natgillin/translations-raw huggingface dataset:
In rats, maternal toxicity, embryofoetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
U štakora su bili opaženi toksičnost za majku, embriofetalna toksičnost (resorpcije), smanjena tjelesna težina fetusa, malformacije repa i kralježnice, smanjena osifikacija (kralježaka, sternebre i falangi) te ekstralumbalni kralješci i rebra kodvisokih izloženosti.
Breast-feeding: it is unknown whether entecavir is excreted in human milk.
Dojenje: Nije poznato izlučuje li se entekavir u majčino mlijeko.
Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Do 240. tjedna ispitivanja u bolesnika prethodno neliječenih analozima nukleozida, genotipski dokazane ETVr supstitucije na rtT184, rtS202 ili rtM250 utvrđene su u 3 bolesnika liječena entekavirom, a u njih 2 nastupio je virološki proboj (vidjeti tablicu).
Liver biopsy results: 57 patients from the pivotal nucleoside-naive studies 022 (HBeAg positive) and 027 (HBeAg negative) who enrolled in a long-term rollover study were evaluated for long-term liver histology outcomes.
Rezultati biopsije jetre: 57 bolesnika iz ključnih ispitivanja 022 (HBeAg pozitivni) i 027 (HBeAg negativni), koja su se provela u bolesnika prethodno neliječenih analozima nukleozida, bilo je uključeno u dugotrajno rotacijsko ispitivanje da bi se procijenio dugotrajni ishod na temelju histoloških nalaza jetre.
Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Dobroćudni digestivni simptomi, poput mučnine, povraćanja i boli u trbuhu, mogu ukazivati na razvoj laktacidoze.
ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
ALT-a (≤ 1 puta iznad GGN) nastupila je u 27% bolesnika liječenih entekavirom i 21% bolesnika liječenih lamivudinim na kraju doziranja.
Entecavir Accord 0.5 mg
Entekavir Accord 0,5 mg
Pharmacokinetics in paediatric patients with renal or hepatic impairment have not been studied.
Farmakokinetika u pedijatrijskih bolesnika s oštećenjem funkcije bubrega ili jetre nije ispitivana.
Entecavir exposure among lamivudine-experienced subjects receiving once daily doses of entecavir 0.030 mg/kg up to a maximum dose of 1.0 mg was similar to the exposure achieved in adults receiving once daily doses of 1.0 mg.
Izloženost entekaviru u ispitanika prethodno liječenih lamivudinom koji su primali doze entekavira od 0,030 mg/kg do najviše 1,0 mg jednom dnevno bila je slična izloženosti koja se postiže u odraslih koji primaju doze od 1,0 mg jednom dnevno.
HIV/HBV co-infected patients receiving concomitant antiretroviral therapy: entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Bolesnici istodobno inficirani HIV-om i HBV-om koji istodobno primaju antiretrovirusnu terapiju: entekavir se ispitao u 68 odraslih osoba s istodobnom infekcijom HIV-om i HBV-om koji su primali HAART koji sadrži lamivudin (vidjeti dio 5.1).
For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR at end of dosing.
Za 26 bolesnika liječenih entekavirom i 28 bolesnika liječenih lamivudinom koji su nastavili liječenje nakon 52. tjedna (medijan 96 tjedana), 96% bolesnika liječenih entekavirom i 64% bolesnika liječenih lamivudinom imalo je HBV DNK < 300 kopija/ml mjereno PCR-om na kraju doziranja.
Paediatric population: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatment-naïve children and adolescents from 2 to < 18 years of age with HBeAgpositive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Pedijatrijska populacija: U ispitivanju 189, koje je još u tijeku, ispituje se djelotvornost i sigurnost entekavira u 180 djece i adolescenata u dobi od 2 do < 18 godina s HBeAg pozitivnom kroničnom infekcijom hepatitisom B, kompenziranom bolešću jetre i povišenim razinama ALT-a, koji prethodno nisu bili liječeni analozima nukleozida.
Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Rezistencija u staničnim kulturama: U odnosu na divlji tip HBV-a, LVDr virusi čija reverzna transkriptaza sadrži supstitucije rtM204V i rtL180M imaju 8 puta smanjenu osjetljivost na entekavir.
Renal impairment: entecavir clearance decreases with decreasing creatinine clearance.
Oštećenje bubrega: klirens entekavira smanjuje se sa smanjenjem klirensa kreatinina.
In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM).
Uz to, visoke izloženosti entekaviru nisu imale štetne učinke na γ polimerazu ili sintezu mitohondrijske DNK u
Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Jezgra tablete: kalcijev karbonat, preželatinizirani škrob, karmelozanatrij, polisaharidi soje, hidrat limunske kiseline, natrijev stearilfumarat.
Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM.
Entekavir-TP slabi je inhibitor staničnih DNK polimeraza α, β i δ s vrijednostima
HBV DNA < 50 IU/mLa HBeAg seroconversion a
HBV DNK < 50 IU/mla HBeAg serokonverzija a
In repeat-dose toxicology studies in dogs, reversible perivascular inflammation was observed in the central nervous system, for which no-effect doses corresponded to exposures 19 and 10 times those in humans (at 0.5 and 1 mg respectively).
U ispitivanjima toksičnosti ponovljenih doza u pasa primijećena je reverzibilna perivaskularna upala u središnjem živčanom sustavu, gdje su doze bez učinka odgovarale izloženostima koje su bile 19 (za dozu od 0,5 mg) odnosno 10 (za dozu od 1 mg) puta veće od onih u ljudi.
Based on urinary excretion of unchanged drug, the bioavailability has been estimated to be at least 70%.
procijenilo se da je bioraspoloživost najmanje 70%.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
The entecavir dosage was 0.5 mg daily in the pivotal studies (mean exposure 85 weeks) and 1 mg daily in the rollover study (mean exposure 177 weeks), and 51 patients in the rollover study initially also received lamivudine (median duration 29 weeks).
Doza entekavira u ključnim ispitivanjima bila je 0,5 mg dnevno (srednja vrijednost izloženosti: 85 tjedana), a u rotacijskom ispitivanju 1 mg dnevno (srednja vrijednost izloženosti: 177 tjedana); 51 bolesnik u rotacijskom ispitivanju na početku je primao i lamivudin
Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Entekavir Accord je indiciran i za liječenje kronične HBV infekcije u pedijatrijskih bolesnika u dobi od 2 do < 18 godina s kompenziranom bolešću jetre, koji prethodno nisu bili liječeni analozima nukleozida i koji imaju dokazanu aktivnu replikaciju virusa i konstantno povišene vrijednosti ALT-a u serumu ili histološki dokazanu umjerenu do tešku upalu ili fibrozu.
For patients with baseline Ishak fibrosis score ≥ 2, 25/43 (58%)
Među bolesnicima s početnom vrijednošću fibroze ≥ 2 prema Ishakovom indeksu, 25/43 (58%) je imalo smanjenje ≥ 2 boda.
The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Vrijeme do nastupa HCC ili smrti (kojegod da se dogodilo prije) bilo je usporedivo u ove dvije liječene skupine; kumulativne stope smrtnosti tijekom ispitivanja bile su 23% (23/102) u bolesnika liječenih entekavirom i 33% (29/89) u bolesnika liječenih adefovir dipivoksilom, a kumulativne stope
Calcium carbonate Starch, Pregelatinized Carmellose sodium Soy polysaccharides Citric acid monohydrate Sodium stearyl fumarate
Jezgra tablete: kalcijev karbonat škrob, preželatinizirani karmelozanatrij polisaharidi soje hidrat limunske kiseline natrijev stearilfumarat
In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
U malog postotka bolesnika refrakternih na lamivudin, ETVr supstitucije na ostacima rtT184, rtS202 ili rtM250 bile su prisutne od početka.
Each 1 mg film-coated tablet contains 52 mg soy polysaccharides.
Jedna filmom obložena tableta od 1 mg sadrži 52 mg polisaharida soje.
Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours.
polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
Entecavir Accord dosage*
Doza lijeka Entekavir Accord*
A reduction of the daily dose using entecavir oral solution, as detailed in the table, is recommended.
Preporučuje se smanjiti dnevnu dozu pomoću oralne otopine entekavira, kako je prikazano u tablici.
c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
a Roche COBAS Amplicor PCR test (LLOQ = 300 kopija/ml).
Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Srednja vrijednost HBV DNK u serumu mjereno PCR-om bila je 7,83 log10 kopija/ml, srednja vrijednost ALT-a u serumu bila je 100 U/l; 54% bolesnika bilo je HBeAg pozitivno, a 35% bolesnika imalo je LVDr supstitucije na početku ispitivanja.
For patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Za bolesnike s hepatitisom B refrakternim na liječenje lamivudinom, vidjeti dijelove 4.4 i 5.1.
The cumulative probability of emerging genotypic entecavir resistance after 1, 2, 3, 4 and 5 years treatment in the lamivudine-refractory studies was 6%, 15%, 36%, 47% and 51%, respectively.
Kumulativna vjerojatnost pojave genotipske rezistencije na entekavir u ispitivanjima rezistencije na lamivudin iznosila je 6% nakon 1 godine, 15% nakon 2 godine, 36%
Tablet core:
Ovojnica tablete:
ALT normalizationa HBV DNA < 50 IU/mL
Normalizacija ALT-aa HBV DNK < 50 IU/ml a
Entecavir Accord 1 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
Entekavir Accord 1 mg filmom obložene tablete hipromeloza, titanijev dioksid (E171), makrogol, željezov oksid, crveni (E172)
Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Genotipska rezistencija na entekavir u svih 5 godina ispitivanja kod bolesti refrakterne na lamivudin 1. godina 2. godina 3. godina a 4. godina a 5. godina a
Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Djeca tjelesne težine od najmanje 32,6 kg mogu uzimati tabletu od 0,5 mg ili može biti dostupna oralna otopina entekavira.
Hepatic impairment: no dose adjustment is required in patients with hepatic impairment.
Oštećenje funkcije jetre: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije jetre.
b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥ 300 copies/ml) c NC=M (noncompleters=missing) dDefined as decrease or no change from baseline in CTP score.
b Nd=Neu (nedovršeno=neuspjeh), liječenje prekinuto prije tjedna analize, uključujući razloge za prekid kao što su smrt, nedostatak djelotvornosti, štetni događaj, nepridržavanje terapije/nije praćen, smatralo se terapijskim neuspjehom (npr.,
At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population.
U trenutku uključivanja u ispitivanje, u cijeloj je ispitivanoj populaciji srednja vrijednost HBV DNK bila 8,1 log10 IU/ml, a srednja vrijednost ALT-a 103 U/l.
30 x 1 film-coated tablets 90 x 1 film-coated tablets
30 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta
This medicinal product contains soy polysaccharides.
Ovaj lijek sadrži polisaharide soje.
For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Kod bolesnika kojima je prvobitno dodijeljeno liječenje entekavirom, smanjenje HBV DNK u 48. tjednu bilo je -4,20 log10 kopija/ml, normalizacija ALT-a nastupila je u 37% bolesnika s abnormalnom vrijednošću ALT-a na početku ispitivanja i niti jedan bolesnik nije postigao HBeAg serokonverziju.
Experience in nucleoside-naive patients with compensated liver disease:
Iskustvo u bolesnika prethodno neliječenih analozima nukleozida s kompenziranom bolešću jetre:
Soy polysaccharides: This medicinal product contains soy polysaccharides.
Polisaharidi soje: Ovaj lijek sadrži polisaharide soje.
For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Za bolesnike tjelesne težine od 10 do 32,5 kg preporučuje se oralna otopina entekavira.
10.7% e 27% e 41.3% e
10,7% e
Bottle pack: 30 film-coated tablets
Pakiranje u boci: 30 filmom obloženih tableta
LVD 100 mg once daily n
LVD 100 mg jednom dnevno n
Among entecavir-treated nucleoside-naive patients, ALT elevations had a median time to onset of 2324 weeks, and 86% (24/28) of ALT elevations occurred in HBeAg negative patients.
Među bolesnicima liječenima entekavirom prethodno neliječenima analozima nukleozida, povišenja ALT-a nastupila su nakon medijana od 23-24 tjedna, a u 86% (24/28) slučajeva povišenje ALT-a nastupilo je u HBeAg negativnih bolesnika.
Therefore, therapy with entecavir should not be used for HIV/HBV co-infected patients who are not receiving HAART.
Stoga se terapija entekavirom ne smije primjenjivati u bolesnika istodobno inficiranih HIV-om i HBV-om koji ne primaju HAART.
The paediatric resistance assessment is based on data from nucleoside-treatment-naive paediatric patients with HBeAg-positive chronic HBV infection in two ongoing clinical trials (028 and 189).
Ocjena rezistencije u pedijatrijskih bolesnika temelji se na podacima prikupljenima u pedijatrijskih bolesnika s HBeAg pozitivnom kroničnom HBV infekcijom prethodno neliječenih analozima nukleozida iz dvaju kliničkih ispitivanja koja su još u tijeku (028 i189).
virus (HBV) through sexual contact or body fluids (including blood contamination).
uzimanje lijeka Entekavir Accord neće spriječiti prijenos infekcije virusom hepatitisa B (HBV) na druge osobe putem spolnog kontakta ili tjelesnih tekućina (uključujući kontaminiranu krv).
If you have any concerns consult your doctor.
Ako ste zbog toga zabrinuti, potražite savjet liječnika.
For patients with LVDr substitutions at baseline, the percentage of patients with HBV DNA <300 copies/ml was 44% for entecavir and 20% for adefovir at week 24 and 50% for entecavir and 17% for adefovir at week 48.
Među bolesnicima s LVDr supstitucijama na početku ispitivanja, postotak bolesnika s HBV DNK <300 kopija/ml bio je 44% bolesnika liječenih entekavirom i 20% liječenih adefovirom u 24. tjednu te 50% liječenih entekavirom i 17% liječenih adefovirom u 48. tjednu.
Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg.
Izloženost entekaviru u ispitanika koji nisu bili liječeni analozima nukleozida, a primali su doze entekavira od 0,015 mg/kg do najviše 0,5 mg jednom dnevno bila je slična izloženosti koja se postiže u odraslih koji primaju doze od 0,5 mg jednom dnevno.
30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
• 30 × 1 filmom obloženu tabletu; 3 blistera s 10 × 1 filmom obloženom tabletom, svaka u Al/Al perforiranim blisterima s jediničnim dozama, ili
Breast-feeding should be discontinued during treatment with Entecavir Accord.
Dojenje treba prekinuti tijekom liječenja lijekom Entekavir
In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Prekid liječenja mora se razmotriti u sljedećim slučajevima: Kod HBeAg pozitivnih odraslih bolesnika, liječenje se mora primjenjivati barem do 12 mjeseci nakon postizanja HBe serokonverzije (nestanak HBeAg i nestanak HBV DNK s prisutnim antiHBe na dva uzastopna mjerenja u uzorcima seruma u razmaku od najmanje 3-6 mjeseci) ili do HBs serokonverzije ili postoji gubitak djelotvornosti (vidjeti dio 4.4).
Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Smanjenje HIV RNK prijavljeno je u bolesnika s istodobnom infekcijom HIV-om i HBV-om koji su primali monoterapiju entekavirom bez HAART-a.
Cmax and Cmin at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
Cmax u stanju dinamičke ravnoteže je 4,2, a Cmin 0,3 ng/ml za dozu od 0,5 mg odnosno 8,2 i 0,5 ng/ml za dozu od 1 mg.
These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
Ova su ispitivanja pružila iskustvo liječenja entekavirom tijekom medijana od 99 tjedana u 195
Experience in lamivudine-refractory patients with compensated liver disease: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
U randomiziranom, dvostruko slijepom ispitivanju u HBeAg pozitivnih bolesnika refrakternih na lamivudin (026), od kojih je 85% bolesnika na početku imalo LVDr mutacije, bolesnici koji su primali lamivudin pri ulasku u ispitivanje prebačeni su na entekavir u dozi od 1 mg jednom dnevno, bez razdoblja ispiranja i razdoblja preklapanja (n = 141), ili su nastavili uzimati lamivudin u dozi od
With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.
Za bolesnike s hepatitisom B refrakternim na liječenje lamivudinom, vidjeti dijelove 4.2, 4.4 i 5.1.
Creatinine clearance (ml/min)
Klirens kreatinina (ml/min)
Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Jedna filmom obložena tableta od 0,5 mg sadrži 26 mg polisaharida soje.
Entecavir Accord 0.5 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Entekavir Accord 0,5 mg filmom obložene tablete hipromeloza, titanijev dioksid (E171), makrogol, polisorbat 80
90 x 1 film-coated tablet
90 x 1 filmom obložena tabelta
Exacerbations of hepatitis during and after discontinuation of entecavir therapy have also been reported (see section 4.4 and c. Description of selected adverse reactions).
Također su prijavljene egzacerbacije hepatitisa tijekom i nakon prekida terapije entekavirom (vidjeti dio 4.4 i c.
In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
U ispitivanjima u bolesnika prethodno neliječenih analozima nukleozida, 6% bolesnika liječenih entekavirom i 10% bolesnika liječenih lamivudinim imalo je povišenja ALT-a (> 10 puta iznad GGN i > 2 puta iznad referentne vrijednosti [minimalno od početne vrijednosti ili posljednjeg mjerenja na kraju doziranja]) tijekom praćenja nakon prestanka liječenja.
Immune system disorders: rare
Poremećaji probavnog sustava: često
You should not take Entecavir Accord to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
ako u isto vrijeme ne uzimate lijekove protiv HIV-a, jer to može smanjiti učinkovitost budućeg liječenja protiv HIV-a.
Decompensated liver disease
Dekompenzirana bolest jetre
(96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Od ovih 57 bolesnika, 55 (96%) je imalo histološko poboljšanje kako je prethodno definirano (vidjeti gore), a 50 (88%) je imalo smanjenje fibroze za ≥ 1 boda prema
Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Tablični prikaz nuspojava, opažena je jedna dodatna nuspojava [sniženje bikarbonata u krvi (2%)] u bolesnika liječenih entekavirom do 48. tjedna.
Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Entekavir Accord se može primijeniti u djece čija je jetra oštećena, ali još uvijek ispravno radi (kompenzirana bolest jetre) Infekcija virusom hepatitisa B može dovesti do oštećenja jetre.
HBV DNA < 50 IU/mL and HBeAg seroconversion a
HBV DNK < 50 IU/ml i HBeAg serokonverzija a
It is not known whether entecavir, the active ingredient in Entecavir Accord, is excreted in human breast milk.
Nije poznato izlučuje li se entekavir, djelatna tvar u lijeku Entekavir Accord, u majčino mlijeko.
For patients who met protocol-defined response criteria, response was sustained throughout the 24week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
bolesnika s odgovorom na entekavir naspram 73% (68/93) bolesnika s odgovorom na lamivudin u ispitivanju 022 te 46% (131/286) bolesnika s odgovorom na entekavir naspram 31% (79/253)
Among entecavir-treated patients on-treatment exacerbations had a median time of onset of 4-5 weeks.
Među bolesnicima koji se liječe entekavirom, egzacerbacije su nastupile s medijanom od 4-5 tjedana.
copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n= 50] versus 60.5% [n= 135], respectively).
Također, bolesnici s bolešću refrakternom na lamivudin u kojih se postigla vrijednost HBV DNK < 104 log10 kopija/ml mjerena PCR-om u 24. tjednu imali su nižu stopu rezistencije od onih koji nisu postigli tu vrijednost (5-godišnja kumulativna vjerojatnost od 17,6% [n= 50] naspram 60,5% [n= 135]).