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.
Danish: Muligheden for interaktioner med andre samtidigt administrerede lægemidler bør overvejes; særligt hvis udskillelsen primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, f.eks. trimethoprim.
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Danish: Lamivudin absorberes godt fra mave-tarmkanalen, og oral biotilgængelighed hos voksne er normalt 80-85 %.
English: PENTA 13 2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17)
Danish: 3 til 12 år (N=19) PENTA 15 3 til 36 måneder (N=17)
English: This is consistent with the lower rates of antiviral suppression observed in these patients.
Danish: Dette er konsistent med de lavere virologisk responsrater set hos disse patienter.
English: The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral solution.
Danish: Doseringssprøjten er vedlagt til nøjagtig afmåling af den foreskrevne dosis oral opløsning.
English: Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats (see section 5.3).
Danish: Dyrestudier med lamivudin viste en stigning i tidlig embryonisk mortalitet hos kaniner, men ikke hos rotter (se pkt.
English: Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Danish: Placer sprøjten i munden med spidsen mod indersiden af kinden.
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.
Danish: Epivir oral opløsning, der gives samtidig med sorbitolholdige lægemidler, bør kun anvendes, når en tabletformulering ikke kan anvendes, og fordelene ved behandling opvejer mulige risici, herunder lavere virologisk suppression.
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.
Danish: Baseret på mere end 200 mor/barn-par behandlet for hiv er serumkoncentrationerne af lamivudin meget lave hos ammede spædbørn, hvis mødre behandles for hiv (< 4 % af moderens serumkoncentration), og falder gradvist til ikke-detekterbare niveauer, når ammede spædbørn når en alder på 24 uger.
English: Each 15 ml dose contains 3 g sucrose (20% w/v).
Danish: Hver 15 ml dosis indeholder 3 g saccharose (20 % w/v).
English: Keep in touch with your doctor, and do not stop taking Epivir without your doctor's advice.
Danish: Hold kontakt med lægen, og stop ikke med at tage Epivir uden at tale med lægen først.
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Danish: For zidovudin ses en beskeden stigning i Cmax (28 %) ved samtidig administration af lamivudin, men den samlede eksposition (AUC) ændres ikke signifikant.
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal clearance.
Danish: Sandsynligheden for metaboliske interaktioner er lav som følge af begrænset metabolisme og plasmaproteinbinding og næsten fuldstændig renal clearance.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Danish: Der foreligger ingen data for sikkerheden af lamivudin ved administration til spædbørn under 3 måneder.
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Epivir.
Danish: Husk at fortælle det til lægen eller på apoteket, hvis du begynder at tage ny medicin, mens du er i behandling med Epivir.
English: Children from three months of age: As an accurate dosage cannot be achieved with the 300 mg nonscored tablet formulation in this patient population, it is recommended that the Epivir 150 mg scored tablet formulation is used and the corresponding recommended dosage instructions are followed.
Danish: Børn fra 3 måneder: Da der ikke kan opnås præcis dosering med 300 mg tabletter uden delekærv i denne patientpopulation, anbefales det at anvende Epivir 150 mg tabletter med delekærv og følge den tilhørende anbefalede doseringsvejledning.
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.
Danish: Flere tilfælde af resistens blev set blandt patienter, der havde fået lamivudin opløsning, i kombination med andre antiretrovirale opløsninger sammenlignet med dem, der fik tilsvarende doser af tabletformulering.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Danish: Hvis der er tegn på forværring i leversygdommen hos disse patienter, bør afbrydelse eller ophør med behandlingen overvejes (se pkt.
English: Any solution regimen at any time All tablet based regimen throughouts
Danish: Hvilket som helst regime med opløsninger til hver tid Regimer baseret kun på tabletter
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection,
Danish: • hvis du tidligere har haft en leversygdom, herunder hepatitis B eller C (hvis du har hepatitis B,
English: Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment.
Danish: Ud fra disse data er dosisjustering ikke nødvendig hos patienter med moderat eller svært nedsat leverfunktion, medmindre den er ledsaget af nedsat nyrefunktion.
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.
Danish: Pædiatriske farmakokinetiske studier med både oral opløsning og tabletter har vist, at dosering én gang daglig giver ækvivalent AUC0-24 sammenlignet med dosering af den samme totale daglige dosis 2 gange daglig.
English: If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
Danish: Hvis overdosering finder sted, bør patienten overvåges, og symptomatisk standardbehandling iværksættes om nødvendigt.
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir or other medicines you are taking, or an effect of the HIV disease itself.
Danish: Når du bliver behandlet for hiv, kan det være svært at afgøre, om dine symptomer skyldes Epivir eller anden medicin, eller om de skyldes hiv-sygdommen i sig selv.
English: Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Danish: Epivir indeholder også konserveringsmidler (parahydroxybenzoater), der kan udløse en overfølsomhedsreaktion (eventuelt forsinket).
English: The following adverse reactions have been reported during therapy for HIV disease with Epivir.
Danish: De følgende bivirkninger er rapporteret under behandling af hiv-sygdom med Epivir.
English: Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Danish: Lamivudin er en nukleosidanalog, der er aktiv mod humant immundefekt virus (hiv) og hepatitis B virus (HBV).
English: Following oral administration lamivudine was excreted in breast milk at similar concentrations to those found in serum.
Danish: Efter oral administration blev lamivudin udskilt i mælk i koncentrationer svarende til koncentrationerne målt i serum.
English: Push the plastic adapter into the neck of the bottle.
Danish: Sæt plasttilpasningsstykket i flaskehalsen.
English: Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Danish: Lamivudin påvirker ikke farmakokinetikken af trimethoprim eller sulfamethoxazol.
English: Epivir can be used during pregnancy if clinically needed.
Danish: Hvis det er klinisk nødvendigt, kan Epivir anvendes under graviditet.
English: What Epivir contains
Danish: Epivir indeholder
English: Epivir is not recommended for use as monotherapy.
Danish: Epivir anbefales ikke som monoterapi.
English: • other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
Danish: • andre lægemidler, der indeholder lamivudin (mod hiv-infektion eller hepatitis B-infektion)
English: However, the extent (based on the AUC) of lamivudine absorbed is not influenced.
Danish: Mængden af absorberet lamivudin påvirkes dog ikke (baseret på AUC).
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Danish: Metabolismen af lamivudin involverer ikke CYP3A, hvilket gør interaktioner med andre lægemidler, som metaboliseres via dette system (f.eks. PI'er) usandsynlige.
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.
Danish: Tripel nukleosidterapi: Der er rapporteret om høj hyppighed af virologisk svigt og forekomst af resistens på et tidligt stadie, når lamivudin kombineres med tenofovirdisoproxilfumerat og abacavir såvel som tenofovirdisoproxilfumarat og didanosin, som et 1 gang daglig regime.
English: The frequency of which is unknown (see section 4.4).
Danish: Hyppigheden heraf er ukendt (se pkt.
English: Swallow the tablets, with some water.
Danish: Tabletterne skal synkes med vand.
English: Epivir contains sucrose.
Danish: Epivir indeholder saccharose.
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.
Danish: Flerstof antiretroviralbehandling hvor lamivudin er indeholdt har vist sig, at være effektiv hos antiretroviral-naïve patienter, såvel som hos patienter, der er smittet med virus, der indeholder M184V mutationer.
English: This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. ml, dvs. den er i det væsentlige natriumfri.
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.
Danish: Ud fra antagelsen, at kreatininclearance og lamivudinclearance korreleres ens hos børn og voksne, anbefales det, at dosis til børn med nedsat nyrefunktion reduceres i forhold til deres kreatininclearance på samme måde som hos voksne.
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.
Danish: Hos børn gav administration af tabletter samtidigt med andre antiretrovirale tabletter højere lamivudin-plasma-AUC∞ og -Cmax end oral opløsning givet samtidigt med andre antiretrovirale orale opløsninger.
English: Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA >1000 copies/ml.
Danish: Analyser af genotyperesistens blev udført på prøver med plasma hiv-1 RNA >1.000 kopier/ml.
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).
Danish: Dosis bør derfor justeres ved anvendelse af Epivir oral opløsning til patienter med kreatininclearance under 30 ml/min (se tabellerne).
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 µg.h/ml (18%).
Danish: Den gennemsnitlige (CV) AUC over et doseringsinterval på 12 timer er 4,7 g·time/ml (18 %).
English: Metabolism and nutrition disorders Very rare: Lactic acidosis
Danish: Metabolisme og ernæring Meget sjælden: Laktacidose
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).
Danish: • leversygdom som gulsot, forstørret lever eller fedtlever, leverbetændelse (hepatitis).
English: The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC, Cmax, and tmax.
Danish: 150 mg tabletten er bioækvivalent og dosisproportional med 300 mg tabletten med hensyn til AUC, Cmax og tmax.
English: The malformative risk is unlikely in humans based on those data.
Danish: Baseret på disse data er risikoen for misdannelser usandsynlig hos mennesker.
English: • cladribine (used to treat hairy cell leukaemia).
Danish: • cladribin (mod hårcelleleukæmi).
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.
Danish: På tidspunktet for randomisering til én gang daglig eller to gange daglig dosering (uge 0), havde de patienter som fik tabletformuleringen en højere virologisk responsrate end de patienter, der på et tidspunkt havde fået en flydende formulering.
English: Each 15 ml dose contains 44.1 mg sodium.
Danish: Hver 15 ml dosis indeholder 44,1 mg natrium.
English: There are no data available on the use of lamivudine in children with renal impairment.
Danish: Der foreligger ingen oplysninger om brug af lamivudin hos børn med nedsat nyrefunktion.
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.
Danish: Sandsynligheden for metaboliske interaktioner mellem lamivudin og andre lægemidler er lav på grund af begrænset levermetabolisme (5-10 %) og lav plasmaproteinbinding.
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).
Danish: Den aktive del, intracellulær lamivudin triphosphat, har en forlænget terminal halveringstid i cellen (16 til 19 timer), sammenlignet med plasma lamivudin halveringstiden (5 til 7 timer).
English: Uncommon side effects that may show up in blood tests are:
Danish: Ikke almindelige bivirkninger, der kan ses i blodprøver:
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.
Danish: Da lamivudins mutagene aktivitet in vitro ikke bekræftes in vivo, kan det konkluderes, at der ikke skulle være risiko for genotoksicitet hos patienter i behandling med lamivudin.
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.
Danish: Samtidig administration af sorbitolopløsning (3,2 g, 10,2 g, 13,4 g) med en enkelt 300 mg dosis lamivudin oral opløsning resulterede i dosisafhængige fald på 14 %, 32 % og 36 % i lamivudineksponering (AUC) og 28 %, 52 % og 55 % fald i lamivudins Cmax hos voksne.
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.
Danish: Estimater af den glomerulære filtration antyder, at en passende dosis til børn på 6 uger og derover til at opnå samme plasmakoncentration som hos voksne og børn kunne være 8 mg/kg/dag.
English: Week 0 (after 36 weeks on Treatment) Any solution regimen at any time All tablet based regimen throughouts Week 96
Danish: Uge 0 (efter 36 ugers behandling) Hvilket som helst regime med opløsninger
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).
Danish: Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset binding til plasmaproteinet albumin ( 16 % - 36 % til serumalbumin i in vitro-studier).
English: A small amount of the ingredients in Epivir can also pass into your breast milk.
Danish: Indholdsstofferne i Epivir kan også udskilles i små mængder i mælken.
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.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er omkring 0,32 l/time/kg; overvejende ved renal clearance ( 70 %) via det organiske kationiske transportsystem.
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.
Danish: Fund fra kliniske forsøg med pædiatriske patienter, der fik lamivudin i kombination med andre antiretovirale lægemidler (abacavir, nevirapin/efavirenz eller zidovudin), har vist, at resistensprofilen set hos pædiatriske patienter svarer til den, der er set hos voksne, med henblik på forekomst af genotype substitutioner og deres relative frekvens.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Danish: Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling har større risiko for alvorlige og potentielt fatale leverpåvirkninger.
English: Excipients: Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Danish: Indholdsstoffer: Diabetespatienter bør advares om, at hver dosis (150 mg = 15 ml) indeholder 3 g saccharose.
English: Dosing according to weight bands is recommended for Epivir tablets.
Danish: Dosering af Epivir-tabletter ud fra vægtgrupper anbefales.
English: No antagonistic effects in vitro were seen with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and zidovudine).
Danish: Der blev ikke observeret nogen antagonistisk effekt ved lamivudin og andre antiretrovirale lægemidler in vitro (lægemidler testet: abacavir, didanosin, nevirapin og zidovudin).
English: 6 Contents of the pack and other information
Danish: 6 Pakningsstørrelser og yderligere oplysninger
English: Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided.
Danish: Samtidig administration af lamivudin og høje doser af trimethoprim/sulfamethoxazol til behandling af Pneumocystis jirovecii pneumoni (PCP) og toxoplasmose bør undgås.
English: General disorders and administration site conditions Common: Fatigue, malaise, fever
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: Træthed, utilpashed, feber
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle personer, der får kombinationsbehandling mod hiv, får en sygdom, der kaldes osteonekrose.
English: Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were similar to non-pregnant women.
Danish: Gravide: Farmakokinetikken af oral lamivudin sent i graviditeten svarede til den hos ikke-gravide kvinder.
English: Epivir and similar medicines may cause side effects in unborn babies.
Danish: Epivir og lignende lægemidler kan give fosteret bivirkninger.
English: If you forget to take Epivir
Danish: Hvis du har glemt at tage Epivir
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
Danish: Opsummering af steady state lamivudin-AUC (0-24) (µg∙time/ml) i plasma og statistiske sammenligninger af dosering én gang daglig og 2 gange daglig på tværs af studier
English: • emtricitabine (used to treat HIV infection)
Danish: • emtricitabin (anvendes mod hiv-infektion)
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Danish: Denne variant opstår både in vitro og i hiv-1 inficerede patienter behandlet med lamivudin-indeholdende antiretroviral behandling.
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.
Danish: Til behandling af hiv-infektion er det dog vist, at kun doser på 300 mg lamivudin (i kombination med andre antiretrovirale stoffer) daglig, er virkningsfuldt.
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Danish: Brug doseringssprøjten, der ligger i pakningen, til at afmåle den nøjagtige dosis.
English: Priory Street
Danish: Harmire Road
English: Due to similarities, Epivir should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Danish: Grundet ligheder bør Epivir ikke administreres sammen med andre cytidin-analoger såsom emtricitabin.
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).
Danish: Resistens hiv-1-resistens over for lamivudin involverer udviklingen af M184V-aminosyreændringer tæt ved den aktive del af viral revers transkriptase (RT).
English: BOTTLE CARTON FOR ORAL SOLUTION
Danish: KARTON TIL BEHOLDER TIL ORAL OPLØSNING
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.
Danish: Engangsdosering (300 mg 1 gang daglig): Et klinisk studie har vist, at der ikke er forskel på dosering af Epivir 1 gang daglig og Epivir 2 gange daglig.
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)).
Danish: Selvom det ikke er blevet undersøgt, vil den samme virkning forventes med andre osmotisk virkende polyalkoholer eller monosaccharidalkoholer (f.eks. xylitol, mannitol, lactitol, maltitol (se pkt.
English: Consider more frequent monitoring of HIV-1 viral load when Epivir is used with chronically-administered, sorbitol-containing medicines [e.g. Ziagen oral solution].
Danish: Overvej hyppigere overvågning af hiv-1 virusmængde, når Epivir vedvarende anvendes sammen med sorbitolholdige lægemidler (f.eks. Ziagen oral opløsning).
English: Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05.
Danish: Farmakoterapeutisk klassifikation - nukleosidanalog, ATC-kode - J05A F05.
English: A 150 mg strength Epivir tablet is also available for the treatment of children from 3 months of age who weigh less than 25 kg:
Danish: Epivir-tabletter findes også i en styrke på 150 mg til behandling af børn over 3 måneder, der vejer mindre end 25 kg.
English: Each 300 mg tablet contains 0.756 mg sodium.
Danish: Hver 300 mg tablet indeholder 0,756 mg natrium.