = 48) ili u skupine koje su nastavile primati prvobitni režim (n = 49) 48 tjedana.
English: • That a multidisciplinary approach is recommended for the management of adolescent patients • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil-containing products such as Tenofovir disoproxil Zentiva
Croatian: • Da u bolesnika zaraženih HIV-om i HBV-om postoji povećan rizik od bubrežne bolesti povezan s primjenom lijekova koji sadrže tenofovirdizoproksil, kao što je Tenofovir disoproxil Zentiva.
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Croatian: U bolesnika liječenih tenofovirdizoproksilom ili placebom, srednja vrijednost BMD Z-rezultata lumbalne kralježnice iznosila je -1,004 i -0,809, a srednja vrijednost BMD Z-rezultata cijelog tijela bila je -0,866 i -0,584 na početku ispitivanja.
English: The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Croatian: Srednja vrijednost brzine povećanja koštane mase lumbalne kralježnice u 48. tjednu u skupini liječenoj tenofovirdizoproksilom bila je slična onoj u skupini liječenoj stavudinom ili zidovudinom.
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.
Croatian: povišeni ALT (≥ 2 x ULN) u serumu ili povišene razine ALT-a u serumu u prethodna 24 mjeseca] bilo je liječeno tenofovirdizoproksilom od 245 mg (n = 52) ili je primalo placebo (n = 54) tijekom 72 tjedna.
English: Response to treatment with tenofovir disoproxil was also similar in subjects who were HBeAg-negative compared with those who were HBeAg-positive at baseline with 77% (43/56) HBeAg-positive and 75.0% (3/4) HBeAg-negative subjects achieving HBV DNA < 400 copies/ml (69 IU/ml) at Week 48.
Croatian: Odgovor na liječenje tenofovirdizoproksilom također je bio sličan u početno HBeAg negativnih i HBeAg pozitivnih ispitanika sa 77% (43/56) HBeAg pozitivnih i 75,0% (3/4) HBeAg negativnih ispitanika koji su postigli HBV DNK < 400 kopija/ml (69 IU/ml) u 48. tjednu.
English: Hepatitis B clinical studies: Assessment of adverse reactions from HBV clinical study data is primarily based on experience in two double-blind comparative controlled studies in which 641 adult patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
Croatian: Klinička ispitivanja hepatitisa B: Procjena nuspojava u kliničkim ispitivanjima hepatitisa B primarno se temelji na iskustvu iz dva dvostruko slijepa komparativna kontrolirana ispitivanja u kojima je 641 odrasli bolesnik s kroničnim hepatitisom B i kompenziranom bolešću jetre liječen s 245 mg tenofovirdizoproksila dnevno (n = 426) ili 10 mg adefovirdipivoksila dnevno (n = 215) tijekom 48 tjedana.
English: (21/28) of immune-active patients in the tenofovir disoproxil group had normal ALT at week 72 compared to 34% (11/32) in the placebo group.
Croatian: Sedamdeset pet posto (21/28) imunološki aktivnih bolesnika u skupini liječenoj tenofovirdizoproksilom imalo je normalnu vrijednost ALT-a u 72. tjednu u usporedbi s 34% (11/32) onih u skupini liječenoj placebom.
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Croatian: Procjene genotipa provedene u svih bolesnika s vrijednostima HBV DNK > 400 kopija/ml u 48. (n = 16), 96. (n = 5), 144. (n = 1), 192. (n = 2), 240. (n = 1), 288. (n = 1) i 384. tjednu (n = 2) na monoterapiji tenofovirdizoproksilom pokazale su da se nisu razvile mutacije povezane s rezistencijom na tenofovirdizoproksil.
English: Adefovir dipivoxil 10 mg n = 125
Croatian: Adefovirdipivoksil 10 mg n = 125
English: Genotypic data from paired baseline and on treatment HBV isolates were available for 6/8 patients with HBV DNA > 400 copies/ml at week 48.
Croatian: Podaci o genotipu iz sparenih početnih rezultata te HBV izolata tijekom liječenja bili su dostupni za 6/8 bolesnika s HBV DNK > 400 kopija/ml u 48. tjednu.
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 tenofovirdizoproksil, odnosno u skupinu koja je bila liječena emtricitabinom i tenofovirdizoproksil.
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-1740144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Croatian: Nuspojave su se procijenile na temelju jednog randomiziranog ispitivanja (ispitivanje GS-US-1740115) u 106 adolescentnih bolesnika (u dobi od 12 do < 18 godina) s kroničnim hepatitisom B koji su primali liječenje tenofovirdizoproksilom u dozi od 245 mg (n = 52) ili placebo (n = 54) tijekom 72 tjedna te randomiziranog ispitivanja (ispitivanje GS-US-174-0144) u 89 bolesnika s kroničnim hepatitisom B (od 2 do < 12 godina) koji su primali liječenje tenofovirdizoproksilom (n = 60) ili placebo (n = 29) tijekom 48 tjedana.
English: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Croatian: Povećanje ukupne koštane mase bilo je manje u skupini liječenoj tenofovirdizoproksilom nego u skupini liječenoj stavudinom ili zidovudinom.
English: Patients with decompensated liver disease: The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study (GS-US-174-0108) in which adult patients received treatment with tenofovir disoproxil (n = 45) or emtricitabine plus tenofovir disoproxil (n = 45) or entecavir (n = 22) for 48 weeks.
Croatian: Bolesnici s dekompenziranom bolešću jetre: Sigurnosni profil tenofovirdizoproksila u bolesnika s dekompenziranom bolešću jetre procijenjen je u dvostruko slijepom kontroliranom ispitivanju s aktivnom kontrolom (GS-US-174-0108) u kojem su odrasli bolesnici liječeni tenofovirdizoproksilom (n = 45) ili emtricitabinom u kombinaciji s tenofovirdizoproksilom (n = 45) ili entekavirom (n = 22) tijekom 48 tjedana.
English: Lopinavir/Ritonavir (400 mg b.i.d./100 mg b.i.d.)
Croatian: Lopinavir/ritonavir (400 b.i.d./100 b.i.d.)
English: l 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: l Prikazani brojevi su kumulativni postoci koji se temelje na Kaplan-Meierovoj analizi isključujući podatke prikupljene nakon dodavanja emtricitabina otvorenom liječenju tenofovirdizoproksilom (KM-tenofovirdizoproksil).
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any adolescent patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Croatian: • Da ako se u bilo kojeg adolescentnog bolesnika koji prima tenofovirdizoproksil potvrdi da je fosfat u serumu < 3,0 mg/dl (0,96 mmol/l), treba ponovno ocijeniti funkciju bubrega unutar jednoga tjedna.
English: In patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Croatian: U bolesnika s bubrežnim čimbenicima rizika treba pažljivo procijeniti istovremenu primjenu tenofovirdizoproksila s pojačanim inhibitorom proteaze.
English: Emtricitabine 200 mg/ tenofovir disoproxil 245 mg (n = 45)
Croatian: Emtricitabin 200 mg/ tenofovirdizoproksil 245 mg (n = 45)
English: In studies GS-US-174-0102 and GS-US-174-0103, 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: (1 subject)
Croatian: (1 bolesnik)
English: Whole body BMD at least 4% decrease
Croatian: Smanjenje BMD-a cijelog tijela za najmanje 4%
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Croatian: Procjene genotipa provedene u svih bolesnika s vrijednostima HBV DNK > 400 kopija/ml u 48. (n = 39), 96. (n = 24), 144. (n = 6), 192. (n = 5), 240. (n = 4), 288. (n = 6) i 384. tjednu (n = 2) na monoterapiji tenofovirdizoproksilom pokazale su da se nisu razvile mutacije povezane s rezistencijom na tenofovirdizoproksil.
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
Croatian: Podaci o mineralnoj gustoći kostiju (BMD) iz ispitivanja GS-US-174-0144 sažeto su navedeni u Tablici 9:
English: Musculoskeletal and connective tissue disorders: Uncommon:
Croatian: Poremećaji mišićno-koštanog i vezivnog tkiva: Manje često:
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/ml rose sharply after they began treatment with open-label tenofovir disoproxil (PLB- tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Croatian: Kod bolesnika koji su primali placebo tijekom dvostruko slijepog perioda, udio bolesnika s HBV DNK < 400 kopija/ml naglo je porastao nakon što su počeli otvoreno liječenje tenofovirdizoproksilom (skupina PLB-tenofovirdizoproksil): 74,1% (40/54) bolesnika u skupini PLBtenofovirdizoproksil imalo je HBV DNK < 400 kopija/ml u 192. tjednu.
English: 11l a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384
Croatian: 11l a Temelji se na algoritmu dugoročne ocjene (LTE analiza) - Bolesnici koji su prekinuli sudjelovanje u ispitivanju bilo kada prije 384. tjedna zbog postizanja protokolom definirane mjere ishoda i oni koji su dovršili 384 tjedna liječenja uključeni su u nazivnik.
English: Tenofovir disoproxil has not been studied in patients over the age of 65.
Croatian: Tenofovirdizoproksil se nije ispitivao u bolesnika starijih od 65 godina.
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. tjednu (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: 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.
Croatian: Srednja promjena MELD rezultata od početne vrijednosti a p-vrijednost za usporedbu skupina koje primaju kombinirane lijekove koji sadrže tenofovir naspram skupine na entekaviru = 0,622. b p-vrijednost za usporedbu skupina koje primaju kombinirane lijekoe koji sadrže tenofovir nasuprot skupine na entekaviru = 1,000.
English: Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Croatian: Tenofovir disoproxil Zentiva se ne smije istovremeno primjenjivati s adefovirdipivoksilom.
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 od manju od 400 kopija/ml.
English: The potential risks and benefits associated with co-administration of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir with tenofovir disoproxil given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Croatian: Potrebno je razmotriti moguće rizike i koristi povezane s istovremenom primjenom ledipasvira/sofosbuvira, sofosbuvira/velpatasvira ili sofosbuvira/velpatasvira/voksilaprevira s tenofovirdizoproksilom danim zajedno s pojačanim inhibitorom HIV proteaze (npr. atazanavirom ili darunavirom), osobito u bolesnika pod povećanim rizikom od poremećaja funkcije bubrega.
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.
Croatian: Srednje vrijednosti promjene u 48. tjednu (kraj dvostruko slijepe faze) bile su -0,215 i -0,165 u BMD Z-rezultatu lumbalne kralježnice te -0,254 i0,179 u ukupnom BMD Z-rezultatu cijelog tijela za skupine koje su primale tenofovirdizoproksil, odnosno placebo.
English: There are limited clinical data with respect to the effect of tenofovir disoproxil on fertility.
Croatian: Nema dovoljno kliničkih podataka o učinku tenofovirdizoproksila na plodnost u čovjeka.
English: At week 72, overall 88% (46/52) of patients in the tenofovir disoproxil treatment group and 0% (0/54) of patients in the placebo group had HBV DNA < 400 copies/ml.
Croatian: U 72. tjednu, ukupno je 88% (46/52) bolesnika u skupini liječenoj tenofovirdizoproksilom i 0% (0/54) bolesnika u skupini liječenoj placebom imalo HBV DNK < 400 kopija/ml.
English: 50 Theodor Pallady Blvd. Bucharest 032266
Croatian: 50 Theodor Pallady Blvd.
English: HIV-1 infection
Croatian: Infekcija virusom HIV-1
English: SN: [outer packaging only]
Croatian: PC: [samo vanjsko pakiranje] SN: [samo vanjsko pakiranje] NN: [samo vanjsko pakiranje]
English: Exacerbations of hepatitis after discontinuation of treatment In HBV infected patients, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of HBV therapy (see section 4.4).
Croatian: U bolesnika inficiranih HBV-om javili su se klinički i laboratorijski dokazi egzacerbacija bolesti nakon prekida terapije hepatitisa B (vidjeti dio 4.4).
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 pozitivnih i HBeAg negativnih 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: 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).
Croatian: Unutar ove skupine provedena je genotipizacija u svih bolesnika s HBV DNK > 400 kopija/ml u 48. tjednu (n = 6), 72. tjednu (n = 5), 96. tjednu (n = 4), 144. tjednu (n = 2) i 192. tjednu (n = 3).
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 vezana uz tenofovirdizoproksil.
English: Experience in patients with decompensated liver disease at 48 weeks (study GS-US-174-0108) Study GS-US-174-0108 is a randomised, double-blind, active controlled study evaluating the safety and efficacy of tenofovir disoproxil (n = 45), emtricitabine plus tenofovir disoproxil (n = 45), and entecavir (n = 22), in patients with decompensated liver disease.
Croatian: Iskustva u bolesnika s dekompenziranom bolešću jetre u 48. tjednu (ispitivanje GS-US-174-0108) Ispitivanje GS-US-174-0108 je randomizirano, dvostruko slijepo ispitivanje s aktivnom kontrolom u kojem se procjenjuju sigurnost i djelotvornost tenofovirdizoproksila (n = 45), emtricitabina u kombinaciji s tenofovirdizoproksilom (n = 45) i entekavira (n = 22) u bolesnika s dekompenziranom bolešću jetre.
English: Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Croatian: Kronični hepatitis B: Izloženost tenofoviru u stanju dinamičke ravnoteže u adolescenata zaraženih HBV-om (u dobi od 12 do < 18 godina) koji su primali peroralno dnevnu dozu tenofovirdizoproksila od 245 mg bila je slična izloženosti postignutoj u odraslih koji su primali tenofovirdizoproksil u dozi od 245 mg jedanput na dan.
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 tenofovirdizoproksilom, bolesnici su imali srednju vrijednost CPT rezultata 7,2, srednju vrijednost HBV DNK od 5,8 log10 kopija/ml i srednju vrijednost serumskog ALT-a 61 IU/l na početku.