FrancophonIA/ELRC3.0 huggingface dataset:
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 je kao i mnogi drugi analozi nukleozida pokazao aktivnost u citogenetskim testovima in vitro i testu limfoma miševa.
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied.
Croatian: Budući da se lamivudin može odstraniti dijalizom, pri liječenju predoziranja može se koristiti kontinuirana hemodijaliza, iako nisu provedena ispitivanja.
English: Liver disease: If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SPC.
Croatian: Bolest jetre: Ako se lamivudin istodobno koristi za liječenje HIV i HBV infekcija, dodatne informacije o primjeni lamivudina u liječenju hepatitisa B dostupne su u sažetku opisa svojstava lijeka za Zeffix.
English: Uncommon: Transient elevations in liver enzymes (AST, ALT) Rare: Hepatitis
Croatian: Manje često: prolazni porast jetrenih enzima (AST, ALT) Rijetko: hepatitis
English: Uncommon side effects that may show up in blood tests are:
Croatian: Manje česte nuspojave koje se mogu otkriti krvnim pretragama su:
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART).
Croatian: Zabilježeni su slučajevi osteonekroze, pogotovo u bolesnika s općepriznatim faktorima rizika, uznapredovalom HIV bolesti ili dugotrajnom izloženosti kombiniranom antiretrovirusnom liječenju.
English: Triple nucleoside therapy: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when lamivudine was combined with tenofovir disoproxil fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily regimen.
Croatian: Liječenje s tri analoga nukleozida: Postoje izvješća o visokoj stopi virološkog neuspjeha i pojavi rezistencije u ranom stadiju u kojem se lamivudin kombinira s tenofovir disoproksil fumaratom i abakavirom, odnosno s tenofovir disoproksil fumaratom i didanozinom, u režimu doziranja jedanput na dan.
English: The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral solution.
Croatian: Štrcaljka za oralno doziranje priložena je za precizno mjerenje propisane doze oralne otopine.
English: The Epivir 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg.
Croatian: Epivir 10 mg/ml oralna otopina može biti najprikladnija formulacija kako bi se dosegla preporučena doza u djece s oštećenjem bubrega u dobi od najmanje 3 mjeseca, čija je tjelesna težina manja od 25 kg.
English: No antagonistic effects in vitro were seen with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and zidovudine).
Croatian: Nisu primijećeni antagonistički učinci in vitro s primjenom lamivudina i ostalih antiretrovirotika (testirani lijekovi: abakavir, didanozin, nevirapin i zidovudin).
English: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Croatian: Kako bi se osigurala primjena čitave doze, tabletu/tablete bi trebalo progutati bez drobljenja.
English: This medicine contains 300 mg propylene glycol in each 15ml.
Croatian: Ovaj lijek sadrži 300 mg propilenglikola u svakih 15 ml.
English: When possible, avoid chronic coadministration of Epivir with medicinal products containing sorbitol or other osmotic acting polyalcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Croatian: Kada je moguće, izbjegavajte kroničnu istodobnu primjenu lijeka Epivir s lijekovima koji sadrže sorbitol ili druge poliole osmotskog djelovanja ili monosaharidne alkohole (npr. ksilitol, manitol, laktitol, maltitol).
English: However, the extent (based on the AUC) of lamivudine absorbed is not influenced.
Croatian: Međutim to ne utječe na apsorbiranu količinu lamivudina (na osnovi AUC).
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Croatian: Rezistencija HIV-l na lamivudin uključuje promjenu aminokiseline M184V u blizini aktivnog mjesta virusne reverzne transkriptaze (RT).
English: No special requirements for disposal
Croatian: Nema posebnih zahtjeva za zbrinjavanje
English: In neonates one week of age, lamivudine oral clearance was reduced when compared to paediatric patients and is likely to be due to immature renal function and variable absorption.
Croatian: U novorođenčadi u dobi od tjedan dana smanjen je oralni klirens lamivudina u usporedbi sa starijom djecom, vjerojatno zbog nezrele funkcije bubrega i varijabilne apsorpcije.
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Croatian: Rezultati kliničkih ispitivanja pokazuju da ova kombinacija lijekova značajno smanjuje rizik od progresije bolesti i mortaliteta.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Croatian: Rezultati testova in vitro sugeriraju da nastavak primjene lamivudina u antiretrovirusnom liječenju, unatoč razvoju M184V, može osigurati rezidualnu antiretrovirusnu aktivnost (najvjerojatnije putem smanjene virulentnosti).
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28 % increase in peak plasma levels.
Croatian: Istodobna primjena zidovudina dovodi do 13% veće izloženosti zidovudinu i 28% porasta vršnih razina u plazmi.
English: More cases of resistance were detected among patients who had received lamivudine solution, in combination with other antiretroviral solutions, compared with those who received similar doses of tablet formulation.
Croatian: Otkriveno je više slučajeva rezistencije među bolesnicima koji su primali lamivudin oralnu otopinu u kombinaciji s drugim antiretrovirusnim lijekovima u obliku otopine u odnosu na one koji su primali slične doze u obliku tableta.
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Croatian: Mutanti M184V imaju značajno smanjenu osjetljivost na lamivudin i smanjeni kapacitet replikacije virusa in vitro.
English: It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Croatian: Pripada skupini lijekova koji se nazivaju nukleozidni analozi inhibitora reverzne transkriptaze.
English: Children receiving lamivudine oral solution according to the recommended dosage regimen achieve plasma lamivudine exposure within the range of values observed in adults.
Croatian: Djeca koja primaju oralnu otopinu lamivudina sukladno preporučenom režimu doziranja postižu razinu izloženosti lamivudinu u plazmi koja je unutar raspona vrijednosti primijećenih u odraslih.
English: <30 As doses below 150 mg are needed the use of the oral solution is recommended
Croatian: Budući da su potrebne doze manje od 150 mg, preporučuje se primjena oralne otopine
English: Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTI's are available.
Croatian: Stoga se nastavak liječenja lamivudinom, unatoč pojavi M184V mutacija, treba razmotriti samo u slučajevima kada nisu dostupni drugi aktivni inhibitori nukleozidne reverzne transkriptaze.
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 smrtnosti embrija u kunića, ali ne i u štakora (vidjeti dio 5.3).
English: A rare side effect that may show up in blood tests is: • an increase in an enzyme called amylase.
Croatian: Rijetka nuspojava koja se može otkriti krvnim pretragama je: • povišena vrijednost enzima amilaze.
English: If Epivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see Zeffix SPC).
Croatian: Ako se ukida liječenje lijekom Epivir u bolesnika zaraženih i HIV-om i HBV-om, preporučuje se periodičko praćenje jetrenih funkcijskih testova i markera HBV replikacije jer prestanak uzimanja lamivudina može izazvati akutnu egzacerbaciju hepatitisa (vidjeti sažetak opisa svojstava lijeka za Zeffix).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street, Ware
Croatian: Glaxo Operations UK Limited (posluje kao Glaxo Wellcome Operations) Priory Street, Ware
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance.
Croatian: Vjerojatnost metaboličkih interakcija je mala zbog ograničenog metabolizma i vezanja na proteine u plazmi te gotovo potpuni bubrežni klirens.
English: Metabolism and nutrition disorders Very rare: Lactic acidosis
Croatian: Poremećaji metabolizma i prehrane Vrlo rijetko: laktacidoza
English: Adults, adolescents and children weighing at least 25 kg The usual dose of Epivir is 30 ml (300 mg) a day.
Croatian: Odrasli, adolescenti i djeca tjelesne težine najmanje 25 kg Uobičajena doza lijeka Epivir je 30 ml (300 mg) na dan.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Epivir.
Croatian: Ako Vam je liječnik rekao da imate bolest tzv. nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.
English: The dose should therefore be adjusted, using oral solution presentation of Epivir for patients whose creatinine clearance falls below 30 ml/min (see tables).
Croatian: Stoga je potrebna prilagodba doze primjenom Epivir oralne otopine u bolesnika s klirensom kreatinina manjim od 30 ml/min (vidjeti tablice).
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia)
Croatian: • smanjen broj stanica uključenih u zgrušavanje krvi (trombocitopenija)
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogueDNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Croatian: Ispitivanje je pokazalo da su fetusi izloženi kombinaciji lijekova in utero podnijeli viši stupanj DNK inkorporacije analoga nukleozida u više različitih fetalnih organa te je u njih dokazan veći broj skraćenih telomera nego kod onih koji su bili izloženi samo zidovudinu.
English: Once daily dosing (300 mg once a day): a clinical study has demonstrated the non inferiority between Epivir once a day and Epivir twice a day containing regimens.
Croatian: Doziranje jedanput na dan (300 mg jedanput na dan): kliničko je ispitivanje pokazalo da primjena lijeka Epivir jedanput na dan nije inferiorna primjeni dvaput na dan.
English: There are limited pharmacokinetic data for patients less than three months of age.
Croatian: Farmakokinetički podaci u bolesnika u dobi ispod 3 mjeseca su oskudni.
English: The likelihood of metabolic interactions of lamivudine with other medicinal products is low due to the small extent of hepatic metabolism (5-10%) and low plasma protein binding.
Croatian: Vjerojatnost metaboličke interakcije s drugim lijekovima je mala jer se lamivudin u vrlo maloj mjeri metabolizira u jetri (510%) i slabo veže na proteine plazme.
English: Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40 % increase in lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component did not interact.
Croatian: Zbog djelovanja komponente trimetoprima, primjena trimetoprim/sulfametoksazola u dozi od 160 mg/800 mg uzrokuje 40%-tni porast izloženosti lamivudinu; nema interakcija sa sulfametoksazolom.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (> 70%) via the organic cationic transport system.
Croatian: Srednja vrijednost sistemskog klirensa lamivudina je približno 0,32 l/h/kg, i odvija se pretežno renalnim klirensom (> 70%), putem organskog kationskog transportnog sustava.
English: The pack also includes a polyethylene syringe-adapter, and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Croatian: Pakiranje također sadrži polietilenski nastavak za štrcaljku, štrcaljku od 10 ml za oralno doziranje od polipropilenske cijevi (sa oznakama za ml) i polietilenskim klipom.
English: Paediatric pharmacokinetic studies with both oral solution and tablet formulations have demonstrated that once daily dosing provides equivalent AUC0-24 to twice daily dosing of the same total daily dose.
Croatian: Pedijatrijska farmakokinetička ispitivanja oralne otopine i tableta pokazala su da doziranje jedanput na dan dovodi do jednake vrijednosti AUC0-24 kao i primjena jednake ukupne dnevne doze u režimu doziranja dvaput na dan.
English: Therefore to achieve similar adult and paediatric exposure, an appropriate dose for neonates is 4 mg/kg/day.
Croatian: Stoga je, kako bi se postigla izloženost slična onoj u odraslih i starije djece, prikladna doza za novorođenčad 4 mg/kg/dan.
English: Epivir is also available as a tablet formulation for patients who weigh at least 14 kg (see section 4.4).
Croatian: Epivir je dostupan i u obliku tablete za bolesnike tjelesne težine od najmanje 14 kg (vidjeti dio 4.4).
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare: Pancreatitis, elevations in serum amylase
Croatian: Često: mučnina, povraćanje, bol ili grčevi u abdomenu, proljev Rijetko: pankreatitis, povišene razine serumskih amilaza.
English: A recommended dosage regimen for patients with creatinine clearance below 50 ml/min is shown in the dosage section (see section 4.2).
Croatian: Preporuke za određivanje doze u bolesnika s klirensom kreatinina <50 ml/min dane su u odjeljku o doziranju (vidjeti dio 4.2).
English: Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Croatian: Temeljem tih podataka, dozu nije potrebno prilagoditi u bolesnika s umjerenim do teškim oštećenjem jetre osim ako istodobno nije prisutno oštećenje bubrega.
English: How to take Epivir
Croatian: Kako uzimati Epivir
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Croatian: U bolesnika koji već boluju od poremećaja jetrene funkcije, uključujući kronični aktivni hepatitis, češće su zabilježeni poremećaji funkcije jetre tijekom kombinacijskog antiretrovirusnog liječenja te takve bolesnike treba pratiti prema uobičajenoj praksi.
English: This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl parahydroxybenzoate
Croatian: Ovaj lijek također sadrži šećer, konzervanse: metilparahidroksibenzoat i propilparahidroksibenzoat.
English: Moreover, Epivir should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Croatian: Osim toga, Epivir se ne smije uzimati ni s jednim drugim lijekom koji sadrži lamivudin (vidjeti dio 4.4).
English: The true extent of penetration or relationship with any clinical efficacy is unknown.
Croatian: Nisu poznati pravi razmjeri prolaska niti njihov utjecaj na kliničku djelotvornost.
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Croatian: U kliničkim je ispitivanjima dokazano da kombinacija lamivudina i zidovudina odgađa pojavu zidovudin-rezistentnih izolata u osoba koje ranije nisu dobivale nikakvu antiretrovirusnu terapiju.
English: These medicines should not be used with Epivir:
Croatian: Sljedeći se lijekovi ne smiju primjenjivati istodobno s lijekom Epivir:
English: In 60 healthy adult volunteers, Epivir 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at steady-state to Epivir 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax.
Croatian: U 60 odraslih zdravih dobrovoljaca dokazano je da je farmakokinetika lijeka Epivir u stanju ravnoteže, u dozi od 300 mg jedanput na dan, ekvivalentna lijeku Epivir u dozi 150 mg dvaput na dan s obzirom na AUC24 i Cmax intracelularnog trifosfata.
English: Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily.
Croatian: Djeca u dobi od 3 mjeseca do godinu dana: Preporučena doza je 0,5 ml/kg (5 mg/kg) dvaput na dan.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Croatian: Križna rezistencija koju prenosi M184V RT ograničena je na skupinu inhibitora nukleozida.
English: Children receiving lamivudine oral solution concomitantly with other antiretroviral oral solutions in clinical trials developed viral resistance more frequently than children receiving tablets (see the description of the clinical experience in paediatric population (ARROW study) and section 5.2).
Croatian: U djece koja su u kliničkim ispitivanjima primala oralnu otopinu lamivudina istodobno s drugim antiretrovirusnim lijekovima u obliku oralne otopine virusna rezistencija razvila se češće nego u djece koja su primala tablete (vidjeti opis kliničkog iskustva u pedijatrijskoj populaciji (ispitivanje ARROW) i dio 5.2).
English: Adults, adolescents and children who weigh at least 25 kg: The usual dose is one 300 mg tablet once a day.
Croatian: Odrasli, adolescenti i djeca tjelesne težine najmanje 25 kg: Uobičajena doza je jedna tableta od 300 mg jedanput na dan.
English: Children weighing ≥ 20 kg to <25 kg: The recommended dose is 225 mg daily.
Croatian: Djeca tjelesne težine od ≥ 20 kg do < 25 kg: Preporučena doza je 225 mg na dan.
English: This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija.
English: In children, administration of tablets given concomitantly with other antiretroviral tablets delivered higher plasma lamivudine AUC∞ and Cmax than oral solution given concomitantly with other antiretroviral oral solutions.
Croatian: U djece je primjena tableta istodobno s drugim antiretrovirusnim lijekovima u obliku tableta dovela do viših plazmatskih vrijednosti AUC∞ i Cmax lamivudina nego oralna otopina primijenjena istodobno s drugim antiretrovirusnim lijekovima u obliku oralne otopine.
English: Administration of Epivir tablets is bioequivalent to Epivir oral solution with respect to AUC∞ and Cmax in adults.
Croatian: Primjena Epivir tableta bioekvivalentna je Epivir oralnoj otopini s obzirom na AUC∞ i Cmax u odraslih.
English: These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Croatian: Ti su rezultati dobiveni pri ispitivanju populacije koja do tada nije bila liječena antiretrovirusnom terapijom, tj. najvećim se dijelom radilo o asimptomatskim bolesnicima zaraženima HIV-om (CDC stadij A).
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Croatian: Interakcija s trimetoprimom, sastojkom kotrimoksazola, uzrokuje 40% porast izloženosti lamivudinu u terapijskim dozama.
English: Following oral administration lamivudine was excreted in breast milk at similar concentrations to those found in serum.
Croatian: Nakon peroralne primjene lamivudin se izlučuje u majčinom mlijeku u koncentracijama sličnima onima izmjerenima u serumu.
English: The oral solution also contains the following other ingredients: sugar (sucrose 3 g/15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavourings.
Croatian: Oralna otopina također sadrži sljedeće pomoćne tvari: šećer (saharoza 3 g/15 ml), metilparahidroksibenzoat, propilparahidroksibenzoat, bezvodnu citratnu kiselinu, natrijev citrat, propilenglikol, vodu, umjetnu aromu jagode i umjetnu aromu banane.
English: Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 5.2).
Croatian: Zidovudin ne utječe na farmakokinetiku lamivudina (vidjeti dio 5.2.).
English: The frequency of which is unknown (see section 4.4).
Croatian: Učestalost te nuspojave nije poznata (vidjeti dio 4.4).
English: Driving and using machines Epivir is unlikely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Epivir utjecati na sposobnost upravljanja vozilima i strojevima.
English: Lamivudine has been widely used as a component of antiretroviral combination therapy with other antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse transcriptase inhibitors).
Croatian: Lamivudin se široko primjenjuje kao jedan od lijekova u kombiniranoj antiretrovirusnoj terapiji s drugim antiretrovirusnim lijekovima iste skupine (nukleozidni inhibitori reverzne transkriptaze) ili drugih skupina (inhibitori proteaze, nenukleozidni inhibitori reverzne transkriptaze).
English: The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Croatian: Srednji omjer koncentracija lamivudina u cerebrospinalnoj tekućini i serumu 2-4 sata nakon peroralne primjene iznosi oko 0,12.
English: Each 150 mg tablet contains 0.378 mg sodium.
Croatian: Jedna tableta od 150 mg sadrži 0,378 mg natrija.
English: Coadministration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose of lamivudine oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure (AUC) and 28%, 52%, and 55% in the Cmax of lamivudine in adults.
Croatian: Istodobna primjena otopine sorbitola (3,2 g, 10,2 g, 13,4 g) s jednom dozom od 300 mg oralne otopine lamivudina rezultirala je o dozi ovisnim smanjenjem od 14%, 32% i 36% u izloženosti lamivudinu (AUC) i 28%, 52% i 55% u Cmax lamivudina kod odraslih osoba.
English: Discard one month after first opening
Croatian: Baciti mjesec dana nakon prvog otvaranja
English: Whenever possible in children, Epivir as tablet formulation should preferably be used.
Croatian: Kad god je to moguće, kod djece treba dati prednost primjeni lijeka Epivir u obliku tableta.
English: Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V mutations.
Croatian: Kombinacija antiretrovirusnih lijekova koja sadržava lamivudin pokazala se djelotvornom u bolesnika koji prethodno nisu primali antiretrovirusne lijekove kao i u bolesnika kojima su izolirani virusi s mutacijama M184V.
English: Drug Interactions: Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Croatian: Interakcije s drugim lijekovima: Epivir se ne smije primjenjivati s drugim lijekovima koji sadrže lamivudin ili emtricitabin (vidjeti dio 4.5).