FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare: Pancreatitis, elevations in serum amylase
Danish: Almindelig: Kvalme, opkastning, mavesmerter eller -kramper, diarré Sjælden: Pancreatitis, stigning i serum amylase.
English: The pack also includes a polyethylene syringe-adapter, and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Danish: Pakningen indeholder desuden et tilpasningsstykke af polyethylen samt en 10 ml doseringssprøjte bestående af et kammer af polypropylen (med angivelse af ml) og et stempel af polyethylen.
English: do not stop Epivir without your doctor's advice, as your hepatitis may come back)
Danish: må du ikke stoppe med at tage Epivir uden at tale med lægen først, da det kan få hepatitis til at blusse op igen)
English: Discard the oral solution one month after first opening.
Danish: Kasser den orale opløsning 1 måned efter første åbning af flasken.
English: Administration of Epivir tablets is bioequivalent to Epivir oral solution with respect to AUC∞ and Cmax in adults.
Danish: Epivir-tabletter er bioækvivalente med Epivir oral opløsning med hensyn til AUC og Cmax hos voksne.
English: If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered.
Danish: Hvis behandling med 2 daglige doser er uhensigtsmæssig, kan behandling med én daglig dosis (10 mg/kg) overvejes.
English: • an increase in the level of liver enzymes.
Danish: • øget niveau af leverenzymer.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige, de er.
English: Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47%).
Danish: Tages lamivudin sammen med mad, resulterer det i en forsinket tmax og en lavere Cmax (nedsat med 47 %).
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Danish: Ved de højeste doser sås mindre påvirkning af indikatorer for lever- og nyrefunktion samt af og til reduktioner af levervægt.
English: Dosing recommendations - Adults, adolescents and children (weighing at least 25 kg): Creatinine clearance (ml/min)
Danish: Anbefalet dosering - voksne, unge og børn (der vejer mindst 25 kg): Kreatininclearance (ml/min)
English: Remove the syringe from the adapter.
Danish: Træk sprøjten ud af tilpasningsstykket.
English: Whenever possible in children, Epivir as tablet formulation should preferably be used.
Danish: Ved behandling af børn med Epivir, skal tabletformuleringen anvendes, hvor muligt.
English: These medicines should not be used with Epivir:
Danish: Følgende lægemidler må ikke tages sammen med Epivir:
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.
Danish: Epivir findes også som oral opløsning til børn over 3 måneder eller til patienter, der har behov for en lavere dosis, eller som ikke kan synke tabletter.
English: What you need to know before you take Epivir
Danish: Det skal du vide, før du begynder at tage Epivir
English: This medicine contains 300 mg propylene glycol in each 15ml.
Danish: Dette lægemiddel indeholder 300 mg propylenglycol pr. 15 ml.
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.
Danish: 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.
English: Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine Randomisation of ARROW with Plasma HIV-1 RNA <80 copies/ml: Subgroup Analysis by Formulation
Danish: Andele af personer i én gang daglig versus to gange daglig randomisering til abacavir+lamivudin af ARROW med plasma hiv-1 RNA <80 kopier/ml: Subgruppeanalyse efter formulering
English: If Epivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see Zeffix SPC).
Danish: Hvis behandlingen med Epivir afbrydes hos hiv-patienter med hepatitis B-virus infektion, bør der foretages periodisk monitorering af både leverfunktionen og markører for HBV-replikationen, idet seponeringen af lamivudin kan medføre akut forværrelse af hepatitis (se også i produktresumeet for Zeffix).
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesia)
Danish: Almindelig: Hovedpine, søvnløshed Meget sjælden: Perifer neuropati (eller paræstesi)
English: Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily.
Danish: Børn fra 3 måneder til 1 år: Den anbefalede dosis er 0,5 ml/kg (5 mg/kg) to gange daglig.
English: Children receiving lamivudine oral solution concomitantly with other antiretroviral oral solutions in clinical trials developed viral resistance more frequently than children receiving tablets (see the description of the clinical experience in paediatric population (ARROW study) and section 5.2).
Danish: Børn, der i kliniske forsøg fik lamivudin oral opløsning samtidig med andre antiretrovirale orale opløsninger, udviklede hyppigere viral resistens end børn, der fik tabletter (se beskrivelsen af den kliniske erfaring i pædiatrisk population (ARROW studie) og pkt.
English: Children weighing ≥ 20 kg to <25 kg: The recommended dose is 225 mg daily.
Danish: Børn, der vejer ≥ 20 kg til <25 kg: Den anbefalede dosis er 225 mg daglig.
English: Epivir is also available as a tablet formulation for patients who weigh at least 14 kg (see section 4.4).
Danish: Epivir forefindes også i tabletform til patienter, der vejer mindst 14 kg (se pkt.
English: A fertility study in rats has shown that lamivudine had no effect on male or female fertility.
Danish: Et fertilitetsstudie hos rotter har vist, at lamivudin ikke påvirker fertiliteten hos hanner og hunner.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Danish: Krydsresistens overført af M184V TR er begrænset inden for klassen af nucleosid inhibitorer af antiviralte stoffer.
English: Talk to your doctor if this applies to you or your child.
Danish: Kontakt lægen, hvis det gælder for dig eller dit barn.
English: Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects.
Danish: Nogle patienter, der tager Epivir eller andre kombinationsbehandlinger mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: Placental transfer of lamivudine has been shown to occur in humans.
Danish: Overførelse af lamivudin gennem placenta er set hos mennesker.
English: This difference in suppression rates between tablets and solutions remained through Week 96 with once daily dosing.
Danish: Forskellen i virologisk responsrate mellem tabletter og opløsning vedblev til uge 96 ved dosering én gang daglig.
English: Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets.
Danish: Børnesikret HDPE beholder eller PVC/aluminium blisterpakning, begge indeholdende 60 tabletter.
English: Hypromellose (E464) Titanium dioxide (E171), Macrogol,
Danish: Hypromellose (E464) Titandioxid (E171) Macrogol
English: In 60 healthy adult volunteers, Epivir 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at steady-state to Epivir 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax.
Danish: Hos 60 raske voksne frivillige er Epivir 300 mg 1 gang daglig vist at være farmakokinetisk ekvivalent ved steady state over for Epivir 150 mg 2 gange daglig med hensyn til intracellulær triphosphat AUC24 og Cmax.
English: Bottle contents: 240 ml oral solution
Danish: Indhold: 240 ml oral opløsning
English: For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Danish: Hos patienter, som også er smittet med hepatitis, og som bliver gravide under behandling med lamivudin, bør det vurderes, om der er en risiko for tilbagevenden af hepatitis ved seponering af lamivudin.
English: Paediatric population:a randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Danish: Pædiatrisk population: Randomiseret sammenligning af behandling, som indeholdt dosering med abacavir og lamivudin én gang daglig vs. dosering 2 gange daglig blev foretaget indenfor et randomiseret, multicenter, kontrolleret studie med HIV-inficerede pædiatriske patienter.
English: The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Danish: Forholdet mellem in vitro-følsomheden af hiv over for lamivudin og det kliniske respons af behandling hvor lamivudin er indeholdt undersøges fortsat.
English: Lamivudine has been widely used as a component of antiretroviral combination therapy with other antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse transcriptase inhibitors).
Danish: Lamivudin er i vid udstrækning blevet anvendt som komponent i antiretroviral kombinationsbehandling i kombination med andre antiretrovirale stoffer fra den samme gruppe (NRTI'er) eller fra andre grupper (PI'er, non-nucleosid reverse transkriptase inhibitorer).
English: Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Danish: Zidovudin og stavudin beholder deres antivirale aktivitet over for lamivudinresistent hiv-1.
English: Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Danish: Nedsat leverfunktion: Data fra patienter med moderat til svært nedsat leverfunktion viser, at farmakokinetikken af lamivudin ikke påvirkes nævneværdigt ved dysfunktion af leveren.
English: Renal impairment: Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance.
Danish: Nedsat nyrefunktion: Koncentrationen af lamivudin er øget hos patienter med moderat til svært nedsat nyrefunktion som følge af nedsat clearance.
English: BOTTLE LABEL FOR ORAL SOLUTION
Danish: ETIKET TIL BEHOLDER TIL ORAL OPLØSNING
English: Adults, adolescents and children who weigh at least 25 kg: The usual dose is one 300 mg tablet once a day.
Danish: Voksne, unge og børn, der vejer mindst 25 kg: Den sædvanlige dosis er 1 tablet (300 mg) 1 gang daglig.
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.
Danish: Leversygdom: Hvis lamivudin anvendes samtidig til behandling af såvel hiv som HBV, kan der findes yderligere information i produktresumeet for Zeffix vedrørende behandlingen af hepatitis B med lamivudin.
English: Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Danish: Epivir er indiceret som del af en antiretroviral kombinationsbehandling til Human Immundefekt Virus (hiv)-inficerede voksne og børn.
English: A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
Danish: Et transplacentalt genotoksicitetsstudie udført på aber sammenlignede zidovudin alene med kombinationen af zidovudin og lamivudin i human-ækvivalente doser.
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).
Danish: Meget sjælden bivirkning, der kan ses i blodprøver: • manglende dannelse af nye røde blodceller i knoglemarven (pure red cell aplasia).
English: Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40 % increase in lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component did not interact.
Danish: Administration af trimethoprim/sulfamethoxazol 160 mg/800 mg øger ekspositionen af lamivudin med 40 % på grund af trimethoprimdelen.
English: 5 to <15
Danish: 5 til < 15
English: From intravenous studies, the mean volume of distribution is 1.3 l/kg.
Danish: Det gennemsnitlige fordelingsvolumen er 1,3 l/kg ifølge intravenøse studier.
English: Moreover, Epivir should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Danish: Derudover bør Epivir ikke tages sammen med andre lægemidler, der indeholder lamivudin (se pkt.
English: Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Danish: Administration af trimethoprim/sulfamethoxazol sammen med lamivudin til patienter med nedsat nyrefunktion bør vurderes omhyggeligt.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig behandling af hepatitits B eller C med antivirale midler henvises til oplysninger om disse produkter.
English: The active ingredient in Epivir is lamivudine.
Danish: Det aktive stof i Epivir hedder lamivudin.
English: Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a child resistant closure.
Danish: Karton med 240 ml oral opløsning med lamivudin 10 mg/ml i en hvid high density polyethylen (HDPE)-flaske med børnesikret låg.
English: At a therapeutic dose of 300 mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 µg.h/ml (21%), respectively.
Danish: Ved en terapeutisk dosis på 300 mg én gang daglig er den gennemsnitlige (CV) stady state state Cmax, Cmin og 24 timers AUC henholdsvis 2,0 g/ml (26 %), 0,04 g/ml (34 %) og 8,9 g·time/ml (21 %).
English: The clinical relevance of such findings remains, however, not well defined.
Danish: Den kliniske relevans af disse resultater er dog stadig ikke vel defineret.
English: Clear, colourless to pale yellow solution.
Danish: Klar farveløs til svagt gullig opløsning.
English: Abacavir maintains its antiretroviral activities against lamivudineresistant HIV-1 harbouring only the M184V mutation.
Danish: Abacavir beholder den antiretrovirale aktivitet over for lamivudin-resistente hiv-1, der kun har M184V mutationen.
English: A recommended dosage regimen for patients with creatinine clearance below 50 ml/min is shown in the dosage section (see section 4.2).
Danish: Anbefalet dosis til patienter med kreatininclearance under 50 ml/minut er anført under doseringsafsnittet (se pkt.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Danish: Det er vigtigt, at du læser oplysningerne under 'Andre mulige bivirkninger ved kombinationsbehandling af hiv' senere i dette punkt.
English: Other possible side effects of combination therapy for HIV Combination therapy such as Epivir may cause other conditions to develop during HIV treatment.
Danish: Andre mulige bivirkninger ved kombinationsbehandling af hiv Kombinationsbehandling som Epivir kan forårsage andre sygdomme under behandlingen af hiv.
English: When possible, avoid chronic coadministration of Epivir with medicinal products containing sorbitol or other osmotic acting polyalcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Danish: Undgå vedvarende anvendelse af Epivir sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer eller monosaccaharidalkoholer (f.eks. xylitol, mannitol, lactitol, maltitol), når det er muligt.
English: Children receiving lamivudine oral solution according to the recommended dosage regimen achieve plasma lamivudine exposure within the range of values observed in adults.
Danish: Børn, som får lamivudin oral opløsning i henhold til doseringsanbefalingerne, opnår lamivudin-plasmaniveauer indenfor det interval, der er observeret hos voksne.
English: Children weighing 14 to < 20 kg: The recommended dose is 150 mg daily.
Danish: Børn, der vejer 14 kg til < 20 kg: Den anbefalede dosis er 150 mg daglig.
English: Sucrose 20 % w/v (3 g/15 ml) Methyl parahydroxybenzoate Propyl parahydroxybenzoate Citric acid Anhydrous Propylene glycol Sodium citrate
Danish: Saccharose 20 % w/v (3 g/15 ml) Methylparahydroxybenzoat Propylparahydroxybenzoat Citronsyre, vandfri Propylenglycol
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Danish: Som en generel regel bør data fra dyrestudier så vel som den kliniske erfaring fra gravide kvinder vurderes, når det besluttes at anvende antiretrovirale midler til behandling af hiv-infektion hos gravide kvinder og som konsekvens heraf reducere risikoen for overførelse af hiv til det nyfødte barn.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Danish: Hos patienter med leverinsufficiens, herunder kronisk aktiv hepatitis, ses oftere abnorm leverfunktion i forbindelse med den antiretrovirale behandling, og disse patienter skal kontrolleres jf standardpraksis.
English: Children receiving lamivudine oral tablets according to the recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet formulation has higher bioavailability (see section 4.2).
Danish: Børn, som får lamivudintabletter i henhold til doseringsanbefalingerne, opnår højere lamivudin-plasmaniveauer end børn, som får oral opløsning, da der administreres højere mg/kg-doser med tabletformuleringen, som også har højere biotilgængelighed (se sektion 4.2).
English: The active substance is lamivudine.
Danish: Aktivt stof: Lamivudin.
English: <30 As doses below 150 mg are needed the use of the oral solution is recommended
Danish: 150 mg 1 gang daglig  30 Da der er behov for doser under 150 mg, anbefales det at anvende oral opløsning 15 til < 30
English: What Epivir is and what it is used for What you need to know before you take Epivir How to take Epivir
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Epivir Sådan skal du tage Epivir Bivirkninger
English: Drug Interactions: Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Danish: Lægemiddelinteraktioner: Epivir må ikke tages sammen med andre lægemidler, der indeholder lamivudin eller emtricitabin (se pkt.
English: Film-coated tablets:
Danish: Filmovertrukne tabletter:
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia)
Danish: • nedsat antal af blodceller, der har betydning for blodets størkning (trombocytopeni)
English: Microcrystalline cellulose (E460), Sodium starch glycollate Magnesium stearate
Danish: Mikrokrystallinsk cellulose (E460) Natriumstivelsesglycolat Magnesiumstearat
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).
Danish: Nedsat nyrefunktion: 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 pkt.
English: Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTI's are available.
Danish: Ved fremkomst af M184V-mutationer bør man kun overveje at fortsætte med lamivudin i de tilfælde, hvor der ikke længere er andre virksomme NRTI'er.
English: Week 0 (After ≥36 Weeks on Treatment) Plasma HIV-1 RNA <80 c/ml Risk difference (once daily-twice daily)
Danish: Uge 0 (efter ≥36 ugers behandling) Plasma HIV-1-RNA <80 kopier/ml Risikodifference (én gang daglig vs. to gange daglig)
English: • high doses of co-trimoxazole, an antibiotic
Danish: • høje doser af sulfamethoxazol med trimethoprim (et antibiotikum)
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.
Danish: Patienter, som skifter fra at tage 2 daglige doser til at tage én daglig dosis, skal tage den anbefalede ene daglige dosis (som beskrevet ovenfor) ca. 12 timer efter den seneste af de 2 daglige doser.
English: United Kingdom.
Danish: Storbritannien eller
English: Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4).
Danish: Epivir findes også som oral opløsning til børn over 3 måneder, som vejer mindre end 14 kg, eller til patienter med synkebesvær (se pkt.
English: The nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.
Danish: Ligesom zidovudin udskilles nukleosidanalogerne (f.eks. didanosin) ikke ved denne mekanisme og interagerer sandsynligvis ikke med lamivudin.
English: -2.3% (95% CI -9.3% to +4.7%), p=0.52
Danish: -2,3 % (95 % CI - 9,3 % til +4,7 %), p=0,52
English: Driving and using machines Epivir is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Epivir påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene maskiner.
English: Insert the syringe firmly into the adapter.
Danish: Sæt sprøjten godt fast i tilpasningsstykket.
English: It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2).
Danish: Der skal tages højde for, at data vedrørende behandling med én daglig dosis er meget begrænsede hos denne population (se pkt.
English: White, diamond shaped scored tablets engraved with “GX CJ7” on both faces.
Danish: Hvide, ruderformede tabletter med delekærv, der er præget “GX CJ7” på begge sider.
English: Studies in animals showed that lamivudine had no effect on fertility (see section 5.3).
Danish: Dyrestudier har vist, at lamivudin ikke påvirker fertiliteten (se pkt.
English: 300 mg or
Danish: 300 mg eller
English: 30 to<50
Danish: 30 til  50
English: Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Danish: Mitokondriel dysfunktion: Det er påvist in vitro og in vivo, at nukleosid- og nukleotidanaloger i forskellig udstrækning forårsager skader på mitokondrierne.
English: Uncommon: Transient elevations in liver enzymes (AST, ALT) Rare: Hepatitis
Danish: Ikke almindelig: Midlertidige stigninger af leverenzymer (ASAT, ALAT) Sjælden: Hepatitis