FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Croatian: Liječenje analozima nukleozida treba prekinuti u slučaju brzog povišenja razina aminotransferaza, progresivne hepatomegalije ili metaboličke acidoze/laktacidoze nepoznatog podrijetla.
English: Treatment with 10 mg adefovir dipivoxil has not been shown to be effective against HIV replication and therefore should not be used to control HIV infection.
Croatian: Liječenje s 10 mg adefovirdipivoksila nije se pokazalo djelotvornim u sprječavanju replikacije HIV-a te se stoga ne smije koristiti za kontrolu infekcije HIV-om.
English: Histological improvement was seen regardless of baseline demographic and hepatitis B characteristics, including prior interferon-alpha therapy.
Croatian: Histološko poboljšanje uočeno je neovisno o početnim demografskim karakteristikama i karakteristikama hepatitisa B, uključujući tu i prethodnu terapiju alfa-interferonom.
English: The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and frequency (see Table 1).
Croatian: Nuspojave koje se smatraju barem moguće povezanima s liječenjem navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti (vidjeti tablicu 1).
English: The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.
Croatian: Nije poznat odnos između odgovora na liječenje i dugoročnih ishoda kao što su hepatocelularni karcinom ili dekompenzirana ciroza.
English: • Tell your doctor at once if you could be allergic to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
Croatian: • Odmah obavijestite svog liječnika ako biste mogli biti alergični na adefovir, adefovirdipivoksil ili neki drugi sastojak Hepsere.
English: Adefovir dipivoxil
Croatian: Adefovirdipivoksil
English: • lamivudine-resistant HBV with either compensated or decompensated liver disease, including patients pre- and post-liver transplantation or co-infected with HIV.
Croatian: • HBV-om rezistentnim na lamivudin i kompenziranom ili dekompenziranom bolešću jetre uključujući pacijente prije i nakon transplantacije jetre ili one istovremeno zaražene HIV-om.
English: Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/day.
Croatian: Nefrotoksičnost je primijećena u životinja prilikom sistemskih izloženosti najmanje 3 do 10 puta većih od onih postignutih kod ljudi pri preporučenoj terapijskoj dozi od 10 mg/dan.
English: Hepsera contains lactose
Croatian: Hepsera sadrži laktozu
English: Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Croatian: Hepsera se koristi za liječenje kroničnog hepatitisa B, infekcije koju uzrokuje virus hepatitisa B (HBV), u odraslih.
English: • Don't stop taking Hepsera without your doctor's advice.
Croatian: • Nemojte prekidati liječenje Hepserom bez prethodnog savjetovanja s liječnikom.
English: Hepsera 10 mg tablets are round, white to off-white tablets.
Croatian: Hepsera 10 mg tablete su okrugle, bijele do gotovo bijele tablete.
English: It is recommended that mothers being treated with adefovir dipivoxil do not breast-feed their infants.
Croatian: Preporučuje se da majke liječene adefovirdipivoksilom ne doje svoju djecu.
English: Plasma adefovir concentrations declined in a biexponential manner with a median terminal elimination half-life of 7.22 h (4.72-10.70 h).
Croatian: Koncentracije adefovira u plazmi opadaju bieksponencijalno uz medijan terminalnog poluvremena eliminacije od 7,22 h (4,72-10,70 h).
English: On the basis of these data, the frequency of these adverse drug reactions is calculated to be 0.4% corresponding to the frequency category uncommon.
Croatian: Na temelju navedenih podataka izračunato je da učestalost navedenih nuspojava iznosi 0,4 %, što odgovara kategoriji učestalosti „manje često“.
English: Paediatric population:
Croatian: Pedijatrijska populacija:
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i pakiranju iza oznake „EXP“.
English: No differences in the median fibrosis score were seen between groups using the Knodell fibrosis score.
Croatian: Nisu uočene razlike u medijanu rezultata na ljestvici fibroze između skupina prema Knodellovoj ljestvici fibroze.
English: In a long-term safety study of 125 HBeAg negative patients with compensated liver disease, the adverse event profile was overall unchanged after a median exposure of 226 weeks.
Croatian: U ispitivanjima dugoročne sigurnosti primjene u 125 pacijenata negativnih na HBeAg s kompenziranom bolešću jetre, profil nuspojava ukupno je bio nepromijenjen nakon medijana izloženosti od 226 tjedana.
English: Higher doses must not be administered.
Croatian: Ne smiju se primjenjivati više doze.
English: The median (min-max) renal clearance of adefovir in subjects with normal renal function (Clcr > 80 ml/min) is 211 ml/min (172-316 ml/min), approximately twice calculated creatinine clearance (Cockroft-Gault method).
Croatian: Medijan (min.-maks.) bubrežnog klirensa adefovira u ispitanika s normalnom bubrežnom funkcijom (Clcr > 80 ml/min) iznosi 211 ml/min (172-316 ml/min), što je približno dvostruka vrijednost izračunatog klirensa kreatinina (Cockroft-Gault metoda).
English: These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained.
Croatian: Ove pacijente treba pomno nadzirati radi mogućih nuspojava te kako bi se potvrdila održanost djelotvornosti.
English: In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ml at or beyond 1 year of treatment.
Croatian: Kako bi se smanjio rizik od rezistencije u pacijenata koji primaju monoterapiju adefovirdipivoksilom potrebno je uzeti u obzir promjenu liječenja ako serumski HBV DNK ostane iznad 1000 kopija/ml za vrijeme ili nakon godine dana liječenja.
English: By the end of the study, 7 of 12 patients (58 %) with bridging fibrosis or cirrhosis at baseline, had an improved Ishak fibrosis score of ≥ 2 points.
Croatian: Do kraja ispitivanja, 7 od 12 pacijenata (58%) s premoštavajućom fibrozom ili cirozom na početku liječenja, imalo je poboljšan rezultat na Ishakovoj ljestvici fibroze za ≥ 2 boda.
English: • Weakness
Croatian: • slabost
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Improvement in liver function was also seen after one year of therapy.
Croatian: Nakon godine dana terapije uočeno je i poboljšanje jetrene funkcije.
English: There are no data on the effect of adefovir dipivoxil on transmission of HBV from mother to infant.
Croatian: Nema podataka o učinku adefovirdipivoksila na prijenos HBV-a s majke na dijete.
English: Co-infection with hepatitis C or D: There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C or hepatitis D.
Croatian: Istovremena infekcija hepatitisom C ili D: Nema podataka o djelotvornosti adefovirdipivoksila u pacijenata istovremeno zaraženih hepatitisom C ili D.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: While the overall risk of renal impairment in patients with adequate renal function is low, this is of special importance in patients both at risk of or having underlying renal dysfunction, and also in patients receiving medicinal products that may affect renal function.
Croatian: Dok je ukupni rizik od oštećenja funkcije bubrega u pacijenata s odgovarajućom bubrežnom funkcijom nizak, ovo je osobito važno za pacijente u kojih je taj rizik prisutan ili koji već imaju postojeći poremećaj bubrežne funkcije, kao i one koji primaju lijekove koji mogu oštetiti bubrežnu funkciju.
English: Paediatric population: Hepsera is not recommended for use in children below the age of 18 years due to limitations of the available data on safety and efficacy (see section 5.1).
Croatian: Pedijatrijska populacija: Hepsera se ne preporučuje za primjenu u djece mlađe od 18 godina zbog nedovoljno podataka o sigurnosti i djelotvornosti (vidjeti dio 5.1).
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Croatian: Benigni probavni simptomi kao što su mučnina, povraćanje i bol u trbuhu mogu ukazivati na razvoj laktacidoze.
English: - In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Croatian: - U HBeAg pozitivnih pacijenata bez ciroze, liječenje treba provoditi najmanje 6 do 12 mjeseci nakon potvrde serokonverzije HBe (gubitak HbeAg-a i HBV DNK-a s detekcijom anti-HBe) ili do serokonverzije HBs ili gubitka djelotvornosti (vidjeti dio 4.4).
English: {MM/YYYY}
Croatian: NN: {broj}
English: Resistance: Resistance to adefovir dipivoxil (see section 5.1) can result in viral load rebound which may result in exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to liver decompensation and possible fatal outcome.
Croatian: Rezistencija: Rezistencija na adefovirdipivoksil (vidjeti dio 5.1) može uzrokovati povratak (rebound) virusnog opterećenja, što može rezultirati egzacerbacijom hepatitisa B i, u uvjetima oslabljene jetrene funkcije, uzrokovati dekompenzaciju jetre s mogućim smrtonosnim ishodom.
English: In these clinical studies patients had active viral replication (HBV DNA ≥ 100,000 copies/ml) and elevated ALT levels (≥ 1.2 x Upper Limit of Normal (ULN)).
Croatian: U ovim kliničkim ispitivanjima pacijenti su imali aktivnu replikaciju virusa (HBV DNK ≥ 100 000 kopija/ml) i povišene razine ALT-a (≥ 1,2 x gornja granica normale (GGN)).
English: • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis.
Croatian: • kompenziranom bolešću jetre i dokazom aktivne replikacije virusa, dugotrajno povišenom serumskom razinom alanin-aminotransferaze (ALT) i histološkim dokazom aktivne upale jetre i fibroze.
English: Adefovir dipivoxil is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti adefovirdipivoksil tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: On the basis of an algorithm defining possible proximal renal tubulopathy and/or Fanconi syndrome as confirmed abnormalities, 28 cases of proximal renal tubulopathy (including possible Fanconi syndrome) were retrieved in the clinical safety dataset.
Croatian: Na temelju algoritma koji definira moguću proksimalnu bubrežnu tubulopatiju i/ili Fanconijev sindrom kao potvrđene abnormalnosti, u kliničkim skupovima podataka o sigurnosti primjene pronađeno je 28 slučajeva proksimalne bubrežne tubulopatije (uključujući mogući Fanconijev sindrom).
English: In patients who develop renal insufficiency and have advanced liver disease or cirrhosis, dosing interval adjustment of adefovir or switch to an alternative therapy for hepatitis B infection should be considered.
Croatian: U pacijenata koji razviju bubrežnu insuficijenciju i imaju uznapredovalu bolest jetre ili cirozu, potrebno je razmotriti prilagodbu intervala doziranja adefovira ili prebacivanje na drugu terapiju infekcije hepatitisa B.
English: Method of administration Hepsera tablets should be taken once daily, orally with or without food.
Croatian: Način primjene Tablete Hepsere treba uzimati peroralno jedanput na dan sa ili bez hrane.
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Croatian: Serumske razine ALT i HBV DNK treba redovito pratiti nakon prekida liječenja kako bi se uočio bilo koji znak kasnog virološkog pogoršanja.
English: Cmax (ng/ml) AUC0-∞ (ng·h/ml) CL/F (ml/min) CLrenal (ml/min)
Croatian: Cmax (ng/ml) AUC0-∞ (ng·h/ml)
English: Patients with advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation which may be fatal.
Croatian: Pacijenti s uznapredovalom bolešću jetre ili cirozom mogu biti pod povećanim rizikom od dekompenzacije jetre nakon egzacerbacije hepatitisa, što može biti smrtonosno.
English: To differentiate between elevations in transaminases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Croatian: Da bi se povišenje transaminaza zbog odgovora na liječenje razlikovalo od povišenja koje može biti povezano s laktacidozom, liječnici trebaju provjeriti jesu li promjene ALT-a povezane s poboljšanjima drugih laboratorijskih biljega kroničnog hepatitisa B.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj}
English: The primary dose-limiting toxic effect associated with administration of adefovir dipivoxil in animals (mice, rats and monkeys) was renal tubular nephropathy characterised by histological alterations and/or increases in blood urea nitrogen and serum creatinine.
Croatian: Primarni toksični učinak koji ograničava dozu povezan s primjenom adefovirdipivoksila u životinja (miševi, štakori i majmuni) bila je bubrežna tubularna nefropatija karakterizirana histološkim promjenama i/ili porastom dušika iz ureje u krvi i kreatinina u serumu.
English: If viral rebound occurs, resistance testing should be performed.
Croatian: U slučaju povratka virusnog opterećenja treba provesti testiranje rezistencije.
English: Adefovir was not mutagenic in microbial mutagenicity assays involving Salmonella typhimurium (Ames) and Escherichia coli in the presence and absence of metabolic activation.
Croatian: Adefovir nije pokazao mutageno djelovanje u testovima mikrobne mutagenosti koji su uključivali Salmonellu typhimurium (Ames) i Escherichiu coli u prisutnosti i odsutnosti metaboličke aktivacije.
English: • vancomycin and aminoglycosides, used for bacterial infections
Croatian: • vankomicin ili aminoglikozide koji se koriste za liječenje bakterijskih infekcija
English: Caution should be exercised when prescribing adefovir dipivoxil to the elderly, keeping in mind the greater frequency of decreased renal or cardiac function in these patients, and the increase in concomitant diseases or concomitant use of other medicinal products in the elderly.
Croatian: Treba biti oprezan prilikom propisivanja adefovirdipivoksila starijim pacijentima, imajući u vidu veću učestalost smanjene bubrežne i srčane funkcije u ovih pacijenata te veći broj istovremeno prisutnih bolesti ili istovremenu primjenu drugih lijekova u starijih osoba.
English: Absorption: The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59 %.
Croatian: Apsorpcija: Oralna bioraspoloživost adefovira iz 10 mg adefovirdipivoksila je 59%.
English: After reviewing the description of the cases, 5 cases of possible proximal renal tubulopathy and/or Fanconi syndrome were sufficiently well documented with no alternative aetiology and/or having a temporal association with Hepsera treatment.
Croatian: Nakon ocjene opisa ovih slučajeva zaključeno je da je 5 slučajeva moguće proksimalne bubrežne tubulopatije i/ili Fanconijevog sindroma bilo dovoljno dobro dokumentirano i bez alternativne etiologije i/ili vremenski povezano s liječenjem lijekom Hepsera.
English: The silica gel desiccant is contained in either a separate sachet or a small canister and should not be swallowed.
Croatian: Silika gel se nalazi u maloj vrećici ili malom spremniku te se ne smije progutati.
English: Adefovir diphosphate has an intracellular half-life of 12 to 36 hours in activated and resting lymphocytes.
Croatian: Adefovir difosfat ima unutarstanični poluživot od 12 do 36 sati u aktiviranim limfocitima te onima u stanju mirovanja.
English: Hepsera is indicated for the treatment of chronic hepatitis B in adults with:
Croatian: Hepsera je indicirana za liječenje kroničnog hepatitisa B u odraslih s:
English: White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Croatian: Bijele do gotovo bijele, okrugle, plosnate tablete s ukošenim rubovima, promjera 7 mm, s utisnutim znakom „GILEAD“ i „10“ na jednoj strani te stiliziranim oblikom jetre na drugoj strani.
English: Studies in orally dosed animals do not indicate teratogenic or foetotoxic effects.
Croatian: Ispitivanja na životinjama kojima je lijek davan peroralno ne ukazuju na teratogene ili fetotoksične učinke.
English: Paediatric population: The pharmacokinetics of adefovir dipivoxil were studied in an efficacy and safety study of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged 2 to < 18 years).
Croatian: Pedijatrijska populacija:Farmakokinetički podaci za adefovirdipivoksil proučavani su u ispitivanjima djelotvornosti i sigurnosti dnevne doze od 0,25 mg/kg do 10 mg adefovirdipivoksila u djece (u dobi od 2 do < 18 godina).
English: - In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Croatian: - U HBeAg negativnih pacijenata bez ciroze, liječenje treba provoditi najmanje do pojave serokonverzije HBs ili dokazanog gubitka djelotvornosti.
English: Hepsera [outer packaging only]
Croatian: [samo vanjsko pakiranje]
English: Animal studies do not indicate harmful effects of adefovir dipivoxil on male and female fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke adefovirdipivoksila na mušku ili žensku plodnost.
English: Hepatic impairment: Pharmacokinetic properties were similar in patients with moderate and severe hepatic impairment compared to healthy volunteers (see section 4.2).
Croatian: Oštećenje funkcije jetre: Farmakokinetička svojstva bila su slična u pacijenata s umjerenim do jakim oštećenjem funkcije jetre u usporedbi sa zdravim dobrovoljcima (vidjeti dio 4.2).
English: Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Croatian: Bez obzira na to, postoji mogući rizik od odabira sojeva HIV-a koji su rezistentni na adefovir s mogućom križnom rezistencijom na druge antiretrovirusne lijekove.
English: Linearity/non-linearity: The pharmacokinetics of adefovir are proportional to dose when given as adefovir dipivoxil over the dose range of 10 to 60 mg.
Croatian: Linearnost/nelinearnost: Farmakokinetika adefovira proporcionalna je dozi kad se daje kao adefovirdipivoksil u rasponu doza od 10 do 60 mg.
English: Studies in animals administered adefovir intravenously have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama kojima je intravenski davan adefovir pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: High baseline ALT levels (≥ 2 x ULN) and Knodell Histology Activity Index (HAI) scores (≥ 10) and low HBV DNA (< 7.6 log10 copies/ml) were associated with greater histological improvement.
Croatian: Visoke početne razine ALT-a (≥ 2 x GGN) i visok Knodellov indeks histološke aktivnosti (HAI) (≥ 10) te niska razina HBV DNK (< 7,6 log10 kopija/ml) bili su povezani s većim histološkim poboljšanjem.
English: A high rate (30%) of hepatic flares was reported following discontinuation of adefovir dipivoxil during the 3 years open-label phase of the study.
Croatian: Visoka stopa (30%) pogoršanja jetrene bolesti prijavljena je nakon prekida primjene adefovirdipivoksila tijekom 3 godine otvorene faze ispitivanja.
English: Renal failure, abnormal renal function, hypophosphatemia
Croatian: zatajenje bubrega, abnormalna bubrežna funkcija, hipofosfatemija
English: In patients with decompensated liver disease, adefovir should always be used in combination with a second agent, without cross-resistance to adefovir, to reduce the risk of resistance and to achieve rapid viral suppression.
Croatian: U pacijenta s dekompenziranom bolešću jetre, adefovir treba uvijek primjenjivati u kombinaciji s drugim lijekom bez križne rezistencije na adefovir, kako bi se smanjio rizik od rezistencije i postgla brza supresija virusa.
English: With up to 3 years of exposure, no patients receiving both adefovir dipivoxil and lamivudine developed resistance to adefovir dipivoxil.
Croatian: Uz izloženost u trajanju do 3 godine, nijedan pacijent koji je primao i adefovirdipivoksil i lamivudin nije razvio rezistenciju na adefovirdipivoksil.
English: It is recommended to administer adefovir dipivoxil (one 10 mg tablet) every 48 hours in these patients.
Croatian: Kod ovih pacijenata preporučuje se primjena adefovirdipivoksila (jedna tableta od 10 mg) svakih 48 sati.
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation (see section 4.8).
Croatian: U pacijenata s kompenziranom bolešću jetre, ovi porasti serumskog ALT-a općenito nisu popraćeni porastom serumske koncentracije bilirubina ili dekompenzacijom jetre (vidjeti dio 4.8).
English: The proposed dose interval modification is based on extrapolation of limited data in patients with end stage renal disease (ESRD) and may not be optimal.
Croatian: Predložena prilagodba intervala doziranja temelji se na ekstrapolaciji ograničenih podataka u pacijenata u završnom stadiju bubrežne bolesti te možda nije optimalna.
English: Clinically and statistically significant improvement in fibrosis was seen in the changes in Ishak scores from the start of adefovir dipivoxil treatment to the end of the study (week 240) (median change: Δ= -1).
Croatian: Klinički i statistički značajno poboljšanje fibroze uočeno je u promjenama rezultata na Ishakovoj ljestvici od početka liječenja adefovirdipivoksilom do kraja ispitivanja (240. tjedan) (promjena medijana vrijednosti: Δ= -1).
English: • Inflammation of the pancreas (pancreatitis)
Croatian: • upala gušterače (pankreatitis)
English: In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4 %, over the adefovir concentration range of 0.1 to 25 μg/ml.
Croatian: In vitro vezivanje adefovira na proteine ljudske plazme ili seruma iznosi ≤ 4% u rasponu koncentracije adefovira od 0,1 do 25 μg/ml.
English: Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with 10 mg adefovir dipivoxil (see section 4.4).
Croatian: Klinički i laboratorijski dokaz egzacerbacije hepatitisa dogodio se nakon prekida liječenja s 10 mg adefovirdipivoksila (vidjeti dio 4.4).
English: Skin and subcutaneous tissue disorders: Common:
Croatian: Poremećaji kože i potkožnog tkiva: Često:
English: Adefovir can be removed by haemodialysis; the median haemodialysis clearance of adefovir is 104 ml/min.
Croatian: Adefovir se može ukloniti hemodijalizom; a medijan vrijednosti klirensa adefovira hemodijalizom je 104 ml/min.