natgillin/translations-raw huggingface dataset:
Patients 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).
Bolesnici 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).
Entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
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.
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.
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.
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 Week 96.
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.
Uncommon (at least 1 in 1,000 patients): rash, hair loss.
Manje često (u najmanje 1 na 1000 bolesnika): osip, ispadanje kose.
This is important because Entecavir Mylan is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Entekavir Mylan uklanja iz tijela putem bubrega i možda će Vam trebati prilagoditi dozu ili raspored doziranja.
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).
Odgovori bolesnika koji su na početku imali 4 boda prema Knodellovom indeksu fibroze (ciroza) mogli su se usporediti s ukupnim odgovorima u svim mjerama ishoda djelotvornosti (svi su bolesnici imali kompenziranu bolest jetre).
Paediatric patients with 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.
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.
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.
Results for the main efficacy endpoints at Week 48 and Week 96 are presented in the table below.
Rezultati za glavne mjere ishoda za djelotvornost u 48. tjednu i 96. tjednu prikazane su u sljedećoj tablici.
Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section 4.4).
Stoga se u takvim situacijama entekavir ne smije primjenjivati, zbog mogućeg razvoja rezistencije HIV-a (vidjeti dio 4.4).
Exacerbations after discontinuation of treatment
Egzacerbacije nakon prekida liječenja
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.
Entekavir, nukleozidni analog gvanozina koji je aktivan protiv HBV polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Liječenje mora započeti liječnik s iskustvom u liječenju kronične infekcije hepatitisom B.
If you take more Entecavir Mylan than you should Contact your doctor at once.
Ako uzmete više lijeka Entekavir Mylan nego što ste trebali Odmah se javite liječniku.
Tablet coating: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
Ovojnica tablete: titanijev dioksid (E171), hipromeloza, makrogol 400, polisorbat 80.
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).
Your dose will depend on: whether you have been treated for HBV infection before, and what medicine you received.
• tome jeste li se prije liječili zbog HBV-infekcije i koje ste lijekove primali.
Resistance and specific precaution for lamivudine-refractory patients
Rezistencija i posebne mjere opreza kod bolesnika refrakternih na lamivudin
No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian cell 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.
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).
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).
- emerging genotypic ETVr c
- pojavom genotipske ETVr c
achieved HBV DNA <300 copies/ml at Week 48.
(9/14) je postiglo HBV DNK < 300 kopija/ml u 48. tjednu.
Entecavir Mylan must not be used during pregnancy unless specifically directed by your doctor.
Entekavir Mylan ne smijete uzimati tijekom trudnoće osim ako to nije izričita uputa liječnika.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Razine ALT-a i HBV DNK u serumu treba redovito pratiti nakon prekida liječenja (vidjeti dio 4.4.).
Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir Mylan contains lactose”), magnesium stearate
Jezgra tablete: mikrokristalična celuloza, krospovidon, laktoza hidrat, (vidjeti dio 2, „Entekavir Mylan sadrži laktozu”), magnezijev stearat
common: vomiting, diarrhoea, nausea, dyspepsia
često: povraćanje, proljev, mučnina, dispepsija
Patients continued their lamivudine-regimen and were assigned to add either entecavir 1 mg once daily (n = 51) or placebo (n = 17) for 24 weeks followed by an additional 24 weeks where all received entecavir.
Bolesnici su nastavili svoj režim lamivudinom i uz njega dodali ili entekavir u dozi od 1 mg jednom dnevno (n = 51) ili placebo (n = 17), koje su uzimali tijekom 24 tjedna, nakon čega su tijekom dodatna 24 tjedna svi primali entekavir.
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.
U ispitivanju 048, 191 bolesnik s HBeAg pozitivnom ili negativnom kroničnom HBV infekcijom i dokazanom dekompenzacijom jetre, koja se definirala kao CTP indeks 7 ili viši, primao je entekavir u dozi od 1 mg jednom dnevno ili adefovir dipivoksil u dozi od 10 mg jednom dnevno.
In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥21 times those in humans.
U trudnih 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.
- genotypic ETVr with virologic breakthrough d
- genotipskom ETVr s virološkim probojem d
Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablets, and in bottles containing 30 or 90 tablets.
Entekavir Mylan 0,5 mg filmom obložene tablete Entekavir Mylan 1 mg filmom obložene tablete isporučuju se u blisterima koji sadrže 30 tableta, perforiranim blisterima koji sadrže 30 x 1 ili 90 x 1 tableta, i u bočicama koje sadrže 30 ili 90 tableta.
What Entecavir Mylan looks like and contents of the pack
Kako Entekavir Mylan izgleda i sadržaj pakiranja
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.
common: insomnia
često: nesanica
For children and adolescents (from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg Filmcoated Tablets are available or an oral solution may be available.
Za djecu i adolescente (od 2 do manje od 18 godina), dostupne su Entekavir Mylan 0,5 mg filmom obložene tablete ili može biti dostupna oralna otopina.
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV-infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
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.
do not stop taking Entecavir Mylan without your doctor's advice since your hepatitis may worsen after stopping treatment.
• nemojte prestati uzimati Entekavir Mylan ako Vam to nije savjetovao liječnik, budući da Vam se hepatitis može pogoršati nakon prestanka liječenja.
Exacerbations of hepatitis
Egzacerbacije hepatitisa
d ≥1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
d Povećanje od ≤ 1 log10 iznad najniže točke HBV DNK mjerene PCR-om, što je bilo potvrđeno uzastopnim mjerenjima ili na kraju specificirane vremenske točke.
The safety of entecavir in paediatric patients from 2 to <18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189).
Sigurnost entekavira u pedijatrijskih bolesnika u dobi od 2 do < 18 godina temelji se na dvama kliničkim ispitivanjima u ispitanika s kroničnom HBV infekcijom koja su još u tijeku; jednom farmakokinetičkom ispitivanju faze 2 (ispitivanje 028) i jednom ispitivanju faze 3 (ispitivanje 189).
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).
Bolesnici s bolešću refrakternom na liječenje lamivudinom (tj. s dokazanom viremijom za vrijeme liječenja lamivudinom ili prisutnim mutacijama za rezistenciju na lamivudin [LVDr]) (vidjeti dijelove 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).
What you need to know before you take Entecavir Mylan
Što morate znati prije nego počnete uzimati Entekavir Mylan
Entecavir Mylan can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Entekavir Mylan se može primjenjivati u osoba koje imaju oštećenu jetru, ali ona još ispravno radi (kompenzirana bolest jetre) i u osoba koje imaju oštećenu jetru i ona ne radi ispravno (dekompenzirana bolest jetre).
High baseline Knodell necroinflammatory scores (>10) were associated with greater histological improvement in nucleoside-naive patients.
Visoki početni Knodellov indeks nekroze i upale (> 10) bio je povezan s većim histološkim poboljšanjem kod bolesnika prethodno neliječenih analozima nukleozida.
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).
Kriteriji za odgovor bili su virološka supresija HBV (HBV DNK < 0,7 MEq/ml prema bDNK) i nestanak HBeAg (u HBeAg pozitivnih bolesnika) ili ALT < 1,25 puta iznad GGN (u HBeAg negativnih bolesnika).
b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58
b Uključuje bolesnike s najmanje jednim mjerenjem HBV DNK pomoću PCR-a tijekom terapije u 24. tjednu ili kasnije do
Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:
Entekavir Mylan je indiciran za liječenje kronične infekcije virusom hepatitisa B (HBV) (vidjeti dio 5.1) u odraslih s:
There are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Nema podataka o djelotvornosti entekavira u bolesnika koji su istodobno inficirani virusom hepatitisa C ili D.
f Denominator is patients with abnormal values at baseline.
f U nazivniku su bolesnici s abnormalnim vrijednostima na početku ispitivanja.
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 Vašu sposobnost upravljanja vozilima i rada na strojevima.
OPA/Aluminium/PVC-Aluminium foil blister packs containing 30 film-coated tablets.
Blisteri od OPA/aluminij/PVC-aluminijske folije, koji sadrže 30 filmom obloženih tableta.
Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Stoga nije vjerojatno da će između entekavira i drugih lijekova nastupiti interakcije posredovane CYP450.
Do not take Entecavir Mylan if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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), ali ne i tijekom razdoblja doziranja pri vrijednostima AUC-a ≤ 92 puta većima od onih koje se postižu u ljudi pri dozi od 0,5 mg ili ekvivalentnoj pedijatrijskoj dozi.
HBV DNA <50 IU/mL and HBeAg seroconversiona HBV DNA <50 IU/mLa HBeAg seroconversiona ALT normalisationa HBV DNA <50 IU/mLa
HBV DNK < 50 IU/mla HBeAg serokonverzijaa Normalizacija ALTa HBV DNK < 50 IU/mla
Entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
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).
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).
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).
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 ≤ 2 log10/ml, koje je prethodilo ili koincidiralo s povišenjem ALT-a.
At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count
Na početku ispitivanja, bolesnici liječeni entekavirom imali su medijan trajanja prethodne terapije lamivudinom od 4,8 godina i medijan broja CD4 od 494 stanica/mm3 (sa samo 5 ispitanika s brojem CD4 < 200 stanica/mm3).
A lower rate of virologic response (HBV DNA <50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥8.0 log10 IU/ml (see section 5.1).
Primijećena je niža stopa virološkog odgovora (HBV DNK < 50 IU/ml) u pedijatrijskih bolesnika čija je početna vrijednost HBV DNK bila ≤ 8,0 log10 IU/ml (vidjeti dio 5.1).
90 x 1 film-coated tablets
90 x 1 filmom obložena tableta
Cumulative probability of: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Kumulativna vjerojatnost: - pojave genotipske ETVr c - genotipske ETVr c s virološkim probojem d
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA
Other medicines and Entecavir Mylan
Drugi lijekovi i Entekavir Mylan
There are no adequate data from the use of entecavir in pregnant women.
Nema odgovarajućih podataka o primjeni entekavira u trudnica.
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).
c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
c Roche Cobas Amplicor PCR test (LLOQ = 300 kopija/ml)
The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults (see Summary of the safety profile and section 5.1).
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).
Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048).
Iskustvo u bolesnika s dekompenziranom bolešću jetre: profil sigurnosti entekavira u bolesnika s dekompenziranom bolešću jetre procijenio se u randomiziranom usporednom ispitivanju otvorenog tipa u kojem su bolesnici liječeni entekavirom u dozi od 1 mg/dan (n = 102) ili adefovir dipivoksilom u dozi od 10 mg/dan (n = 89) (ispitivanje 048).
For patients with baseline Ishak fibrosis score ≥2, 25/43 (58%) had a ≥2-point decrease.
Među bolesnicima s početnom vrijednošću fibroze ≤ 2 prema Ishakovom indeksu, 25/43 (58%) je imalo smanjenje ≤ 2 boda.
Entecavir Mylan tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Entekavir Mylan tablete su antivirusni lijek, koji se primjenjuje za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B (HBV) u odraslih.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Teški slučajevi, ponekad sa smrtnim ishodom, bili su povezani s pankreatitisom, zatajenjem jetre/jetrenom steatozom, zatajenjem bubrega i višim razinama laktata u serumu.
Children and adolescents Entecavir Mylan should not be used for children below 2 years of age or weighing less than 10 kg.
Entekavir Mylan se ne smije primjenjivati u djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
Cumulative probability of: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d a Results reflect use of a 1 mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
Kumulativna vjerojatnost: - pojave genotipske ETVr c - genotipske ETVr c s virološkim probojem d a Rezultati primjene doze entekavira od 1 mg za 147 od 149 bolesnika u 3. godini i sve bolesnike u 4. i 5. godini i kombinirane terapije entekavirom i lamivudinom (nakon čega je uslijedila dugotrajna terapija entekavirom) tijekom medijana od 20 tjedana za 130 od 149 bolesnika u 3. godini i 1 tjedan za 1 od 121 bolesnika u 4. godini u rotacijskom ispitivanju.
Entecavir clearance decreases with decreasing creatinine clearance.
Klirens entekavira smanjuje se sa smanjenjem klirensa kreatinina.
Entecavir Mylan 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 Mylan 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.
Patients in specific year with: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Bolesnici u određenoj godini s: - pojavom genotipske ETVr c - genotipskom ETVr c s virološkim probojem d
The safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudinecontaining HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Profil sigurnosti entekavira u ograničenog broja bolesnika s istodobnom infekcijom HIV-om i HBVom koji su primali HAART režim koji sadrži lamivudin (visoko aktivnu antiretrovirusnu terapiju), bio je sličan profilu sigurnosti entekavira u bolesnika inficiranih samo HBV-om (vidjeti dio 4.4).
OPA/Aluminium/PVC-Aluminium perforated unit-dose foil blister packs containing 30 x 1 or 90 x 1 film-coated tablets.
OPA/aluminij/PVC-aluminij perforirani blisteri s jediničnim dozama koji sadrže 30 x 1 ili 90 x 1 filmom obloženih tableta.
rare: anaphylactoid reaction
rijetko: anafilaktoidna reakcija
For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Za bolesnike tjelesne težine od 10 kg do 32,5 kg preporučuje se oralna otopina entekavira.