natgillin/translations-raw huggingface dataset:
If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily.
Ako su Vas prebacili na Baraclude zato što liječenje lamivudinom nije bilo uspješno, morate uzimati Baraclude na prazan želudac jednom dnevno.
It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.
Važno je da žene u reproduktivnoj dobi koje se liječe lijekom Baraclude koriste učinkovitu metodu kontracepcije, kako bi se izbjegla trudnoća.
Take Baraclude as long as your doctor has told you.
Uzimajte Baraclude onoliko dugo koliko Vam je rekao liječnik.
If you forget to take Baraclude
Ako ste zaboravili uzeti Baraclude
What Baraclude looks like and contents of the pack
Kako Baraclude izgleda i sadržaj pakiranja
ULN=upper limit of normal, LLN=lower limit of normal.
GGN=gornja granica normale, DGN=donja granica normale.
Belgique/België/Belgien
Belgique/België/Belgien N.V.
For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Za djecu i adolescente (od 2 do manje od 18 godina): Liječnik Vašeg djeteta odredit će pravu dozu na temelju tjelesne težine djeteta.
If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time.
Ako propustite dozu lijeka Baraclude, uzmite je čim prije, a onda sljedeću dozu uzmite prema rasporedu u uobičajeno vrijeme.
Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark.
Držeći žlicu tako da su oznake količine okrenute prema Vama, provjerite je li napunjena do odgovarajuće oznake.
Children and adolescents (from 2 to less than 18 years of age) can take Baraclude with or without food.
Djeca i adolescenti (u dobi od 2 do manje od 18 godina) mogu uzimati Baraclude s hranom ili bez nje.
The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below:
Točna doza Baraclude oralne otopine za djecu i adolescente izračunava se prema tjelesnoj težiti i uzima se jednom dnevno kroz usta, kako je prikazano u nastavku:
Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
Liječnik Vam može propisati nižu dozu ili savjetovati da je uzimate rjeđe od jednom na dan. stanju
Baraclude tablets do not contain maltitol and can be taken by patients with fructose intolerance.
Baraclude tablete ne sadrže maltitol i njih mogu uzimati bolesnici s nepodnošenjem fruktoze.
Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2).
Neki bolesnici moraju uzimati Baraclude na prazan želudac (pogledajte pod Baraclude s hranom i pićem u dijelu 2).
Other medicines and Baraclude
Drugi lijekovi i Baraclude
It is recommended that the dosing spoon be rinsed with water after each daily dose.
Preporučuje se isprati doznu žličicu vodom nakon svake dnevne doze.
Authorised Representative in the EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany
Predstavnik nositelja odobrenja u EEA za Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Njemačka.
Do not dilute or mix this solution with water or anything else.
Nemojte je razrjeđivati ni miješati s vodom ili nečim drugim.
If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach.
Ako je bolest jetre jako uznapredovala, i liječnik će Vas upozoriti na to da uzimate Baraclude na prazan želudac.
This medicinal product must not be mixed with water, other solvents or other medicinal products.
Lijek se ne smije miješati s vodom, drugim otapalima ili drugim lijekovima.
Patients may be dosed with or without food.
Doza se bolesnicima može dati s hranom ili bez nje.
Luxembourg/Luxemburg
Luxembourg/Luxemburg N.V.
The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Mjernu žlicu proizvodi Comar Plastics Division, One Comar Place, Buena, NJ 08310, SAD.
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.
Upitajte liječnika radi li Vam jetra ispravno i, ukoliko to nije slučaj, kako bi to moglo utjecati na Vaše liječenje lijekom Baraclude.
Swallow the medicine directly from the measuring spoon.
Progutajte lijek izravno iz mjerne žlice.
Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Baraclude pripada klasi lijekova koji mogu prouzročiti laktacidozu (suvišak mliječne kiseline u krvi) i povećanje jetre.
Store in the original carton.
Čuvati u originalnom pakiranju.
1.1%e 10.7% e 27% e 41.3% e
1,1%e 10,7% e
HBV DNA < 50 IU/mLa
HBV DNK < 50 IU/mla
do not stop taking Baraclude without your doctor's advice since your hepatitis may worsen after stopping treatment.
Nemojte prestati uzimati Baraclude ako Vam to nije savjetovao liječnik, budući da Vam se hepatitis može pogoršati nakon prestanka liječenja.
Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
To je važno zato što se Baraclude uklanja iz tijela putem bubrega i možda će Vam trebati prilagoditi dozu ili raspored doziranja.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
Maltitol: Baraclude oral solution contains maltitol.
Maltitol: Baraclude oralna otopina sadrži maltitol.
You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Ne smijete uzimati Baraclude za liječenje infekcije hepatitisom B ako u isto vrijeme ne uzimate lijekove protiv HIV-a, jer to može smanjiti učinkovitost budućeg liječenja protiv HIV-a.
2 years After opening, the solution can be used up to the expiry date on the bottle.
2 godine Nakon otvaranja: otopina se može primjenjivati do isteka roka valjanosti navedenog na boci.
Baraclude contains lactose
Baraclude sadrži laktozu
Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to 1/10); uncommon (≥ 1/1,000 to < 1/100); rare(≥ 1/10,000 to < 1/1,000).
Učestalost se definira kao vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10.000 i < 1/1000).
For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available
Za djecu i adolescente (od 2 do manje od 18 godina): Dostupne su Baraclude oralna otopina ili Baraclude 0,5 mg tablete
Baraclude should not be used during pregnancy unless clearly necessary.
Baraclude se ne smije primjenjivati tijekom trudnoće, osim ako to stvarno nije neophodno.
How to take BARACLUDE Not all patients need to take the same dose of Baraclude.
Ne moraju svi bolesnici uzimati istu dozu lijeka Baraclude.
In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM).
Uz to, visoke izloženosti entekaviru nisu imale štetne učinke na γ polimerazu ili sintezu mitohondrijske DNK u HepG2 stanicama (Ki > 160 µM).
HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa
HBV DNK < 50 IU/ml i HBeAg serokonverzijaa HBV DNK < 50 IU/mla HBeAg serokonverzijaa Normalizacija ALT-aa
Use the spoon as follows:
Koristite žlicu na sljedeći način:
HBV DNAa
HBV DNKa
Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.
Baraclude 0,05 mg/ml oralna otopina isporučuje se u boci koja sadrži 210 ml oralne otopine.
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
TEKST VANJSKE KUTIJE (ZA BOCU I BLISTERE) I TEKST NALJEPNICE NA BOCI
Baraclude must not be used during pregnancy unless specifically directed by your doctor.
Baraclude ne smijete uzimati tijekom trudnoće osim ako to nije izričita uputa liječnika.
The lower Cmax and AUC when taken with food is not considered to be of clinical relevance in nucleoside-naive patients but could affect efficacy in lamivudine-refractory patients (see section 4.2).
Niže Cmax i AUC kad se entekavir uzima s hranim ne smatraju se klinički značajnim u bolesnika prethodno neliječenih analozima nukleozida, ali mogle bi utjecati na djelotvornost u bolesnika refrakternih na lamivudin (vidjeti dio 4.2).
Also contains: maltitol, preservatives E216, E218.
POPIS POMOĆNIH TVARI Također sadrži: maltitol, konzervanse E216, E218.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
* for doses < 0.5 mg Baraclude oral solution is recommended.
* Za doze < 0,5 mg preporučuje se Baraclude oralna otopina.
It has not been demonstrated that Baraclude is safe to use during pregnancy.
Nije se dokazala sigurnost lijeka Baraclude tijekom trudnoće.
By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Nadmetanjem s prirodnim supstratom deoksigvanozinom TP, entekavir-TP funkcionalno inhibira 3 aktivnosti virusne polimeraze: (1) pripremanje HBV polimeraze, (2) reverznu transkripciju negativnog lanca DNK iz pregenomske glasničke RNK i (3) sintezu pozitivnog lanca HBV DNK.
Baraclude should be taken orally.
Baraclude se uzima peroralno.
Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml
Pomoćna tvar s poznatim učinkom 380 mg maltitola/ml 1,5 mg metilhidroksibenzoata/ml 0,18 mg propilhidroksibenzoata/ml 0,3 mg natrija/ml
Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Baraclude se može primijeniti u djece čija je jetra oštećena, ali još uvijek ispravno radi (kompenzirana bolest jetre)
A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended.
Preporučuje se smanjiti dnevnu dozu pomoću Baraclude oralne otopine, kako je prikazano u tablici.
If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Ako Vam liječnik da uputu da uzimate Baraclude na prazan želudac, to znači da ga morate uzeti najmanje 2 sata nakon obroka i najmanje 2 sata prije sljedećeg obroka.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijamaRMP-a..
Lactose: this medicinal product contains 120.5 mg of lactose in each 0.5 mg daily dose or 241 mg of lactose in each 1 mg daily dose.
Laktoza: Ovaj lijek sadrži 120,5 mg laktoze po 0,5 mg dnevne doze odnosno 241 mg laktoze po 1 mg dnevne doze.
- emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
Kumulativna vjerojatnost: - pojave genotipske ETVrc - genotipske ETVrc s virološkim probojemd
What you need to know before you take BARACLUDE Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Baraclude ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
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.
Mechanism of action: 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.
Mehanizam djelovanja: Entekavir, nukleozidni analog gvanozina koji je aktivan protiv HBV polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
The recommended once-daily dose in paediatric patients weighing at least 10 kg, is presented in the table below.
Preporučena doza koja se primjenjuje jednom dnevno u pedijatrijskih bolesnika tjelesne težine od najmanje 10 kg navedena je u sljedećoj tablici.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacijerizika).
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected 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.
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).
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci, blisteru ili kutiji iza oznake „EXP“.
Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium.
Natrij: Jedan ml lijeka sadrži 0,015 mmol (ili 0,3 mg) natrija.
Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija
UNIQUE IDENTIFIER - 2D BARCODE
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
The film-coated tablets (tablets) are pink and triangular-shaped.
Filmom obložene tablete (tablete) su ružičaste tablete trokutastog oblika.
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.
Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Parahidroksibenzoati: Baraclude oralna otopina sadrži konzervanse metilhidroksibenzoat i propilhidroksibenzoat, koji mogu uzrokovati alergijske reakcije (vjerojatno odgođene).
ALT normalisation (≤ 1 times ULN)
ALT normalizacija (≤ 1 puta GGN)
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.)
Baraclude 1 mg film-coated tablets Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other.
Baraclude 1 mg filmom obložene tablete Ružičasta tableta trokutastog oblika s utisnutom oznakom „BMS” na jednoj strani i „1612” na drugoj.
210 ml oral solution in a HDPE bottles with child-resistant closures (polypropylene).
210 ml oralne otopine u boci od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu (od polipropilena).
Baraclude oral solution is designed as a ready-to-use product.
Baraclude oralna otopina napravljena je kao lijek spreman za uporabu.
For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Za primjereno doziranje u pedijatrijskoj populaciji dostupne su Baraclude oralna otopina ili Baraclude 0,5 mg filmom obložene tablete.
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).
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets.
Boca od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu koja sadrži 30 filmom obloženih tableta.
At least 32.6 kgb
9,5 ml najmanje 32,6 kgb
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.
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 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.
Outer carton: Baraclude 1 mg
Kutija: Baraclude 1 mg
Baraclude oral solution comes with a measuring spoon with markings from 0.5 up to 10 milliliters.
Baraclude oralna otopina isporučuje se s mjernom žlicom s oznakama od 0,5 do 10 mililitara.
This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Ovaj lijek sadrži metilhidroksibenzoat (E218) i propilhidroksibenzoat (E216) koji mogu uzrokovati alergijske reakcije (moguće odgođene).
Albumin (≥1 X LLN)b
Albumin (≥1 x DGN)b
ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Normalizacija ALT-a (≤ 1 puta iznad GGN) nastupila je u 27% bolesnika liječenih entekavirom i 21% bolesnika liječenih lamivudinim na kraju doziranja.
You should not breast-feed during treatment with Baraclude.
Ne smijete dojiti tijekom liječenja lijekom Baraclude.
Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Jezgra tablete: krospovidon, laktoza hidrat, magnezijev stearat, mikrokristalična celuloza i povidon.
A lactose-free Baraclude oral solution is available for these individuals.
Za te je osobe dostupna Baraclude oralna otopina bez laktoze.
There are no recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.
Nema preporuka za doziranje lijeka Baraclude u djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
Breast-feeding should be discontinued during treatment with Baraclude.
Dojenje treba prekinuti tijekom liječenja lijekom Baraclude.
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).
Razvoj rezistencije HIVa opažen je kad se entekavir primjenjivao za liječenje kroničnog hepatitisa B u bolesnika s HIVinfekcijom koji nisu primali visoko aktivnu antiretrovirusnu terapiju (HAART) (vidjeti dio 5.1).
Also, lamivudine-refractory patients who achieved HBV DNA < 104 log10 copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n= 50] versus 60.5% [n= 135], respectively).
Također, bolesnici s bolešću refrakternom na lamivudin u kojih se postigla vrijednost HBV DNK < 104 log10 kopija/ml mjerena PCR-om u 24. tjednu imali su nižu stopu rezistencije od onih koji nisu postigli tu vrijednost (5-godišnja kumulativna vjerojatnost od 17,6% [n= 50] naspram 60,5% [n= 135]).
Each 1 mg film-coated tablet contains 241 mg lactose.
Jedna filmom obložena tableta od 1 mg sadrži 241 mg laktoze.
Clinical resistance in Adults: 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.
Klinička rezistencija u odraslih: 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.
Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Baraclude tablete primjenjuju se i za liječenje kronične (dugotrajne) HBV infekcije u djece i adolescenata u dobi od 2 godine do manje od 18 godina.
(96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Od ovih 57 bolesnika, 55 (96%) je imalo histološko poboljšanje kako je prethodno definirano (vidjeti gore), a 50 (88%) je imalo smanjenje fibroze za ≥ 1 boda prema Ishakovom indeksu fibroze.