FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Croatian: Opaženo je konzistentno sniženje razine mokraćne kiseline u serumu u bolesnika u kojih su primjenjivane niske doze acetilsalicilatne kiseline u placebom kontroliranim kliničkim ispitivanjima, u kombinaciji s alopurinolom ili febuksostatom.
English: Atropisomer 1 is extensively metabolised by CYP2C9 whereas atropisomer 2 is minimally metabolised by both CYP2C9 and CYP3A4.
Croatian: Atropoizomer 1 opsežno se metabolizira putem CYP2C9, dok se atropoizomer 2 minimalno metabolizira i putem CYP2C9 i CYP3A4.
English: Serious renal-related adverse reactions, e.g. acute renal failure and renal impairment, were reported in patients treated with lesinurad 400 mg (1%) and placebo (0.4%) and in no patients on lesinurad 200 mg.
Croatian: Ozbiljne nuspojave povezane s bubrezima, npr. akutno zatajenje bubrega i oštećenje funkcije bubrega, prijavljene su u bolesnika liječenih lesinuradom u dozi od 400 mg (1%) i placebom (0,4%), te nisu prijavljene u bolesnika liječenih lesinuradom u dozi od 200 mg.
English: Continuous treatment with Zurampic decreases the frequency of gout flares.
Croatian: Kontinuirano liječenje lijekom Zurampic smanjuje učestalost akutnih napadaja gihta.
English: In the randomised, double-blind, placebo-controlled combination therapy clinical studies, the incidences of patients with adjudicated Major Adverse Cardiovascular Events (CV death, non-fatal myocardial infarction or non-fatal stroke) per 100 patient-years of exposure were: 0.71 (95% CI 0.23, 2.21) for placebo, 0.96 (95% CI 0.36, 2.57) for Zurampic 200 mg, and 1.94 (95% CI 0.97, 3.87) for Zurampic 400 mg, when used in combination with a xanthine oxidase inhibitor.
Croatian: Major Adverse Cardiovascular Events) (KV smrt, ne-fatalni infarkt miokarda ili nefatalni moždani udar) na 100 bolesnik-godina izloženosti bile su: 0,71 (95% CI 0,23, 2,21) za placebo, 0,96 (95% CI 0,36, 2,57) za Zurampic u dozi od 200 mg te 1,94 (95% CI 0,97, 3,87) za Zurampic u dozi od 400 mg, kada se primjenjuje u kombinaciji s inhibitorom ksantin oksidaze.
English: How to take Zurampic
Croatian: Kako uzimati Zurampic
English: Look out for side effects
Croatian: Obratite pažnju na nuspojave
English: Consistent serum uric acid lowering was observed in patients who were receiving thiazide diuretics in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Croatian: Opaženo je konzistentno sniženje razine mokraćne kiseline u serumu u bolesnika u kojih su primjenjivani tiazidni diuretici u placebom kontroliranim kliničkim ispitivanjima, u kombinaciji s alopurinolom ili febuksostatom.
English: The stability of the sustained response was demonstrated with a greater proportion of patients treated with Zurampic 200 mg in combination with allopurinol achieving the target serum uric acid level at each visit for 3 consecutive months (Months 4, 5 and 6) compared to patients treated with placebo in combination with allopurinol (see Table 2).
Croatian: Stabilnost održanog odgovora na liječenje dokazana je s većim udjelom u bolesnika liječenih lijekom Zurampic u dozi od 200 mg u kombinaciji s alopurinolom koji su postigli ciljnu razinu mokraćne kiseline u serumu pri svakom posjetu tijekom 3 uzastopna mjeseca (4., 5. i 6. mjesec) u usporedbi s bolesnicima liječenjima placebom u kombinaciji s alopurinolom (vidjeti Tablicu 2).
English: Your doctor will check how well your kidneys are working before starting and during treatment with Zurampic.
Croatian: Vaši bubrezi prije početka i tijekom liječenja lijekom Zurampic.
English: Campus 21, Liebermannstraße A01/501 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
Croatian: 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
English: In three 12-month placebo-controlled trials of Zurampic in combination with a xanthine oxidase inhibitor versus a xanthine oxidase inhibitor alone (placebo), serum creatinine elevations between 1.5fold and 2-fold over baseline occurred in 3.9% of patients on Zurampic 200 mg, 10.0% of patients on Zurampic 400 mg and 2.3% on placebo; serum creatinine elevations 2-fold or greater over baseline occurred in 1.8% of patients on Zurampic 200 mg, 6.7% of patients on Zurampic 400 mg and 0% on placebo.
Croatian: U tri 12-mjesečna placebom kontrolirana ispitivanja lijeka Zurampic u kombinaciji s inhibitorom ksantin oksidaze u usporedbi sa samo inhibitorom ksantin oksidaze (uz placebo), razina serumskog kreatinina povisila se za 1,5 do 2 puta u odnosu na početnu vrijednost u 3,9% bolesnika liječenih lijekom Zurampic u dozi od 200 mg, 10% bolesnika liječenih lijekom Zurampic u dozi od 400 mg te 2,3% bolesnika liječenih placebom; do dvostrukog ili većeg povišenja razine serumskog kreatinina u odnosu na početnu vrijednost došlo je u 1,8% bolesnika u kojih je primjenjivan Zurampic u dozi od 200 mg, te 6,7% bolesnika u kojih je primjenjivan Zurampic u dozi od 400 mg i u 0% bolesnika koji su primali placebo.
English: CYP2C9 inhibitors and inducers
Croatian: Inhibitori i induktori CYP2C9
English: EU/1/15/1080/005 100x1 film-coated tablets (unit dose)
Croatian: EU/1/15/1080/005 100x1 filmom obloženih tableta (jedinična doza)
English: In both studies, significantly more patients treated with Zurampic 200 mg in combination with allopurinol achieved the target serum uric acid level of less than 6 mg/dL by Month 6 and by Month 12 compared with patients receiving placebo in combination with allopurinol (see Table 2).
Croatian: U oba ispitivanja, značajno je više bolesnika liječenih lijekom Zurampic u dozi od 200 mg u kombinaciji s alopurinolom postiglo ciljnu razinu mokraćne kiseline u serumu manju od 6 mg/dl do šestog i do dvanaestog mjeseca u usporedbi s bolesnicima u kojih je primijenjen placebo u kombinaciji s alopurinolom (vidjeti Tablicu 2).
English: Table 3 Proportion of patients with baseline sUA ≥5.0 mg/dLwho achieve target serum uric acid levels (<5 mg/dL) with Zurampic in combination with febuxostat
Croatian: Tablica 3 Udio bolesnika s početnom vrijednosti sUA >5,0 mg/dl koji su postigli ciljne razine mokraćne kiseline u serumu (<5 mg/dl) uz liječenje lijekom Zurampic u kombinaciji s febuksostatom
English: The most common adverse reaction leading to discontinuation of Zurampic was blood creatinine increased
Croatian: Najčešća nuspojava koja je dovela do prekida primjene lijeka Zurampic bila je povišen kreatinin u krvi (0,8%).
English: Table 2 Proportion of patients who achieved target serum uric acid levels (<6mg/dL) with Zurampic in combination with allopurinol - Pooled data from CLEAR1 and CLEAR2 studies
Croatian: Tablica 2 Udio bolesnika koji su postigli ciljne razine mokraćne kiseline u serumu (<6 mg/dl) uz primjenu lijeka Zurampic u kombinaciji s alopurinolom - združeni podaci iz ispitivanja CLEAR1 i CLEAR2 Udio bolesnika koji su postigli ciljnu razinu mokraćne kiseline u serumu (<6,0 mg/dl) N (%)
English: How to store Zurampic
Croatian: Kako čuvati Zurampic
English: Treatment should be interrupted in patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, and measure serum creatinine promptly.
Croatian: Liječenje treba prekinuti i što prije izmjeriti serumski kreatinin u bolesnika koji prijave simptome koji mogu upućivati na akutnu uričnu nefropatiju, uključujući bol u slabinama, mučninu ili povraćanje.
English: Adverse reactions related to renal function can occur after initiating Zurampic (see section 4.8).
Croatian: Nakon početka primjene lijeka Zurampic, mogu se javiti nuspojave povezane s funkcijom bubrega (vidjeti dio 4.8).
English: Indigo Carmine Brilliant Blue FCF
Croatian: Ovojnica tablete hipromeloza titanijev dioksid triacetin boja Indigo Carmine boja Brilliant Blue FCF
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Grünenthal GmbH
English: Zurampic should not be restarted without another explanation for the serum creatinine abnormalities.
Croatian: Ako ne postoji drugo objašnjenje za abnormalnosti serumskog kreatinina, primjena lijeka Zurampic se ne smije ponovno započeti.
English: Zurampic 200 mg film-coated tablets lesinurad
Croatian: Zurampic 200 mg filmom obložene tablete lesinurad
English: Primary end-point in patients with renal impairment Consistent with the overall population, the proportion of patients with mild to moderate renal impairment (eCrCL 30-89 mL/min) who achieved target serum uric acid levels at Month 6 was 56% for Zurampic 200 mg versus 29% for placebo when added to allopurinol, and 40% for Zurampic 200 mg versus 26% for placebo when added to febuxostat in patients with baseline sUA ≥5.0 mg/dL.
Croatian: U skladu sa sveukupnom populacijom, udio bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (eCrCL od 30 do 89 ml/min) koji su postigli ciljne razine mokraćne kiseline u serumu nakon 6 mjeseci bio je 56% za Zurampic u dozi od 200 mg, naspram 29% za placebo, kada su se primjenjivali u kombinaciji s alopurinolom, te 40% za Zurampic u dozi od 200 mg, naspram 26% za placebo kada su se primjenjivali u kombinaciji s febuksostatom u bolesnika s početnom vrijednosti sUA >5,0 mg/dl.
English: Zurampic 200 mg film-coated tablets
Croatian: Zurampic 200 mg filmom obložene tablete
English: A higher incidence of serum creatinine elevations and renal-related adverse reactions including serious adverse reactions was observed with Zurampic 400 mg when given alone or in combination with a xanthine oxidase inhibitor, with the highest incidence when Zurampic was given as monotherapy.
Croatian: Kada se Zurampic primjenjivao u dozi od 400 mg, samostalno ili u kombinaciji s inhibitorom ksantin oksidaze, opažena je veća incidencija povišenja serumskog kreatinina i nuspojava povezanih s bubrezima, uključujući i ozbiljne nuspojave, uz najvišu incidenciju kada se Zurampic primjenjivao kao monoterapija.
English: Acute gouty attacks (gout flares)
Croatian: Akutni napadaji gihta
English: Zurampic contains lactose
Croatian: Zurampic sadrži laktozu
English: Lesinurad should only be used in combination with a xanthine oxidase inhibitor because combination use reduces the amount of uric acid available for excretion and decreases the risk of renal-related events.
Croatian: Lesinurad primijenjen u kombinaciji s inhibitorom ksantin oksidaze povećava izlučivanje i smanjuje stvaranje mokraćne kiseline, što rezultira jačim sniženjem sUA. Lesinurad se smije primjenjivati samo u kombinaciji s inhibitorom ksantin oksidaze zato što primjena u kombinaciji smanjuje količinu mokraćne kiseline dostupne za izlučivanje i smanjuje rizik od događaja povezanih s bubrezima.
English: Zurampic should not be initiated in kidney transplant recipients.
Croatian: Primjena lijeka Zurampic ne smije se započeti u primatelja presatka bubrega.
English: (200 mg) in patients with mild renal impairment (eCrCL 60 to 89 mL/min), 20% and 73% higher (200 mg) and 3% and 50% higher (400 mg) in patients with moderate renal impairment (eCrCL 30 to 59 mL/min), and 13% higher and 113% higher (400 mg) in patients with severe renal impairment (eCrCL <30 mL/min).
Croatian: Nakon primjene jednokratne doze lesinurada u osoba s oštećenjem funkcije bubrega, u usporedbi s onima koji imaju normalnu funkciju bubrega, vrijednosti Cmax odnosno AUC lesinurada bile su 36% odnosno 30% veće (200 mg) u bolesnika s blagim oštećenjem funkcije bubrega (eCrCL 60 do 89 ml/min), 20% odnosno 73% veće (200 mg) i 3% odnosno 50% (400 mg) veće u bolesnika s umjerenim oštećenjem funkcije bubrega (eCrCL 30 do 59 ml/min) te 13% više odnosno 113% veće (400 mg) u bolesnika s teškim oštećenjem funkcije bubrega (eCrCL <30 ml/min).
English: EU/1/15/1080/004 98 film-coated tablets
Croatian: EU/1/15/1080/004 98 filmom obloženih tableta
English: Monitor for decreased efficacy when Zurampic is co-administered with a CYP2C9 inducer.
Croatian: Potrebno je pratiti bolesnika zbog smanjene djelotvornosti kada se Zurampic primjenjuje istodobno s induktorima CYP2C9.
English: Zurampic in combination with febuxostat in tophaceous gout CRYSTAL enrolled gout patients with measurable tophi.
Croatian: Zurampic u kombinaciji s febuksostatom kod gihta s tofima
English: Fertility
Croatian: Nefrolitijaza
English: Effects on serum uric acid and urinary excretion of uric acid In healthy subjects, lesinurad 200 mg lowered sUA levels and increased renal clearance and fractional excretion of uric acid.
Croatian: U zdravih ispitanika, lesinurad u dozi od 200 mg snizio je razinu mokraćne kiseline u serumu i povisio bubrežni klirens i frakcijsko izlučivanje mokraćne kiseline.
English: EU/1/15/1080/003 30 film-coated tablets
Croatian: EU/1/15/1080/003 30 filmom obloženih tableta
English: EU/1/15/1080/002 28 film-coated tablets
Croatian: EU/1/15/1080/002 28 filmom obloženih tableta
English: EU/1/15/1080/001 10 film-coated tablets
Croatian: EU/1/15/1080/001 10 filmom obloženih tableta
English: Thiazide diuretics
Croatian: Tiazidni diuretici
English: - each Zurampic 200mg film-coated tablet (tablet) contains 200mg of lesinurad.
Croatian: Što Zurampic sadrži - djelatna tvar je lesinurad. - svakaZurampic 200mg filmom obložena tableta(tableta) sadrži200mg lesinurada.
English: Zurampic does not need to be discontinued because of a gout flare.
Croatian: U slučaju akutnog napadaja gihta nije potrebno prekinuti primjenu lijeka Zurampic.
English: Pharmacotherapeutic group: Antigout preparations, preparations increasing uric acid excretion ATC code: M04AB05
Croatian: Farmakoterapijska skupina: Pripravci za liječenje gihta, pripravci koji povećavaju izlučivanje mokraćne kiseline
English: Gout flares may occur after initiation of therapy with Zurampic.
Croatian: Nakon početka liječenja lijekom Zurampic mogu se javiti akutni napadaji gihta.
English: Hepatic impairment
Croatian: Bubrežni događaji
English: Timepoint
Croatian: ROK VALJANOSTI
English: Tel: +39 02 4305 1
Croatian: Grünenthal Italia S.r.l. Tel: +39 02 4305 1
English: Renal failure** Renal impairment Nephrolithiasis
Croatian: Klinički ishodi - povlačenje i smanjenje tofa
English: This summary was last updated in 10-2014.
Croatian: Sažetak je posljednji put ažuriran u 10. 2014.
English: The full EPAR for Temozolomide Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Temozolomide Hexal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose of Temozolomide Hexal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Croatian: Doza Temozolomide Hexal ovisi o tjelesnoj površini bolesnika (izračunava se pomoću visine i tjelesne težine bolesnika) u rasponu od 75 do 200 mg/m2 jednom na dan.
English: Temozolomide Hexal should be taken without food.
Croatian: Temozolomide Hexal treba uzimati bez hrane.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Hexal.
Croatian: Bolesnici će možda također trebati uzeti lijekove da bi spriječili povraćanje prije uzimanja lijeka Temozolomide Hexal.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temozolomide Hexal.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Temozolomide Hexal.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Croatian: • odraslih bolesnika i djece od navršene tri godine starosti s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom, koji je recidivirao ili napreduje nakon standardne terapije.
English: For more information about treatment with Temozolomide Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Temozolomide Hexal pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Hexal.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Temozolomide Hexal.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Hexal is being used alone or with other treatments, and how the patient responds to treatment.
Croatian: Doza i broj doza ovise o tipu tumora koji se liječi, o činjenici je li bolesnik ranije primio terapiju, koristi li se lijek Temozolomide Hexal kao monoterapija ili u kombinaciji s drugom terapijom te kako bolesnik odgovara na terapiju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Hexal on 15 March 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Temozolomide Hexal na snazi u Europskoj uniji od 15. ožujka 2010.
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Croatian: To rezultira nemogućnošću diobe stanica i usporavanjem rasta tumora
English: This means that Temozolomide Hexal is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Croatian: To znači da je Temozolomide Hexal sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Temodal.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Croatian: • odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom (agresivnim tipom malignog glioma).
English: Because Temozolomide Hexal is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Temozolomide Hexal generički lijek i bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Temozolomide Hexal is used first with radiotherapy and then on its own;
Croatian: Temozolomide Hexal se prvo koristi istodobno s radioterapijom (RT), a zatim kao monoterapija;
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Hexal has been shown to have comparable quality and to be bioequivalent to Temodal.
Croatian: CHMP je zaključio kako je, u skladu s preduvjetima EU-a, potvrđeno kako Temozolomide Hexal posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Temodal.
English: Temozolomide Hexal is a ‘generic medicine'.
Croatian: Temozolomide Hexal je „generički lijek”.
English: Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Temodal, koristi nadmašuju utvrđene rizike.
English: The Committee recommended that Temozolomide Hexal be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Temozolomide Hexal.
English: Treatment with Temozolomide Hexal should be prescribed by a doctor with experience in the treatment of brain tumours.
Croatian: Terapiju lijekom Temozolomide Hexal smiju propisivati samo liječnici s iskustvom u liječenju tumora mozga.
English: Other information about Temozolomide Hexal
Croatian: Ostale informacije o lijeku Temozolomide Hexal
English: Temozolomide Hexal temozolomide
Croatian: Temozolomide Hexal temozolomid
English: Because Temozolomide Hexal is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Croatian: Budući da je Temozolomide Hexal generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Temodal.
English: What are the benefit and risk of Temozolomide Hexal?
Croatian: Koje su koristi i rizici lijeka Temozolomide Hexal?
English: Temozolomide Hexal is used on its own in these patients.
Croatian: Temozolomide Hexal se koristi kao monoterapija u ovih bolesnika.
English: The active substance in Temozolomide Hexal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Croatian: Djelatna tvar lijeka Temozolomide Hexal, temozolomid, ubraja se u grupu citostatika pod nazivom alkilirajući pripravci.
English: Temozolomide Hexal is a medicine that contains the active substance temozolomide.
Croatian: Temozolomide Hexal je lijek koji sadrži djelatnu tvar temozolomid.
English: Why has Temozolomide Hexal been approved?
Croatian: Zašto je lijek Temozolomide Hexal odobren?
English: What is Temozolomide Hexal?
Croatian: Što je Temozolomide Hexal?
English: What is Temozolomide Hexal used for?
Croatian: Za što se Temozolomide Hexal koristi?
English: How is Temozolomide Hexal used?
Croatian: Kako se Temozolomide Hexal koristi?
English: How does Temozolomide Hexal work?
Croatian: Kako djeluje Temozolomide Hexal?
English: How has Temozolomide Hexal been studied?
Croatian: Kako je Temozolomide Hexal ispitivan?
English: Content (concentration)
Croatian: Unutarnje pakiranje Sadržaj (koncentracija)
English: 1 spray container
Croatian: 1 sprej za nos
English: Baraclude is taken once a day.
Croatian: Baraclude se uzima jednom na dan.
English: This can happen during the treatment, or after it has been stopped.
Croatian: To se može dogoditi tijekom liječenja ili nakon što se terapija prekine.
English: The full EPAR for Baraclude can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Baraclude nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients also need to know that they may also suffer a worsening of their liver disease.
Croatian: Bolesnici moraju također znati da može doći i do pogoršanja u bolesti jetre.
English: Viral suppression has also been shown in children.
Croatian: Virusna supresija je dokazana i u djece.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Baraclude na snazi u Europskoj uniji od 26. lipnja 2006.
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Croatian: Ako se liječenje smatra primjerenim u slučaju djece, doza ovisi o njihovoj tjelesnoj težini.
English: It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).
Croatian: Dostupan je u tabletama (0,5 mg i 1 mg) i kao peroralna otopina (0,05 mg/ml).
English: The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Croatian: Doza od 0,5 mg može se uzimati sa ili bez hrane, no doza od 1 mg mora se uzeti najmanje 2 sata prije ili 2 sata nakon obroka.
English: Other information about Baraclude
Croatian: Ostale informacije o lijeku Baraclude
English: Baraclude entecavir
Croatian: Baraclude entekavir
English: The treatment duration is determined by how the patient responds.
Croatian: Trajanje liječenja određuje se ovisno o tome kako bolesnik reagira na lijek.
English: This is a summary of the European public assessment report (EPAR) for Baraclude.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Baraclude.