FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and 2.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 1.5 fold while the Cmax of the active metabolite decreased (0.52 fold change).
Croatian: Nakon primjene umjerenog inhibitora CYP3A4 eritromicin propionata (500 mg dvaput dnevno tijekom 9 dana) kod zdravih ženskih dobrovoljaca, Cmax i AUC ulipristalacetata povećali su se za 1,2 odnosno 2,9 puta, a AUC aktivnog metabolita ulipristalacetata povećala se za 1,5 puta dok se Cmax aktivnog metabolita smanjila (za 0,52 puta).
English: Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - glavobolja - osjećaj vrtnje (vrtoglavica) - bol u trbuhu, osjećaj mučnine - akne - bol u mišićima i kostima (koštano-mišićna bol) - vrećica tekućine unutar jajnika (cista na jajnicima), osjetljivost/bol u dojkama, bol u donjem dijelu trbuha (zdjelici) - navale vrućine - premorenost (umor) - porast tjelesne težine.
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose, respectively, p=0.027).
Croatian: U ispitivanju 4, u 61,9% odnosno 72,7% bolesnica amenoreja je postignuta na kraju prvog i drugog ciklusa liječenja zajedno (doza od 5 mg, odnosno 10 mg, p=0,032).
English: NA N=202 N=192
Croatian: NP N=199 N=191 NP N=202 N=192
English: How to store Esmya
Croatian: Kako čuvati Esmyu
English: Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - krvarenje iz nosa - probavne tegobe, nadutost - pucanje vrećice s tekućinom unutar jajnika (puknuće ciste na jajnicima) - oticanje dojki.
English: Physician's guide to prescribing
Croatian: Vodič za liječnika za propisivanje lijeka Esmya
English: Hot flush
Croatian: Navale vrućine (valunzi)
English: 10 mg/day N=132
Croatian: 10 mg/ dan N=132
English: Liver function tests must be performed before starting treatment.
Croatian: Prije početka liječenja potrebno je napraviti testove jetrene funkcije.
English: - Certain medicines used to treat epilepsy (e.g. phenytoin, fosphenytoin, phenobarbital,
Croatian: - Određeni lijekovi koji se koriste za liječenje epilepsije (primjerice, fenitoin, fosfenitoin,
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 10 mg/day N=176
Croatian: 10 mg/ dan N=176
English: 10 mg/day N=107
Croatian: 10 mg/ dan N=107
English: Esmya 5 mg tablets Ulipristal acetate
Croatian: Esmya 5 mg tablete ulipristalacetat
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja*
English: Ulipristal acetate is excreted in human milk.
Croatian: Ulipristalacetat se izlučuje u majčino mlijeko u ljudi.
English: If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding,
Croatian: Ako tijekom ponovljenog intermitentnog liječenja, nakon početnog smanjenja krvarenja ili amenoreje dođe do promijenjenog perzistentnog ili neočekivanog uzorka krvarenja kao što je intermenstrualno krvarenje treba napraviti pretrage endometrija, uključujući biopsiju endometrija, kako bi se isključilo postojanje neke druge bolesti u podlozi, uključujući malignu bolest endometrija.
English: In addition, an additional check of your liver 2-4 weeks after your treatment has stopped should be done.
Croatian: Osim toga, 2 do 4 tjedna nakon prestanka liječenja bit će provedena dodatna provjera Vaše jetre.
English: Ulipristal acetate 10 mg/day N=94
Croatian: ulipristalacetat 10 mg/dan N=94
English: These changes return to normal after treatment is stopped and your periods restart.
Croatian: Te se promjene povlače nakon prekida liječenja te nakon ponovnog početka mjesečnice.
English: PATIENT CARD
Croatian: Kartica za bolesnicu
English: Patient card
Croatian: KARTICA ZA BOLESNICU
English: Drug hypersensitivity
Croatian: Preosjetljivost na lijek
English: Ulipristal acetate 5 mg/day N=93
Croatian: ulipristalacetat 5 mg/dan N=93
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Angioedema
Croatian: Hipofiza
English: Amenorrhea Endometrial thickening*
Croatian: Poremećaji reproduktivnog sustava i dojki amenoreja zadebljanje endometrija*
English: Microcrystalline cellulose Mannitol
Croatian: 6.1 Popis pomoćnih tvari celuloza, mikrokristalična manitol karmelozanatrij, umrežena talk magnezijev stearat
English: Renal and urinary disorders
Croatian: Poremećaji bubrega i mokraćnog sustava urinarna inkontinencija
English: Drug hypersensitivity*
Croatian: Poremećaji imunološkog sustava preosjetljivost na lijek*
English: Ulipristal acetate 5 mg/day N=95
Croatian: ulipristalacetat 5 mg/dan N=95
English: Endometrial thickening
Croatian: Zadebljanje endometrija
English: Ulipristal acetate 10 mg/day N=95
Croatian: ulipristalacetat 10 mg/dan N=95
English: Pituitary
Croatian: omaglica
English: Dry mouth Constipation
Croatian: Poremećaji probavnog sustava bol u trbuhu mučnina suha usta konstipacija dispepsija flatulencija
English: Blood triglycerides increased
Croatian: (trigliceridi) što je vidljivo u krvnim pretragama.
English: See also section 2 Warnings and precautions.
Croatian: Vidjeti i dio 2.
English: Musculoskeletal pain
Croatian: Krvarenje iz maternice
English: Never share needles.
Croatian: Nikada nemojte dijeliti igle.
English: Take care not to infect other people
Croatian: Pazite da ne zarazite druge osobe
English: • Risk Management plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: The next dose should be taken at the usual time.
Croatian: Sljedeća doza treba se uzeti u uobičajeno vrijeme.
English: Talk to your doctor.
Croatian: Porazgovarajte sa svojim liječnikom.
English: These mutations most likely are compensatory mutations.
Croatian: Ove mutacije su najvjerojatnije kompenzatorne mutacije.
English: If you take more Sebivo than you should
Croatian: Ako uzmete više Sebiva nego što ste trebali
English: Do not pour it back into the bottle as this could cause contamination.
Croatian: Ne vraćajte je u bocu jer bi to moglo uzrokovati kontaminaciju.
English: The primary data analysis was conducted after all patients had reached week 52.
Croatian: Primarna analiza podataka je provedena nakon što su svi bolesnici dosegli 52. tjedan.
English: The majority of the population enrolled was Asian.
Croatian: Najveći dio uključenih bolesnika bili su Azijati.
English: Your doctor will decide which treatment is most appropriate for you.
Croatian: Vaš liječnik će odlučiti koja je terapija najprimjerenija za Vas.
English: If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.
Croatian: Ako je prijavljen bilo koji od ovih simptoma, potrebno je napraviti detaljni pregled mišića kako bi se procijenila mišićna funkcija.
English: The median treatment duration was 104 weeks.
Croatian: Medijan trajanja liječenja bio je 104 tjedana.
English: The proposed dose modifications are based on extrapolation and may not be optimal.
Croatian: Predloženo prilagođavanje doze temelji se na ekstrapolaciji i možda nije optimalno.
English: Sebivo may also cause other side effects:
Croatian: Sebivo može također izazvati druge nuspojave:
English: Telbivudine did not show any carcinogenic potential.
Croatian: Telbivudin nije pokazao nikakav kancerogeni potencijal.
English: < 30 (not requiring dialysis)
Croatian: <30 (kojima ne treba dijaliza)
English: The combination of telbivudine with these medicinal products should be used with caution.
Croatian: Kombinaciju telbivudina s tim lijekovima treba s oprezom primjenjivati.
English: What Sebivo is and what it is used for
Croatian: Što je Sebivo i za što se koristi
English: Detailed instructions on how to use this are given in the section “Instructions for use”.
Croatian: Detaljne upute za njeno korištenje navedene su u dijelu “Upute za uporabu”.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Croatian: Ako osjećate omaglicu dok uzimate ovaj lijek, nemojte upravljati vozilom ili koristiti bilo kakve alate ili strojeve.
English: The most common HBV genotypes were B (26%) and C (51%).
Croatian: Najčešći HBV genotipovi bili su B (26%) i C (51%).
English: Titanium dioxide (E171) Macrogol
Croatian: Titanijev dioksid (E171) Makrogol
English: Swallow it whole with some water.
Croatian: Progutajte je cijelu, s malo vode.
English: Elderly (age above 65 years)
Croatian: Starijie osobe (iznad 65 godina starosti)
English: Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.
Croatian: Liječnik će s Vama raspraviti o mogućim rizicima uzimanja Sebiva tijekom trudnoće.
English: Treatment discontinuation should be considered as follows:
Croatian: Prekid liječenja treba razmotriti u sljedećim slučajevima:
English: - If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby.
Croatian: Ako imate hepatitis B i zatrudnite, porazgovarajte s liječnikom o tome kako možete najbolje zaštititi svoje dijete.
English: Close the bottle firmly.
Croatian: Čvrsto zatvorite bocu.
English: macrogol.
Croatian: makrogol.
English: The mechanism behind these events is not known (see section 4.4).
Croatian: Mehanizam iza tih događaja nije poznat (vidjeti dio 4.4).
English: Take Sebivo at about the same time each day.
Croatian: Uzimajte Sebivo svakoga dana u približno isto vrijeme.
English: Take the tablet at about the same time each day.
Croatian: Tabletu uzimajte svakoga dana u približno isto vrijeme.
English: What you need to know before you take Sebivo
Croatian: Što morate znati prije nego počnete uzimati Sebivo
English: No novel mutation was reported.
Croatian: Nije zabilježena niti jedna nova mutacija.
English: The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar.
Croatian: Sveukupni sigurnosni profil analiza u trajanju do 104 i 208 tjedana bio je sličan.
English: Pregnancy and breast-feeding - Do not use Sebivo during pregnancy unless your doctor recommends it.
Croatian: Trudnoća i dojenje - Sebivo nemojte uzimati tijekom trudnoće, osim ako Vam to ne preporuči liječnik.
English: Daily dose adjustment
Croatian: Prilagođavanje dnevne doze
English: SEM: Standard error of mean Roche COBAS Amplicor
Croatian: SEM: Standardna pogreška srednje vrijednosti Roche COBAS Amplicor
English: Week 52 Week 104 Week 156 Week 208
Croatian: 52. tjedan 104. tjedan 156. tjedan 208. tjedan
English: Please read these instructions carefully so that you know how to use the solution correctly.
Croatian: Pažljivo pročitajte ove upute da biste znali kako pravilno koristiti otopinu.
English: Do not change your dose or stop taking Sebivo without talking to your doctor.
Croatian: Ne mijenjajte dozu i nemojte prestati uzimati Sebivo bez prethodnog razgovora sa svojim liječnikom.
English: Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo.
Croatian: Neki ljudi mogu dobiti vrlo ozbiljne simptome hepatitisa kada prestanu uzimati lijekove kao što je Sebivo.
English: The clinical significance of these reductions has not been determined.
Croatian: Klinički značaj tih smanjenja nije utvrđen.
English: If you stop taking Sebivo
Croatian: Ako prestanete uzimati Sebivo
English: Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016
Croatian: Datum posljednje obnove odobrenja: 16. prosinca 2016.
English: Remove the dosing cup and open the bottle.
Croatian: Uklonite dozirnu čašu i otvorite bocu.
English: Patients should be followed closely.
Croatian: Bolesnike treba pažljivo pratiti.
English: HBV DNA at week 24
Croatian: HBV DNA u 24. tjednu
English: Genotypic mutation pattern and cross-resistance
Croatian: Obrazac genotipskih mutacija i križna rezistencija
English: If you forget to take Sebivo - If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its regular time.
Croatian: Ako ste zaboravili uzeti Sebivo - Ako zaboravite uzeti Sebivo, uzmite ga čim se sjetite i zatim uzmite Vašu sljedeću dozu prema uobičajenom rasporedu.
English: Note: If the amount poured into the cup exceeds the required dose, discard the excess in the sink.
Croatian: Napomena: Ako količina ulivena u čašu premašuje potrebnu dozu, višak odbacite u sudoper.
English: Optimal therapy should be guided by resistance testing.
Croatian: Optimalno liječenje treba biti vođeno ispitivanjem rezistencije.
English: HBV DNA should be monitored every 6 months to assure continued response.
Croatian: Razinu HBV DNK potrebno je pratiti svakih 6 mjeseci kako bi se osigurao kontinuirani odgovor.
English: Such increased risk cannot be excluded for other interferon alfa (pegylated or standard).
Croatian: Takav povećan rizik ne može se isključiti za druge interferone alfa (pegilirane ili standardne).
English: Predictability at week 24
Croatian: Predvidljivost u 24. tjednu
English: Muscle symptoms may progress and become serious, sometimes leading to muscle breakdown
Croatian: Mišićni simptomi se mogu pogoršati i postati ozbiljni te ponekad dovesti do razgradnje mišića
English: Tell your doctor or pharmacist if you are being treated with interferon.
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko se liječite interferonom.
English: Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.
Croatian: Ovisno o rezultatima tih pretraga, Vaš liječnik Vas može savjetovati da promijenite učestalost uzimanja
English: Therefore, close clinical monitoring is recommended in these patients.
Croatian: Stoga se u ovih bolesnika preporučuje pažljiv klinički nadzor.
English: Metabolism and nutrition disorders Rare*
Croatian: Poremećaji metabolizma i prehrane Rijetko*
English: Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades.
Croatian: Nemojte dijeliti osobne predmete na kojima može biti krvi ili drugih tjelesnih tekućina, poput četkica za zube ili britvica.
English: Effect of food on oral absorption
Croatian: Utjecaj hrane na oralnu apsorpciju
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Croatian: U slučaju produljenog liječenja duljeg od 2 godine, preporučuju se redovite ponovne procjene kojima se potvrđuje da je nastavak odabranog liječenja i dalje prikladan za bolesnika.
English: Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Croatian: Sebivo pripada skupini lijekova koji se nazivaju antivirusni lijekovi, a koriste se za liječenje infekcija izazvanih virusima.
English: Creatine kinase elevation
Croatian: Porast kreatin kinaze
English: Lactic acidosis is a rare but serious side effect which can occasionally be fatal.
Croatian: Laktacidoza je rijetka ali ozbiljna nuspojava, koja ponekad može biti i smrtonosna.
English: Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
Croatian: Hemodijaliza (do 4 sata) smanjuje sustavnu izloženost telbivudinu za otprilike 23%.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porođaj ni na postnatalni razvoj (vidjeti dio 5.3).
English: Hold the syringe above the cup.
Croatian: Držite štrcaljku iznad čaše.
English: A maximum tolerated dose of telbivudine has not been determined.
Croatian: Najveća podnošljiva doza telbivudina nije određena.
English: Patients with previous exposure to nucleoside/nucleotide analogues
Croatian: Bolesnici koji su prethodno bili izloženi nukleozidnim/nukleotidnim analozima
English: If a dose is missed, the patient may take the missed dose only up to 4 hours prior to the next scheduled dose.
Croatian: Ako se propusti doza, bolesnik može uzeti propuštenu dozu jedino do 4 sata prije sljedeće propisane doze.
English: On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1).
Croatian: Pokazalo se da je odgovor na liječenje u 24. tjednu prediktivan za dugotrajni odgovor (vidjeti tablicu 7. u dijelu 5.1).
English: Sebivo should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.
Croatian: Sebivo se u trudnoći smije primjenjivati samo ako korist za majku nadmašuje mogući rizik za plod.
English: Fertility was assessed in conventional studies performed in adult rats, and as part of a juvenile toxicology study.
Croatian: Plodnost je bila procjenjivana u konvencionalnim ispitivanjima provedenim na odraslim štakorima, te kao dio toksikološkog ispitivanja na mladim životinjama.
English: What Sebivo is and what it is used for What you need to know before you take Sebivo How to take Sebivo
Croatian: Što se nalazi u ovoj uputi Što je Sebivo i za što se koristi Što morate znati prije nego počnete uzimati Sebivo Kako uzimati Sebivo
English: Paediatrics and elderly (65 years age and above) Pharmacokinetic studies have not been conducted in paediatric or elderly subjects.
Croatian: Pedijatrijski bolesnici i starije osobe (65 godina i stariji) Nisu provedena ispitivanja farmakokinetike u pedijatrijskih ili starijih ispitanika.
English: If you cannot measure the prescribed amount precisely using the dosing cup alone, you should use the oral syringe.
Croatian: Ako ne možete precizno izmjeriti propisanu količinu koristeći samo dozirnu čašu, trebate upotrijebiti štrcaljku za usta.
English: Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Croatian: Zbog ograničenih dostupnih podataka (cirozu je imalo oko 3% uključenih bolesnika), telbivudin treba s posebnim oprezom primjenjivati u bolesnika s cirozom.
English: Duration of therapy The optimal treatment duration is unknown.
Croatian: Optimalno trajanje liječenja nije poznato.
English: Most grade 3 or 4 CK elevations were asymptomatic and transient.
Croatian: Većina porasta kreatin kinaze stupnja 3 ili 4 bilo je asimptomatsko i prolazno.
English: What Sebivo looks like and contents of the pack
Croatian: Kako Sebivo izgleda i sadržaj pakiranja
English: The concentration of telbivudine that effectively inhibited 50% of viral synthesis (EC50) was approximately 0.2 M.
Croatian: Koncentracija telbivudina koja je učinkovito inhibirala 50% sinteze virusa (EC50) iznosila je otprilike 0,2 M.
English: to 1.4 (SD 0.9) with a mean change of -6.3 (SD 2.8).
Croatian: na 1,4 (SD 0,9) sa srednjom promjenom od -6,3 (SD 2,8).
English: EU/1/07/388/001 28 film-coated tablets EU/1/07/388/002 98 film-coated tablets
Croatian: EU/1/07/388/001 28 filmom obloženih tableta EU/1/07/388/002 98 filmom obloženih tableta
English: There are no clinical data on the effects of telbivudine on male or female fertility.
Croatian: Ne postoje klinički podaci o učincima telbivudina na plodnost muškaraca ili žena.
English: Clinical results at week 104
Croatian: Klinički rezultati u 104. tjednu
English: Telbivudine is excreted in the milk of rats.
Croatian: Telbivudin se izlučuje u mlijeko ženki štakora.
English: Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment.
Croatian: Odmah obavijestite svog liječnika o bilo kojem novom ili neuobičajenom simptomu kojeg primijetite nakon prestanka liječenja.
English: However the ovarian and uterine parameters of those females mating successfully were unaffected.
Croatian: Međutim, parametri jajnika i maternice onih ženki koji su se uspješno parile nisu bili zahvaćeni.
English: If you have sexual intercourse with a partner who is not immune against hepatitis B, always use condoms and avoid any other exchange of body fluids.
Croatian: Ako imate spolni odnos s partnerom koji nije zaštićen protiv hepatitisa B, uvijek koristite kondom i izbjegavajte bilo koju drugu izmjenu tjelesnih tekućina.
English: Cases were more often secondary to other serious conditions (e.g. rhabdomyolysis) and/or associated with muscle-related events (e.g. myopathy, myositis).
Croatian: Slučajevi su češće bili posljedica drugih ozbiljnih stanja (npr. rabdomioliza) i/ili su bili povezani s događajima vezanim uz mišiće (npr. miopatija, miozitis).
English: Table 2 lists the adverse reactions according to MedDRA system organ class and frequency using the following convention: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Tablica 2 navodi nuspojave prema MedDRA klasifikaciji organskih sustava i učestalosti na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients who failed to achieve virological response following treatment with lamivudine for more than 24 weeks are unlikely to benefit from telbivudine monotherapy.
Croatian: Bolesnici koji nisu uspjeli postići virusni odgovor nakon liječenja lamivudinom u trajanju od više od 24 tjedna vjerojatno neće imati koristi od monoterapije telbivudinom.
English: - if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines.
Croatian: - ako ste zaraženi HIV-om, imate hepatitis C ili D, ili ako se liječite nekim antivirusnim lijekom.
English: Dizziness, headache
Croatian: Omaglica, glavobolja
English: Drink the solution or administer it to the patient immediately.
Croatian: Popijte otopinu ili je odmah dajte bolesniku.
English: Other side effects of this type of medicine
Croatian: Drugi učinci lijekova iz ove skupine
English: Limited clinical data (less than 300 pregnancy outcomes) after exposure to telbivudine during the first trimester of pregnancy indicate no malformative toxicity and a large amount of data (more than 1000 pregnancy outcomes) after exposure during the second and third trimesters indicate no foetal/neonatal toxicity.
Croatian: Ograničeni klinički podaci (manje od 300 ishoda trudnoće) nakon izloženosti telbivudinu tijekom prvog tromjesečja trudnoće ne ukazuju na malformativnu toksičnost, a velika količina podataka (više od 1000 ishoda trudnoće) nakon izloženosti tijekom drugog i trećeg tromjesečja ne ukazuje na fetalnu/neonatalnu toksičnost.
English: Children and adolescents Sebivo is not recommended for use in children and adolescents.
Croatian: Sebivo se ne preporučuje za primjenu u djece i adolescenata.
English: - However, if it is within 4 hours before your next dose, skip the dose you missed and take the next one at the usual time.
Croatian: - Međutim, ako je već unutar 4 sata za uzimanje sljedeće doze, izostavite propuštenu dozu i uzmite sljedeću u uobičajeno vrijeme.
English: The renal clearance of telbivudine approaches normal glomerular filtration rate, suggesting that filtration is the main mechanism of excretion.
Croatian: Bubrežni klirens telbivudina približava se normalnoj brzini glomerularne filtracije, što upućuje na zaključak da je filtracija glavni mehanizam izlučivanja.