FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Slovenian: Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če imajo bolečine v sklepih, toge sklepe ali težave z gibljivostjo.
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 zdravnika ali farmacevta, če kateri koli neželeni učinek postane resen ali moteč, ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu.
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 okužb z virusom HIV izkazal za učinkovitega samo dnevni odmerek lamivudina 300 mg (v kombinaciji z drugimi protiretrovirusnimi zdravili).
English: The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Slovenian: Klinično pomembna učinka, ki so ju opazili, sta bila zmanjšanje števila rdečih krvnih celic in nevtropenija.
English: The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Slovenian: Neželeni učinki, za katere vsaj obstaja možnost, da so povezani z zdravljenjem, so razvrščeni spodaj po organskih sistemih in absolutni pogostosti.
English: Very rare: Peripheral neuropathy (or paraesthesia).
Slovenian: Zelo redki: periferna nevropatija (ali parestezija).
English: Creatinine clearance (ml/min) First dose
Slovenian: očistek kreatinina (ml/min) prvi odmerek vzdrževalni odmerek
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Slovenian: Lamivudin se iz prebavil dobro absorbira, biološka uporabnost peroralno vnesenega lamivudina pri odraslih je običajno med 80 in 85 %.
English: There are limited pharmacokinetic data for patients less than three months of age.
Slovenian: Podatki o farmakokinetičnih lastnostih pri bolnikih, mlajših od treh mesecev, so omejeni.
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: Treba je upoštevati možnost interakcij z drugimi zdravili, ki se uporabljajo sočasno, še posebno, če je njihova glavna pot izločanja aktivna renalna sekrecija prek organskega kationskega transportnega sistema (npr. s trimetoprimom).
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (<4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Slovenian: Na podlagi podatkov pri več kot 200 parih mater in otrok, zdravljenih zaradi okužbe HIV, so koncentracije lamivudina v serumu dojenih otrok, mater, zdravljenih zaradi okužbe s HIV, zelo majhne (manj kot 4 % koncentracije v materinem serumu) in se progresivno zmanjšujejo do nezaznavne ravni, ko dojeni otroci dosežejo 24 tednov starosti.
English: If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika nadzirati in po potrebi uvesti standardno podporno zdravljenje.
English: A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Slovenian: Opazili so zmerno povečanje vrednosti Cmax (28-odstotno) zidovudina, če so ga uporabili sočasno z lamivudinom, vendar se celotna izpostavljenost (AUC) ni znatno spremenila.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Slovenian: Ni podatkov o varnosti lamivudina, kadar ga dajemo dojenčkom starih manj kot 3 mesece.
English: A rare side effect that may show up in blood tests is: • an increase in an enzyme called amylase.
Slovenian: Redek neželeni učinki, ki se lahko pokaže v preiskavah krvi, je: • povečanje encima imenovanega amilaza.
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Slovenian: Zelo redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je: • nesposobnost kostnega mozga proizvajati nove rdeče krvne celice (čista aplazija rdečih krvnih celic).
English: If you are breast-feeding, or thinking about breast-feeding: Talk to your doctor immediately.
Slovenian: Če dojite ali razmišljate o dojenju: Takoj se posvetujte z zdravnikom.
English: Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Slovenian: Lamivudin nima učinka na farmakokinetiko trimetoprima ali sulfametoksazola.
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: Na voljo je tudi zdravilo v obliki peroralne raztopine za zdravljenje otrok, starejših od treh mesecev, in bolnikov, ki potrebujejo nižji odmerek, kot je običajno ali tablet ne morejo jemati.
English: Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were similar to non-pregnant women.
Slovenian: Nosečnost: Farmakokinetika lamivudina po peroralnem vnosu je bila v pozni nosečnosti podobna kot pri ženskah, ki niso noseče.
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: Povprečni sistemski očistek lamivudina je približno 0,32 l/h/kg, pri čemer je glavni delež ledvični očistek (več kot 70 %) prek organskega kationskega transportnega sistema.
English: • if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na lamivudin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in pljučnica s povzročiteljem Pneumocystis jirovecii (pogosto omenjena kot PCP).
English: This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Slovenian: Odmerka zaradi tega ni treba prilagoditi, razen če ima bolnik tudi okvaro ledvic (glejte poglavji 4.5 in 4.2).
English: Rare: Angioedema.
Slovenian: Redki: angioedem.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Take reakcije so ponavadi opazili v prvih nekaj tednih ali mesecih po uvedbi kombiniranega protiretrovirusnega zdravljenja.
English: 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 80 film-coated tablets 90 film-coated tablets 100 film-coated tablets 500 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet 500 filmsko obloženih tablet
English: As doses below 150 mg are needed the use of an oral solution is recommended
Slovenian: Ker so potrebni manjši odmerki od 150 mg, je priporočljiva uporaba peroralne raztopine.
English: These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown etiology, particularly neurologic findings.
Slovenian: Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, pri katerih se pojavijo resne klinične ugotovitve neznanega vzroka, še zlasti nevrološke.
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 je pri teh bolnikih opazno poslabšanje bolezni jeter, je treba razmisliti o prekinitvi ali trajni opustitvi zdravljenja (glejte poglavje 4.8).
English: No specific signs or symptoms have been identified following such overdose.
Slovenian: Po takšnem prevelikem odmerjanju niso opazili specifičnih znakov ali simptomov.
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 priporočeni 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.
English: The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell (16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).
Slovenian: Aktivna spojina, znotrajcelični lamivudin trifosfat, ima v celici daljši končni razpolovni čas (16 do 19 ur) v primerjavi z razpolovnim časom lamivudina v plazmi (5 do 7 ur).
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Slovenian: Pri otrocih, katerih matere so med nosečnostjo jemale zaviralce nukleozidne reverzne transkriptaze (ZNRT), je korist zaradi zaščite proti HIV odtehtala tveganje zaradi neželenih učinkov.
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 mutagene aktivnosti lamivudina in vitro niso mogli potrditi s testi in vivo, sklepajo, da lamivudin pri zdravljenju bolnikov ne bi smel predstavljati genotoksičnega tveganja.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Slovenian: Pomembno je, da preberete spodnje informacije v razdelku »Drugi možni neželeni učinki kombiniranega zdravljenja okužbe s HIV«.
English: Tell your doctor if you are being treated with any of these.
Slovenian: Povejte zdravniku, če se zdravite s katerim koli od teh zdravil.
English: Limited data are available on the consequences of ingestion of acute overdoses in humans.
Slovenian: O posledicah zaužitja akutnih prevelikih odmerkov pri ljudeh so na voljo samo omejeni podatki.
English: The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown.
Slovenian: Mutant M184V RT kaže manj kot 4-kratno zmanjšanje občutljivosti za didanozin; klinični pomen teh ugotovitev ni znan.
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 ni bil genotoksičen v odmerkih, pri kakršnih so koncentracije v plazmi približno 40- do 50-krat večje od pričakovanih kliničnih koncentracij v plazmi.
English: Its main mode of action is as a chain terminator of viral reverse transcription.
Slovenian: Glavni način delovanja je prekinitev verige pri virusni reverzni transkripciji.
English: If you or your child has a kidney problem, your dose may be altered.
Slovenian: Če imate vi ali vaš otrok težave z ledvicami, se vam bodo odmerki morda spremenili.
English: Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Slovenian: Lamivudin je nukleozidni analog, ki učinkuje proti virusu humane imunske pomanjkljivosti (HIV) in virusu hepatitisa B (HBV).
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.
Slovenian: Trojno zdravljenje z nukleozidi: obstajajo poročila o visoki stopnji virološkega neuspeha in pojavu odpornosti v zgodnjem stadiju okužbe, ko so lamivudin kombinirali s tenofovirdizoproksil fumaratom in abakavirjem ter s tenofovirdizoproksil fumaratom in didanozinom v režimu odmerjanja enkrat dnevno.
English: Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo supresijo imunskega sistema in višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV in/ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
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: A 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 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: A recommended dosage regimen for patients with creatinine clearance below 50 ml/min is shown in the dosage section (see section 4.2).
Slovenian: Priporočeni režim odmerjanja za bolnike z očistkom kreatinina, manjšim od 50 ml/min, je opisan v razdelku o odmerjanju (glejte poglavje 4.2).
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 zdravnika ali farmacevta ali pa na urgentni oddelek najbližje bolnišnice.
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Slovenian: Druga zdravila (npr. ranitidin in cimetidin) se samo deloma izločajo z uporabo tega mehanizma in ne kažejo interakcij z lamivudinom.
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Slovenian: Sočasna uporaba z zidovudinom povzroči 13-odstotno povečanje izpostavljenosti zidovudinu in 28odstotno povečanje največjih koncentracij v plazmi.
English: Alternatively, 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: Za bolnike, ki tablet ne morejo požirati, se lahko tableto/-i/-e se tudi zdrobi in se jo/ju/jih doda v manjšo količino redke hrane ali tekočine, ki se jo mora nato v celoti takoj zaužiti (glejte poglavje 5.2).
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 58-66 %) zmanjšana.
English: This conclusion is based on the physicochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Slovenian: Ta zaključek temelji na fizikalno-kemijskih in farmakokinetičnih podatkih ter predpostavki, da bolnik tableto zdrobi, jo v celoti doda redki hrani ali tekočini in takoj zaužije.
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 jih presnavlja ta sistem (npr. zaviralci proteaz), niso verjetne.
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Slovenian: Medtem ko jemljete svoje zdravilo, boste morda potrebovali dodatne preglede, vključno s krvnimi preiskavami.
English: If you take more Lamivudine Teva Pharma B.V. than you should Accidentally taking too much Lamivudine Teva Pharma B.V. is unlikely to cause any serious problems.
Slovenian: Če ste vzeli večji odmerek zdravila Lamivudine Teva Pharma B.V., kot bi smeli Če ste pomotoma vzeli prevelik odmerek zdravila Lamivudine Teva Pharma B.V., je malo verjetno, da bi prišlo do kakršnih koli resnih težav.
English: Whenever possible in children, lamivudine as tablet formulation should preferably be used.
Slovenian: Kadar je mogoče, naj se pri otrocih lamivudin uporablja v obliki tablet.
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 µg•h/ml (18%).
Slovenian: Povprečna (KV) vrednost AUC pri 12-urnem presledku med odmerjanji je 4,7 µg.h/ml (18 %).
English: Once daily dosing (300 mg once a day): a clinical study has demonstrated the non-inferiority between lamivudine once a day and lamivudine twice a day containing regimens.
Slovenian: Odmerjanje enkrat dnevno (300 mg enkrat dnevno): klinična študija je pokazala, da režim odmerjanja lamivudina enkrat dnevno ni manj učinkovit od odmerjanja dvakrat dnevno.
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 uporabi zdrobljenih tablet v manjši količini redke hrane ali tekočine ni pričakovati vpliva na farmacevtsko kakovost in s tem na klinično učinkovitost.
English: Renal impairment: In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance; therefore the dose should be adjusted (see section 4.2).
Slovenian: Okvara ledvic: pri bolnikih z zmerno do hudo okvaro ledvic je končni razpolovni čas lamivudina v plazmi daljši zaradi zmanjšanega očistka, zato je treba odmerek prilagoditi (glejte poglavje 4.2).
English: Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Slovenian: Uporabo kotrimoksazola v kombinaciji z lamivudinom pri bolnikih, ki imajo okvaro ledvic, je treba pozorno oceniti.
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Slovenian: Omejeni podatki kažejo, da lamivudin prehaja v osrednje živčevje in doseže cerebrospinalno tekočino.
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: 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: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Slovenian: Medsebojno delovanje s trimetoprimom, komponento kotrimoksazola, povzroči 40-odstotno povečanje izpostavljenosti lamivudinu pri terapevtskih odmerkih.
English: Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Slovenian: Na podlagi teh podatkov bolnikom z zmerno ali hudo okvaro jeter ni treba prilagoditi odmerka, razen v primeru sočasne okvare ledvic.
English: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1).
Slovenian: 1206 pediatričnih bolnikov, okuženih z virusom HIV, starih od 3 mesece do 17 let, so vključili v preskušanje ARROW (COL105677), pri čemer jih je 669 prejemalo abakavir in lamivudin bodisi enkrat ali dvakrat na dan (glejte poglavje 5.1).
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Slovenian: Mutanti M184V kažejo močno zmanjšano občutljivost za lamivudin in tudi zmanjšano zmožnost virusne replikacije in vitro.
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 podobnih koncentracijah, kot so bile ugotovljene v serumu.
English: Tablet containers
Slovenian: Vsebniki za tablete
English: Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2)
Slovenian: Bolniki, ki bodo prehajali med peroralno raztopino z lamivudinom in tabletami z lamivudinom, morajo slediti priporočilom glede odmerjanja, ki so specifična za določeno formulacijo (glejte poglavje 5.2).
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied.
Slovenian: Ker se lamivudin izloča z dializo, se za zdravljenje prevelikega odmerjanja lahko uporabi neprekinjena hemodializa, vendar te možnosti še niso preučili.
English: The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Slovenian: Odnos med občutljivostjo virusa HIV na lamivudin in vitro in kliničnim odzivom na zdravljenje, ki vključuje lamivudin, še preučujejo.
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: Študija je pokazala, da je pri fetusih, ki so bili in utero izpostavljeni kombinaciji, prišlo do bolj obširne vgraditve DNA nukleozidnih analogov v več organov fetusa in večjega skrajšanja telomer kot pri tistih, ki so bili izpostavljeni samo zidovudinu.