FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Post-treatment ALT Elevations in 2 Placebo-Controlled Studies in Adults
Croatian: Tablica 3.: Porast razina ALT nakon liječenja u 2 placebom-kontrolirana ispitivanja u odraslih
English: Not everyone responds to treatment with Zeffix in the same way.
Croatian: Ne reagiraju svi jednako na liječenje lijekom Zeffix.
English: Delta hepatitis or hepatitis C
Croatian: Hepatitis delta ili hepatitis C
English: Undetectable HBV DNA
Croatian: Nemjerljiva HBV DNK
English: Remove the applicator from the adapter.
Croatian: Skinite aplikator s nastavka.
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Croatian: Uočen je blagi porast Cmax (28 %) zidovudina pri istovremenoj primjeni s lamivudinom, međutim ukupna izloženost (AUC) nije bila značajno promijenjena.
English: Zeffix can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function normally (decompensated liver disease).
Croatian: Zeffix se može primjenjivati u ljudi čija je jetra oštećena, ali još uvijek normalno funkcionira (kompenzirana bolest jetre) te u kombinaciji s drugim lijekovima u ljudi kojima je jetra oštećena i ne funkcionira normalno (dekompenzirana bolest jetre).
English: The results of long term carcinogenicity studies with lamivudine in rats and mice did not shown any carcinogenic potential.
Croatian: Rezultati dugoročnih studija kancerogenosti u miševa i štakora nisu pokazali da lamivudin ima kancerogeni potencijal.
English: †Comparable to a Grade 3 toxicity in accordance with modified WHO criteria.
Croatian: †Usporedivo s 3. stupnjem toksičnosti prema izmijenjenim kriterijima WHO-a.
English: The risk for developing YMDD mutant was 63% versus 13% with a cut off of 1000 copies/ml (NUCB3009 and NUCB3018).
Croatian: Rizik od razvoja YMDD mutiranog tipa virusa bio je 63% prema 13% s prekidom na 1000 kopija/ml (NUCB3009 i NUCB3018).
English: To protect other people from becoming infected with hepatitis B:
Croatian: Da biste zaštitili druge ljude od zaraze hepatitisa B:
English: 6 Turn the bottle the right way up.
Croatian: Okrenite bocu na pravu stranu.
English: Creatinine clearance ml/min
Croatian: Klirens kreatinina ml/min
English: With prolonged treatment, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Croatian: Kod dugotrajnog se liječenja preporučuje redovna procjena kako bi se potvrdilo da je nastavak primjene odabrane terapije i dalje primjeren za bolesnika.
English: In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported.
Croatian: U bolesnika zaraženih HIV-om zabilježeni su slučajevi pankreatitisa i periferne neuropatije (ili parestezije).
English: Transmission of hepatitis B
Croatian: Prijenos hepatitisa B
English: Table 2: Efficacy results 5 years by YMDD status (Asian Study) NUCB3018
Croatian: Tablica 2.: Rezultati djelotvornosti nakon 5 godina prema statusu YMDD tipa virusa (azijska studija) NUCB3018
English: What Zeffix looks like and contents of the pack
Croatian: Kako Zeffix izgleda i sadržaj pakiranja
English: Hepatitis B is a virus which infects the liver, causes long term (chronic) infection, and can lead to liver damage.
Croatian: Hepatitis B je virus koji zahvaća jetru, uzrokuje dugotrajnu (kroničnu) infekciju i može dovesti do njenog oštećenja.
English: Mitochondrial dysfunction
Croatian: Disfunkcija mitohondrija
English: When lamivudine was discontinued, the majority of patients (70 %) had a return of viral replication.
Croatian: Nakon prekida liječenja lamivudinom u većine bolesnika (70%) je ponovo nastupila replikacija virusa.
English: • other medicines containing lamivudine, used to treat HIV infection (sometimes called the AIDS virus)
Croatian: • druge lijekove koji sadrže lamivudin, koji se primjenjuju za liječenje infekcija HIV-om (ponekad zvanu AIDS)
English: Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Croatian: Bolesnike koji razviju znakove insuficijencije jetre tijekom ili nakon liječenja treba, po potrebi, pratiti češće.
English: Herts SG12 0DJ United Kingdom or
Croatian: Herts SG12 0DJ Ujedinjeno Kraljevstvo ili
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you're taking Zeffix.
Croatian: Ne zaboravite reći liječniku ili ljekarniku ako počnete uzimati neki novi lijek za vrijeme terapije lijekom Zeffix.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Croatian: Treba razmotriti mogućnost interakcije s drugim istovremeno primijenjenim lijekovima, osobito ako je njihov glavni put eliminacije aktivna bubrežna sekrecija putem organskog kationskog transportnog sustava, kao što je slučaj s trimetoprimom.
English: Pharmacotherapeutic group - Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC Code: J05AF05.
Croatian: Farmakoterapijska skupina - Antivirotici za sistemsku primjenu, inhibitori nukleozidne i nukleotidne reverzne transkriptaze, ATK oznaka: J05AF05.
English: Muscle disorders, including myalgia and cramps*
Croatian: Mišićni poremećaji, uključujući mialgiju i grčeve*
English: Due to the marginal liver function in these patients, hepatitis reactivation at discontinuation of lamivudine or loss of efficacy during treatment may induce severe and even fatal decompensation.
Croatian: Zbog marginalne funkcije jetre u tih bolesnika, ponovni razvoj hepatitisa nakon prestanka liječenja lamivudinom ili gubitak djelotvornosti tijekom liječenja mogu inducirati tešku, pa i fatalnu dekompenzaciju.
English: The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.
Croatian: Aplikator za peroralnu primjenu priložen je za precizno mjerenje propisane doze oralne otopine.
English: Zeffix may make you feel tired, which could affect your ability to drive or use machines.
Croatian: Zeffix može uzrokovati umor, što može utjecati na sposobnost upravljanja vozilima i strojevima.
English: At the end of 5 years, all patients had HBV DNA levels that were undetectable or lower than pre-treatment levels.
Croatian: Nakon 5 godina u svih bolesnika razine HBV DNK bile su nemjerljive ili niže nego prije početka liječenja.
English: Zeffix also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Croatian: Zeffix također sadrži i konzervanse (parahidroksibenzoate) koji mogu uzrokovati alergijske reakcije
English: Zeffix contains sugar and preservatives
Croatian: Zeffix sadrži šećere i konzervanse
English: Frequency categories are only assigned to those adverse reactions considered to be at least possibly causally related to lamivudine.
Croatian: Kategorije učestalosti su dodijeljene samo nuspojavama za koje se smatra da su bar moguće uzročno povezane s lamivudinom.
English: However, relapse following seroconversion can occur.
Croatian: Međutim, može doći do ponovnog nastupa bolesti nakon serokonverzije.
English: Available human data from the Antiretroviral Pregnancy Registry reporting more than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect.
Croatian: Podaci iz registra trudnoća žena koje koriste antiretrovirusnu terapiju (Antiretroviral Pregnancy Registry) u kojem je zabilježeno više od 1000 ishoda nakon izloženosti u prvom tromjesečju trudnoće i više od 1000 ishoda nakon izloženosti u drugom i trećem tromjesečju u trudnica ne ukazuju na malformacijski i feto/neonatalni učinak.
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85 %.
Croatian: Lamivudin se dobro apsorbira iz gastrointestinalnog trakta, a bioraspoloživost peroralno primijenjenog lamivudina u odraslih normalno je između 80 i 85%.
English: Then continue your treatment as before.
Croatian: Nastavite s liječenjem na uobičajen način.
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reduction in liver weights.
Croatian: Pri najvišim dozama primijećen je manji učinak na pokazatelje funkcije jetre i bubrega, uz povremeno smanjenje težine jetre.
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Croatian: In vitro lamivudin inhibira unutarstaničnu fosforilaciju kladribina što dovodi do potencijalnog rizika od gubitka djelotvornosti kladribina u slučaju kombinacije u kliničkom okruženju.
English: Patients with ALT Elevation/ Patients with Observations*
Croatian: Bolesnici s porastom ALT/ bolesnici koji su promatrani*
English: Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Croatian: Zeffix je antivirusni lijek koji potiskuje virus hepatitisa B i pripada skupini lijekova koji se nazivaju nukleozidni analozi inhibitora reverzne transkriptaze (NRTI).
English: Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased lamivudine exposure by about 40 %.
Croatian: Primjena trimetoprim /sufametoksazola 160 mg/800 mg povećala je izloženost lamivudinu za oko 40%.
English: From intravenous studies the mean volume of distribution is 1.3 l/kg.
Croatian: U ispitivanjima je dokazano da je kod intravenske primjene srednja vrijednost volumena distribucije 1,3 l/kg.
English: Immunosuppressive treatments
Croatian: Imunosupresivni lijekovi
English: This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage.
Croatian: To znači da će uzimati uzorke krvi kako bi provjerio jesu li vrijednosti jetrenih enzima povišene, što može ukazivati na oštećenje jetre.
English: 3 Insert the applicator (C) firmly into the adapter.
Croatian: Čvrsto umetnite aplikator (C) u nastavak.
English: The total amount of lamivudine ingested by a breastfed infant is very low and is therefore likely to result in exposures exerting a sub-optimal antiviral effect.
Croatian: Ukupna količina lamivudina koju dojenče dobije putem majčinog mlijeka vrlo je niska i vjerojatno će dovesti do izloženosti lijeku sa suboptimalnim antivirusnim učincima.
English: The formation of further viral DNA is blocked by incorporation of lamivudine-TP into the chain and subsequent chain termination.
Croatian: Stvaranje nove virusne DNK blokirano je inkorporacijom lamivudin-trifosfata u lanac i posljedičnim prekidanjem lanca.
English: Co-administration of lamivudine with food resulted in a delay of tmax and a lower Cmax (decreased by up to 47 %).
Croatian: Istovremena primjena lamivudina s hranom odgađa tmax i smanjuje Cmax (smanjuje se do 47%).
English: Use the oral applicator supplied with the pack to measure your dose accurately (see also Section 3).
Croatian: Koristite aplikator za primjenu kroz usta koji se nalazi u pakiranju kako biste točno odmjerili dozu (pogledajte i dio 3).
English: If you have further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Consider more frequent monitoring of HBV viral load when chronic co-administration cannot be avoided.
Croatian: Razmotrite češće praćenje opterećenja virusom HBV-a kada se kronična istodobna primjena ne može izbjeći.
English: Lamivudine is an antiviral agent which is active against hepatitis B virus in all cell lines tested and in experimentally infected animals.
Croatian: Lamivudin je antivirusni lijek koji djeluje protiv virusa hepatitisa B u svim ispitivanim staničnim linijama i pokusno zaraženim životinjama.
English: When possible, avoid chronic co-administration of Zeffix with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Croatian: Kada je moguće, izbjegavajte kroničnu istodobnu primjenu lijeka Zeffix s lijekovima koji sadrže sorbitol ili druge poliole osmotskog djelovanja ili monosaharidne alkohole (npr. ksilitol, manitol, laktitol, maltitol).
English: Zeffix can pass into breast-milk.
Croatian: Zeffix može prijeći u majčino mlijeko.
English: Other side effects Other side effects have occurred in a very small number of people but their exact frequency is unknown
Croatian: Druge su se nuspojave javile u vrlo malog broja ljudi, ali njihova učestalost nije poznata
English: • lactic acidosis (excess lactic acid in the blood).
Croatian: • Laktacidoza (nakupljanje mliječne kiseline u krvi)
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Croatian: Glaxo Operations UK Limited (posluje kao Glaxo Wellcome Operations)
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: Intolerancija na pomoćne tvari Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom saharoza-izomaltaza ne bi trebali uzimati ovaj lijek.
English: Treatment with Zeffix can reduce the amount of hepatitis B virus in your body.
Croatian: Liječenje lijekom Zeffix može smanjiti količinu virusa hepatitisa B u tijelu.
English: Check with your doctor if you think this applies to you.
Croatian: Provjerite sa svojim liječnikom ako mislite da se ovo odnosi na Vas.
English: YMDD1 Non-YMDD1
Croatian: Bez-YMDD1
English: Lamivudine has been administered to children and adolescents with compensated CHB in a placebo controlled study of 286 patients aged 2 to 17 years.
Croatian: Lamivudin je primjenjivan u djece i adolescenata s kompenziranim kroničnim hepatitisom B u placebo-kontroliranom ispitivanju u koje je bilo uključeno 286 bolesnika u dobi od 2 do 17 godina.
English: 5 to < 15
Croatian: 5 do <15
English: 7 Put the applicator into your mouth, placing the tip of the applicator against the inside of your cheek.
Croatian: Stavite aplikator u usta, tako da vrh aplikatora prislonite uz unutarnju stranu obraza.
English: In patients with chronic hepatitis B there was no observed difference in incidence of these events between placebo and lamivudine treated patients.
Croatian: U bolesnika s kroničnim hepatitisom B nisu zabilježene razlike u incidenciji tih događaja između bolesnika liječenih lamivudinom i onih koji su dobivali placebo.
English: If lamivudine is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see section 4.4).
Croatian: Ako se liječenje lamivudinom prekine, bolesnike treba periodički pratiti zbog moguće pojave rekurentnog hepatitisa (vidjeti dio 4.4).
English: As the in vitro mutagenic activity of lamivudine could not be confirmed by in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Croatian: Budući da se mutageni učinak in vitro ne može potvrditi in vivo testovima, zaključeno je da lamivudin ne bi trebao predstavljati genotoksičnu opasnost za bolesnika.
English: Don't stop taking Zeffix without your doctor's advice, as there is a risk of your hepatitis getting worse.
Croatian: Nemojte prestati uzimati Zeffix ako Vam to nije preporučio liječnik jer postoji rizik od pogoršanja hepatitisa.
English: Improvement in liver function was also seen after one year of therapy.
Croatian: Nakon godinu dana liječenja ustanovljeno je i poboljšanje funkcije jetre.
English: 30 to < 50
Croatian: 30 do <50
English: The dosage should, therefore, be reduced for patients with a creatinine clearance of < 50 ml/minute.
Croatian: Dozu stoga treba smanjiti u bolesnika s klirensom kreatinina < 50 ml/minuti.
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Croatian: Lamivudin se u bakterijskim testovima nije pokazao mutagenim, ali kao i mnogi drugi analozi nukleozida pokazao je aktivnost u citogenetskim testovima in vitro i testu limfoma miševa.
English: Some lateonset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Croatian: Zabilježeni su i neki neurološki poremećaji koji su nastupili kasnije (hipertonus, konvulzije, abnormalnosti ponašanja).
English: Boxes containing 28 or 84 film-coated tablets in double foil blisters, laminated with polyvinyl chloride.
Croatian: Kutije s 28 ili 84 filmom obloženih tableta u blisterima s dvoslojnom folijom, laminiranim polivinil kloridom.
English: Dose reduction in patients with a creatinine clearance of < 50 ml/min is necessary (see section 4.2).
Croatian: Potrebno je smanjiti dozu u bolesnika s klirensom kreatinina < 50 ml/min (vidjeti dio 4.2).
English: No specific signs or symptoms have been identified following such overdose.
Croatian: Nakon predoziranja nisu zabilježeni specifični znaci ni simptomi.
English: Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats (see section 5.3).
Croatian: Ispitivanja lamivudina na životinjama ukazala su na porast rane embrionalne smrtnosti u kunića, ali ne i u štakora (vidjeti dio 5.3).
English: ALT normalisation
Croatian: Normalizacija ALT
English: - Week 260 normal above normal < baseline above normal > baseline
Croatian: - 260. tjedan normalne više od normalnih < početnih više od normalnih > početnih
English: In a retrospective study to determine the factors associated with HBV DNA breakthrough, 159 Asian HBeAg-positive patients were treated with lamivudine and followed up for a median period of almost 30 months.
Croatian: U retrospektivnom ispitivanju čiji je cilj bio odrediti čimbenike povezane s HBV DNK prodorom, 159 azijskih HBeAg pozitivnih bolesnika bilo je liječeno lamivudinom i praćeno s medijanom trajanja od gotovo 30 mjeseci.
English: The majority of lamivudine is excreted unchanged in the urine via glomerular filtration and active secretion (organic cationic transport system).
Croatian: Većina lijeka izlučuje se urinom u nepromijenjenom obliku glomerularnom filtracijom i aktivnom sekrecijom (organski kationski transportni sustav).
English: Lamivudine is predominantly eliminated by active organic cationic secretion.
Croatian: Lamivudin se pretežno izlučuje aktivnom organskom kationskom sekrecijom.
English: Talk to your doctor or pharmacist.
Croatian: Obavijestite svog liječnika ili ljekarnika.
English: Do not take Zeffix:
Croatian: Nemojte uzimati Zeffix:
English: The frequency categories assigned to the adverse reactions are mainly based on experience from clinical trials including a total of 1,171 patients with chronic hepatitis B receiving lamivudine at 100mg.
Croatian: Kategorije učestalosti dodijeljene nuspojavama uglavnom se temelje na iskustvu iz kliničkih ispitivanja u kojima je sudjelovao ukupno 1171 bolesnik s kroničnim hepatitisom B na terapiji lamivudinom u dozi od 100 mg.
English: If you are already taking another medicine that contains lamivudine for HIV infection, your doctor will continue to treat you with the higher dose, (usually 150 mg twice a day), because the dose of lamivudine in Zeffix (100 mg) is not enough to treat HIV infection.
Croatian: Ako već uzimate drugi lijek koji sadrži lamivudin za infekciju HIV-a, liječnik će Vas nastaviti liječiti višom dozom (obično 150 mg dva puta na dan), zbog toga što doza lamivudina u lijeku Zeffix (100 mg) nije dovoljna za liječenje infekcije HIV-a.
English: • if you're allergic to lamivudine or to any of the other ingredients of this medicine (listed in Section 6).
Croatian: ako ste alergični na lamivudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If you are planning to change your HIV treatment, discuss this change with your doctor first.
Croatian: razgovarajte o ovoj promjeni prvo sa svojim liječnikom.
English: When full, the applicator contains 10 ml of solution.
Croatian: Kada je aplikator pun, sadrži 10 ml otopine.
English: In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
Croatian: U nekontroliranim ispitivanjima u kojima je lamivudin primijenjen prije i tijekom transplantacije, zabilježena je učinkovita supresija HBV DNK i normalizacija ALT.
English: Reproductive studies in animals have not shown evidence of teratogenicity and showed no effect on male or female fertility.
Croatian: Ispitivanja reproduktivne toksičnosti na životinjama nisu dala dokaze o teratogenosti ili utjecaju na fertilitet mužjaka ili ženki.
English: Limited data shows lamivudine penetrates the central nervous system and reaches the cerebro-spinal fluid (CSF).
Croatian: Ograničeni podaci pokazuju da lamivudin prodire u središnji živčani sustav i ulazi u cerebrospinalnu tekućinu.
English: Lamivudine induces early embryolethality when administered to pregnant rabbits at exposure levels comparable to those achieved in man, but not in the rat even at very high systemic exposures.
Croatian: Lamivudin inducira ranu smrt embrija ako se daje gravidnim ženkama kunića u razinama izloženosti koje su slične onima u ljudi, ali ne i kod ženki štakora čak niti kod vrlo visoke sistemske izloženosti.
English: The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.
Croatian: Drugi sastojci su: mikrokristalična celuloza, natrijev škroboglikolat, magnezijev stearat, hipromeloza, titanijev dioksid, makrogol 400, polisorbat 80, sintetski žuti i crveni željezov oksid.
English: What you need to know before you take Zeffix
Croatian: Što morate znati prije nego počnete uzimati Zeffix
English: There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A).
Croatian: Nisu opažene klinički značajne interakcije u bolesnika koji su istodobno s lamivudinom uzimali neki od uobičajenih imunosupresivnih lijekova (npr. ciklosporin A).
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged substance.
Croatian: Vjerojatnost metaboličkih interakcija je mala zbog ograničenog metabolizma i vezanja na proteine u plazmi te gotovo potpune eliminacije nepromijenjenog lijeka putem bubrega.
English: The efficacy of lamivudine in patients co-infected with Delta hepatitis or hepatitis C has not been established and caution is advised.
Croatian: Djelotvornost lamivudina u bolesnika koji su ujedno zaraženi hepatitisom delta (D) ili hepatitisom C nije ustanovljena i preporučuje se oprez.
English: A very common side effect (these may affect more than 1 in 10 people) which may show up in blood tests is:
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) koje se mogu pojaviti u Vašim krvnim testovima su:
English: Due to similarities, Zeffix should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Croatian: Zeffix se, zbog sličnosti, ne smije primjenjivati istodobno s drugim citidinskim analozima, poput emtricitabina.
English: Your doctor may prescribe a lower dose if you have problems with your kidneys.
Croatian: Vaš liječnik će možda morati smanjiti dozu lijeka Zeffix ako imate problema s bubrezima.
English: Leave the adapter in the bottle.
Croatian: Nastavak ostavite u boci.
English: Don't drive or use machines unless you are sure you're not affected.
Croatian: Nemoje upravljati vozilima ni strojevima osim ako niste sigurni da lijek ne utječe negativno na Vas.