FrancophonIA/ELRC3.0 huggingface dataset:
English: There are only limited data on the safety and efficacy of this dosing interval adjustment guideline.
Croatian: Postoje samo ograničeni podaci o sigurnosti i djelotvornosti ove smjernice za prilagodbu intervala doziranja.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Croatian: Kod produljenog liječenja na više od dvije godine, preporučuje se redovna ponovna procjena, kako bi se potvrdilo da je nastavak odabrane terapije odgovarajući za pacijenta.
English: No patients became HBsAg- or HBeAg-negative during the study.
Croatian: Nijedan pacijent nije postao HBsAg ili HBeAg negativan tijekom ispitivanja.
English: Increases in creatinine
Croatian: porast kreatinina
English: Five patients achieved and maintained HBsAg seroconversion (HBsAg negative/HBsAb positive).
Croatian: Pet pacijenata postiglo je i održalo serokonverziju HBsAg (HBsAg negativni/HBsAb pozitivni).
English: The available data do not appear to indicate any difference in pharmacokinetics with regard to race.
Croatian: Čini se da dostupni podaci ne ukazuju na nikakvu razliku u farmakokinetici s obzirom na rasu.
English: Your doctor should run tests to check your kidneys and liver are working properly, before and during your treatment.
Croatian: Liječnik treba napraviti pretrage kako bi provjerio rade li Vaši bubrezi i jetra pravilno prije i za vrijeme ovog liječenja.
English: Hepsera can be taken with or without food.
Croatian: Hepsera se može uzimati s hranom ili bez nje.
English: Lactic acidosis occurs more often in women, particularly if they are very overweight.
Croatian: Laktacidoza se javlja češće u žena, osobito ako su jako pretile.
English: Side effects before or after having a liver transplant
Croatian: Nuspojave prije ili nakon transplantacije jetre
English: If you forget to take Hepsera or you vomit
Croatian: Ako ste zaboravili uzeti Hepseru ili ako povraćate
English: • It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:
Croatian: • Posebno je važno obavijestiti svog liječnika ako uzimate ili ste nedavno uzimali bilo koje od sljedećih lijekova koji mogu oštetiti Vaše bubrege ili stupiti u interakciju s Hepserom:
English: • look out for possible signs of lactic acidosis - see section 4, Possible side effects.
Croatian: • pazite na moguće znakove laktacidoze - vidjeti dio 4 Moguće nuspojave.
English: In case of emergence of resistance, treatment should be modified.
Croatian: U slučaju pojave rezistencije treba prilagoditi liječenje.
English: In these patients, including patients with decompensated liver disease, treatment cessation is not recommended and these patients should be monitored closely during therapy.
Croatian: U tih pacijenata, uključujući pacijente s dekompenziranom bolešću jetre, ne preporučuje se prekid liječenja i te pacijente treba pomno nadzirati tijekom terapije.
English: What Hepsera looks like and contents of the pack
Croatian: Kako Hepsera izgleda i sadržaj pakiranja
English: Hepsera does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Croatian: Hepsera ne smanjuje rizik od prijenosa HBV-a na druge osobe spolnim odnosom ili kontaminacijom krvlju.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 tablets and outer cartons containing 90 (3 bottles of 30) tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 30 tableta i kutije koje sadrže 90 (3 boce od 30) tableta.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data):
Croatian: Učestalost sljedećih nuspojava nije poznata (učestalost nije moguće procijeniti na temelju dostupnih podataka):
English: • If you do miss a dose of Hepsera, take it as soon as you can, and then take your next scheduled dose at its regular time.
Croatian: • Ako propustite dozu Hepsere, uzmite lijek što je prije moguće, a potom uzmite svoju sljedeću dozu u redovno vrijeme.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: • Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.
Croatian: - Pretrage također mogu pokazati sniženje fosfata (često) ili povišenje kreatinina (vrlo često) u krvi.
English: The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Croatian: Tablete su označene s „GILEAD“ i „10“ na jednoj strani i stiliziranim oblikom jetre na drugoj strani.
English: It is not known whether Hepsera is safe to use during human pregnancy.
Croatian: Nije poznato je li Hepsera sigurna za primjenu tijekom trudnoće u ljudi.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines and herbal products obtained without a prescription.
Croatian: • Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove i biljne lijekove koje ste dobili bez recepta.
English: Patients should be closely monitored after stopping treatment.
Croatian: Pacijente treba pomno nadzirati nakon prekida liječenja.
English: EU/1/03/251/001 EU/1/03/251/002
Croatian: EU/1/03/251/002
English: • foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections
Croatian: • foskarnet, cidofovir ili tenofovir disoproksil fumarat za virusne infekcije
English: It can cause too much lactic acid in the blood and enlargement of the liver.
Croatian: Lijek može uzrokovati preveliku količinu mliječne kiseline u krvi i uvećanje jetre.
English: Gender, age and ethnicity: The pharmacokinetics of adefovir were similar in male and female patients.
Croatian: Dob, spol i rasa: Farmakokinetika adefovira bila je slična u muških i ženskih pacijenata.
English: Improvements or stabilisation were seen in Child-Pugh-Turcotte score.
Croatian: Poboljšanja ili stabilizacija uočeni su u rezultatu na ljestvici Child-Pugh-Turcotte.
English: Do not store above 30ºC (86ºF).
Croatian: Ne čuvati na temperaturi iznad 30°C (86°F).
English: Safety in patients with decompensated disease:
Croatian: Sigurnost primjene u pacijenata s dekompenziranom bolešću:
English: At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Croatian: Pri koncentracijama znatno višima (> 4000 puta) od onih primijećenih in vivo, adefovir nije inhibirao niti jedan od sljedećih izooblika humanog CYP450: CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
English: Pharmacokinetic studies have not been conducted in the elderly.
Croatian: Ispitivanja farmakokinetike nisu provedena u starijih osoba.
English: Normalisation of ALT, albumin, bilirubin and prothrombin time was seen at week 48 in 51-85 % of the patients.
Croatian: Normalizacija ALT-a, albumina, bilirubina i protrombinskog vremena uočena je u 48. tjednu u 51% do 85% pacijenata.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: Overall, the safety profile of adefovir dipivoxil in children was consistent with the known safety profile in adult patients.
Croatian: Ukupno gledano, sigurnosni profil adefovirdipivoksila u djece bio je sukladan poznatom sigurnosnom profilu u odraslih pacijenata.
English: • Once you start taking Hepsera:
Croatian: • Kad počnete uzimati Hepseru:
English: • Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
Croatian: • Obavijestite svog liječnika ako imate bolest bubrega ili ako pretrage ukazuju na probleme s Vašim bubrezima.
English: Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.
Croatian: Pacijente treba nadzirati svakih 6 mjeseci određivanjem biokemijskih, viroloških i seroloških biljega hepatitisa B.
English: The clinical significance of these observed changes in HBV DNA has not been established.
Croatian: Klinički značaj ovih zapaženih promjena u HBV DNK nije utvrđen.
English: • Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Croatian: • Odmah obavijestite svog liječnika o bilo kojim novim, neuobičajenim ili pogoršanim simptomima koje ste primijetili nakon prestanka liječenja.
English: The safety data derived from 5 pivotal randomized controlled studies, including a total of 1,174 patients, were reviewed.
Croatian: Ocijenjeni su podaci o sigurnosti primjene dobiveni iz 5 ključnih randomiziranih kontroliranih ispitivanja koja su obuhvatila ukupno 1174 pacijenta.
English: It's best for your doctor to monitor your health after stopping treatment with Hepsera.
Croatian: Najbolje je da liječnik nadzire Vaš zdravstveni status nakon prekida liječenja Hepserom.
English: The demonstration of the benefit of adefovir dipivoxil is based on histological, virological, biochemical, and serological responses in adults with:
Croatian: Dokaz koristi adefovirdipivoksila temelji se na histološkim, virološkim, biokemijskim i serološkim odgovorima u odraslih s:
English: Long-term safety data in patients with compensated disease:
Croatian: Podaci o dugoročnoj sigurnosti primjene u pacijenata s kompenziranom bolešću:
English: The risk of this occurring is increased with long-term use of Hepsera.
Croatian: Taj je rizik povećan kod dugotrajne primjene Hepsere.
English: See section 2 for more details.
Croatian: Za više pojedinosti, vidjeti dio 2.
English: Infection with the hepatitis B virus leads to damage to the liver.
Croatian: Infekcija virusom hepatitisa B uzrokuje oštećenje jetre.
English: • Stomach pain Contact your doctor at once if you get any of these symptoms.
Croatian: • bol u trbuhu Odmah se obratite svom liječniku ako osjetite ijedan od ovih simptoma.
English: Other possible side effects
Croatian: Druge moguće nuspojave
English: As adefovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Croatian: S obzirom na to da je adefovir strukturno sličan analozima nukleozida, ovaj se rizik ne može isključiti.
English: These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained (see sections 4.4 and 4.8).
Croatian: Te pacijente treba pomno nadzirati na moguće nuspojave te kako bi se potvrdila održanost djelotvornosti (vidjeti dijelove 4.4 i 4.8).
English: • your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.
Croatian: • liječnik Vas treba uputiti na krvne pretrage svaka tri mjeseca kako bi se provjerilo drži li lijek kroničnu infekciju hepatitisa B pod kontrolom.
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF08.
Croatian: Farmakoterapijska skupina: Inhibitori reverzne transkriptaze nukleozida i nukleotida, ATK oznaka: J05AF08.
English: • Obligation to conduct post-authorisation measures
Croatian: • Obaveza provođenja mjera nakon davanja odobrenja
English: If you accidentally take too many Hepsera tablets, contact your doctor or nearest hospital immediately.
Croatian: Ako slučajno uzmete više tableta Hepsere nego što ste trebali, odmah se obratite svom liječniku ili najbližoj bolnici.
English: If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Croatian: U slučaju predoziranja pacijenta se mora nadzirati radi znakova toksičnosti i mora se primijeniti standardno potporno liječenje prema potrebi.
English: Therefore, the standard recommended procedures for immunisation of infants should be followed to prevent neonatal acquisition of HBV.
Croatian: Stoga se treba pridržavati standardnih preporučenih postupaka za imunizaciju dojenčadi, da bi se izbjegla zaraza novorođenčeta HBV-om.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Croatian: Ova uputa o lijeku dostupna je na svim jezicima EU-a/EGP-a na internetskim stranicama Europske agencije za lijekove.
English: The MAH shall complete, within the stated timeframe, the following measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: The clinical significance of these findings as they relate to histological improvement is not known.
Croatian: Klinički značaj ovih nalaza u vezi s histološkim poboljšanjem nije poznat.
English: No adverse effects on development were seen at systemic exposures approximately 12 times that achieved in humans at the therapeutic dose.
Croatian: Nisu uočeni štetni učinci na razvoj pri sistemskoj izloženosti približno 12 puta većoj od one koja se postiže u ljudi pri terapijskoj dozi.
English: Some of the signs of lactic acidosis are:
Croatian: Neki znaci laktacidoze su:
English: • amphotericin B, for fungal infections
Croatian: • amfotericin B za gljivične infekcije
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU I UNUTARNJEM PAKIRANJU
English: Patients were all HBeAg positive and had median CD4 cell count of 441 cells/mm3 (no patient had CD4 count < 200 cells/mm3).
Croatian: Svi su pacijenti bili HBeAg pozitivni i imali su medijan broja CD4 stanica od 441 stanice/mm3 (nijedan pacijent nije imao broj CD4 stanica < 200 stanica/mm3).
English: Furthermore, for the few patients who remained on drug at week 240 (n=12) BMI Z score was lower than typical for their age and gender.
Croatian: Nadalje, u nekoliko pacijenata koji su nastavili primati lijek u 240. tjednu (n=12) Z rezultat indeksa tjelesne mase (BMI) bio je niži od tipičnog za njihovu dob i spol.
English: You do not need to take another tablet if you are sick more than 1 hour after taking Hepsera.
Croatian: Ne trebate uzeti drugu tabletu ako ste povraćali više od sat vremena nakon uzimanja Hepsere.
English: If you stop taking Hepsera
Croatian: Ako prestanete uzimati Hepseru
English: Each tablet contains 113 mg lactose monohydrate.
Croatian: Jedna tableta sadrži 113 mg laktoza hidrata.
English: Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1).
Croatian: Početak liječenja Hepserom smije se razmotriti samo kad primjena drugog antivirusnog lijeka s višom genetskom barijerom prema rezistenciji nije dostupna ili nije prikladna (vidjeti dio 5.1).
English: Treatment cessation for chronic hepatitis B in these patients is not recommended.
Croatian: Ne preporučuje se prekid liječenja kroničnog hepatitisa B u ovih pacijenata.
English: Due to their limitations, the clinical data available do not allow to draw definitive conclusions on the benefit/risk ratio of the adefovir treatment in children with chronic hepatitis B (see section 4.2).
Croatian: Zbog svojih ograničenja, dostupni klinički podaci ne omogućavaju donošenje konačnih zaključaka o omjeru dobrobiti/rizika liječenja adefovirom u djece s kroničnim hepatitisom B (vidjeti dio 4.2).
English: What Hepsera is and what it is used for What you need to know before you take Hepsera How to take Hepsera
Croatian: Što je Hepsera i za što se koristi Što morate znati prije nego počnete uzimati Hepseru
English: Some patients have had symptoms or blood tests indicating that their hepatitis has worsened after stopping treatment with Hepsera.
Croatian: Neki su pacijenti imali simptome ili rezultate krvnih pretraga koji su ukazivali na pogoršanje hepatitisa nakon prekida liječenja Hepserom.
English: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100) or not known (identified through postmarketing safety surveillance and the frequency cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) ili nepoznato (identificirane tijekom praćenja nakon stavljanja lijeka u promet, a učestalost se ne može procijeniti iz dostupnih podataka).
English: • If you are sick (vomit) less than 1 hour after taking Hepsera take another tablet.
Croatian: • Ako povraćate manje od sat vremena nakon uzimanja Hepsere uzmite drugu tabletu.
English: • Kidney problems may lead to softening of the bones (which causes bone pain and sometimes leads to fractures) and muscle pain or weakness.
Croatian: • problemi s bubrezima koji mogu uzrokovati omekšavanje kostiju (što uzrokuje bol u kostima a ponekad i prijelom) te bol u mišićima ili slabost
English: • Digestive problems including wind or discomfort after eating meals
Croatian: • probavni problemi uključujući vjetrove ili neugodu u trbuhu nakon obroka
English: • HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease.
Croatian: • HBeAg pozitivnim i HBeAg negativnim kroničnim hepatitisom B i kompenziranom bolešću jetre.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Croatian: Treba biti oprezan prilikom propisivanja analoga nukleozida bilo kojem pacijentu (osobito pretilim ženama) s hepatomegalijom, hepatitisom ili drugim poznatim čimbenicima rizika za bolest jetre.
English: Improvement was defined as a reduction from baseline of two points or more in the Knodell necro-inflammatory score with no concurrent worsening in the Knodell fibrosis score.
Croatian: Poboljšanje je bilo definirano kao sniženje rezultata u odnosu na početne vrijednosti za dva boda ili više na Knodellovoj nekro-upalnoj ljestvici bez istovremenog pogoršanja rezultata na Knodellovoj ljestvici fibroze.
English: • If you are allergic to adefovir, adefovir dipivoxil or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na adefovir, adefovirdipivoksil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: General: Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should still be taken.
Croatian: Općenito: Pacijente treba upozoriti da nije dokazano da terapija adefovirdipivoksilom smanjuje rizik od prijenosa virusa hepatitisa B na druge osobe te da je stoga i dalje moraju primjenjivati odgovarajuće mjere opreza.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Stoga pacijenti s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: They are the same as some of the common side effects of Hepsera.
Croatian: Isti su kao i neke česte nuspojave Hepsere.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for adefovir, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za adefovir, znanstveni zaključci CHMP-a su sljedeći:
English: How to take Hepsera Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Return any left over tablets to your pharmacist.
Croatian: Sve preostale tablete trebate vratiti ljekarniku.
English: Hepsera 10 mg tablets
Croatian: Hepsera 10 mg tablete
English: CARTON AND BOTTLE LABELLING
Croatian: OZNAČIVANJE NA NALJEPNICI BOCE I KARTONSKE KUTIJE
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with adefovir dipivoxil and that renal function (creatinine clearance and serum phosphate) be monitored every four weeks during the first year and then every three months thereafter.
Croatian: Preporučuje se izračunati klirens kreatinina za sve pacijente prije početka terapije adefovirdipivoksilom i nadzirati bubrežnu funkciju (klirens kreatinina i fosfate u serumu) svaka četiri tjedna tijekom prve godine, a potom svaka tri mjeseca.
English: Elderly: No data are available to support a dose recommendation for patients over the age of 65 years (see section 4.4).
Croatian: Starije osobe: Nisu dostupni podaci na temelju kojih bi se mogla preporučiti doza za pacijente starije od 65 godina (vidjeti dio 4.4).
English: • After stopping Hepsera tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Croatian: • Nakon što prestanete uzimati Hepseru odmah obavijestite svog liječnika o bilo kojim novim, neuobičajenim ili pogoršanim simptomima koje ste primijetili nakon prekida liječenja.
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence
Croatian: proljev, povraćanje, bol u trbuhu, dispepsija, mučnina, flatulencija
English: • The recommended dose is one 10 mg tablet each day, taken with or without food.
Croatian: • Preporučena doza je jedna tableta od 10 mg svaki dan koja se uzima s hranom ili bez nje.
English: EU/1/03/251/001 30 tablets EU/1/03/251/002 90 (3 bottles of 30) tablets
Croatian: EU/1/03/251/001 90 (3 boce od 30) tableta
English: If you are lactose-intolerant, or if you have been told that you have an intolerance to some sugars, talk to your doctor before taking Hepsera.
Croatian: Ako ne podnosite laktozu ili Vam je rečeno da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja Hepsere.
English: In over two thirds of patients suppression of serum HBV DNA was associated with normalisation of ALT levels.
Croatian: U više od dvije trećine pacijenata supresija serumskog HBV DNK bila je povezana s normalizacijom razina ALT-a.
English: • Do not breast-feed while taking Hepsera.
Croatian: • Nemojte dojiti dok uzimate Hepseru.
English: Depending on the results, your doctor may change how often you take Hepsera.
Croatian: Ovisno o rezultatima, liječnik Vam može promijeniti učestalost uzimanja Hepsere.
English: After 96, 144, 192 and 240 weeks of treatment with adefovir dipivoxil, resistance surveillance was performed for 293, 221, 116 and 64 patients, respectively.
Croatian: Nakon 96., 144., 192. odnosno 240. tjedna liječenja adefovirdipivoksilom, ispitivanje rezistencije provedeno je u 293, 221, 116 odnosno 64 pacijenata.
English: Adefovir dipivoxil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Adefovirdipivoksil treba koristiti tijekom trudnoće samo ako moguća korist opravdava mogući rizik za fetus.
English: It is not known whether the active substance in this medicine passes into breast milk.
Croatian: Nije poznato prelazi li djelatna tvar iz ovog lijeka u majčino mlijeko.
English: Patients with creatinine clearance between 30 and 49 ml/min:
Croatian: Pacijenti s klirensom kreatinina između 30 i 49 ml/min: