natgillin/translations-raw huggingface dataset:
HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.
HBeAg pozitivni (ispitivanje 026): liječenje entekavirom u trajanju do 96 tjedana (n = 141) rezultiralo je kumulativnim stopama odgovora od 30% za HBV DNK < 300 kopija/ml mjereno PCR-om, 85% za normalizaciju ALT-a i 17% za HBeAg serokonverziju.
Bilirubin (≤1 X ULN)b
ALT (≤1 x GGN)b Albumin (≥1 x DGN)b Bilirubin (≤1 x GGN)b
You should not breast-feed during treatment with Entecavir Accord.
Ne smijete dojiti tijekom liječenja lijekom Entekavir Accord.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU IZVAN POGLEDA
Film-coated tablet 30 film-coated tablets
Filmom obložena tableta 30 filmom obloženih tableta
1 mg once daily
1 mg jednom dnevno
Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Oštećenje funkcije bubrega: Preporučuje se prilagoditi dozu kod bolesnika s oštećenjem funkcije bubrega (vidjeti dio 4.2).
90 x 1 film-coated tablet; 9 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters.
• 90 × 1 filmom obloženu tabletu; 9 blistera s 10 × 1 filmom obloženom tabletom, svaka u Al/Al perforiranim blisterima s jediničnim dozama
The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng∙h/ml, and 0.47 ng/ml, respectively.
U tih je ispitanika Cmax iznosio 14,48 ng/ml, AUC(0-24) 38,58 ng∙h/ml, a Cmin 0,47 ng/ml.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
4.2 Doziranje i način primjene Liječenje mora započeti liječnik s iskustvom u liječenju kronične infekcije hepatitisom B.
f Denominator is patients with abnormal values at baseline.
U nazivniku su bolesnici s abnormalnim vrijednostima na početku ispitivanja.
LVD 100 mg once daily
LVD 100 mg jednom dnevno
For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Ova se indikacija temelji, kako za kompenziranu, tako i za dekompenziranu bolest jetre, na podacima iz kliničkog ispitivanja u bolesnika s HBeAg pozitivnom i HBeAg negativnom HBV infekcijom prethodno nisu bili liječeni analozima nukleozida.
Entecavir
Doziranje
Amylase levels > 3 times baseline occurred in 2% of patients, lipase levels > 3 times baseline in 18% and platelets < 50,000/mm3 in < 1%.
Razine amilaze > 3 puta iznad početne vrijednosti javile su se u 2% bolesnika, razine lipaze > 3 puta iznad početne vrijednosti u 18% i trombociti < 50 000/mm3 u < 1% bolesnika.
Among entecavir-treated patients, on-treatment ALT elevations had a median time to onset of 4-5 weeks, generally resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10/ml reduction in viral load that preceded or coincided with the ALT elevation.
Među bolesnicima liječenima entekavirom, povišenja ALT-a tijekom liječenja nastupila su nakon medijana od 4-5 tjedana i općenito se povukla s nastavkom liječenja, a u većini su slučajeva bila povezana sa smanjenjem virusnog opterećenja od
In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during posttreatment follow-up.
U ispitivanjima u bolesnika s hepatitisom refrakternim na lamivudin, kad se pratio samo ograničen broj bolesnika, povišenja ALT-a tijekom praćenja nakon liječenja nastupila su u 11% bolesnika liječenih entekavirom i niti u jednog bolesnika liječenog lamivudinom.
Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Bolesnici istodobno inficirani virusom humane imunodeficijencije (HIV) i HBV-om koji istodobno ne primaju antiretrovirusnu terapiju: Entekavir se nije ispitivao u bolesnika istodobno inficiranih HIVom i HVB-om koji nisu istodobno primali učinkovito liječenje protiv HIV-a.
Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies
Pojava genotipske rezistencije na entekavir do kraja 5. godine ispitivanja u bolesnika prethodno neliječenih analozima nukleozida
Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets.
Entekavir Accord dostupan je samo u obliku filmom obloženih tableta od 0,5 i 1 mg.
The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
U tih je ispitanika Cmax iznosio 6,31 ng/ml, AUC(0-24) 18,33 ng∙h/ml, a Cmin 0,28 ng/ml.
In the presence of LVDr mutations, 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 (see section 4.4.
Ako su prisutne LVDr mutacije, 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 (vidjeti dio 4.4.).
Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Abnormalnosti laboratorijskih nalaza: Do 48. tjedna niti jedan od bolesnika liječenih entekavirom s dekompenziranom bolešću jetre nije imao povišenja ALT > 10 puta iznad GGN i > 2 puta iznad početne vrijednosti, a 1% bolesnika imao je povišenja ALT > 2 puta iznad početne vrijednosti s ukupnim bilirubinom > 2 puta iznad GGN i > 2 puta iznad početne vrijednosti.
After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.The population pharmacokinetic analysis covering patients in the age range 1675 years did not identify age as significantly influencing entecavir pharmacokinetics.
Nakon prilagodbe za razlike u klirensu kreatinina i tjelesnoj težini, stariji ispitanici imali su 12,5% višu AUC od mladih ispitanika.
ETV 1 mg once daily
ETV 1 mg jednom dnevno
0.5 mg once daily
0,5 mg jednom dnevno
This substitution was detected only in the presence of lamivudine resistance-associated substitutions rtL180M plus rtM204V.
Ta je supstitucija bila opažena samo u prisutnosti supstitucija rtL180M plus rtM204V povezanih s rezistencijom na lamivudin.
Entecavir Accord contains soy polysaccharides
Entekavir Accord sadrži polisaharide soje.
Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2).
Neki bolesnici moraju uzimati Entekavir Accord na prazan želudac (pogledajte pod Entekavir
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.
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.
Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines.
Omaglica, umor (iscrpljenost) i pospanost (izrazita pospanost) česte su nuspojave koje mogu narušiti
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.
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.
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).
(HBV DNK < 0,7 MEq/ml prema bDNK) i nestanak HBeAg (u HBeAg pozitivnih bolesnika) ili ALT
Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Uputa o lijeku: Informacije za korisnika Entekavir Accord 0,5 mg filmom obložene tablete Entekavir Accord 1 mg filmom obložene tablete entekavir
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.
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
*p<0.05
*p vrijednost naspram lamivudina < 0,05
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.
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.
30 x 1 film-coated tablet
30 x 1 filmom obložena tableta
ETV 0.5 mg once daily
ETV 0,5 mg jednom dnevno
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.
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.
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.
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.
An oral solution may be available for patients with body weight less than 32.6 kg.
Za bolesnike tjelesne težine manje od 32,6 kg može biti dostupna oralna otopina.
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.
Postoji cjepivo koje može zaštititi osobe u kojih postoji rizik od zaraze HBV-om.
: anaphylactoid reaction
: anafilaktoidna reakcija
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).
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
Severe Managed with Haemodialysis
liječeni hemodijali zom
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.
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.
0.05 mg once daily* OR 0.5 mg every 5-7 days
0,05 mg jednom dnevno* ILI 0,5 mg svakih 5-7 dana
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.
Ako su Vas prebacili na Entekavir Accord zato što liječenje lamivudinom nije bilo uspješno,
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.
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.
Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Jedna tableta sadrži entekavir hidrat ekvivalentan 1 mg entekavira.
Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Jedna tableta sadrži entekavir hidrat ekvivalentan 0,5 mg entekavira.
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.
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.
HBsAg lossb Normalization of:
bodova u odnosu na početne vrijednostic,e Nestanak HBsAgb Normalizacija:f
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.
Postoji dozi proporcionalno povećanje vrijednosti Cmax i AUC-a nakon primjene višekratnih doza u rasponu od 0,1-1 mg.
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.
Na početku ispitivanja bolesnici su imali srednju vrijednost CTP indeksa od 8,59 bodova i 26% bolesnika imalo je CTP klasu C.
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
Entekavir Accord tablete su antivirusni lijek, koji se primjenjuje za liječenje kronične
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%.
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
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.
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),
Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Entekavir Accord 0,5 mg filmom obložene tablete Entekavir Accord 1 mg filmom obložene tablete
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.
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
Adefovir Dipivoxil 10 mg once daily
Adefovir dipivoksil 10 mg jednom dnevno
Entecavir Accord 0.5 mg tablets entecavir
Entekavir Accord 0,5 mg tablete entekavir
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.
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.
Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
(log10 kopija/ml)c HBV DNK nemjerljiva (< 300 kopija/ml pomoću PCR)c ALT normalizacija (≤ 1 puta GGN)
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.
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.
Entecavir Accord 1 mg tablets entecavir
Entekavir Accord 1 mg tablete entekavir
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).
Nakon početne antivirusne terapije, u nekih se bolesnika serumska ALT može povisiti kako se serumske razine HBV DNK snizuju (vidjeti dio 4.8).
Psychiatric disorders: common : insomnia
Psihijatrijski poremećaji: često
Emerging entecavir resistance in lamivudine-refractory studies through Week 240 is summarized in the table.
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.
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.
kompenziranom bolešću jetre i dokazanom aktivnom replikacijom virusa, konstantno povišenim razinama alanin aminotransferaze (ALT) u serumu i histološki dokazanom aktivnom upalom i/ili fibrozom.
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
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.
Baseline Creatinine Clearance (ml/min) Unimpaired
Klirens kreatinina na početku ispitivanja (ml/min) Neoštećen
Blister packs: EU/1/17/1211/005 EU/1/17/1211/006
Blister pakiranje: EU/1/17/1211/005
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.
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.
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).
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).
Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
Blister pakiranje: EU/1/17/1211/002
Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Stoga nije vjerojatno da će između entekavira i drugih lijekova nastupiti interakcije posredovane
0.3 mg once daily* OR 0.5 mg every 48 hours
0,3 mg jednom dnevno* ILI 0,5 mg svakih 48 sati
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.
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
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.
U kombiniranim ispitivanjima HBV-a na kulturama stanica, abakavir, didanozin, lamivudin, stavudin,
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).
< 300 kopija/ml mjereno PCR-om, 79% za normalizaciju ALT, 26% za HBeAg serokonverziju i 2% za HBsAg serokonverziju (3% za nestanak HBsAg).
Periodic Safety Update Reports
Sažetak profila sigurnosti
Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
b primarni ishod c Roche Cobas Amplicor PCR test (LLOQ = 300 kopija/ml)
0.15 mg once daily* OR 0.5 mg every 72 hours
0,15 mg jednom dnevno* ILI 0,5 mg svaka 72 sata
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%.
Razine albumina < 2,5 g/dl izmjerene su u 30% bolesnika, razine lipaze > 3 puta iznad početne vrijednosti u 10% i trombociti
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).
infekcijom koji nisu primali visoko aktivnu antiretrovirusnu terapiju (HAART) (vidjeti dio 5.1).
0.25 mg once daily* OR 0.5 mg every 48 hours
0,25 mg jednom dnevno* ILI 0,5 mg svakih 48 sati
taking Entecavir Accord will not stop you from infecting other people with hepatitis B
Ne smijete uzimati Entekavir Accord za liječenje infekcije hepatitisom B
The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.
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