natgillin/translations-raw huggingface dataset:
Of the 61 patients who were evaluable for efficacy (received entecavir for at least 1 month), 60 also received hepatitis B immune globulin (HBIg) as part of the post-transplant prophylaxis regimen.
Od 61 bolesnika u kojih se mogla napraviti procjena djelotvornosti (primali su entekavir najmanje 1 mjesec), 60 ih je također primilo imunoglobulin protiv hepatitisa B (HBIg) u sklopu profilaktičkog režima nakon transplantacije.
What Entecavir Accord looks like and contents of the pack
Kako Entekavir Accord izgleda i sadržaj pakiranja
whether you have kidney problems.
tome imate li tegobe s bubrezima.
At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
U 24. tjednu, smanjenje virusnog opterećenja HBV-om bilo je značajno veće kod bolesnika liječenih entekavirom (-3,65 naspram povećanju od 0,11 log10 kopija/ml).
Cases of lactic acidosis have been reported, often in association with hepatic decompensation, other serious medical conditions or drug exposures (see section 4.4).
Prijavljeni su slučajevi laktacidoze, često povezani s dekompenzacijom jetre, drugim ozbiljnim zdravstvenim stanjima ili izlaganjem nekom lijeku (vidjeti dio 4.4).
Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Knodellovom indeksu fibroze (ciroza) mogli su se usporediti s ukupnim odgovorima u svim mjerama ishoda djelotvornosti (svi su bolesnici imali kompenziranu bolest jetre).
Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors
Farmakoterapijska skupina: antivirusni lijekovi za sustavnu primjenu, nukleozidni i nukleotidni inhibitori reverzne transkriptaze
After opening the bottle use within 90 days.
Bočicu upotrijebiti u roku od 90 dana nakon otvaranja.
Entecavir Accord are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Entekavir Accord se isporučuje u kutijama koje sadrže 30 x 1 ili 90 x 1 filmom obloženu tabletu (u blisterima s jediničnim dozama) i u bocama koje sadrže 30 filmom obloženih tableta.
Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
Početna demografska i obilježja HBV bolesti bila su usporediva između 2 liječene skupine i u različitim dobnim kohortama.
Blister pack:
Blister pakiranje:
In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.
U antivirusnim testovima HIV-a, entekavir u mikromolarnim koncentracijama nije imao antagonističku aktivnost na anti-HIV aktivnost u kulturi stanica ovih šest NRTI ili emtricitabina.
All dosing will be taken once daily orally (by mouth).
Doza se uvijek uzima jednom dnevno kroz usta.
Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola, PLA 3000
KW20A Kordin Industrial Park Paola, PLA 3000
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST VANJSKE KUTIJE (ZA BOCU I BLISTERE)
This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥ 100 times those in humans.
Ovaj se nalaz nije opazio u ispitivanjima toksičnosti ponovljenih doza u drugih vrsta, uključujući majmune kojima se entekavir primjenjivao svakodnevno tijekom 1 godine uz izloženosti koje su bile ≥ 100 puta veće od onih u ljudi.
At Week 72 post-transplant, none of 55 observed cases had virologic recurrence of HBV [defined as HBV DNA ≥50 IU/ml (approximately 300 copies/ml)], and there was no reported virologic recurrence at time of censoring for the remaining 6 patients.
U 72. tjednu nakon transplantacije, niti jedan od 55 promatranih slučajeva nije prijavio virološki povrat HBV-a [definiran kao HBV DNK ≥50 IU/ml (približno 300 kopija/ml)] i nije bilo prijavljenog virološkog povrata u vrijeme cenzuriranja podataka za preostalih 6 bolesnika.
Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Stoga je potrebno poduzeti odgovarajuće postupke kako bi se spriječio neonatalni prijenos HBV-a.
By 48 weeks of post-treatment follow-up, a substantial number of HBeAg negative patients lost response.
Odgovor je do kraja 48. tjedna praćenja nakon liječenja izgubio znatan broj HBeAg negativnih bolesnika.
In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
U bolesnika sa suboptimalnim virološkim odgovorom nakon 24 tjedna liječenja entekavirom potrebno je razmotriti modifikaciju liječenja (vidjeti dijelove 4.5 i 5.1).
Take Entecavir Accord as long as your doctor has told you.
Uzimajte Entekavir Accord onoliko dugo koliko Vam je rekao liječnik.
decompensated liver disease (see section 4.4)
dekompenziranom bolešću jetre (vidjeti dio 4.4)
The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
U ispitnoj populaciji bilo je 82% muškaraca, 39% bijelaca i 37% azijata, prosječne dobi od 49 godina; 89% bolesnika imalo je HBeAg-negativnu bolest u vrijeme transplantacije.
Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Promjene na testisima (degeneracija sjemenih kanalića) bile su očite u ispitivanjima toksičnosti ponovljenih doza u glodavaca i pasa pri izloženostima koja su bile ≥ 26 puta veće od onih u ljudi.
How to store Entecavir Accord
Kako čuvati Entekavir Accord
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
upitajte liječnika radi li Vam jetra ispravno i, ukoliko to nije slučaj, kako bi to moglo utjecati na Vaše liječenje lijekom Entekavir Accord.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su navedene padajućim slijedom prema ozbiljnosti.
Resistance is mediated by reduced inhibitor binding to the altered HBV reverse transcriptase, and resistant HBV exhibits reduced replication capacity in cell culture.
Rezistencija je posredovana smanjenim vezanjem inhibitora za promijenjenu HBV reverznu transkriptazu, a rezistentni HBV pokazuje smanjeni kapacitet umnažanja u staničnoj kulturi.
Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
Bolesnike treba pomno pratiti zbog nuspojava kad se entekavir istodobno primjenjuje s takvim lijekovima.
Also, patients with decompensated liver disease may be at higher risk for lactic acidosis and for specific renal adverse events such as hepatorenal syndrome.
Također, bolesnici s dekompenziranom bolešću jetre mogu imati viši rizik od laktacidoze i specifičnih bubrežnih štetnih događaja, kao što je hepatorenalni sindrom.
The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.
Učestalost i priroda štetnih događaja u ovom ispitivanju bile su sukladne onima koje su se očekivale u bolesnika s transplantatom jetre i poznatom sigurnosnom profilu entekavira.
What Entecavir Accord is and what it is used for What you need to know before you take Entecavir Accord How to take Entecavir Accord Possible side effects
Što je Entekavir Accord i za što se koristi Što morate znati prije nego počnete uzimati Entekavir Accord Kako uzimati Entekavir Accord
Results for selected study endpoints at weeks 24 and 48 are shown in the table.
Rezultati za odabrane mjere ishoda ispitivanja u 24. i 48. tjednu prikazane su u sljedećoj tablici.
Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥ 50 IU/ml at Week 48 or
Genotipske procjene provedene su za sve bolesnike s dostupnim uzorcima koji su doživjeli virološki proboj do 96. tjedna ili koji su imali HBV DNK ≥ 50 IU/ml u 48. tjednu ili 96. tjednu.
The lower Cmax and AUC when taken with food is not considered to be of clinical relevance in nucleoside-naive patients but could affect efficacy in lamivudine-refractory patients (see section 4.2).
Cmax i AUC kad se entekavir uzima s hranim ne smatraju se klinički značajnim u bolesnika prethodno neliječenih analozima nukleozida, ali mogle bi utjecati na djelotvornost u bolesnika refrakternih na lamivudin (vidjeti dio 4.2).
Subjects were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Ispitanici su randomizirani (2:1) da primaju slijepo liječenje entekavirom u dozi od 0,015 mg/kg do najviše 0,5 mg/dan (N = 120) ili placebo (N = 60).
Week 96 .
96. tjedan
Elderly: the effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Starije osobe: Učinak dobi na farmakokinetiku entekavira procijenio se usporedbom starijih ispitanika u dobi od 65 do 83 godine (prosječna dob žena: 69 godina, muškaraca: 74 godine) s mlađim ispitanicima u dobi od 20 do 40 godina (prosječna dob žena: 29 godina, muškaraca: 25 godina).
There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Postoje samo ograničeni podaci o bolesnicima istodobno inficiranima HIV-om koji imaju nizak broj CD4 stanica (< 200 stanica/mm3).
uncommon (at least 1 in 1,000 patients): rash, hair loss.
manje često (u najmanje 1 na 1000 bolesnika): osip, ispadanje kose.
All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥ 1 point decrease (median decrease from baseline was 1.5 points).
Svi (10/10) bolesnici s uznapredovalom fibrozom ili cirozom na početku ispitivanja (stupanj fibroze 4, 5 ili 6 prema Ishakovom indeksu) imali su smanjenje za ≥ 1 boda (medijan smanjenja u odnosu na početnu vrijednost bio je 1,5 boda).
High-density polyethylene (HDPE) bottle contians a silica gel cainster with child resistant polypropylene closure containing 30 film-coated tablets.
Boca od polietilena visoke gustoće (HDPE) sadrži spremnik silika-gela s polipropilenskim zatvaračem sigurnim za djecu koja sadrži 30 filmom obloženih tableta.
Co-infection with hepatitis C or D: there are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Istodobna infekcija hepatitisom C ili D: Nema podataka o djelotvornosti entekavira u bolesnika koji su istodobno inficirani virusom hepatitisa C ili D.
Other medicines and Entecavir Accord
Drugi lijekovi i Entekavir Accord
Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF United Kingdom
Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF Ujedinjeno Kraljevstvo
Administration of 0.5 mg entecavir with a standard high-fat meal (945 kcal, 54.6 g fat) or a light meal (379 kcal, 8.2 g fat) resulted in a minimal delay in absorption (1-1.5 hour fed vs. 0.75 hour fasted), a decrease in Cmax of 44-46%, and a decrease in AUC of 18-20%.
Primjena 0,5 mg entekavira sa standardnim punomasnim obrokom (945 kcal, 54,6 g masti) ili laganim obrokom (379 kcal, 8,2 g masti) rezultirala je minimalnom odgodom apsorpcije (1-1,5 sati nakon obroka naspram 0,75 sati natašte), smanjenjem Cmax za 44-46% i smanjenjem AUC-a za 18-20%.
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo
b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
b Uključuje bolesnike s najmanje jednim mjerenjem HBV DNK pomoću PCR-a tijekom terapije u 24. tjednu ili kasnije do 58. tjedna (1. godina), nakon 58. tjedna do 102. tjedna (2. godina), nakon 102. tjedna do 156. tjedna (3. godina), nakon 156. tjedna do 204. tjedna (4. godina) ili nakon 204. tjedna do 252. tjedna (5. godina).
For patients who are not able to swallow tablets or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
Bolesnicima koji ne mogu progutati tablete ili kojima se preporučuje smanjenje doze mogu biti dostupne drugi lijekovi koji sadrže entekavir u prikladnijim formulacijama.
If treatment is discontinued without regard to treatment response, the rate of post-treatment ALT flares could be higher.
Ako se liječenje prekine bez obzira na odgovor na liječenje, stopa povišenja ALT-a nakon liječenja može biti viša.
** on haemodialysis days, administer entecavir after haemodialysis.
** Na dane hemodijalize, entekavir primijeniti nakon hemodijalize.
Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Vrijednosti ALT-a u serumu moraju biti konstantno povišene najmanje 6 mjeseci prije liječenja pedijatrijskih bolesnika s kompenziranom bolešću jetre zbog HBeAg pozitivnog kroničnog hepatitisa B; a najmanje 12 mjeseci u bolesnika s HBeAg negativnom bolešću.
Paediatric patients with a body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet with or without food.
Pedijatrijskim bolesnicima tjelesne težine od najmanje 32,6 kg treba primijeniti dnevnu dozu od jedne tablete od 0,5 mg, s hranom ili bez nje.
Age/gender:
Dob/spol:
In clinical studies in patients with compensated liver disease, the most common adverse reactions of any severity with at least a possible relation to entecavir were headache (9%), fatigue (6%), dizziness (4%) and nausea (3%).
U kliničkim ispitivanjima u bolesnika s kompenziranom bolešću jetre, najčešće nuspojave bilo koje težine kod kojih je postojala barem mogućnost da su povezane s entekavirom bile su glavobolja (9%), umor (6%), omaglica (4%) i mučnina (3%).
For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Za odrasle je preporučena doza 0,5 mg ili 1 mg jednom dnevno kroz usta.
Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Rezistencija i posebne mjere opreza kod bolesnika refrakternih na lamivudin: Mutacije HBV polimeraze koje kodiraju supstitucije zaslužne za rezistenciju na lamivudin mogu dovesti do posljedičnog nastanka sekundarnih supstitucija, uključujući onih povezanih s rezistencijom na entekavir (ETVr).
Antiviral activity: entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Antivirusna aktivnost: Entekavir je inhibirao sintezu HBV DNK (50%-tno smanjenje, EC50) pri koncentraciji od 0,004 µM u ljudskim HepG2 stanicama transficiranima divljim tipom HBV-a.
Hepatic impairment: pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function.
Oštećenje jetre: Farmakokinetički parametri u bolesnika s umjerenim ili teškim oštećenjem jetre bili su slični onima u bolesnika s normalnom funkcijom jetre.
Also contains soy polysaccharides.
Također sadrži polisaharide soje.
- emerging genotypic ETVr c
- pojave genotipske ETVr c
Entecavir Accord must not be used during pregnancy unless specifically directed by your doctor.
Entekavir Accord ne smijete uzimati tijekom trudnoće osim ako to nije izričita uputa liječnika.
No pharmacokinetic interactions between entecavir and lamivudine, adefovir or tenofovir were observed.
Nisu opažene farmakokinetičke interakcije između entekavira i lamivudina, adefovira ili tenofovira.
No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammaliancell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Nije bilo dokaza genotoksičnosti u Amesovom testu mikrobne mutagenosti, testu genske mutacije na stanicama sisavaca te transformacijskom testu na stanicama embrija sirijskog hrčka.
By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Nadmetanjem s prirodnim supstratom deoksigvanozinom TP, entekavir-TP funkcionalno inhibira 3 aktivnosti virusne polimeraze: (1) pripremanje HBV polimeraze, (2) reverznu transkripciju negativnog lanca DNK iz pregenomske glasničke RNK i (3) sintezu pozitivnog lanca
No testicular changes were evident in a 1-year study in monkeys.
Testikularne promjene nisu se pronašle u ispitivanju na majmunima u trajanju od 1 godine.
An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to > 10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
Analiza inhibicijske aktivnosti entekavira protiv panela laboratorijskih i kliničkih izolata HIV-1 u raznim vrstama stanica i raznim uvjetima testiranja pokazala je da se vrijednosti EC50 kreću od 0,026 do > 10 µM; niže vrijednosti EC50 bile su opažene kad su se u testu koristile manje razine virusa.
In cell culture, entecavir selected for an M184I substitution at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations.
U kulturi stanica, postojala je selekcija M184I supstitucije pri mikromolarnim koncentracijama entekavira, što se potvrdilo inhibicijskim pritiskom pri visokim koncentracijama entekavira.
In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans.
U gravidnih ženki štakora i kunića kojima se primjenjivao entekavir, razine bez embriotoksičnih i za majku toksičnih učinaka odgovarale su izloženostima koje su bile ≥ 21 puta veće od onih u ljudi.
Entecavir Accord 1 mg
Entekavir Accord 1 mg
Clinical experience: the demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Kliničko iskustvo: Korist od liječenja pokazala se na temelju histoloških, viroloških, biokemijskih i seroloških odgovora nakon 48 tjedana liječenja u aktivno kontroliranim kliničkim ispitivanjima 1633 odrasla bolesnika s infekcijom kroničnim hepatitisom B, dokazom umnažanja virusa i kompenziranom bolešću jetre.
The ETVr substitutions at residues rtT184, rtS202 and rtM250 alone have only a modest effect on entecavir susceptibility, and have not been observed in the absence of LVDr substitutions in more than 1000 patient samples sequenced.
ETVr supstitucije na ostacima rtT184, rtS202 i rtM250 same imaju samo skroman učinak na osjetljivost na entekavir i nisu bile opažene u odsutnosti LVDr supstitucija u sekvencioniranim uzorcima iz više od 1000 bolesnika.
Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Funkciju jetre treba pratiti u redovitim razmacima, uz praćenje kliničke slike i laboratorijskih nalaza, tijekom najmanje 6 mjeseci nakon prekida terapije hepatitisa B.
Gender/age: there was no apparent difference in the safety profile of entecavir with respect to gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Spol/dob: Nije bilo vidljive razlike u profilu sigurnosti entekavira s obzirom na spol (≈ 25% žena u kliničkim ispitivanjima) ili dob (≈ 5% bolesnika u dobi od > 65 godina).
Liver transplant recipients: the safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.
Primatelji transplantata jetre: Sigurnost i djelotvornost entekavira u dozi od 1 mg jednom dnevno bile su procijenjene u ispitivanju na jednoj skupini od 65 bolesnika koji su primili transplantat jetre zbog komplikacija kronične infekcije HBV-om i imali HBV DNK <172 IU/ml (približno 1000 kopija/ml) u vrijeme transplantacije.
- emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
- pojave genotipske ETVrc - genotipske ETVrc s virološkim probojemd
In studies in patients with compensated liver disease, histological improvement was defined as a ≥ 2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
U ispitivanjima u bolesnika s kompenziranom bolešću jetre, histološko poboljšanje definiralo se kao smanjenje za ≥ 2 boda na Knodellovom indeksu nekroze i upale u odnosu na početnu vrijednost, bez pogoršanja Knodellovog indeksa fibroze.
There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Nije bilo vidljive razlike u djelotvornosti entekavira na temelju spola (≈ 25% žena u kliničkim ispitivanjima) ili dobi (≈ 5% bolesnika u dobi od > 65 godina).
Since entecavir is predominantly eliminated by the kidney (see section 5.2), coadministration with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of either medicinal product.
Kako se entekavir najvećim dijelom eliminira bubrezima (vidjeti dio 5.2), istodobna primjena lijekova koji smanjuju funkciju bubrega ili se natječu za aktivnu tubularnu sekreciju može povećati koncentraciju jednog ili drugog lijeka u serumu.
Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Rezultati u 48. tjednu randomiziranih, dvostruko slijepih ispitivanja u kojima se uspoređivao entekavir (ETV) s lamivudinom (LVD) u HBeAg pozitivnih (022) i HBeAg negativnih (027) bolesnika prikazani su u sljedećoj tablici.
Patients with advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Bolesnici s uznapredovalom bolešću jetre ili cirozom mogu imati povećani rizik od dekompenzacije jetre nakon egzacerbacije hepatitisa pa se stoga moraju pomno pratiti tijekom terapije.
What you need to know before you take Entecavir Accord Do not take Entecavir Accord if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Entekavir Accord ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).