natgillin/translations-raw huggingface dataset:
Den gennemsnitlige systemiske clearance af lamivudin er omkring 0, 32 l/ time/ kg; overvejende ved renal clearance (> 70%) via det organiske kationiske transportsystem.
The mean systemic clearance of lamivudine is approximately 0.32 l/ h/ kg, with predominantly renal clearance (> 70%) via the organic cationic transport system.
Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset binding til plasmaproteinet albumin (< 16% - 36% til serumalbumin i in vitro- undersøgelser).
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).
2- 4 timer efter peroral indgift var det gennemsnitlige forhold mellem lamivudinkoncentrationen i cerebrospinalvæsken og plasma ca.
The mean ratio CSF/ serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
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).
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).
Hos 60 raske voksne frivillige er Epivir 300 mg 1 gang dagligt vist at være farmakokinetisk ekvivalent ved steady- state over for Epivir 150 mg 2 gange daglig med hensyn til intracellulær triphosphat AUC24 og Cmax.
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.
Sandsynligheden for metaboliske interaktioner mellem lamivudin og andre lægemidler er lav på grund af begrænset levermetabolisme (5- 10%) og lav plasmaproteinbinding.
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.
Elimination:
9 Elimination:
Anbefalet dosis til patienter med kreatininclearance under 50 ml/ minut er anført under doseringsafsnittet (se afsnit 4. 2).
A recommended dosage regimen for patients with creatinine clearance below 50 ml/ min is shown in the dosage section (see section 4.2).
9 Interaktion med trimethoprim øger ekspositionen af lamivudin med 40% ved terapeutiske doser.
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Dette kræver ikke justering af dosis, medmindre patienten også lider af nedsat nyrefunktion (se afsnit 4. 5 og afsnit 4. 2).
This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Indgift af trimethoprim/ sulfamethoxazol sammen med lamivudin til patienter med nedsat nyrefunktion bør vurderes omhyggeligt.
Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Generelt er farmakokinetikken af lamivudin ens hos pædiatriske patienter og voksne.
In general, lamivudine pharmacokinetics in paediatric patients is similar to adults.
På grund af disse forskelle er den anbefalede dosis af lamivudin til børn (over 3 måneder og med en vægt på mindre end 30 kg) 4 mg/ kg to gange daglig.
Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/ kg twice daily.
3800 til 5000 ng. h/ ml.
This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng. h/ ml.
Det skyldes sandsynligvis, at nyrefunktionen ikke er fuldt udviklet og varierende absorption.
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.
For at opnå plasmakoncentrationer som hos voksne og børn anbefales derfor en dosis på 4 mg/ kg/ dag til spædbørn.
Therefore to achieve similar adult and paediatric exposure, the recommended dose for neonates is 4 mg/ kg/ day.
Vurdering af den glomerulære filtration antyder, at den anbefalede dosis til børn på 6 uger og derover kunne være 8 mg/ kg/ dag for at opnå plasmakoncentrationer som hos voksne og børn.
Glomerular filtration estimates suggests that to achieve similar adult and paediatric exposure, the recommended dose for children aged six weeks and older could be 8 mg/ kg/ day.
Farmakokinetikken af lamivudin sent i graviditeten svarede til den hos ikke- gravide kvinder efter peroral indgift.
Following oral administration, lamivudine pharmacokinetics in late- pregnancy were similar to non-pregnant women.
Ved de højeste doser sås mindre påvirkning af indikatorer for lever - og nyrefunktion samt af og til reduktioner af levervægt.
At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Lamivudin var ikke mutagent i bakterieforsøg, men viste som mange andre nukleosidanaloger aktivitet i en in vitro- cytogenprøve og i muselymfomcelletesten.
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.
Lamivudin var ikke genotoksisk in vivo ved doser, der medførte plasmakoncentrationer omkring 40- 50 gange højere end de forventede kliniske plasmakoncentrationer.
Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
En transplacental genotoksicitetsundersøgelse udført på aber sammenlignede zidovudin alene med kombinationen af zidovudin og lamivudin i human- ækvivalente doser.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
Studiet viste, at fostre, der in utero udsættes for kombinationsbehandlingen, opretholdte et højere niveau af nukleosid- analogt DNA i multiple foetale organer, og udviste også tegn på kortere telomere end dem der kun fik zidovudin.
The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue- DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Tabletkerne:
10 Tablet core:
Mikrokrystallinsk cellulose (E460) Natriumstivelsesglycollat Magnesiumstearat
Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
10 Filmovertræk:
Tablet film-coat:
Hypromellose (E464) Titandioxid (E171) Macrogol Polysorbat 80
Hypromellose (E464) Titanium dioxide (E171), Macrogol, Polysorbate 80
PVC/ aluminium blisterpakning:
PVC/ aluminium foil blister packs:
Børnesikret HDPE beholder eller PVC/ aluminium blisterpakning, begge indholdende 60 tabletter.
Child resistant HDPE bottles or PVC/ aluminium foil blister packs each containing 60 tablets.
EU/ 1/ 96/ 015/ 001 (Beholder) EU/ 1/ 96/ 015/ 004 (Blisterpakning)
EU/ 1/ 96/ 015/ 001 (Bottle) EU/ 1/ 96/ 015/ 004 (Blister pack)
DATO FOR FØRSTE MARKDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
8. august 1996 Dato for fornyelse:
8 August 1996 Date of last renewal:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
11 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Epivir 10 mg/ ml oral opløsning.
Epivir 10 mg/ ml oral solution
Sukrose 20% (3 g/ 15 ml) Methylparahydroxybenzoat Propylparahydroxybezoat
Sucrose 20% (3 g/ 15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate
Den anbefalede dosis Epivir er 300 mg daglig.
Adults and adolescents over 12 years of age: the recommended dose of Epivir is 300 mg daily.
Denne dosis kan gives som 150 mg (15 ml) 2 gange dagligt eller 300 mg (30 ml) 1 gang dagligt (se afsnit 4. 4).
This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4).
Patienter, der skifter til engangsdoseringen, skal tage 150 mg (15 ml) 2 gange daglig og skifte til 300 mg (30 ml) 1 gang daglig den efterfølgende morgen.
Patients changing to the once daily regimen should take 150 mg (15 ml) twice a day and switch to 300 mg (30 ml) once a day the following morning.
Hvis det foretrækkes at engangsdoseringen gives om aftenen, skal der tages 150 mg (15 ml) Epivir den første morgen, efterfulgt at 300 mg (30 ml) om aftenen.
Where an evening once daily regimen is preferred, 150 mg (15 ml) of Epivir should be taken on the first morning only, followed by 300 mg (30 ml) in the evening.
Hvis man skifter tilbage til doseringen med 2 gange daglig, skal patienten færdiggøre én dags behandling og starte med 150 mg (15 ml) 2 gange daglig den efterfølgende morgen.
When changing back to a twice daily regimen, patients should complete the days treatment and start 150 mg (15 ml) twice a day the following morning.
Maksimal døgndosis er 300 mg.
Three months to 12 years of age: the recommended dose is 4 mg/ kg twice daily up to a maximum of 300 mg daily.
Epivir findes også som tabletter.
Epivir is also available as a tablet formulation.
12 Nedsat nyrefunktion:
13 Renal impairment:
Anbefalet dosering - voksne og unge over 12 år:
Dosing recommendations – Adults and adolescents over 12 years:
150 mg (15 ml) 2 gange daglig 150 mg (15 ml) 1 gang daglig 100 mg (10 ml) 1 gang daglig 50 mg (5 ml) 1 gang daglig 25 mg (2, 5 ml) 1 gang daglig
150 mg (15 ml) twice daily 150 mg (15 ml) once daily 100 mg (10 ml) once daily 50 mg (5 ml) once daily 25 mg (2.5 ml) once daily
Anbefalet dosering - børn mellem 3 måneder og 12 år:
Dosing recommendations – Children from 3 months to 12 years:
Hos patienter med moderat til svært nedsat nyrefunktion er den terminale plasmahalveringstid af lamivudin øget på grund af nedsat clearance, derfor bør dosis justeres (se afsnit 4. 2).
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).
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.
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.
De bør derfor følges tæt af læger med erfaring i behandling af sygdomme, som ledsager HIV.
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.
13 Overførsel af HIV:
14 Transmission of HIV:
Det er blevet antaget, at der er en forbindelse mellem visceral lipomatose og proteasehæmmere (PI’ er) samt lipoatrofi og nucleosid revers transkriptase inhibitorer (NRTI’ er).
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Typisk er sådanne reaktioner observeret inden for de første få
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 15 aggravation of symptoms.
14 uger eller måneder efter påbegyndelsen af CART.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Diabetespatienter bør advares om, at hver dosis (150 mg = 15 ml) indeholder 3 g sukrose.
Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of sucrose.
Patienter med sjældne arvelige sygdomme som fruktoseintolerans, glucose- galaktose malabsorption eller underskud af sucrase- isomaltase bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Der er udelukkende lavet interaktionsstudier hos voksne
Interaction studies have only been performed in adults
15 Muligheden for interaktioner med andre samtidigt indgivne lægemidler bør overvejes; særligt hvis udskillelsen primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, f. eks. trimethoprim.
16 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.
Andre lægemidler (f. eks. ranitidin, cimetidin) udskilles kun delvist ved denne mekanisme og har vist sig ikke at interagere med lamivudin.
Other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Ligesom zidovudin udskilles nukleosidanalogerne (f. eks. didanosin og zalcitabin) ikke ved denne mekanisme og interagerer sandsynligvis ikke med lamivudin.
The nucleoside analogues (e. g. didanosine and zalcitabine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.
4. 7 Virkninge på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Meget sjælden:
Headache, insomnia Very rare:
Perifer neuropati (eller paræstesi).
Peripheral neuropathy (or paraesthesia)
16 Luftveje, thorax og mediastinum Almindelige:
Respiratory, thoracic and mediastinal disorders Common:
Mave- tarmkanalen Almindelige:
17 Gastrointestinal disorders Common:
Pancreatitis, stigning i serum amylase.
Pancreatitis elevations in serum amylase.
Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden HIV- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART).
17 Lamivudin er en nukleosidanalog, der er aktiv mod humant immundefekt virus (HIV) og hepatitis B virus (HBV).
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Lamivudin metaboliseres intracellulært til den aktive del lamivudin 5 ′ - trifosfat, hvis primære virkningsmekanisme er at afslutte kæden i HIV revers- transkription.
It is metabolised intracellularly to the active moiety, lamivudine 5’ -
Trifosfatet hæmmer selektivt replikationen af HIV- 1 og HIV- 2 in vitro.
Its main mode of action is as a chain terminator of viral reverse transcription.
Det er også aktivt mod zidovudinresistente kliniske HIV- isolater.
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.
Denne variant opstår både in vitro og i HIV- 1 inficerede patienter behandlet med lamivudin- indeholdende antiretroviral behandling.
This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Abacavir beholder den antiretrovirale aktivitet over for lamivudin- resistente HIV- 1, der kun har M184V mutationen.
Abacavir maintains its antiretroviral activities against lamivudine- resistant HIV-1 harbouring only the M184V mutation.
Kliniske undersøgelser har vist, at Lamivudin i kombination med zidovudin kan reducere HIV- 1- virus byrden samt øge CD4- celletallet.
In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral load and increase CD4 cell count.
Til behandling af HIV- infektion er det dog vist, at kun doser på 300 mg lamivudin (i kombination med andre antiretrovirale stoffer) dagligt, er virkningsfuldt.
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.
18 Lamivudin er ikke specifikt undersøgt til behandling af HIV- patienter, som samtidig er smittet med HBV.
19 Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Engangsdosering (300 mg 1 gang dagligt): en klinisk undersøgelse har vist, at der ikke er forskel på dosering af Epivir 1 gang daglig og Epivir 2 gange daglig.
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.
Den aktive del, intracellulær lamivudintrifosfat, har en forlænget terminal halveringstid i cellen (16 til 19 timer) sammenlignet med plasmahalveringstiden af lamivudin (5 til 7 timer).
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).
Det er vist hos 60 raske frivillige, at Epivir 300 mg 1 gang daglig er farmakokinetisk ækvivalent ved steady - state med Epivir 150 mg 2 gange daglig med hensyn til intracellulær trifosfat AUC24 og Cmax.
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.
Interaktion med trimethoprim øger ekspositionen af lamivudin med 40% ved terapeutiske doser.
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a40% increase in lamivudine exposure at therapeutic doses.
19 Farmakokinetik hos børn:
20 Pharmacokinetics in children:
På grund af disse forskelle er den anbefalede dosis af lamivudin til børn (over 3 måneder og med en vægt på mindre end 30 kg) 4 mg/ kg to dange daglig.
Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/ kg twice daily.
sucrose 20% (3 g/ 15 ml) methylparahydroxybenzoat propylparahydroxybenzoat citronsyre, vandfri propylenglycol natriumcitrat syntetisk jordbærsmagsstof syntetisk banansmagsstof Renset vand
Sucrose 20% (3 g/ 15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate Artificial strawberry flavour Artificial banana flavour
20 6. 2 Uforligeligheder
6.2 Incompatibilities
Må ikke opbevares over 25 ºC.
Do not store above 25°C.
Karton med 240 ml oral opløsning med lamivudin 10 mg/ ml i en hvid high density polyethylen (HDPE) - flaske med børnesikret låg.
Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure.
Pakningen indeholder en 10 ml doseringssprøjte af polypropylen og et tilpasningsstykke af polyethylen.
A 10 ml polypropylene oral dosing syringe and a polyethylene adapter are also included in the pack.
Brugsvejledning findes i pakningen.
Instructions for use are included in the pack.
Epivir 300 mg filmovertrukne tabletter.
Epivir 300 mg film-coated tablets
Hver filmovertrukken tablet indeholder 300 mg lamivudin.
Each film-coated tablet contains 300 mg lamivudine.
Grå, ruderformede og præget “ GX EJ7 ” på den ene side.
Grey, diamond shaped and engraved with “ GX EJ7” on one face.
De begrænsede data, der foreligger, er for utilstrækkelige til at foreslå specifikke doseringsanbefalinger (se afsnit 5. 2).
Less than three months of age: the limited data available are insufficient to propose specific dosage recommendations (see section 5.2)
22 Nedsat nyrefunktion:
23 Renal impairment:
Overførsel af HIV:
24 Transmission of HIV:
23 Pancreatitis:
Pancreatitis:
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/ or 25 focal mycobacterium infections, and Pneumocystis carinii pneumonia.
24 Leversygdom:
Liver disease:
Hvis der er tegn på forværring i leversygdommen hos disse patienter, bør afbrydelse eller ophør med behandlingen overvejes.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Muligheden for interaktioner med andre samtidigt indgivne lægemidler bør overvejes; særligt hvis udskillelsen primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, f. eks. trimethoprim.
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.
For zidovudin ses en beskeden stigning i Cmax (28%) ved samtidig indgift af lamivudin, men den samlede eksposition (AUC) ændres ikke signifikant.
26 A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
25 Metabolismen af lamivudin involverer ikke CYP3A, hvilket gør interaktioner med andre lægemidler, som metaboliseres via dette system (f. eks.
Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e. g.
Sjældne:
Pancreatitis.
Stigning i serum amylase.
Elevations in serum amylase.
26 Hud og subkutane væv Almindelige:
27 Skin and subcutaneous tissue disorders Common:
Der er ved brug af nukleosidanaloger rapporteret tilfælde af lactacidose, undertiden fatal, sædvanligvis i forbindelse med svær hepatomegali med fedtinfiltration (se afsnit 4. 4).
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues (see section 4.4).
Lamivudin metaboliseres intracellulært til den aktive del lamivudin 5 ′ - trifosfat, hvis primære virkningsmekanisme er at afslutte kæden i HIV revers transkription.
It is metabolised intracellularly to the active moiety, lamivudine 5’ - triphosphate.
M184V
This variant arises both in vitro and in HIV-1
27 mutanter udviser markant reduceret følsomhed over for lamivudin, og udviser mindsket viral replikationskapacitet in vitro.
M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Disse resultater er opnået i en antiretroviral naiv gruppe, primært bestående af asymptomatisk HIV- inficerede patienter (CDC trin A).
These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Efter peroral indgift er gennemsnitstiden (tmax) for at opnå maksimal
Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Interaktion med trimethoprim øger ekspositionen af lamivudin med 40% ved terapeutiske doser.
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Farmakokinetik hos børn:
30 Pharmacokinetics in children:
På grund af disse
In addition, systemic clearance values were greater in younger paediatric patients and decreased with age, approaching adult values around 12 years of age.
29 forskelle er den anbefalede dosis af lamivudin til børn (over 3 måneder og med en vægt på mindre end 30 kg) 4 mg/ kg to dange daglig.
Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/ kg twice daily.
Filmovertræk:
Tablet film-coat: