natgillin/translations-raw huggingface dataset:
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Sebivo je indiciran za liječenje kroničnog hepatitisa B u odraslih bolesnika s kompenziranom bolešću jetre i dokazanom replikacijom virusa, trajno povišenim razinama serumske alanin aminotransferaze (ALT) i histološkim dokazom aktivne upale i/ili fibroze.
In reproductive toxicology studies in adult animals, fertility was slightly reduced when both male and female rats received telbivudine.
U ispitivanjima reproduktivne toksičnosti na odraslim životinjama, plodnost je bila blago smanjena kada su i mužjaci i ženke štakora primali telbivudin.
Women should not breastfeed if they are taking Sebivo.
Žene koje uzimaju Sebivo ne smiju dojiti.
By contrast, telbivudine-5'-triphosphate at concentrations up to 100 M did not inhibit cellular DNA polymerases , , or .
Nasuprot tome, telbivudin5'-trifosfat u koncentracijama do 100 M nije inhibirao staničnu DNK polimerazu ,  ni .
The tablet can be taken with or without food.
Tabletu možete uzimati sa ili bez hrane.
HBeAg-negative (n = 446)
HBeAg-negativni (n = 446)
Before pouring any solution into the cup, please check the position of the appropriate graduation to avoid any potential waste or spillage.
Prije nego što ulijete otopinu u čašu, provjerite položaj odgovarajuće graduacije kako biste izbjegli potencijalni gubitak ili prolijevanje otopine.
Child-resistant screw cap with a guarantee-ring.
Sigurnosni zatvarač za djecu s navojem sa sigurnosnim prstenom.
Before pouring any solution into the cup, please check the position of the 5 and 10 ml marks to avoid any potential waste or spillage.
Prije nego što ulijete otopinu u čašu, provjerite položaj oznaka za 5 i 10 ml kako biste izbjegli potencijalno bacanje ili prolijevanje otopine.
For both HBeAg-positive and HBeAg-negative patients, week 24 HBV DNA results were a predictor of long-term favourable outcomes.
I u HBeAg-pozitivnih i negativnih bolesnika, rezultati HBV DNK u 24. tjednu su predviđali dugoročne povoljne ishode.
Table 9 Pharmacokinetic parameters (mean  SD) of telbivudine in subjects with various degrees of renal function
Tablica 9 Farmakokinetički parametri (srednja vrijednost  SD) telbivudina u ispitanika s različitim stupnjevima bubrežne funkcije
There are no data on telbivudine treatment in patients with established adefovir-resistant hepatitis B virus single mutations of rtN236T or A181V.
Ne postoje podaci o liječenju telbivudinom u bolesnika s ustanovljenom infekcijom virusom hepatitisa B rezistentnim na adefovir s jednostrukim rtN236T ili A181V mutacijama.
Most CK elevations were asymptomatic and CK values typically decreased by the next visit on continued treatment.
U većini je slučajeva porast kreatin kinaze bio asimptomatski, a vrijednosti kreatin kinaze su se tipično smanjivale do sljedećeg posjeta tijekom kontinuiranog liječenja.
Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness regardless of the degree of increases in creatine kinase (CK) levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Mogućnost da je riječ o miopatiji, koja se definira kao trajna i neobjašnjiva bol u mišićima i/ili mišićna slabost, bez obzira na stupanj porasta razina kreatin kinaze, potrebno je razmotriti u svakog bolesnika s difuznim, neobjašnjivim mialgijama, osjetljivošću mišića, mišićnom slabošću ili miozitisom (definiran kao miopatija s histološkim dokazom oštećenja mišića).
Use within 2 months of opening the bottle.
Oralnu otopinu potrebno je upotrijebiti u roku 2 mjeseca nakon otvaranja boce.
Sebivo may reduce the risk of passing your hepatitis B virus on to your unborn baby if taken in combination with Hepatitis B immune globulin and Hepatitis B vaccine.
Sebivo može smanjiti rizik od prenošenja virusa hepatitisa B na Vaše nerođeno dijete ako se uzima u kombinaciji s imunim globulinom protiv hepatitisa B i cjepivom protiv hepatitisa B.
Other medicines and Sebivo
Drugi lijekovi i Sebivo
Literature shows that exposure to telbivudine in the second and/or third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if telbivudine is given in addition to Hepatitis B immune globulin and Hepatitis B vaccine.
Literaturni podaci pokazuju da izloženost telbivudinu u drugom i/ili trećem tromjesečju trudnoće smanjuje rizik od prijenosa HBV-a s majke na dijete ako se telbivudin daje uz imuni globulin protiv hepatitisa B i cjepivo protiv hepatitisa B.
There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
Zasada nema podataka o djelotvornosti i sigurnosti kombinacija telbivudina s ostalim antiviroticima.
Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy including telbivudine (see section 4.4).
Egzacerbacije hepatitisa B nakon prekida liječenja Zabilježene su teške, akutne egzacerbacije hepatitisa B u bolesnika koji su prekinuli terapiju hepatitisa B uključujući telbivudin (vidjeti dio 4.4).
The incidence of post-treatment alanine aminotransferase (ALT) flares in the two treatment arms are further described in Table 4 below.
Incidencija porasta alanin aminotransferaze (ALT) nakon liječenja u obje skupine bolesnika je dodatno opisana niže u Tablici 4.
Table 1 Dosing regimen adjustment of Sebivo in patients with renal impairment
Tablica 1 Prilagođavanje sheme doziranja Sebiva u bolesnika s oštećenjem bubrega
For patients with detectable HBV DNA after 24 weeks of therapy, treatment modification should be considered.
U bolesnika u kojih se nakon 24 tjedna terapije ustanovi HBV DNK potrebno je razmotriti promjenu liječenja.
A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Ispitivanje u kojem je istražena kombinacija telbivudina, 600 mg na dan, i pegiliranog interferona alfa-2a, 180 µg jedanput tjedno supkutanom primjenom, ukazuje da je ova kombinacija povezana s povećanim rizikom od razvoja periferne neuropatije.
• The mean Ishak score of 2.2 (SD 1.1) at baseline improved (p < 0.0001) to 0.9 (SD 1.0) with a mean change of -1.3 (SD 1.3).
• Prosječan Ishak skor od 2,2 (SD 1,1) na početku, poboljšan je (p <0,0001) na 0,9 (SD 1,0) sa srednjom promjenom od -1,3 (SD 1,3).
See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Za detalje ispitivanja i specifične karakteristike bolesnika na kojima se temelji ova indikacija vidjeti dio 5.1.
N/A = not applicable * Virological breakthrough: “1 log above nadir” definition assessed at week 104
N/P = nije primjenjivo * Virusni proboj: procijenjeno u 104. tjednu prema definiciji “1 log iznad najniže vrijednosti”
Simultaneously press down (2a) and turn the child resistant cap (2b) to the left to open the bottle.
2. Istovremeno pritisnite (2a) i zakrenite sigurnosni zatvarač za djecu (2b) na lijevo kako biste otvorili bocu.
Sebivo has not been investigated in co-infected hepatitis B patients (e.g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Sebivo nije ispitivan u bolesnika s hepatitisom B i drugom istodobnom infekcijom (npr. u bolesnika koji su istodobno inficirani virusom humane imunodeficijencije [HIV], virusom hepatitisa C [HCV] ili virusom hepatitisa D [HDV]).
In adult rats, fertility was reduced when both male and female rats were treated with telbivudine at doses of 500 or 1000 mg/kg/day (lower fertility index compared to concurrent controls).
U odraslih štakora, plodnost je bila smanjena kada su i mužjaci i ženke štakora primili telbivudin u dozama od 500 ili 1000 mg/kg/dan (indeks plodnosti bio je niži u usporedbi s podudarnim kontrolama).
The most common adverse reactions were grade 3 or 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
Najčešće nuspojave bile su povišenje kreatin kinaze u krvi 3. ili 4. stupnja (6,8%), umor (4,4%), glavobolja (3,0%) i mučnina (2,6%).
Pack sizes: 28 or 98 film-coated tablets
Veličine pakiranja: 28 ili 98 filmom obloženih tableta
• The mean Knodell necroinflammatory score of 7.6 (SD 2.9) at baseline improved (p < 0.0001)
• Prosječan Knodellov nekroinflamatorni skor 7,6 (SD 2,9) na početku, poboljšan je (p <0,0001)
In rabbits doses of telbivudine providing exposure levels of 37 times those observed in humans at the therapeutic dose (600 mg) were associated with an increased incidence of abortion and early delivery.
U kunića su doze telbivudina s kojima su razine izloženosti bile 37 puta veće od onih uočenih u ljudi pri terapijskoj dozi (600 mg) bile povezane s povećanom incidencijom pobačaja i prijevremenog porođaja.
The effectiveness of dosing interval adjustment has not been clinically evaluated.
Učinkovitost prilagođavanja intervala doziranja nije klinički ispitana.
Severe acute exacerbations of chronic hepatitis B are relatively frequent, and are characterised by transient elevation of serum ALT.
Teške akutne egzacerbacije kroničnog hepatitisa B relativno su česte, a obilježava ih prolazni porast serumskog ALT-a.
In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
U bolesnika s kompenziranom bolešću jetre ovaj porast serumskog ALT-a općenito nije praćen povišenim razinama serumskog bilirubina, niti drugim znakovima dekompenzacije jetre.
The difference in populations is due to patient discontinuation from the study and missing HBV DNA assessment at week 52.
Razlika među populacijama posljedica je prekida sudjelovanja ispitanika u ispitivanju i izostanka određivanja HBV DNK u 52. tjednu.
An increased risk of developing peripheral neuropathy has been observed in one study when telbivudine and pegylated interferon alfa-2a were co-administered (see section 4.5).
Povećan rizik za razvoj periferne neuropatije uočen je pri istodobnoj primjeni telbivudina i pegiliranog interferona alfa-2a u jednom ispitivanju (vidjeti dio 4.5).
If peripheral neuropathy is suspected, treatment with telbivudine should be reconsidered (see section 4.8).
Ako se posumnja na perifernu neuropatiju, potrebno je razmotriti nastavak liječenja telbivudinom (vidjeti dio 4.8).
Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage.
Hepatitis B uzrokovan je infekcijom virusom hepatitisa B, koji se umnaža u jetri i uzrokuje oštećenja jetre.
Therefore, virological response should be closely monitored in patients with increased dosage interval (see sections 4.2 and 5.2).
Stoga u bolesnika s povećanim intervalom doziranja treba pažljivo pratiti virološki odgovor (vidjeti dijelove 4.2 i 5.2).
In addition, telbivudine does not alter the pharmacokinetics of lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate or ciclosporin.
Uz to, telbivudin ne mijenja farmakokinetiku lamivudina, adefovir dipivoksila, tenofovir dizoproksil fumarata ili ciklosporina.
Following dose interval adjustment for creatinine clearance, no additional dose modification is necessary during routine haemodialysis (see section 4.2).
Nakon prilagođavanja intervala doziranja prema klirensu kreatinina, nikakva druga prilagođavanja doze nisu nužna pri rutinskoj hemodijalizi (vidjeti dio 4.2).
Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/min, including patients on haemodialysis.
Telbivudin se eliminira prvenstveno izlučivanjem putem bubrega te se stoga preporučuje prilagođavanje intervala doziranja u bolesnika s klirensom kreatinina <50 ml/min, uključujući bolesnike na hemodijalizi.
Steady state was achieved after 5 to 7 days of once-daily administration with an approximate 1.5-fold accumulation in systemic exposure, suggesting an effective accumulation half-life of approximately 15 hours.
Stanje dinamičke ravnoteže postignuto je nakon 5 do 7 dana pri primjeni jedanput na dan, uz nakupljanje od približno 1,5 puta pri sustavnoj izloženosti, što pokazuje da efektivno poluvrijeme nakupljanja iznosi oko 15 sati.
Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Tijekom liječenja preporučuje se povremena provjera funkcije jetre (vidjeti dio 4.4).
In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Telbivudin se in vitro slabo veže (3,3%) na ljudske proteine plazme.
Do not chew, split or crush it.
Nemojte je žvakati, lomiti ni drobiti.
Telbivudine monotherapy is not an option for patients with established lamivudine-resistant hepatitis B virus infection.
Monoterapija telbivudinom nije izbor za bolesnike s ustanovljenom infekcijom hepatitis B virusom rezistentnim na lamivudin.
Clinical and virological efficacy endpoints were evaluated separately in the HBeAg-positive and HBeAg-negative patient populations.
Mjere ishoda kliničke i virološke djelotvornosti ispitivane su odvojeno u populacijama HBeAgpozitivnih i u HBeAg-negativnih bolesnika.
HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml).
Razine HBV DNK potrebno je pratiti tijekom 24 tjedna liječenja kako bi se osigurala potpuna supresija virusa (HBV DNK manji od 300 kopija/ml).
Stopping treatment with Sebivo may result in a worsening of your hepatitis B infection i.e. progression of the disease and abnormal test results (increase of viral load, ALT increase).
Prestanak liječenja Sebivom može dovesti do pogoršanja infekcije hepatitisom B, tj. do napredovanja bolesti i pojave poremećenih rezultata pretraga (porast virusnog opterećenja, porast ALT).
Holding the cup at eye level, carefully and slowly pour the solution from the bottle into the cup until it comes to about halfway between the 5 ml and 10 ml marks.
Držeći čašu u razini očiju, pažljivo i polako ulijte otopinu iz boce u čašu dok ne dođe do oko pola razine između oznake za 5 ml i 10 ml.
Simultaneously press down (2a) and turn the child-resistant cap (2b) to the left to open the bottle.
2. Istovremeno pritisnite prema dolje (2a) i zakrenite sigurnosni zatvarač za djecu (2b) na lijevo kako biste otvorili bocu.
The absence of activity of telbivudine against HIV has not been evaluated in clinical trials.
Izostanak djelovanja telbivudina protiv HIV-a nije bio procjenjivan u ispitivanjima.
HBeAg-negative patients: The mean age of patients was 43 years, 79% were male, 65% were Asian, 23% were Caucasian, and 11% had previously received alfa-interferon therapy.
HBeAg-negativni bolesnici: Srednja dob bolesnika bila je 43 godine, 79% bili su muškarci, 65% bili su Azijati, 23% bili su bijelci, a 11% ih je ranije primalo terapiju interferonom alfa.
Swallow the entire contents of the dosing cup immediately.
Odmah progutajte cjelokupni sadržaj dozirne čaše.
A small number (total of 98) of Caucasian patients were treated with telbivudine.
Malen broj bolesnika bijele rase (ukupno 98) liječeno je telbivudinom.
Study NV-02B-015
Ispitivanje NV-02B-015
Do not stop Sebivo unless your doctor tells you to.
Sebivo nemojte prestati uzimati, osim ako Vam to ne kaže liječnik.
Genotypic analysis of 50 HBV isolates from telbivudine-treated patients at week 208 (CLDT600A2303) revealed a similar resistance profile as reported at week 104.
Genotipska analiza 50 HBV izolata od bolesnika liječenih telbivudinom koji su uzimani u 208. tjednu (CLDT600A2303) pokazala je profil rezistencije sličan onom koji je uočen u 104. tjednu.
Immediately swallow the solution direct from the syringe.
Odmah progutajte otopinu izravno iz štrcaljke.
In the 104-week clinical studies, reported adverse reactions were usually classified as mild or moderate in severity.
U ispitivanjima u trajanju od 104 tjedana, prijavljene nuspojave najčešće su bile klasificirane kao blage do umjerene s obzirom na težinu.
Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B) may affect plasma concentrations of telbivudine and/or the coadministered substance.
Budući da se telbivudin eliminira prvenstveno izlučivanjem putem bubrega, primjena Sebiva istodobno s drugim tvarima koje utječu na bubrežnu funkciju (npr. aminoglikozidi, diuretici s djelovanjem na petlju, spojevi platine, vankomicin, amfotericin B) može utjecati na koncentracije u plazmi telbivudina i/ili tvari koja se s njime istodobno primjenjuje.
Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring.
Sebivo 20 mg/ml oralna otopina isporučuje se kao 300 ml bistre, bezbojne do blijedo žute oralne otopine u smeđoj staklenoj boci s bijelim polipropilenskim sigurnosnim zatvaračem za djecu koji uključuje polietilenski zatvarač i sigurnosni prsten.
No evidence of impaired fertility was seen in other studies when either male or female rats were treated at doses up to 2000 mg/kg/day and mated with untreated rats (systemic exposure levels approximately 6-14 times higher than those achieved in humans).
Nije bilo dokaza smanjene plodnosti u drugim ispitivanjima u kojima su ili mužjaci ili ženke štakora primili doze do 2000 mg/kg/dan i parili se sa štakorima koji nisu primili telbivudin (razine sustavne izloženosti bile su približno 6-14 puta više od onih dostignutih u ljudi).
White to slightly yellowish, oval film-coated tablet, imprinted with “LDT” on one side.
Bijela do blago žućkasta, ovalna filmom obložena tableta s otisnutom oznakom “LDT” na jednoj strani.
Patients with undetectable HBV DNA at week 24 had better outcomes at 156 and 208 weeks (Table 8).
U bolesnika u kojih razina HBV DNK u 24. tjednu nije bila mjerljiva, imali su bolje ishode u 156. i 208. tjednu (Tablica 8).
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Razine ALT-a i HBV DNK u serumu nakon prestanka liječenja treba redovito pratiti kako bi se otkrio bilo koji kasni virusni recidiv.
Telbivudine
Telbivudin
For Ishak Fibrosis Score, improvement measured as ≥ 1 point reduction in Ishak Fibrosis Score from baseline to week 52.
Za skor fibroze po Ishaku, poboljšanje izmjereno kao smanjenje za ≥1 boda od početka liječenja do 52. tjedna, mjereno prema skoru fibroze po Ishaku.
The cumulative genotypic rates by week 104 were 25.1% (115/458) for HBeAg-positive patients and 10.8% (24/222) for HBeAg-negative patients.
Kumulativna stopa genotipske rezistencije u 104. tjednu bila je 25,1% (115/458) za HBeAg-pozitivne bolesnike i 10,8% (24/222) za HBeAg-negativne bolesnike.
The no observed adverse effect level (NOAEL) for effects on fertility or mating parameters amounted to 250 mg/kg/day, which provided exposure levels 2.5 to 2.8 times higher than those achieved in humans with normal renal function at the therapeutic dose.
Razina bez zapaženih štetnih događaja (engl. no observed adverse effect level, NOAEL) za učinke na parametre plodnosti ili parenja odgovarala je količini od 250 mg/kg/dan, čime su se dobile razine izloženosti 2,5 do 2,8 puta više od onih postignutih u ljudi s normalnom bubrežnom funkcijom kod primjene terapijske doze.
Push the plunger slowly and carefully until the solution reaches the 6 ml mark.
Gurajte klip polako i pažljivo dok otopina ne dođe do oznake za 6 ml.
The telbivudine area under the plasma concentration-time curve (AUC0-∞) was 28.0  8.5 gh/ml (mean  SD).
Površina ispod krivulje ovisnosti koncentracije u plazmi o vremenu (AUC0-∞) za telbivudin iznosila je 28,0  8,5 gh/ml (srednja vrijednost  SD).
The pharmacokinetics of telbivudine have been studied in patients (without chronic hepatitis B) with various degrees of hepatic impairment and in some patients with decompensated liver disease.
Farmakokinetika telbivudina ispitivana je u bolesnika (bez kroničnog hepatitisa B) s različitim stupnjevima oštećenja jetre i u nekih bolesnika s dekompenziranom bolešću jetre.
Combination of telbivudine with pegylated or standard interferon alfa (see sections 4.4 and 4.5).
Kombinacija telbivudina s pegiliranim ili standardnim interferonom alfa (vidjeti dijelove 4.4 i 4.5).
Rinse the cup and syringe with clean water.
12. Isperite čašu i štrcaljku čistom vodom.
Based on the results shown in Table 9, adjustment of the dose interval for telbivudine is recommended in patients with creatinine clearance of  50 ml/min (see sections 4.2 and
Na temelju rezultata prikazanih u Tablici 9, bolesnicima s klirensom kreatinina <50 ml/min preporučuje se prilagođavanje intervala doziranja za telbivudin (vidjeti dijelove 4.2 i 4.4).
Preparing a 6 ml dose of medicine using the oral syringe
Priprema doze lijeka od 6 ml korištenjem štrcaljke za usta
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment.
Nakon što prekinete liječenje Sebivom, liječnik će pratiti Vaše zdravstveno stanje i redovito obavljati krvne pretrage radi provjere stanja jetre, jer se infekcija hepatitisom B može pogoršati ili postati vrlo ozbiljna nakon prestanka liječenja.
How to take Sebivo
Kako uzimati Sebivo
Nonetheless, there have also been reports of severe - and sometimes fatal - post-treatment disease exacerbations.
No bilo je i izvještaja o teškim egzacerbacijama bolesti nakon prekida liječenja, ponekad i sa smrtnim ishodom.
Sebivo is to be taken orally, with or without food.
Način primjene Sebivo se uzima peroralno, sa ili bez hrane.
Grade 3 or 4 CK elevations newly occurred in 15.9% of patients treated with telbivudine for 208 weeks.
Porast kreatin kinaze stupnja 3 ili 4 ponovno se pojavio u 15,9% bolesnika liječenih telbivudinom tijekom 208 tjedana.
If you are on a controlled sodium diet, ask your doctor for advice.
Ako uzimate hranu s kontroliranim sadržajem natrija, obratite se Vašem liječniku za savjet.
• In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBsAg seroconversion or there is evidence of loss of efficacy.
• u HBeAg-pozitivnih bolesnika koji nemaju cirozu, liječenje treba primjenjivati najmanje 6 do 12 mjeseci nakon potvrđene HBe serokonverzije (nestanak HBeAg i nestanak HBV DNK uz detekciju anti-HBe) ili do HBs serokonverzije ili do pojave dokaza o gubitku djelotvornosti.
Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Ugradnja telbivudin-5'trifosfata u virusnu DNK izaziva prekid lanca DNK, rezultirajući inhibicijom umnažanja HBV-a.
There are no adequate efficacy and safety data in patients with decompensated cirrhosis.
Ne postoje podaci o djelotvornosti i sigurnosti u bolesnika s dekompenziranom cirozom.
UNIQUE IDENTIFIER - HUMAN READABLE DATA [folding box only]
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM [samo na kutiji]
In the juvenile toxicology study, rats were treated from day 14 to day 70 post-partum and were mated with rats receiving the same treatment (no sibling mating).
U toksikološkom ispitivanju na mladim životinjama, štakori su primali telbivudin od 14. do 70. dana nakon okota i parili su se sa štakorima koji su primali jednako liječenje (braća/sestre se nisu parili).