FrancophonIA/ELRC3.0 huggingface dataset:
English: b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis score.
Croatian: b Poboljšanje rezultata na Knodellovoj ljestvici nekroinflamatorne aktivnosti od najmanje dva boda bez pogoršanja na Knodellovoj ljestvici fibroze.
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 3 below).
Croatian: U ispitivanju GS-US-174-0103 značajno veći udio bolesnika u skupini koja je dobivala tenofovirdizoproksil imao je normaliziranu razinu ALT-a u odnosu na skupinu bolesnika koja je dobivala adefovirdipivoksil te je nestanak HBsAg u 48. tjednu (vidjeti tablicu 3).
English: Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Croatian: Tijekom liječenja preporučuje se povremeno praćenje jetrene funkcije (vidjeti dio 4.4).
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil Zentiva (see sections 4.2, 4.4 and 5.2).
Croatian: Tenofovirdizoproksil može prouzročiti bubrežnu toksičnost, pa se preporučuje pomno nadziranje funkcije bubrega u svakog odraslog bolesnika s oštećenjem funkcije bubrega koji se liječe lijekom Tenofovir disoproxil Zentiva (vidjeti dio 4.2, 4.4 i 5.2).
English: While taking Tenofovir disoproxil Zentiva you may still develop infections or other illnesses associated with HIV infection.
Croatian: Tijekom uzimanja lijeka Tenofovir disoproxil Zentiva može doći do razvoja infekcije i drugih bolesti povezanih s infekcijom virusom HIV-a.
English: No significant effect on darunavir/ritonavir PK parameters.
Croatian: Bez značajnog učinka na farmakokinetičke parametre darunavira/ritonavira.
English: • That patients should have their baseline renal function assessed prior to initiating Tenofovir disoproxil Zentiva therapy
Croatian: • Da bolesnicima treba odrediti početnu funkciju bubrega prije početka terapije lijekom Tenofovir disoproxil Zentiva.
English: What Tenofovir disoproxil Zentiva is and what it is used for What you need to know before you take Tenofovir disoproxil Zentiva How to take Tenofovir disoproxil Zentiva Possible side effects
Croatian: Što je Tenofovir disoproxil Zentiva i za što se koristi Što morate znati prije nego počnete uzimati lijek Tenofovir disoproxil Zentiva
English: The 144-week, double-blind, active controlled phase of study GS-99-903 evaluated the efficacy and safety of tenofovir disoproxil 245 mg versus stavudine when used in combination with lamivudine and efavirenz in HIV-1 infected adult patients naïve to antiretroviral therapy.
Croatian: U dvostruko slijepoj fazi ispitivanja s aktivnom kontrolom GS-99-903, koja je trajala 144 tjedna, ocjenjivale su se djelotvornost i sigurnost tenofovirdizoproksila u dozi od 245 mg u usporedbi sa stavudinom kod kombinirane primjene s lamivudinom i efavirenzom u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnom terapijom.
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE)
Croatian: Neuspjeh podnošljivosti (trajni prekid ispitivanja lijeka zbog nuspojave) n (%)a
English: Tenofovir disoproxil should be avoided in antiretroviral experienced patients with strains harbouring the K65R mutation (see section 4.4).
Croatian: Primjenu tenofovirdizoproksila valja izbjegavati u bolesnika prethodno liječenih antiretrovirusnim lijekovima sa sojem koji nosi mutaciju K65R (vidjeti dio 4.4).
English: A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Croatian: Veći rizik od oštećenja funkcije bubrega zabilježen je u bolesnika koji primaju tenofovirdizoproksil u kombinaciji s inhibitorom proteaze pojačanim ritonavirom ili kobicistatom.
English: months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Croatian: - Kod HBeAg pozitivnih bolesnika bez ciroze, liječenje se mora primjenjivati najmanje 12 mjeseci nakon HBe serokonverzije (nestanak HBeAg i HBV DNK s detekcijom anti-Hbe na dvama uzastopnim uzorcima seruma u razmaku od najmanje 3 do 6 mjeseci) ili sve do HBs serokonverzije ili do gubitka djelotvornosti (vidjeti dio 4.4).
English: In the HBeAg positive subjects randomised to emtricitabine plus tenofovir disoproxil, 13 of 68 subjects (19%) experienced HBeAg loss, and 7 of 68 subjects (10%) experienced anti-HBe seroconversion through week 240.
Croatian: Među HBeAg-pozitivnih ispitanika randomiziranih za emtricitabin i tenofovirdizoproksil, 13 od 68 (19%) ispitanika imalo je nestanak HBeAg, a 7 od 68 (10%) ispitanika imalo je anti-HBe serokonverziju kroz 240 tjedana.
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.
Croatian: U ispitivanju GS-US-174-0144, 89 HBeAg negativih i HbeAg pozitivnih bolesnika u dobi od 2 do < 12 godina s kroničnim hepatitisom B liječeno je tenofovirdizoproksilom od 6,5 mg/kg do najveće doze od 245 mg (n = 60) ili placebom (n = 29) jedanput na dan tijekom 48 tjedana.
English: Eight patients had HIV that expressed K65R in the tenofovir disoproxil 245 mg arm, 7 of these occurred during the first 48 weeks of treatment and the last one at week 96.
Croatian: U skupini koja je primala 245 mg tenofovirdizoproksila 8 bolesnika imalo je HIV koji je izražavao mutaciju K65R, koja se u njih 7 pojavila tijekom prvih 48 tjedana liječenja, a u posljednjeg bolesnika u 96. tjednu.
English: Mild renal impairment (creatinine clearance 50 - 80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil in patients with mild renal impairment.
Croatian: Blago oštećenje funkcije bubrega (klirens kreatinina 50 - 80 ml/min) Ograničeni podaci iz kliničkih ispitivanja govore u prilog doziranju tenofovirdizoproksila u dozi od 245 mg jedanput na dan u bolesnika s blagim oštećenjem funkcije bubrega.
English: After 240 weeks of treatment, 117 of 141 subjects (83%) randomised to tenofovir disoproxil had HBV DNA < 400 copies/ml, and 51 of 79 subjects (65%) had ALT normalisation.
Croatian: Nakon 240 tjedana liječenja, 117 od 141 (83%) ispitanika randomiziranogih za tenofovirdizoproksil imalo je HBV DNK < 400 kopija/ml, a 51 od 79 (65%) ispitanika imalo je normalizaciju ALT-a.
English: Only five had adefovir-associated resistance mutations at baseline.
Croatian: Samo je petero bolesnika na početku imalo mutacije rezistencije povezane s adefovirom.
English: Thirteen percent (6/45) of the tenofovir disoproxil group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil group, and 9% (2/22) of the entecavir group had a confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl.
Croatian: Trinaest posto (6/45) bolesnika u skupini liječenoj tenofovirdizoproksilom, 13% (6/45) bolesnika u skupini liječenoj emtricitabinom i tenofovirdizoproksilom i 9% (2/22) bolesnika u skupini liječenoj entekavirom imalo je potvrđen porast kreatinina u serumu za ≥ 0,5 mg/dl ili potvrđene fosfate u serumu < 2 mg/dl.
English: Subjects must have been naïve to tenofovir disoproxil, with HBV DNA > 105 copies/ml (~ 4.2 log10 IU/ml) and ALT > 1.5 × the upper limit of normal (ULN) at screening.
Croatian: Ispitanici nisu smjeli biti prethodno liječeni tenofovirdizoproksilom, morali su imati razinu HBV DNK > 105 kopija/ml (~ 4,2 log10 IU/ml) i ALT > 1,5 × gornja granica normale (GGN) na probiru.
English: Assessment of adverse reactions for tenofovir disoproxil is based on safety data from clinical studies and post-marketing experience.
Croatian: Procjena nuspojava tenofovirdizoproksila temelji se na sigurnosnim podacima prikupljenima u kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet.
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).
Croatian: Liječenje s 245 mg tenofovirdizoproksila povezano je s promjenom srednje vrijednosti u razini serumske HBV DNK od početne vrijednosti kod bolesnika za koje postoje 48-tjedni podaci od -5,74 log10 kopija/ml (n = 18).
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu hidrat.
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil discontinued study drug due to renal adverse events.
Croatian: U ispitivanju GS-US-104-0352, 8 od 89 pedijatrijskih bolesnika (9,0%) izloženih tenofovirdizoproksilu prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima.
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 96 (n = 17), week 144 (n = 7), and week 192 (n = 8).
Croatian: Unutar ove skupine provedena je genotipizacija u svih bolesnika s HBV DNK > 400 kopija/ml u 96. tjednu (n = 17), 144. tjednu (n = 7) i 192. tjednu (n = 8).
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis.
Croatian: U nekih se bolesnika s uznapredovalom bolešću jetre ili cirozom jetre prekid liječenjane preporučuje jer to može dovesti do pogoršanja hepatitisa.
English: Monitoring of renal function is recommended for patients receiving Tenofovir disoproxil Zentiva (see section 4.4).
Croatian: Preporučuje se praćenje funkcije bubrega u bolesnika koji primaju Tenofovir disoproxil Zentiva (vidjeti dio 4.4).
English: Total clearance has been estimated to be approximately 230 ml/h/kg (approximately 300 ml/min).
Croatian: Prividni klirens tenofovira je procijenjen da iznosi približno 230 ml/h/kg (približno 300 ml/min).
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir disoproxil (see section 4.4).
Croatian: Kod starijih bolesnika postoji veća vjerojatnost smanjene funkcije bubrega, pa je stoga potreban oprez prilikom liječenja starijih bolesnika tenofovirdizoproksilom (vidjeti dio 4.4).
English: ALT (%) Normalised ALTd
Croatian: Normaliziran ALTd
English: Median HBV DNA reduction from baselinec
Croatian: Medijan smanjenja HBV DNK od početne vrijednostic
English: Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients There are limited data on the safety and efficacy of tenofovir disoproxil in patients with impaired renal function.
Croatian: Odrasli bolesnici s klirensom kreatinina < 50 ml/min, uključujući bolesnike na hemodijalizi Sigurnost i djelotvornost tenofovirdizoproksila za bubrege istraživana je samo u vrlo ograničenoj mjeri kod bolesnika s oštećenjem funkcije bubrega.
English: Patients with renal impairment
Croatian: Bolesnici s oštećenjem funkcije bubrega
English: The mean baseline CD4 cell count was 427 cells/mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ml (78% of patients had a viral load of < 5,000 copies/ml) and the mean duration of prior HIV treatment was 5.4 years.
Croatian: Srednja početna vrijednost broja CD4 stanica bila je 427 stanica/mm3, srednja početna vrijednost koncentracije HIV-1 RNK u plazmi bila je 3,4 log10 kopija/ml (78% bolesnika imalo je virusno opterećenje < 5000 kopija/ml), a srednja vrijednost trajanja prethodnog liječenja HIV-a bila je 5,4 godine.
English: In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve adult patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Croatian: U 144-tjednom kontroliranom kliničkom ispitivanju u bolesnika inficiranih HIV-om u kojemu je uspoređivan tenofovirdizoproksil sa stavudinom u kombinaciji s lamivudinom i efavirenzom u odraslih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u obje su liječene skupine zapažena mala smanjenja mineralne gustoće kosti kuka i kralježnice.
English: In HIV Tenofovir disoproxil Zentiva should always be used combined with other medicines to treat HIV infection.
Croatian: Kod HIV -a, Tenofovir disoproxil Zentiva se uvijek treba primjenjivati u kombinaciji s drugim lijekovima za liječenje HIV infekcije.
English: Look out for signs of inflammation or infection soon after you start taking Tenofovir disoproxil Zentiva.
Croatian: Obratite pozornost na znakove upale ili infekcije ubrzo nakon što započnete uzimati lijek
English: - foscarnet, ganciclovir, or cidofovir (for viral infection) - interleukin-2 (to treat cancer) - adefovir dipivoxil (for HBV) - tacrolimus (for suppression of the immune system) - non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Croatian: Ti lijekovi uključuju: aminoglikozide, pentamidin ili vankomicin (za bakterijsku infekciju) amfotericin B (za gljivičnu infekciju) foskarnet, ganciklovir ili cidofovir (za virusnu infekciju) interleukin-2 (za liječenje raka) adefovirdipivoksil (za HBV) takrolimus (za potiskivanje imunološkog sustava) nesteroidne protuupalne lijekove (NSAIL, za ublažavanje bolova u kostima ili mišićima)
English: Assessment of adverse reactions is based on two randomised trials (studies GS-US-104-0321 and GS-US104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Croatian: Procjena nuspojava temelji se na dva randomizirana ispitivanja (ispitivanja GS-US-104-0321 i GS-US-104-0352) u 184 pedijatrijska bolesnika zaraženih virusom HIV-1 (u dobi od 2 do < 18 godina) koji su liječeni tenofovirdizoproksilom (n = 93) ili placebom/aktivnim komparatorom (n = 91) u kombinaciji s drugim antiretrovirusnim lijekovima tijekom 48 tjedana (vidjeti dio 5.1).
English: No dose adjustment is required.
Croatian: Nije nužna prilagodba doziranja.
English: At week 24 the time-weighted average change from baseline in log10 plasma HIV-1 RNA levels (DAVG24) was -0.03 log10 copies/ml and -0.61 log10 copies/ml for the placebo and tenofovir disoproxil 245 mg recipients (p < 0.0001).
Croatian: U 24. tjednu, vremenski ponderirana prosječna promjena od početne vrijednosti izražena kao log10 koncentracije HIV-1 RNK (DAVG24) u plazmi iznosila je -0,03 log10 kopija/ml za primatelje placeba i -0,61 log10 kopija/ml za primatelje tenofovirdizoproksila u dozi od 245 mg (p < 0,0001).
English: If the patient vomits more than 1 hour after taking Tenofovir disoproxil Zentiva they do not need to take another dose.
Croatian: Ako bolesnik povraća nakon više od 1 sata od uzimanja lijeka Tenofovir disoproxil Zentiva, nije potrebno uzeti još jednu dozu.
English: Seventy-four percent (26/35) of patients in the tenofovir disoproxil group had normalised ALT at week 72 compared to 31% (13/42) in the placebo group.
Croatian: U 74% (26/35) bolesnika u skupini liječenoj tenofovirdizoproksilom ALT se normalizirao u 72. tjednu u usporedbi s 31% (13/42) onih u skupini koja je primala placebo.
English: If you throw up less than 1 hour after taking Tenofovir disoproxil Zentiva, take another tablet.
Croatian: Ako ste povraćali u razmaku manjem od 1 sata nakon što se uzeli lijek Tenofovir disoproxil Zentiva, uzmite drugu tabletu.
English: Tenofovir exposure achieved in adolescent patients receiving oral daily doses of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Croatian: Izloženost tenofoviru postignuta u adolescentnih bolesnika koji su primali peroralno dnevnu dozu tenofovirdizoproksila od 245 mg bila je slična izloženosti postignutoj u odraslih koji su primali dozu tenofovirdizoproksila od 245 mg jedanput na dan.
English: Thirty-one of the 32 nucleos(t)ide-experienced patients had prior lamivudine experience.
Croatian: Trideset i jedan od 32 bolesnika koji su prije primali nukleoz(t)idne lijekove primalo je i lamivudin.
English: The proportion of subjects with ALT normalization at week 192 in the tenofovir disoproxil-tenofovir disoproxil group was 75.8% (25/33) among those who were HBeAg positive at baseline and 100.0% (2 of 2 subjects) among those who were HBeAg negative at baseline.
Croatian: U skupini tenofovirdizoproksil-tenofovirdizoproksil udio bolesnika s normaliziranom razinom ALT-a u 192. tjednu bio je 75,8% (25/33) kod onih koji su na početku bili HBeAg pozitivni, te 100,0% (2 od 2 bolesnika) kod onih koji su na početku bili HBeAg negativni.
English: After 240 weeks of treatment with emtricitabine plus tenofovir disoproxil, 115 of 139 subjects (83%) had HBV DNA < 400 copies/ml, and 59 of 83 subjects (71%) had ALT normalisation.
Croatian: Nakon 240 tjedana liječenja emtricitabinom i tenofovirdizoproksilom, 115 od 139 (83%) ispitanika imalo je HBV DNK < 400 kopija/ml, a 59 od 83 (71%) ispitanika imalo je normalizaciju ALT-a.
English: A close monitoring of renal function is required in these patients (see section 4.5).
Croatian: Potrebno je pažljivo pratiti funkciju bubrega u tih bolesnika (vidjeti dio 4.5).
English: Chronic hepatitis B
Croatian: Kronični hepatitis B
English: Tenofovir exposure in HBV infected paediatric patients 2 to <12 years of age receiving an oral daily dose of tenofovir disoproxil 6.5 mg/kg of body weight (tablet or granules) up to a maximum dose of 245 mg was similar to exposures achieved in HIV-1 infected paediatric patients 2 to <12 years of age receiving a once daily dose of tenofovir disoproxil 6.5 mg/kg up to a maximum dose of tenofovir disoproxil 245 mg.
Croatian: Izloženost tenofoviru u pedijatrijskih bolesnika inficiranih HBV-om u dobi od 2 do < 12 godina koji su primali oralne dnevne doze tenofovirdizoproksila od 6,5 mg/kg tjelesne mase (u tabletama ili granulama) do najveće doze od 245 mg bila je slična izloženostima postignutima u pedijatrijskih bolesnika inficiranih virusom HIV-1 u dobi od 2 do < 12 godina koji su primali jednu dnevnu dozu tenofovirdizoproksila od 6,5 mg/kg do najveće doze od 245 mg tenofovirdizoproksila.
English: Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with tenofovir disoproxil.
Croatian: Kod starijih je bolesnika veća vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga potrebno primijeniti oprez kad se stariji bolesnici liječe tenofovirdizoproksilom.
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 5.2).
English: HIV-1: In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Croatian: HIV-1: U ispitivanju GS-US-104-0321, 87 prethodno liječenih bolesnika zaraženih virusom HIV-1, u dobi od 12 do 18 godina starosti, primali su tenofovirdizoproksil (n = 45) ili placebo (n = 42) u kombinaciji s optimiziranim pozadinskim režimom (OBR) tijekom 48 tjedana.
English: HIV-1 clinical studies: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Croatian: Klinička ispitivanja HIV-1: Procjena nuspojava u kliničkim ispitivanjima HIV-1 temelji se na iskustvu iz dva ispitivanja na 653 prethodno liječena bolesnika koji su 24 tjedna dobivali tenofovirdizoproksil (n = 443) ili placebo (n = 210) u kombinaciji s drugim antiretrovirusnim lijekovima te također iz dvostruko slijepog komparativnog kontroliranog ispitivanja u kojem je 600 prethodno neliječenih bolesnika tijekom 144 tjedna dobivalo tenofovirdizoproksil u dozi od 245 mg (n = 299) ili stavudin (n = 301) u kombinaciji s lamivudinom i efavirenzom.
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates by week 48.
Croatian: U tim izolatima nisu utvrđene aminokiselinske supstitucije povezane s rezistencijom na tenofovirdizoproksil do 48. tjedna.
English: The adverse reactions observed in paediatric 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 pedijatrijskih bolesnika koji su primali liječenje tenofovirdizoproksilom bile su sukladne onima opaženima u kliničkim ispitivanjima tenofovirdizoproksila u odraslih (vidjeti dio 4.8 Tablični prikaz nuspojava i 5.1).
English: Tenofovir disoproxil phosphate is the phosphate salt of the prodrug tenofovir disoproxil.
Croatian: Tenofovirdizoproksilfosfat je fosfatna sol predlijeka tenofovirdizoproksila.
English: Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to < 18 years with chronic HBV infection [HBV DNA ≥ 105 copies/ml, elevated serum ALT (≥ 2 x ULN)
Croatian: Kronični hepatitis: U ispitivanju GS-US-174-0115, 106 HBeAg-negativnih i HBeAg-pozitivnih bolesnika u dobi od 12 do < 18 godina s kroničnom HBV-infekcijom [HBV DNK ≥ 105 kopija/ml,
English: Adefovir dipivoxil 10 mg n = 90
Croatian: Adefovirdipivoksil 10 mg n = 90
English: Co-administration of Tenofovir disoproxil Zentiva and didanosine is not recommended as this may result in an increased risk of adverse reactions (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka Tenofovir disoproxil Zentiva i didanozina, jer to može rezultirati povećanim rizikom od nuspojava (vidjeti dio 4.5).
English: Bottle label and outer carton
Croatian: Naljepnica boce i kutija
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ml and 2,050 (50.8%) ng·h/ml, respectively, in normal subjects compared with 289 (46.0%) ng/ml and 2,310 (43.5%) ng·h/ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ml and 2,740 (44.0%) ng·h/ml in subjects with severe hepatic impairment.
Croatian: U normalnih ispitanika srednje vrijednosti (% CV) Cmax i AUC0-∞ tenofovira bile su 223 (34,8%) ng/ml odnosno 2050 (50,8%) ng•h/ml u ispitanika, u usporedbi s 289 (46,0%) ng/ml i 2310 (43,5%) ng•h/ml u ispitanika s umjerenim oštećenjem funkcije jetre te 305 (24,8%) ng/ml i2740 (44,0%) ng•h/ml u ispitanika s teškim oštećenjem funkcije jetre.
English: If bone abnormalities are suspected or detected then appropriate consultation should be obtained.
Croatian: U slučaju sumnje ili otkrića abnormalnosti na kostima, potrebne su odgovarajuće se konzultirati.
English: All patients with normal ALT at baseline and 88% of patients with abnormal ALT at baseline achieved HBV DNA suppression < 400 copies/ml.
Croatian: U svih bolesnika s normalnom početnom razinom ALT-a i 88% bolesnika s abnormalnom početnom razinom ALT-a postigla se supresija HBV DNK na razinu od manju od 400 kopija/ml.
English: Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil.
Croatian: S obzirom na to da takrolimus može utjecati na funkciju bubrega, preporučuje se pomno praćenje bolesnika u slučaju istovremenog liječenja tenofovirdizoproksilom.