FrancophonIA/ELRC3.0 huggingface dataset:
English: OPA/Aluminium/PVC-Aluminium foil blister packs containing 30 film-coated tablets.
Croatian: Blisteri od OPA/aluminij/PVC-aluminijske folije, koji sadrže 30 filmom obloženih tableta.
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 CYP450.
English: 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).
Croatian: • ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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), 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.
English: HBV DNA <50 IU/mL and HBeAg seroconversiona HBV DNA <50 IU/mLa HBeAg seroconversiona ALT normalisationa HBV DNA <50 IU/mLa
Croatian: HBV DNK < 50 IU/mla HBeAg serokonverzijaa Normalizacija ALTa HBV DNK < 50 IU/mla
English: Entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Croatian: 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).
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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
Croatian: 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).
English: 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).
Croatian: 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).
English: 90 x 1 film-coated tablets
Croatian: 90 x 1 filmom obložena tableta
English: Cumulative probability of: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Croatian: Kumulativna vjerojatnost: - pojave genotipske ETVr c - genotipske ETVr c s virološkim probojem d
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA
English: Other medicines and Entecavir Mylan
Croatian: Drugi lijekovi i Entekavir Mylan
English: There are no adequate data from the use of entecavir in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni entekavira u trudnica.
English: 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).
Croatian: Nije bilo vidljive razlike u djelotvornosti entekavira na temelju spola (≈ 25% žena u kliničkim ispitivanjima) ili dobi (≈ 5% bolesnika u dobi od > 65 godina).
English: c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Croatian: c Roche Cobas Amplicor PCR test (LLOQ = 300 kopija/ml)
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 (see Summary of the safety profile and section 5.1).
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).
English: 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).
Croatian: 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).
English: For patients with baseline Ishak fibrosis score ≥2, 25/43 (58%) had a ≥2-point decrease.
Croatian: Među bolesnicima s početnom vrijednošću fibroze ≤ 2 prema Ishakovom indeksu, 25/43 (58%) je imalo smanjenje ≤ 2 boda.
English: Entecavir Mylan tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Croatian: Entekavir Mylan tablete su antivirusni lijek, koji se primjenjuje za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B (HBV) u odraslih.
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, zatajenjem jetre/jetrenom steatozom, zatajenjem bubrega i višim razinama laktata u serumu.
English: Children and adolescents Entecavir Mylan should not be used for children below 2 years of age or weighing less than 10 kg.
Croatian: Entekavir Mylan se ne smije primjenjivati u djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
English: 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.
Croatian: 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.
English: Entecavir clearance decreases with decreasing creatinine clearance.
Croatian: Klirens entekavira smanjuje se sa smanjenjem klirensa kreatinina.
English: 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.
Croatian: 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.
English: Patients in specific year with: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Croatian: Bolesnici u određenoj godini s: - pojavom genotipske ETVr c - genotipskom ETVr c s virološkim probojem d
English: 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).
Croatian: 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).
English: OPA/Aluminium/PVC-Aluminium perforated unit-dose foil blister packs containing 30 x 1 or 90 x 1 film-coated tablets.
Croatian: OPA/aluminij/PVC-aluminij perforirani blisteri s jediničnim dozama koji sadrže 30 x 1 ili 90 x 1 filmom obloženih tableta.
English: rare: anaphylactoid reaction
Croatian: rijetko: anafilaktoidna reakcija
English: For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Croatian: Za bolesnike tjelesne težine od 10 kg do 32,5 kg preporučuje se oralna otopina entekavira.
English: Patients had stable controlled HIV (HIV RNA <400 copies/ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen.
Croatian: Kod bolesnika je HIV bio pod stabilnom kontrolom (HIV RNK < 400 kopija/ml), no imali su rekurentnu viremiju HBV-a tijekom liječenja HAART režimom koji sadrži lamivudin.
English: For appropriate dosing in the paediatric population Entecavir Mylan 0.5 mg Film-coated Tablets are available and for doses below 0.5 mg an oral solution may be available.
Croatian: Za primjereno doziranje u pedijatrijskoj populaciji dostupne su Entekavir Mylan 0,5 mg filmom obložene tablete dok za doze niže od 0,5 mg može biti dostupna oralna otopina.
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: U posebnom ispitivanju u kojem se entekavir primjenjivao trudnim ženkama štakora u laktaciji u dozi od 10 mg/kg dokazala se i izloženost fetusa entekaviru i izlučivanje entekavira u mlijeko.
English: ALT normalisation (≤1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Croatian: Normalizacija ALT-a (≥ 1 puta iznad GGN) nastupila je u 27% bolesnika liječenih entekavirom i 21% bolesnika liječenih lamivudinim na kraju doziranja.
English: Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Croatian: Oštećenje funkcije bubrega: klirens entekavira smanjuje se sa smanjenjem klirensa kreatinina (vidjeti dio 5.2).
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.
English: In rats, maternal toxicity, embryo-foetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
Croatian: U štakora su bili opaženi toksičnost za majku, embriofetalna toksičnost (resorpcije), smanjena tjelesna težina fetusa, malformacije repa i kralježnice, smanjena osifikacija (kralježaka, sternebre i falangi) te ekstralumbalni kralješci i rebra kod visokih izloženosti.
English: Among lamivudine-refractory patients with baseline HBV DNA <107 log10 copies/ml, 64% (9/14)
Croatian: Od bolesnika s bolešću refrakternom na lamivudin i početnom HBV DNK < 107 log10 kopija/ml, 64%
English: The cumulative probability of emerging genotypic entecavir resistance after 1, 2, 3, 4 and 5 years treatment in the lamivudine-refractory studies was 6%, 15%, 36%, 47% and 51%, respectively.
Croatian: Kumulativna vjerojatnost pojave genotipske rezistencije na entekavir u ispitivanjima rezistencije na lamivudin iznosila je 6% nakon 1 godine, 15% nakon 2 godine, 36% nakon 3 godine, 47% nakon 4 godine i 51% nakon 5 godina liječenja.
English: Microcrystalline cellulose Crospovidone Lactose monohydrate Magnesium stearate
Croatian: Jezgra tablete: mikrokristalična celuloza krospovidon laktoza hidrat magnezijev stearat
English: 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.
Croatian: aktivnosti virusne polimeraze: (1) pripremanje HBV polimeraze, (2) reverznu transkripciju negativnog lanca DNK iz pregenomske glasničke RNK i (3) sintezu pozitivnog lanca HBV DNK.
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure containing 30 or 90 film-coated tablets.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu koja sadrži 30 ili 90 filmom obloženih tableta.
English: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
Croatian: U randomiziranom, dvostruko slijepom ispitivanju u HBeAg pozitivnih bolesnika refrakternih na lamivudin (026), od kojih je 85% bolesnika na početku imalo LVDr mutacije, bolesnici koji su primali lamivudin pri ulasku u ispitivanje prebačeni su na entekavir u dozi od 1 mg jednom dnevno, bez razdoblja ispiranja i razdoblja preklapanja (n = 141), ili su nastavili uzimati lamivudin u dozi od 100 mg jednom dnevno (n = 145).
English: Patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Croatian: Bolesnici u kliničkim ispitivanjima koji su se na početku liječili entekavirom u dozi od 0,5 mg (prethodno neliječeni analozima nukleozida) ili 1,0 mg (refrakterni na lamivudin) i u kojih se HBV DNK tijekom terapije mjerio pomoću PCR-a u 24. tjednu ili nakon toga, praćeni su zbog rezistencije.
English: What Entecavir Mylan contains
Croatian: Što Entekavir Mylan sadrži
English: The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Croatian: Vrijeme do nastupa HCC ili smrti (kojegod da se dogodilo prije) bilo je usporedivo u ove dvije liječene skupine; kumulativne stope smrtnosti tijekom ispitivanja bile su 23% (23/102) u bolesnika liječenih entekavirom i 33% (29/89) u bolesnika liječenih adefovir dipivoksilom, a kumulativne stope HCC-a tijekom ispitivanja iznosile su 12% (12/102) za entekavir i 20% (18/89) za adefovir dipivoksil.
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: Razvoj rezistencije HIV- a opažen je kad se entekavir primjenjivao za liječenje kroničnog hepatitisa B u bolesnika s HIV- infekcijom koji nisu primali visoko aktivnu antiretrovirusnu terapiju (HAART) (vidjeti dio 5.1).
English: The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM.
Croatian: Ki entekaviraTP za HBV DNK polimerazu je 0,0012 μM.
English: • In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Croatian: • Kod HBeAg pozitivnih odraslih bolesnika, liječenje se mora primjenjivati barem do 12 mjeseci nakon postizanja HBe serokonverzije (nestanak HBeAg i nestanak HBV DNK s prisutnim anti- HBe na dva uzastopna mjerenja u uzorcima seruma u razmaku od najmanje 3-6 mjeseci) ili do HBs serokonverzije ili postoji gubitak djelotvornosti (vidjeti dio 4.4).
English: 117 Allée des Parcs 69800 Saint Priest
Croatian: 69800 Saint Priest
English: Entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Croatian: Entekavir se uglavnom eliminira bubrezima, a u mokraći se može naći oko 75% doze u obliku neizmijenjenog lijeka pri stanju dinamičke ravnoteže.
English: At the time of the long-term biopsy, all patients had HBV DNA <300 copies/ml and 49/57 (86%) had serum ALT ≤1 times ULN.
Croatian: U vrijeme biopsije jetre, svi su bolesnici imali HBV DNK < 300 kopija/ml, a 49/57 (86%) imalo je serumsku ALT ≥ 1 puta iznad GGN.
English: The entecavir dosage was 0.5 mg daily in the pivotal studies (mean exposure 85 weeks) and 1 mg daily in the rollover study (mean exposure 177 weeks), and 51 patients in the rollover study initially also received lamivudine (median duration 29 weeks).
Croatian: Doza entekavira u ključnim ispitivanjima bila je 0,5 mg dnevno (srednja vrijednost izloženosti: 85 tjedana), a u rotacijskom ispitivanju 1 mg dnevno (srednja vrijednost izloženosti: 177 tjedana); 51 bolesnik u rotacijskom ispitivanju na početku je primao i lamivudin (medijan trajanja 29 tjedana).
English: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatmentnaïve children and adolescents from 2 to <18 years of age with HBeAg positive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Croatian: U ispitivanju 189, koje je još u tijeku, ispituje se djelotvornost i sigurnost entekavira u 180 djece i adolescenata u dobi od 2 do < 18 godina s HBeAg pozitivnom kroničnom infekcijom hepatitisom B, kompenziranom bolešću jetre i povišenim razinama ALT-a, koji prethodno nisu bili liječeni analozima nukleozida.
English: For patients who met protocol-defined response criteria, response was sustained throughout the 24-week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
Croatian: Za bolesnike koji su zadovoljili kriterije odgovora definirane protokolom ispitivanja, odgovor se održao tijekom cijelog razdoblja praćenja od 24 tjedna nakon završetka liječenja u 75% (83/111) bolesnika s odgovorom na entekavir naspram 73% (68/93) bolesnika s odgovorom na lamivudin u ispitivanju 022 te 46% (131/286) bolesnika s odgovorom na entekavir naspram 31% (79/253) bolesnika s odgovorom na lamivudin u ispitivanju 027.
English: It is unknown whether entecavir is excreted in human milk.
Croatian: Nije poznato izlučuje li se entekavir u majčino mlijeko.
English: Each film-coated tablet contains 62.5 mg lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 62,5 mg hidrata laktoze.
English: Each film-coated tablet contains 125 mg lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 125 mg hidrata laktoze.
English: Two-year carcinogenicity studies: in male mice, increases in the incidences of lung tumours were observed at exposures ≥4 and ≥2 times that in humans at 0.5 mg and 1 mg respectively.
Croatian: Dvogodišnja ispitivanja kancerogenosti: u mužjaka miševa opažena su povećanja incidencija tumora pluća pri izloženostima koje su bile ≤ 4 puta veće nego u ljudi kod doze od 0,5 mg i ≤2 puta veće nego u ljudi kod doze od 1 mg.
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: • Kod HBeAg pozitivnih pedijatrijskih bolesnika liječenje treba primjenjivati najmanje 12 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: Titanium dioxide (E171) Hypromellose Macrogol 400
Croatian: Ovojnica tablete: titanijev dioksid (E171) hipromeloza makrogol 400 polisorbat 80
English: 30 x 1 film-coated tablets
Croatian: 30 x 1 filmom obložena tableta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA BOČICU
English: Entecavir Mylan contains lactose
Croatian: Entekavir Mylan sadrži laktozu
English: Toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Croatian: Toksikološka ispitivanja na životinjama kojima se primjenjivao entekavir nisu pokazala da dolazi do oštećenja plodnosti (vidjeti dio 5.3).
English: It has not been demonstrated that entecavir is safe to use during pregnancy.
Croatian: Nije se dokazala sigurnost lijeka entekavir tijekom trudnoće.
English: Post-Liver transplant
Croatian: Poslije transplantacije jetre
English: Proportion undetectable (<300 copies/ml)b Mean change from baseline (log10 copies/ml)c
Croatian: Nemjerljivi udio (< 300 kopija/ml)b Srednja vrijednost promjene od početne vrijednosti (log10 kopija/ml)c
English: Severe Managed with Haemodialysis (n = 6)
Croatian: Teško, liječeni hemodijalizom (n = 6)
English: Breast-feeding should be discontinued during treatment with Entecavir Mylan.
Croatian: Dojenje treba prekinuti tijekom liječenja lijekom Entekavir Mylan.
English: n
Croatian: ND
English: Relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Croatian: U odnosu na divlji tip HBV-a, LVDr virusi čija reverzna transkriptaza sadrži supstitucije rtM204V i rtL180M imaju 8 puta smanjenu osjetljivost na entekavir.
English: Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food.
Croatian: Kompenzirana bolest jetre Bolesnici prethodno neliječeni analozima nukleozida: preporučena doza za odrasle je 0,5 mg jednom dnevno s hranom ili bez nje.
English: ALT normalisation (≤1 times ULN)
Croatian: Normalizacija ALT (≥ 1 puta GGN)