FrancophonIA/ELRC3.0 huggingface dataset:
English: Glomerular filtration estimates suggests that to achieve similar adult and paediatric exposure, an appropriate dose for children aged six weeks and older could be 8 mg/kg/day.
Slovenian: Ocene glomerularne filtracije nakazujejo, da bi za doseganje podobne izpostavljenosti kot pri odraslih, pri otrocih starih 6 tednov ali starejših, lahko bil primeren odmerek 8 mg/kg/dan.
English: However, for the treatment of HIV infection, only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Slovenian: Vendar pa se je za zdravljenje okužbe z virusom HIV kot učinkovit izkazal le lamivudin v odmerku 300 mg na dan (v kombinaciji z drugimi protiretrovirusnimi zdravili).
English: These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Slovenian: Rezultati omenjene študije so bili pridobljeni pri populaciji bolnikov, ki s protiretrovirusnimi zdravili še ni bila zdravljena, v glavnem pa so jo sestavljali asimptomatski, z virusom HIV okuženi bolniki (CDC stadij A).
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Slovenian: Bolniki z napredovano okužbo s HIV (AIDS-om) imajo oslabel imunski sistem, zato je pri njih večja verjetnost, za nastanek resnih okužb (oportunističnih okužb).
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol,
Slovenian: • zdravila (večinoma raztopine), ki vsebujejo sorbitol ali druge sladkorne alkohole (npr. ksilitol,
English: Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Slovenian: Zdravilo Epivir je, kot del kombiniranega protiretrovirusnega zdravljenja, indicirano za zdravljenje odraslih in otrok, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV).
English: Drug Interactions: Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Slovenian: Medsebojno delovanje z drugimi zdravili: Zdravila Epivir se ne sme uporabljati z nobenim drugim zdravilom, ki vsebuje lamivudin, in tudi ne z zdravili, ki vsebujejo emtricitabin (glejte poglavje 4.5).
English: Moreover, Epivir should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Slovenian: Poleg tega se zdravila Epivir ne sme jemati z ostalimi zdravili, ki vsebujejo lamivudin (glejte poglavje 4.4).
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.
Slovenian: Peroralna raztopina vsebuje naslednje druge sestavine: sladkor (saharoza 3 g/15 ml), metilparahidroksibenzoat, propilparahidroksibenzoat, brezvodna citronska kislina, natrijev citrat, propilenglikol, voda, umetni aroma jagode in banane.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Slovenian: O varnosti lamivudina, uporabljenih pri dojenčkih, mlajših od treh mesecev, ni podatkov.
English: Summary of Stead-State Plasma Lamivudine AUC (0-24) (µg.h/ml) and Statistical Comparisons for Once and Twice-Daily Oral Administration Across Studies
Slovenian: Povzetek AUC (0-24) lamivudina v plazmi v stanju dinamičnega ravnovesja (µg.h/ml) in statistične primerjave peroralne uporabe enkrat in dvakrat na dan v študijah
English: Epivir can be used during pregnancy if clinically needed.
Slovenian: Če je klinično potrebno, se zdravilo Epivir lahko uporablja med nosečnostjo.
English: Therefore to achieve similar adult and paediatric exposure, an appropriate dose for neonates is 4 mg/kg/day.
Slovenian: Da bi bila izpostavljenost novorojenčkov primerljiva tisti pri odraslih, je za novorojenčke primeren odmerek 4 mg/kg/dan.
English: If you get any symptoms of infection while you are taking Epivir:
Slovenian: Če dobite znake okužbe, medtem ko jemljete zdravilo Epivir:
English: The active ingredient in Epivir is lamivudine.
Slovenian: Učinkovina v zdravilu Epivir je lamivudin.
English: The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/ml at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200c/ml, <400c/ml, <1000c/ml), which all fell well within this non-inferiority margin.
Slovenian: Dokazano je bilo, da je skupina z odmerjanjem abakavirja + lamivudina enkrat na dan neinferiorna skupini z odmerjanjem dvakrat na dan glede na vnaprej opredeljeno mejo neinferiornosti -12 %, za primarni opazovani dogodek < 80 kopij/ml v 48. tednu in v 96. tednu (sekundarni opazovani dogodek) ter vse druge testirane prage (< 200 kopij/ml, < 400 kopij/ml, < 1000 kopij/ml), ki so bili vsi znotraj omenjene meje neinferiornosti.
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.
Slovenian: Sočasna uporaba raztopine sorbitola (3,2 g; 10,2 g ; 13,4 g) z enkratnim odmerkom 300 mg lamivudina v peroralni raztopini je pri odraslih povzročila od količine sorbitola odvisno zmanjšanje izpostavljenosti (AUC) lamivudinu za 14 %, 32 % oziroma 36 % ter zmanjšanje Cmax lamivudina za 28 %, 52 % in 55 %.
English: Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW (Observed Analysis)
Slovenian: Virološki odziv glede na HIV-1 RNA v plazmi manj kot 80 kopij/ml, v 48. in 96. tednu pri randomizaciji jemanja abakavir + lamivudin enkrat na dan v primerjavi z dvakrat na dan v preskušanju ARROW (analiza opaženih)
English: <30 As doses below 150 mg are needed the use of the oral solution is recommended
Slovenian: Ker so potrebni manjši odmerki od 150 mg, je priporočljiva uporaba peroralne raztopine.
English: Dosing recommendations - Children aged at least 3 months and weighing less than 25 kg: Creatinine clearance (ml/min)
Slovenian: Priporočila glede odmerjanja - Otroci, stari vsaj 3 mesece in tehtajo manj kot 25 kg: Kreatininski očistek (ml/min)
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).
Slovenian: Otroci, ki so v kliničnih preskušanjih prejemali peroralno raztopino lamivudina sočasno z drugimi protiretrovirusnimi peroralnimi raztopinami, so pogosteje razvili virusno odpornost kot otroci, ki so prejemali tablete (glejte opis kliničnih izkušenj pri pediatrični populaciji (študija ARROW) in poglavje
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.
Slovenian: V bakterijskih testih lamivudin ni bil mutagen, vendar je enako kot številni nukleozidni analogi pokazal določeno aktivnost in vitro v citogenetskem testu in testu na celicah mišjega limfoma.
English: However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary (see section 4.2).
Slovenian: Vendar, če bolnik nima oslabljenega delovanja ledvic, odmerka lamivudina ni potrebno prilagoditi (glejte poglavje 4.2).
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia)
Slovenian: • zmanjšanje števila krvnih celic, ki so pomembne pri strjevanju krvi (trombocitopenija),
English: Each 300 mg tablet contains 0.756 mg sodium.
Slovenian: Ena 300 mg tableta vsebuje 0,756 mg natrija.
English: Each 150 mg tablet contains 0.378 mg sodium.
Slovenian: Ena 150 mg tableta vsebuje 0,378 mg 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.
Slovenian: Pri otrocih je jemanje tablet sočasno z drugimi protiretrovirusnimi tabletami privedlo do večjih AUC∞ in Cmax lamivudina v plazmi kot jemanje peroralne raztopine, sočasno z drugimi protiretrovirusnimi peroralnimi raztopinami.
English: A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
Slovenian: V raziskavah genotoksičnosti preko placente so na opicah primerjali zidovudin sam s kombinacijo zidovudina in lamivudina v odmerkih, kakršnim so izpostavljeni ljudje.
English: For patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Slovenian: Pri bolnikih, ki ne morejo pogoltniti tablet, lahko tableto(e) zdrobimo in dodamo v majhno količino poltrde hrane ali tekočine, ki jo je vso potrebno takoj zaužiti (glejte poglavje 5.2).
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo je, da ženske okužene z virusom HIV v nobenem primeru ne dojijo in se tako izognejo eni od možnosti za prenos virusa HIV na otroka.
English: This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl parahydroxybenzoate
Slovenian: To zdravilo vsebuje tudi sladkor in konzervanse: metilparahidroksibenzoat in propilparahidroksibenzoat
English: Any solution regimen at any time All tablet based regimen throughouts
Slovenian: Vsi režimi odmerjanja tablet ob kateremkoli času
English: Children weighing 14 to < 20 kg: The recommended dose is 150 mg daily.
Slovenian: Otroci, ki tehtajo od 14 do 20 kg: Priporočeni odmerek je 150 mg dnevno.
English: Clinical trial evidence from paediatric patients receiving lamivudine with other antiretroviral drugs (abacavir, nevirapine/efavirenz or zidovudine) has shown that the resistance profile observed in paediatric patients is similar to that observed in adults, in terms of the genotypic substitutions detected and their relative frequency.
Slovenian: Izsledki kliničnih preskušanj pri pediatričnih bolnikih, ki so prejemali lamivudin z drugimi protiretrovirusnimi zdravili (abakavir, nevirapin/efavirenz ali zidovudin) so pokazali, da je profil odpornosti, ki so ga opazili pri pediatričnih bolnikih, glede na detekcijo genotipskih substitucij in njihove relativne pogostnosti, podoben tistemu pri odraslih.
English: Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Slovenian: Jetrna okvara: Podatki pridobljeni pri bolnikih z zmerno do hudo jetrno okvaro kažejo, da jetrna disfunkcija na farmakokinetične lastnosti lamivudina znatneje ne vpliva.
English: Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Sindrom imunske reaktivacije: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
Slovenian: Dajanje velikih odmerkov lamivudina v raziskavah toksičnosti na živalih ni bila povezana s toksičnostjo za kakšen pomemben organ.
English: First dose
Slovenian: Začetni odmerek
English: Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 5.2).
Slovenian: Zidovudin ne vpliva na farmakokinetične lastnosti lamivudina (glejte poglavje 5.2).
English: Epivir can be taken with or without food.
Slovenian: Zdravilo Epivir se lahko jemlje s hrano ali brez.
English: Driving and using machines Epivir is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo je verjetno, da bi zdravilo Epivir vplivalo na sposobnost upravljanja vozil in strojev.
English: Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in paediatric patients below 12 years of age.
Slovenian: Otroci: Pri otrocih, mlajših od 12 let, je bila absolutna biološka uporabnost lamivudina (približno 5866 %) zmanjšana.
English: Whenever possible in children, Epivir as tablet formulation should preferably be used.
Slovenian: Kadar je mogoče, naj se pri otrocih zdravilo Epivir uporablja v obliki tablet.
English: For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Slovenian: Pri bolnicah, ki so hkrati okužene s hepatitisom, se zdravijo z lamivudinom in zanosijo, je treba upoštevati možnost ponovitve hepatitisa po prenehanju uporabe lamivudina.
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.
Slovenian: V škatli je priložen tudi polietilenski nastavek za brizgo in 10 ml odmerna brizga, ki je sestavljena iz polipropilenske cevi (z ml lestvico) in polietilenskega bata.
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).
Slovenian: Če je mogoče, se izognite kronični sočasni uporabi zdravila Epivir z zdravili, ki vsebujejo sorbitol ali druge osmotsko delujoče poli-alkohole oziroma monosahardine alkohole (npr. ksilitol, manitol, laktitol, maltitol).
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.
Slovenian: Odmerjanje enkrat na dan (300 mg enkrat na dan): S klinično študijo je bilo dokazano, da sta si odmerjanji zdravila Epivir enkrat na dan in dvakrat na dan enakovredni.
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesia)
Slovenian: Pogosti: glavobol, nespečnost Zelo redki: periferna nevropatija (ali parestezija)
English: It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Slovenian: Sodi v skupino zdravil, ki se imenuje zaviralci nukleozidne reverzne transkriptaze (ZNRT).
English: Take special care with Epivir
Slovenian: Bodite posebno pozorni pri jemanju zdravila Epivir
English: Studies in animals showed that lamivudine had no effect on fertility (see section 5.3).
Slovenian: Študije na živalih so pokazale, da lamivudin ne vpliva na plodnost (glejte poglavje 5.3).
English: No antagonistic effects in vitro were seen with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and zidovudine).
Slovenian: Antagonističnih učinkov z lamivudinom in drugimi protiretrovirusnimi učinkovinami (preskušane učinkovine: abakavir, didanozin, nevirapin in zidovudin) niso zaznali in vitro.
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.
Slovenian: Pri bolnikih, ki so prejemali raztopino lamivudina v kombinaciji z drugimi protiretrovirusnimi raztopinami, je bilo odkritih več primerov odpornosti, v primerjavi s tistimi, ki so prejemali podobne odmerke v obliki tablet.
English: Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine Randomisation of ARROW with Plasma HIV-1 RNA <80 copies/ml: Subgroup Analysis by Formulation
Slovenian: Delež preiskovancev pri randomizaciji jemanja abakavir + lamivudin enkrat na dan v primerjavi z dvakrat na dan v preskušanju ARROW z HIV-1 RNA v plazmi <80 kopij/ml: analiza podskupine glede na formulacijo
English: Excipients: Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Slovenian: Pomožne snovi: Bolnikom s sladkorno boleznijo je treba pojasniti, da vsak odmerek (150 mg = 15 ml) vsebuje 3 g saharoze.
English: An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.
Slovenian: Zdravilo Epivir je na voljo tudi v obliki peroralne raztopine za zdravljenje otrok, starejših od treh mesecev in bolnikov, ki potrebujejo nižji odmerek, kot je običajno, ali ki tablet ne morejo jemati.
English: Sucrose 20 % w/v (3 g/15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate
Slovenian: 6.1 Seznam pomožnih snovi saharoza 20% m/V (3 g/15 ml) metilparahidroksibenzoat propilparahidroksibenzoat brezvodna citronska kislina propilenglikol natrijev citrat umetna aroma jagode umetna aroma banane prečiščena voda
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Opisan je bil tudi pojav avtoimunskih bolezni (npr. pojav Gravesove bolezni in avtoimunskega hepatitisa), toda opisani čas do začetka je bolj spremenljiv in ti učinki se lahko pojavijo veliko mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
English: Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Slovenian: Lamivudin izkazuje in vitro nizko citotoksičnost do limfocitov v perifernem krvnem obtoku, do dozorelih limfocitov in celičnih linij monocitov-makrofagov ter do vrste progenitorskih celic kostnega mozga.
English: 30 to<50
Slovenian: 30 do < 50
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).
Slovenian: Če pri bolnikih, ki so sočasno okuženi z virusom hepatitisa B, zdravilo Epivir ukinemo, je potrebno periodično spremljati tako teste jetrne funkcije kot označevalce replikacije virusa HBV, saj lahko ukinitev lamivudina vodi v akutno poslabšanje hepatitisa (glejte Povzetek glavnih značilnosti zdravila Zeffix).
English: Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure.
Slovenian: Škatle, ki vsebujejo 240 ml peroralne raztopine v belih plastenkah iz polietilena visoke gostote (HDPE) z za otroke varnimi zaporkami.
English: Tell your doctor.
Slovenian: se posvetujte z zdravnikom.
English: Remove the syringe from the adapter.
Slovenian: Odstranite odmerno brizgo iz nastavka.
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Slovenian: Kot splošno navodilo velja, da je treba upoštevati podatke iz študij na živalih, kot tudi klinične izkušnje pri nosečnicah, kadar se odločamo o uporabi protiretrovirusnih učinkovin za zdravljenje okužbe z virusom HIV pri nosečnicah in posledično za zmanjšanje tveganja vertikalnega prenosa na novorojenčka.
English: Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5).
Slovenian: Otroci, od enega leta starosti: Priporočen odmerek je 0,5 ml/kg (5 mg/kg) dvakrat na dan ali 1 ml/kg (10 mg/kg) enkrat na dan (glejte poglavji 4.4 in 4.5).
English: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varnimi zaporkami ali PVC/aluminij pretisni omoti, vsako pakiranje vsebuje po 60 tablet.
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.
Slovenian: Pri 60 zdravih odraslih prostovoljcih se je glede na AUC24 in Cmax znotrajceličnega trifosfata izkazalo, da je v ravnotežnem stanju zdravilo Epivir v odmerku 300 mg enkrat na dan farmakokinetično ekvivalentno zdravilu Epivir v odmerku 150 mg dvakrat na dan.
English: The triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also active against zidovudine-resistant clinical isolates of HIV.
Slovenian: Trifosfat je selektivni zaviralec replikacije virusov HIV-1 in HIV-2 in vitro, učinkuje tudi na klinične izolate virusa HIV, ki so odporni na zidovudin.
English: Paediatric Population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving the oral solution of Epivir as compared to those receiving the tablet formulation.
Slovenian: Pediatrična populacija: V študiji izvedeni pri pediatričnih bolnikih (glejte poglavje 5.1, ARROW študija), so pri otrocih, ki so prejemali zdravilo Epivir v obliki peroralne raztopine, poročali o nižjih stopnjah virusne supresije in pogostejši virusni odpornosti, v primerjavi s tistimi, ki so prejemali tablete.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in lamivudine exposure at therapeutic doses.
Slovenian: Interakcija s trimetoprimom, ki je sestavina kotrimoksazola, pri terapevtskih odmerkih izpostavljenost lamivudinu poveča za 40%.
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.
Slovenian: Po vnosu 160 mg trimetoprima/800 mg sulfametoksazola se izpostavljenost lamivudinu poveča za 40%.
English: PVC/aluminium foil blister packs:
Slovenian: PVC/aluminij pretisni omoti:
English: 5 to <15
Slovenian: 5 do <15
English: Children receiving lamivudine oral tablets according to the recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet formulation has higher bioavailability (see section 4.2).
Slovenian: Otroci, ki prejemajo lamivudin v obliki peroralnih tablet po priporočenem režimu odmerjanja, dosežejo višjo izpostavljenost lamivudinu v plazmi kot otroci, ki prejemajo peroralno raztopino; v obliki tablet se namreč dajejo večji odmerki (v mg/kg), poleg tega pa imajo tablete večjo biološko uporabnost (glejte poglavje 4.2).
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare: Pancreatitis, elevations in serum amylase
Slovenian: Pogosti: navzea, bruhanje, bolečine ali krči v trebuhu, diareja Redki: pankreatitis, povišana raven serumske amilaze