FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2).
Croatian: Neki bolesnici moraju uzimati Entekavir Accord na prazan želudac (pogledajte pod Entekavir
English: HIV/HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Croatian: Bolesnici istodobno inficirani HIV-om i HBV-om koji nisu istodobno primali HAART: Entekavir se nije ispitivao u bolesnika istodobno inficiranih i HIV-om i HBV-om koji nisu istodobno primali učinkovito liječenje protiv HIV-a.
English: Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines.
Croatian: Omaglica, umor (iscrpljenost) i pospanost (izrazita pospanost) česte su nuspojave koje mogu narušiti
English: In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Croatian: U kliničkim ispitivanjima u bolesnika refrakternih na lamivudin, 4% bolesnika imalo je povišenja ALT-a > 3 puta iznad početne vrijednosti, a < 1% je imalo povišen ALT > 2 puta iznad početne vrijednosti zajedno s ukupnim bilirubinom > 2 puta iznad GGN i > 2 puta iznad početne vrijednosti.
English: Response criteria were HBV virological suppression (HBV DNA < 0.7 MEq/ml by bDNA) and loss of HBeAg (in HBeAg positive patients) or ALT < 1.25 times ULN (in HBeAg negative patients).
Croatian: (HBV DNK < 0,7 MEq/ml prema bDNK) i nestanak HBeAg (u HBeAg pozitivnih bolesnika) ili ALT
English: Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Croatian: Uputa o lijeku: Informacije za korisnika Entekavir Accord 0,5 mg filmom obložene tablete Entekavir Accord 1 mg filmom obložene tablete entekavir
English: Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
Croatian: Pedijatrijska populacija: Farmakokinetika entekavira u stanju dinamičke ravnoteže ocijenjena je (ispitivanje 028) u 24 pedijatrijska ispitanika koji prethodno nisu bili liječeni analozima nukleozida i 19 HBeAg pozitivnih pedijatrijskih ispitanika prethodno liječenih lamivudinom, koji su bili u dobi od
English: *p<0.05
Croatian: *p vrijednost naspram lamivudina < 0,05
English: Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
Croatian: Abnormalnosti laboratorijskih nalaza: U kliničkim ispitivanjima u bolesnika prethodno neliječenih analozima nukleozida, 5% je imalo povišen ALT > 3 puta iznad početne vrijednosti, a < 1% imalo je povišenja ALT-a > 2 dva puta iznad početne vrijednosti zajedno s ukupnim bilirubinom povišenim > 2 puta iznad gornje granice normale (GGN) i > 2 puta iznad početne vrijednosti.
English: 30 x 1 film-coated tablet
Croatian: 30 x 1 filmom obložena tableta
English: ETV 0.5 mg once daily
Croatian: ETV 0,5 mg jednom dnevno
English: In HBeAg positive paediatric patients, treatment should be administered for at least 12 months after achieving undetectable HBV DNA and HBeAg seroconversion (HBeAg loss and anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy.
Croatian: mjeseci nakon postizanja nemjerljivih razina HBV DNK i HBeAg serokonverzije (nestanak HBeAg i detekcija anti-HBe protutijela u dva uzastopna uzorka seruma u razmaku od najmanje 3 do 6 mjeseci) ili do HBs serokonverzije ili do gubitka djelotvornosti.
English: When starting therapy in patients with a documented history of lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
Croatian: Prilikom započinjanja terapije u bolesnika s dokumentiranom HBV-rezistencijom na lamivudin, treba razmotriti i dati prednost kombiniranoj uporabi entekavira s drugim antivirusnim lijekom (koji ne dijeli križnu rezistenciju bilo s lamivudinom bilo s entekavirom) naspram monoterapije entekavirom.
English: An oral solution may be available for patients with body weight less than 32.6 kg.
Croatian: Za bolesnike tjelesne težine manje od 32,6 kg može biti dostupna oralna otopina.
English: So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.
Croatian: Postoji cjepivo koje može zaštititi osobe u kojih postoji rizik od zaraze HBV-om.
English: : anaphylactoid reaction
Croatian: : anafilaktoidna reakcija
English: HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Croatian: HBeAg negativni (ispitivanje 027): liječenje entekavirom u trajanju do 96 tjedana (n = 325) rezultiralo je kumulativnim stopama odgovora od 94% za HBV DNK < 300 kopija/ml mjereno PCR-om i 89% za normalizaciju ALT-a, naspram kumulativne stope odgovora na liječenje lamivudinom (n = 313) od
English: Severe Managed with Haemodialysis
Croatian: liječeni hemodijali zom
English: Therefore, in patients with both decompensated liver disease and lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
Croatian: Stoga u bolesnika s dekompenziranom bolešću jetre i HBV-om rezistentnim na lamivudin treba razmotriti primjenu entekavira u kombinaciji s drugim antivirusnim lijekom (kod kojeg ne postoji križna rezistencija na lamivudin ili entekavir) kao bolji izbor od monoterapije entekavirom.
English: 0.05 mg once daily* OR 0.5 mg every 5-7 days
Croatian: 0,05 mg jednom dnevno* ILI 0,5 mg svakih 5-7 dana
English: If you were switched over to Entecavir Accord because the treatment with lamivudine was not successful, you should take Entecavir Accord on an empty stomach once daily.
Croatian: Ako su Vas prebacili na Entekavir Accord zato što liječenje lamivudinom nije bilo uspješno,
English: In these studies, the safety profiles, including laboratory abnormalities, were comparable for entecavir 0.5 mg daily (679 nucleoside-naive HBeAg positive or negative patients treated for a median of 53 weeks), entecavir 1 mg daily (183 lamivudine-refractory patients treated for a median of 69 weeks), and lamivudine.
Croatian: U tim su ispitivanjima entekavir u dozi od 0,5 mg dnevno (679 HBeAg pozitivnih ili negativnih bolesnika prethodno neliječenih analozima nukleozida primalo je entekavir u medijanu od 53 tjedna), entekavir u dozi od 1 mg dnevno (183 bolesnika refrakternih na lamivudin primalo je entekavir u medijanu od 69 tjedana) i lamivudin imali usporedive profile sigurnosti primjene, uključujući i abnormalnosti laboratorijskih nalaza.
English: Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Croatian: Jedna tableta sadrži entekavir hidrat ekvivalentan 1 mg entekavira.
English: Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Croatian: Jedna tableta sadrži entekavir hidrat ekvivalentan 0,5 mg entekavira.
English: Entecavir Accord 0.5 mg film-coated tablets: White to off white, triangle shaped, biconvex filmcoated tablets debossed with ‘J' on one side and ‘110' on other side.
Croatian: Entekavir Accord 0,5 mg filmom obložene tablete: bijele do bjelkaste bikonveksne filmom obložene tablete trokutastog oblika s utisnutom oznakom „J“ na jednoj strani i „110“ na drugoj strani.
English: HBsAg lossb Normalization of:
Croatian: bodova u odnosu na početne vrijednostic,e Nestanak HBsAgb Normalizacija:f
English: There is a doseproportionate increase in Cmax and AUC values following multiple doses ranging from 0.1-1 mg. Steady-state is achieved between 6-10 days after once daily dosing with ≈ 2 times accumulation.
Croatian: Postoji dozi proporcionalno povećanje vrijednosti Cmax i AUC-a nakon primjene višekratnih doza u rasponu od 0,1-1 mg.
English: At baseline, patients had a mean CTP score of 8.59 and 26% of patients were CTP class C. The mean baseline Model for End Stage Liver Disease (MELD) score was 16.23.
Croatian: Na početku ispitivanja bolesnici su imali srednju vrijednost CTP indeksa od 8,59 bodova i 26% bolesnika imalo je CTP klasu C.
English: What Entecavir Accord is and what it is used for Entecavir Accord tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B
Croatian: Entekavir Accord tablete su antivirusni lijek, koji se primjenjuje za liječenje kronične
English: Albumin levels < 2.5 g/dl occurred in < 1% of patients, amylase levels > 3 times baseline in 2%, lipase levels > 3 times baseline in 11% and platelets < 50,000/mm3 in < 1%.
Croatian: Razine albumina < 2,5 g/dl bile su prisutne u < 1% bolesnika, razine amilaze > 3 puta iznad početne vrijednosti bile su prisutna u 2%, razine lipaze > 3 puta iznad početne vrijednosti pronašle su se u 11%, a trombociti
English: In juvenile rats administered entecavir from postnatal days 4 to 80, a moderately reduced acoustic startle response was noted during the recovery period (postnatal days 110 to 114) but not during the dosing period at AUC values ≥ 92 times those in humans at the 0.5 mg dose or paediatric equivalent dose.
Croatian: U mladih štakora kojima je entekavir primijenjen od 4. do 80. postnatalnog dana opažen je umjereno smanjen trzajni odgovor na akustični podražaj tijekom razdoblja oporavka (od 110. do 114. postnatalnog dana),
English: Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Croatian: Entekavir Accord 0,5 mg filmom obložene tablete Entekavir Accord 1 mg filmom obložene tablete
English: Patients with decompensated liver disease: in study 048, 191 patients with HBeAg positive or negative chronic HBV infection and evidence of hepatic decompensation, defined as a CTP score of 7 or higher, received entecavir 1 mg once daily or adefovir dipivoxil 10 mg once daily.
Croatian: Bolesnici s dekompenziranom bolešću jetre: U ispitivanju 048, 191 bolesnik s HBeAg pozitivnom ili negativnom kroničnom HBV infekcijom i dokazanom dekompenzacijom jetre, koja se definirala kao
English: Adefovir Dipivoxil 10 mg once daily
Croatian: Adefovir dipivoksil 10 mg jednom dnevno
English: Entecavir Accord 0.5 mg tablets entecavir
Croatian: Entekavir Accord 0,5 mg tablete entekavir
English: Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Croatian: Entekavir Accord 1 mg filmom obložene tablete: ružičaste bikonveksne filmom obložene tablete trokutastog oblika s utisnutom oznakom „J“ na jednoj strani i „111“ na drugoj strani.
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Croatian: (log10 kopija/ml)c HBV DNK nemjerljiva (< 300 kopija/ml pomoću PCR)c ALT normalizacija (≤ 1 puta GGN)
English: In studies with lamivudine-refractory patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 11% of lamivudine treated patients.
Croatian: U ispitivanjima u bolesnika refrakternih na lamivudin, ALT koji se za vrijeme liječenja povisio > 10 puta iznad GGN i > 2 puta iznad početnih vrijednosti javio se u 2% bolesnika liječenih entekavirom i 11% bolesnika liječenih lamivudinom.
English: Entecavir Accord 1 mg tablets entecavir
Croatian: Entekavir Accord 1 mg tablete entekavir
English: Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Croatian: Nakon početne antivirusne terapije, u nekih se bolesnika serumska ALT može povisiti kako se serumske razine HBV DNK snizuju (vidjeti dio 4.8).
English: Psychiatric disorders: common : insomnia
Croatian: Psihijatrijski poremećaji: često
English: Emerging entecavir resistance in lamivudine-refractory studies through Week 240 is summarized in the table.
Croatian: Pojava rezistencije na entekavir sve do 240. tjedna u ispitivanjima u bolesnika čija je bolest refrakterna na liječenje lamivudinom sažeto je prikazana u sljedećoj tablici.
English: Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Croatian: kompenziranom bolešću jetre i dokazanom aktivnom replikacijom virusa, konstantno povišenim razinama alanin aminotransferaze (ALT) u serumu i histološki dokazanom aktivnom upalom i/ili fibrozom.
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
Croatian: Sigurnost i djelotvornost entekavira provjerile su se i u aktivno kontroliranom kliničkom ispitivanju na 191 bolesniku inficiranom HBV-om s dekompenziranom bolešću jetre i u kliničkom ispitivanju sa 68 bolesnika istodobno inficiranih HBV-om i HIV-om.
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Croatian: Klirens kreatinina na početku ispitivanja (ml/min) Neoštećen
English: Blister packs: EU/1/17/1211/005 EU/1/17/1211/006
Croatian: Blister pakiranje: EU/1/17/1211/005
English: Exacerbations during treatment: in studies with nucleoside naive patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Croatian: Egzacerbacije tijekom liječenja: U ispitivanjima u bolesnika prethodno neliječenih analozima nukleozida, ALT koji se tijekom liječenja povisio > 10 puta iznad GGN i > 2 puta iznad početnih vrijednosti javio se u 2% bolesnika liječenih entekavirom naspram 4% bolesnika liječenih lamivudinom.
English: Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Croatian: 4.4 i 5.1): Preporučena doza za odrasle je 1 mg jednom dnevno, a mora se uzeti na prazan želudac (više od 2 sata prije i više od 2 sata poslije obroka) (vidjeti dio 5.2).
English: Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
Croatian: Blister pakiranje: EU/1/17/1211/002
English: Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Croatian: Stoga nije vjerojatno da će između entekavira i drugih lijekova nastupiti interakcije posredovane
English: 0.3 mg once daily* OR 0.5 mg every 48 hours
Croatian: 0,3 mg jednom dnevno* ILI 0,5 mg svakih 48 sati
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Croatian: Na kraju doziranja, među bolesnicima koji su nastavili liječenje nakon 52. tjedna (medijan 96 tjedana), 81% od 243 bolesnika liječenih entekavirom i 39% od 164 bolesnika liječenih lamivudinom imalo je
English: In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
Croatian: U kombiniranim ispitivanjima HBV-a na kulturama stanica, abakavir, didanozin, lamivudin, stavudin,
English: For lamivudine (n = 355), cumulative response rates were 39% for HBV DNA < 300 copies/ml by PCR, 79% for ALT normalisation, 26% for HBeAg seroconversion, and 2% for HBsAg seroconversion (3% for HBsAg loss).
Croatian: < 300 kopija/ml mjereno PCR-om, 79% za normalizaciju ALT, 26% za HBeAg serokonverziju i 2% za HBsAg serokonverziju (3% za nestanak HBsAg).
English: Periodic Safety Update Reports
Croatian: Sažetak profila sigurnosti
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Croatian: b primarni ishod c Roche Cobas Amplicor PCR test (LLOQ = 300 kopija/ml)
English: 0.15 mg once daily* OR 0.5 mg every 72 hours
Croatian: 0,15 mg jednom dnevno* ILI 0,5 mg svaka 72 sata
English: Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Croatian: Razine albumina < 2,5 g/dl izmjerene su u 30% bolesnika, razine lipaze > 3 puta iznad početne vrijednosti u 10% i trombociti
English: Emergence of HIV resistance has been observed when entecavir was used to treat chronic hepatitis B infection in patients with HIV infection not receiving highly active antiretroviral therapy (HAART) (see section 5.1).
Croatian: infekcijom koji nisu primali visoko aktivnu antiretrovirusnu terapiju (HAART) (vidjeti dio 5.1).
English: 0.25 mg once daily* OR 0.5 mg every 48 hours
Croatian: 0,25 mg jednom dnevno* ILI 0,5 mg svakih 48 sati
English: taking Entecavir Accord will not stop you from infecting other people with hepatitis B
Croatian: Ne smijete uzimati Entekavir Accord za liječenje infekcije hepatitisom B
English: The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.
Croatian: Nuspojave primijećene u pedijatrijskih ispitanika koji su primili liječenje entekavirom bile su sukladne onima primijećenima u kliničkim ispitivanjima entekavira u odraslih (vidjeti Sažetak profila sigurnosti i dio 5.1). e. Druge posebne populacije
English: 0.1 mg once daily* OR 0.5 mg every 72 hours
Croatian: 0,1 mg jednom dnevno* ILI 0,5 mg svaka 72 sata
English: Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with amino acid substitution rtA181C conferred 16- to 122-fold reductions in entecavir phenotypic susceptibility.
Croatian: Kod sojeva rezistentnih na lamivudin koji sadrže supstitucije rtL180M i rtM204V u kombinaciji s aminokiselinskom supstitucijom rtA181C
English: Method of administration Entecavir Accord should be taken orally.
Croatian: Entekavir Accord se uzima peroralno.
English: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Croatian: Ružičaste bikonveksne filmom obložene tablete trokutastog oblika s utisnutom oznakom „J“ na jednoj strani i „111“ na drugoj strani.
English: White to off white, triangle shaped, biconvex film-coated tablets debossed with ‘J' on one side and ‘110' on other side.
Croatian: Bijele do bjelkaste bikonveksne filmom obložene tablete trokutastog oblika s utisnutom oznakom „J“ na jednoj strani i „110“ na drugoj strani.
English: 43.6% e a Results reflect use of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 13 weeks for 48 of 80 patients in Year 3, a median of 38 weeks for 10 of 52 patients in Year 4, and for 16 weeks for 1 of 33 patients in Year 5 in a rollover study.
Croatian: 41,3% e 43,6% e a Rezultati primjene kombinirane terapije entekavirom i lamivudinom (nakon koje je uslijedila dugotrajna terapija entekavirom) tijekom medijana od 13 tjedana za 48 od 80 bolesnika u 3. godini, tijekom medijana od 38 tjedana za 10 od 52 bolesnika u 4. godini i tijekom 16 tjedana za 1 od 33 bolesnika u 5. godini rotacijskog ispitivanja b Uključuje bolesnike s najmanje jednim mjerenjem HBV DNK tijekom terapije pomoću PCR-a u 24. tjednu ili kasnije sve 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).
English: Baseline ALT levels ≥ 2 times ULN and baseline HBV DNA ≤ 9.0 log10 copies/ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ml) in nucleoside-naive HBeAg-positive patients.
Croatian: Početne razine ALT ≥ 2 puta iznad GGN i početne vrijednosti HBV DNK ≤ 9,0 log10 kopija/ml bile su povezane s višim stopama virološkog odgovora
English: In a separate study wherein entecavir was administered to pregnant lactating rats at 10 mg/kg, both foetal exposure to entecavir and secretion of entecavir into milk were demonstrated.
Croatian: 10 mg/kg dokazala se i izloženost fetusa entekaviru i izlučivanje entekavira u mlijeko.
English: Nucleoside naïve patients
Croatian: Bolesnici prethodno neliječeni analozima nukleozida
English: In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Croatian: Ne preporučuje se prekid liječenja kod bolesnika s dekompenziranom bolešću jetre ili cirozom.
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)
Croatian: Nemjerljivi udio (<300 kopija/ml)b
English: Apart from lamivudine, adefovir dipivoxil and tenofovir disoproxil fumarate, the effects of coadministration of entecavir with medicinal products that are excreted renally or affect renal function have not been evaluated.
Croatian: Nisu ispitani učinci istodobne primjene entekavira s lijekovima koji se izlučuju bubrezima ili utječu na funkciju bubrega, osim lamivudina, adefovir dipivoksila i tenofovir dizoproksil fumarata.
English: Entecavir Accord 0.5 mg film-coated tablets
Croatian: Entekavir Accord 0,5 mg filmom obložene tablete
English: Entecavir Accord 1 mg film-coated tablets
Croatian: Entekavir Accord 1 mg filmom obložene tablete
English: Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Croatian: Teški slučajevi, ponekad sa smrtnim ishodom, bili su povezani s pankreatitisom,
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Croatian: 96 tjedana (n = 354) bile su 80% za HBV DNK < 300 kopija/ml mjereno PCR-om, 87% za normalizaciju ALT, 31% za HBeAg serokonverziju i 2% za HBsAg serokonverziju (5% za nestanak
English: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy (see section 4.2).
Croatian: Akutna egzacerbacija hepatitisa prijavljena je i u bolesnika koji su prekinuli terapiju hepatitisa B
English: Post-Liver transplant: entecavir exposure in HBV-infected liver transplant recipients on a stable dose of cyclosporine A or tacrolimus (n = 9) was ≈ 2 times the exposure in healthy subjects with normal renal function.
Croatian: A ili takrolimusa (n = 9) bila je ≈ 2 puta veća od izloženosti u zdravih ispitanika s normalnom funkcijom bubrega.
English: Adefovir Dipivoxil 10 mg once daily n HBV DNA
Croatian: Adefovir dipivoksil 10 mg jednom dnevno n
English: Entecavir Accord 0.5 mg film-coated tablets entecavir
Croatian: Entekavir Accord 0,5 mg filmom obložene tablete entekavir
English: If you get any side effects, talk to your doctor or pharmacist or.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Entecavir Accord 1 mg film-coated tablets entecavir
Croatian: Entekavir Accord 1 mg filmom obložene tablete entekavir