FrancophonIA/ELRC3.0 huggingface dataset:
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Slovenian: Pri sočasnem jemanju drugih zdravil je potrebno upoštevati možnost nastanka interakcij, zlasti, če je glavna pot izločanja teh zdravil aktivna ledvična sekrecija preko kationskega transportnega sistema, npr. trimetoprim.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 16% - 36% to serum albumin in in vitro studies).
Slovenian: Lamivudin izkazuje linearno farmakokinetiko v terapevtskem razponu odmerjanja in se le omejeno veže na glavni plazemski protein albumin (< 16% - 36% serumskega albumina v in vitro študijah).
English: Epivir is not recommended for use as monotherapy.
Slovenian: Zdravila Epivir ni priporočljivo uporabljati kot monoterapijo.
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje mora uvesti zdravnik z izkušnjami pri zdravljenju okužb z virusom HIV.
English: Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations (see section 5.2).
Slovenian: Otroci, mlajši od treh mesecev: Na voljo je malo podatkov, ki ne zadostujejo za navedbo posebnih priporočil za odmerjanje (glejte poglavje 5.2).
English: Week 0 (after 36 weeks on Treatment) Any solution regimen at any time All tablet based regimen throughouts Week 96
Slovenian: 0. teden (po 36 tednih zdravljenja) Katerikoli režimi odmerjanja raztopine ob kateremkoli času
English: Epivir oral solution given concomitantly with sorbitol-containing medicines should be used only when an all-tablet regimen cannot be used and the benefits of treatment outweigh possible risks including lower virological suppression.
Slovenian: Sočasna uporaba peroralne raztopine zdravila Epivir z zdravili, ki vsebujejo sorbitol, je dovoljena le, če ni mogoče uporabljati sheme zdravljenja, ki obsega samo tablete, a koristi zdravljenja odtehtajo možna tveganja, vključno z manjšo virusno supresijo.
English: Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were similar to non-pregnant women.
Slovenian: Nosečnost: Farmakokinetika lamivudina ob koncu nosečnosti je po peroralnem vnosu podobna kot pri ženskah, ki niso noseče.
English: Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children.
Slovenian: Zdravilo Epivir se uporablja za zdravljenje okužbe z virusom HIV (virus humane imunske pomanjkljivosti) pri odraslih in otrocih.
English: Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Epivir vsebuje tudi konzervanse (parahidroksibenzoate), ki lahko povzročijo alergijske reakcije (možne so zapoznele reakcije).
English: If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Slovenian: Če ne morete pogoltniti celih tablet, jih lahko zdrobite in vzamete skupaj z majhno količino hrane ali pijače ter vzemite celoten odmerek naenkrat.
English: Take the syringe out of the bottle and wash it thoroughly in clean water.
Slovenian: Odmerno brizgo odstranite in jo temeljito sperite s čisto vodo.
English: If you take too much, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Slovenian: Če ste vzeli preveč zdravila, se morate za dodatni nasvet obrniti na svojega zdravnika ali farmacevta ali pa na urgentni oddelek najbližje bolnišnice.
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.
Slovenian: Zdravilo Epivir 10 mg/ml peroralna raztopina je najprimernejša formulacija za zagotavljanje priporočenega odmerka pri pediatričnih bolnikih z ledvično okvaro, ki so stari vsaj 3 mesece in tehtajo manj kot 25 kg.
English: What Epivir is and what it is used for What you need to know before you take Epivir How to take Epivir
Slovenian: Kaj je zdravilo Epivir in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Epivir Kako jemati zdravilo Epivir Možni neželeni učinki
English: You may still develop other infections and illnesses linked to HIV infection.
Slovenian: Lahko pa, da se bodo razvile druge okužbe in bolezni, povezane z okužbo s HIV.
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom
Slovenian: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, Velika Britanija
English: Other medicines and Epivir
Slovenian: Druga zdravila in zdravilo Epivir
English: • other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
Slovenian: • druga zdravila, ki vsebujejo lamivudin (uporabljajo se pri zdravljenju okužb s HIV ali okužb s hepatitisom B),
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).
Slovenian: Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
English: As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Slovenian: Ker in vitro ugotovljenega mutagenega učinka lamivudina niso mogli potrditi z in vivo testi, lahko sklepamo, da to zdravilo ne bi smelo predstavljati genotoksičnega tveganja za bolnike, ki ga prejemajo.
English: Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če katerikoli neželeni učinek postane resen ali moteč, ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu.
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Slovenian: Ob največjih odmerkih so opazili manjše učinke na pokazatelje jetrnega in ledvičnega delovanja, kakor tudi občasno zmanjšanje teže jeter.
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Slovenian: Skopi podatki kažejo, da lamivudin prehaja v centralni živčni sistem (CŽS) in doseže cerebrospinalno tekočino (CST).
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.
Slovenian: Pediatrične farmakokinetične študije s peroralno raztopino in tabletami so pokazale, da odmerjanje enkrat na dan zagotavlja enakovredno AUC0-24 kot odmerjanje enakega celotnega dnevnega odmerka dvakrat na dan.
English: Epivir is also available as a tablet formulation for patients who weigh at least 14 kg (see section 4.4).
Slovenian: Zdravilo Epivir je na voljo tudi v obliki tablet za bolnike, ki tehtajo vsaj 14 kg (glejte poglavje 4.4).
English: A rare side effect that may show up in blood tests is: • increase in an enzyme called amylase.
Slovenian: Redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je: • povečanje encima imenovanega amilaza.
English: Although not studied, the same effect would be expected with other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol (see section 4.5)).
Slovenian: Čeprav niso preučevali, bi enak učinek pričakovali pri drugih osmotsko delujočih poli-alkoholih ali monosaharidnih alkoholih (npr. ksilitol, manitol, laktitol, maltitol (glejte poglavje 4.5)).
English: • emtricitabine (used to treat HIV infection)
Slovenian: • emtricitabin (uporablja se pri zdravljenju okužb s HIV),
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Epivir.
Slovenian: Če vam je vaš zdravik povedal, da ste občutljivi na nekatere sladkorje, se pred jemanjem zdravila Epivir posvetujte z zdravnikom.
English: Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect.
Slovenian: Pri zaužitju zdrobljenih tablet z majhno količino poltrde hrane ali tekočine, ni pričakovati vpliva na farmacevtsko kakovost in posledičnih sprememb v kliničnem učinku.
English: If you take more Epivir than you should
Slovenian: Če ste vzeli večji odmerek zdravila Epivir, kot bi smeli
English: Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults; it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults.
Slovenian: Na osnovi predpostavke, da sta očistka kreatinina in lamivudina pri otrocih v enaki medsebojni odvisnosti kot pri odraslih, se pri otrocih z oslabljenim delovanjem ledvic priporoča odmerek zmanjšati ob upoštevanju njihovega kreatininskega očistka in v enakem razmerju kot pri odraslih.
English: Subgroup analyses testing for heterogeneity of once vs twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Slovenian: Analize podskupin za testiranje heterogenosti med odmerjanjem enkrat in dvakrat na dan niso pokazale značilnih vplivov spola, starost ali virusne obremenitve ob randomizaciji.
English: This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni »brez natrija«.
English: From intravenous studies, the mean volume of distribution is 1.3 l/kg.
Slovenian: Raziskave z intravenskim lamivudinom so pokazale, da znaša srednji volumen porazdelitve 1,3 l/kg.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Slovenian: Nekateri bolniki, ki jemljejo zdravila za zdravljenje okužbe s HIV, razvijejo določena stanja, ki so lahko resna.
English: Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats (see section 5.3).
Slovenian: Študije na živalih z lamivudinom so pokazale porast zgodnjih smrti zarodkov pri kuncih, ne pa pri podganah (glejte poglavje 5.3).
English: The true extent of penetration or relationship with any clinical efficacy is unknown.
Slovenian: Dejanski obseg penetracije lamivudina v CŽS in korelacija s klinično učinkovitostjo nista znana.
English: Each 15 ml dose contains 3 g sucrose (20% w/v).
Slovenian: En 15 ml odmerek vsebuje 3 g saharoze (20% m/V).
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Slovenian: Presnova lamivudina ne vključuje CYP3A, zato interakcije z zdravili, ki se presnavljajo s pomočjo tega sistema (npr. zaviralci proteaz), niso verjetne.
English: 6 Contents of the pack and other information
Slovenian: 6 Vsebina pakiranja in dodatne informacije
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Slovenian: Če se pri teh bolnikih opazi poslabšanje jetrne bolezni, je potrebno razmisliti o začasni prekinitvi ali trajni ukinitvi zdravljenja (glejte poglavje 4.8).
English: • cladribine (used to treat hairy cell leukaemia).
Slovenian: • kladribin (uporablja se za zdravljenje dlakastocelične levkemije).
English: Tell your doctor if you are being treated with any of these.
Slovenian: Povejte zdravniku, če se zdravite s katerimkoli od teh zdravil.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).
Slovenian: • težave z jetri, kot so zlatenica, povečana ali zamaščena jetra, vnetje jeter (hepatitis).
English: Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05.
Slovenian: Farmakoterapevtska skupina: Nukleotidni in nukleozidni zaviralci reverzne transkriptaze, Oznaka ATC: J05AF05.
English: Each 15 ml dose contains 44.1 mg sodium.
Slovenian: En 15 ml odmerek vsebuje 44,1 mg natrija.
English: Children weighing ≥ 20 kg to <25 kg: The recommended dose is 225 mg daily.
Slovenian: Otroci , ki tehtajo ≥ 20 kg in <25 kg: Priporočeni odmerek je 225 mg dnevno.
English: Children receiving lamivudine oral solution according to the recommended dosage regimen achieve plasma lamivudine exposure within the range of values observed in adults.
Slovenian: Otroci, ki prejemajo lamivudin v obliki peroralne raztopine po priporočenem režimu odmerjanja, dosežejo izpostavljenost lamivudinu v plazmi v okviru vrednosti, ugotovljenih pri odraslih.
English: • tingling or numbness of the arms, legs, hands or feet.
Slovenian: • občutek mravljinčenja ali odrevenelost rok, nog, dlani ali stopal.
English: The nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.
Slovenian: Nukleozidni analogi (npr. didanozin in zalcitabin) se podobno kot zidovudin ne izločajo s pomočjo omenjenega mehanizma in zanje je malo verjetno, da bi medsebojno delovali z lamivudinom.
English: Following oral administration lamivudine was excreted in breast milk at similar concentrations to those found in serum.
Slovenian: Po peroralnem vnosu se je lamivudin izločal v materino mleko v koncentracijah, ki so podobne tistim ugotovljenim v serumu.
English: What you need to know before you take Epivir
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Epivir
English: If you are a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar.
Slovenian: Če ste sladkorni bolnik, upoštevajte, da vsak odmerek (150 mg = 15 ml) vsebuje 3 g sladkorja.
English: Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Slovenian: Odmerno brizgo vstavite v usta s konico brizge v smeri proti licem.
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Slovenian: Medtem ko jemljete vaše zdravilo, boste morda potrebovali dodatne preglede, vključno s krvnimi preiskavami.
English: Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTI's are available.
Slovenian: Nadaljevanje zdravljenja z lamivudinom kljub mutaciji M184V pride v poštev samo v primerih, ko drugih učinkovitih NRTI ni na voljo.
English: At the time of randomization to once daily vs twice daily dosing (Week 0), those patients who had received tablet formulations had a higher rate of viral load suppression than those who had received any solution formulations at any time.
Slovenian: Pri randomizaciji jemanja enkrat na dan v primerjavi z dvakrat na dan (0. teden), so bolniki, ki so prejemali tablete, imeli višjo stopnjo supresije virusne obremenitve, v primerjavi s tistimi, ki so kadarkoli prejeli zdravilo v obliki katerekoli formulacije raztopine.
English: This medicine contains 300 mg propylene glycol in each 15ml.
Slovenian: To zdravilo vsebuje 300 mg propilenglikola v vsakih 15 ml.
English: If you forget to take Epivir
Slovenian: Če ste pozabili vzeti zdravilo Epivir
English: Date of first authorisation: 8 August 1996 Date of last renewal: 28 July 2006
Slovenian: Datum zadnjega podaljšanja: 28. julij 2006
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.
Slovenian: Raziskava je pokazala, da je pri fetusih, ki so bili in utero izpostavljeni kombinaciji prišlo do obširne vgraditve nukleozidnih analogov DNA v več organov fetusa in večjega skrajšanja telomer, kot pri tistih, ki so bili izpostavljeni samo zidovudinu.
English: Talk to your doctor if this applies to you or your child.
Slovenian: Posvetujte se z zdravnikom, če se to nanaša na vas ali vašega otroka.
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.
Slovenian: Protiretrovirusna terapija z več zdravili, ki vključuje lamivudin, se je izkazala za uspešno pri bolnikih, ki še niso bili deležni protiretrovirusne terapije, kot tudi pri bolnikih okuženih z virusi, ki vsebujejo mutacije M184V.
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.
Slovenian: Pri enem tednu starih novorojenčkih je bil, v primerjavi z drugimi pediatričnimi bolniki, očistek peroralno danega lamivudina manjši, najverjetneje zaradi še nepopolnega ledvičnega delovanja in variabilne absorpcije.
English: A fertility study in rats has shown that lamivudine had no effect on male or female fertility.
Slovenian: Študija plodnosti na podganah je pokazala, da lamivudin ne vpliva na plodnost samcev ali samic.
English: Due to similarities, Epivir should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Slovenian: Zaradi podobnosti, se zdravila Epivir ne sme dajati sočasno z ostalimi analogi citidina, npr. emtricitabinom.
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.
Slovenian: Bolezni jeter: V primeru sočasnega zdravljenja okužbe z virusom HIV in virusom HBV z lamivudinom, so dodatne informacije, ki se nanašajo na uporabo lamivudina pri zdravljenju okužbe z virusom hepatitisa B, na voljo v Povzetku glavnih značilnosti zdravila Zeffix.
English: The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Slovenian: Srednje vrednosti razmerja koncentracij CST/serum lamivudina so znašale približno 0,12, 2 do 4 ure po peroralni aplikaciji.
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.
Slovenian: Srednja vrednost sistemskega očistka lamivudina je približno 0,32 l/h/kg, pri čemer glavni delež odpade na ledvični očistek (> 70%), ki poteka preko organskega kationskega transportnega sistema.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Slovenian: Navzkrižna odpornost, ki jo prenaša M184V RT, je omejena na skupino protiretrovirusnih učinkovin, imenovanih nukleozidni zaviralci.
English: Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily.
Slovenian: Otroci, od treh mesecev do enega leta starosti: Priporočen odmerek je 0,5 ml/kg (5 mg/kg) dvakrat na dan.
English: Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of adult patients with chronic HBV infection (for details of clinical studies, see the prescribing information for Zeffix).
Slovenian: Ugotovili so, da je lamivudin pri odmerku 100 mg enkrat na dan učinkovit tudi za zdravljenje odraslih bolnikov s kronično infekcijo z virusom hepatitisa B (za podrobnosti iz kliničnih raziskav glejte povzetek glavnih značilnosti zdravila Zeffix).
English: These medicines should not be used with Epivir:
Slovenian: Zdravila, ki se ne smejo uporabljati skupaj z zdravilom Epivir:
English: If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Epivir.
Slovenian: Če ste noseči, če postanete noseči ali če načrtujete nosečnost, se posvetujte z zdravnikom o tveganjih in koristih jemanja zdravila Epivir za vas in vašega otroka.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: Poleg oportunističnih okužb se vam lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavi avtoimunska bolezen (to je bolezen, ki nastane, če imunski sistem napade zdrava telesna tkiva).
English: No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
Slovenian: Pri pediatričnih preiskovancih, ki so prejemali zdravljenje bodisi enkrat ali dvakrat na dan, v primerjavi z odraslimi niso ugotovili nobenih dodatnih varnostnih težav.
English: The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Slovenian: Odnos med in vitro občutljivostjo virusa HIV na lamivudin in kliničnim odzivom na zdravljenje z zdravili, ki vsebujejo lamivudin še preučujejo.
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Slovenian: Lamivudin in vivo v odmerkih, po katerih so bile koncentracije v plazmi približno 40- do 50-krat večje od pričakovanih kliničnih koncentracij v plazmi, ni bil genotoksičen.
English: There are no data available on the use of lamivudine in children with renal impairment.
Slovenian: Podatki o uporabi lamivudina pri otrocih z oslabljenim delovanjem ledvic niso na voljo.
English: PENTA 13 2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17)
Slovenian: PENTA 13 Od 2 do 12 let (n = 19)
English: Opportunistic infections: Patients receiving Epivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Slovenian: Oportunistične okužbe: Ker se pri bolnikih, ki se zdravijo z zdravilom Epivir ali s katerim koli drugim protiretrovirusnim zdravljenjem še vedno lahko pojavijo oportunistične okužbe in drugi zapleti vezani na okužbo z virusom HIV, morajo bolniki ostati pod skrbnim kliničnim nadzorom zdravnikov z izkušnjami pri zdravljenju bolezni vezanih na okužbo z virusom HIV.
English: Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
Slovenian: Dajanje lamivudina v zelo velikih odmerkih, ki so ga proučevali v akutnih študijah na živalih, ni toksično vplivalo na noben organ.
English: Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described above) approximately every 24 hours.
Slovenian: Bolniki, ki bodo prešli iz režima odmerjanja dvakrat na dan na režim odmerjanja enkrat na dan, morajo vzeti priporočen enkratni dnevni odmerek (kot je navedeno zgoraj) približno 12 ur po zadnjem odmerku režima odmerjanja dvakrat na dan in nato nadaljevati z jemanjem priporočenega enkratnega dnevnega odmerka (kot je navedeno zgoraj) približno vsakih 24 ur.