FrancophonIA/ELRC3.0 huggingface dataset:
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-tarm-kanalen, og den orale biotilgængelighed hos voksne er normalt 80-85%.
English: Patients receiving lamivudine or any other ART 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.
Danish: Patienter, der får lamivudin eller anden ART, kan fortsat udvikle opportunistiske infektioner og andre komplikationer til hiv-infektion, og de bør derfor forblive under tæt klinisk observation af læger, der har erfaring med behandling af patienter med hiv-associerede sygdomme.
English: If DUTREBIS is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of DUTREBIS as soon as possible.
Danish: Hvis DUTREBIS er glemt inden for 6 timer af det tidspunkt, hvor det normalt bliver taget, skal patienten informeres om at tage den ordinerede dosis DUTREBIS så snart som muligt.
English: Bottle label
Danish: Etiket til flaske
English: The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.
Danish: Den tilsyneladende terminale halveringstid for raltegravir er ca. 9 timer med en kortere -fase halveringstid (1 time), der udgør det meste af AUC.
English: DUTREBIS tablets can be administered with or without food.
Danish: DUTREBIS tabletterne kan administreres med eller uden samtidigt fødeindtag.
English: Following oral administration, lamivudine pharmacokinetics in late pregnancy were similar to non-pregnant women.
Danish: Efter oral administration var lamivudins farmakokinetik den samme som hos ikke-gravide.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om
English: Raltegravir was not teratogenic in developmental toxicity studies in rats and rabbits.
Danish: Raltegravir var ikke teratogent i studierne af udviklingstoksicitet hos rotter og kaniner.
English: Factors associated with failure include high baseline viral load and OBT that did not include at least one potent active agent.
Danish: Faktorer, der er forbundet med failure, omfatter høj viral belastning ved baseline og OBT, som ikke omfattede mindst et potent aktivt middel.
English: DUTREBIS should be used in combination with other active anti-retroviral therapy (ART) (see
Danish: DUTREBIS skal anvendes i kombination med anden aktiv antiretroviral behandling (ART) (se pkt.
English: Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)*
Danish: Systemorganklasse Hyppighed Lamivudin og/eller raltegravir (alene eller i kombination med anden ART)*
English: • rifampicin - used to treat some infections such as tuberculosis.
Danish: • rifampicin - anvendes til behandling af infektioner såsom tuberkulose.
English: Most viruses isolated from patients failing raltegravir had high-level raltegravir resistance resulting from the appearance of two or more mutations.
Danish: De fleste af de isolerede vira fra patienter, som ikke havde effekt af raltegravir, havde høj resistens over for raltegravir, hvilket var et resultat af forekomsten af to eller flere mutationer.
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Danish: Lamivudins metabolisme involverer ikke CYP3A, hvilket gør interaktioner med lægemidler, der metaboliseres af dette system (fx PIer), usandsynlige.
English: Patients received either the 400 mg tablet formulation (6 to 18 years of age) or the chewable tablet formulation (2 to less than 12 years of age).
Danish: Patienterne fik enten 400 mg tabletten (de 6 til 18-årige) eller tyggetabletten (de 2 til under 12-årige).
English: • Women with HIV should not breast-feed their infants because babies can be infected with HIV
Danish: • Kvinder med hiv må ikke amme, da spædbørn kan blive smittet med hiv gennem modermælken.
English: The pharmacokinetics of DUTREBIS in the paediatric patient population has not been studied in clinical studies.
Danish: DUTREBIS' farmakokinetik i den pædiatriske population er ikke undersøgt i kliniske studier.
English: Factors that reduced the likelihood of developing resistance included lower baseline viral load and use of other active anti-retroviral agents.
Danish: Faktorer, som reducerede sandsynligheden for udvikling af resistens, omfattede en lav viral belastning ved baseline samt brug af andre aktive antiretrovirale lægemidler.
English: When concomitant administration of DUTREBIS is warranted, patients should be monitored clinically.
Danish: Når samtidig administration af DUTREBIS er indiceret, skal patienterne monitoreres klinisk.
English: Lactic acidosis generally occurred after a few or several months of treatment.
Danish: Laktatacidose forekom generelt efter få eller flere måneders behandling.
English: Caution should be exercised when administering NRTIs to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Danish: Forsigtighed bør udvises ved administration af NRTIer til alle patienter (især overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom og hepatisk steatose (herunder visse lægemidler og alkohol).
English: Based on these data, raltegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or P-glycoprotein.
Danish: På baggrund af disse data forventes raltegravir ikke at påvirke de lægemidlers farmakokinetik, som er substrater for disse enzymer eller Pglycoprotein.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling bør initieres af en læge med erfaring i behandling af hiv-infektion.
English: In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 1).
Danish: Desuden kan tenofovir øge raltegravirs plasmakoncentrationer, men mekanismen bag denne effekt er ukendt (se tabel 1).
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 lamivudintriphosphat, har en forlænget terminal halveringstid i cellen (16 til 19 timer), sammenlignet med halveringstiden af lamivudin i plasma (5 til 7 timer).
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 hos hiv-1inficerede patienter behandlet med lamivudin-indeholdende antiretroviral behandling.
English: • feeling tired, lack of energy, difficulty in sleeping (insomnia)
Danish: • Træthed, mangel på energi, søvnbesvær (insomni)
English: These neoplasia could result from local deposition and/or aspiration of drug on the mucosa of the nose/nasopharynx during oral gavage dosing and subsequent chronic irritation and inflammation; it is likely that they are of limited relevance for the intended clinical use.
Danish: Disse neoplasier kan være opstået ud fra lokal aflejring og/eller aspiration af lægemiddelstoffet i næsens/nasopharynx slimhinder under dosering via oral sonde og efterfølgende kronisk irritation og inflammation; dette er sandsynligvis af begrænset relevans for den tilsigtede kliniske anvendelse.
English: In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Danish: I tilfælde af overdosering er det hensigtsmæssigt at anvende understøttende standardiserede foranstaltninger, fx fjerne uabsorberet lægemiddel fra mave-tarmkanalen, foretage klinisk monitorering (inklusive elektrokardiogram) og igangsætte understøttende behandling, hvis dette er nødvendigt.
English: The safety profile observed in patients who used atazanavir and / or tenofovir was generally similar to the safety profile of patients who did not use these agents.
Danish: Den sikkerhedsprofil, der blev observeret hos patienter, som fik atazanavir og/eller tenofovir, var sædvanligvis den samme som sikkerhedsprofilen hos de patienter, der ikke fik disse lægemidler.
English: Some patients taking combination treatment for HIV may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, som får kombinationsbehandling mod hiv, kan udvikle en knoglesygdom, som hedder osteonekrose (hvor knoglevævet dør pga. manglende blodforsyning til knoglen).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus-retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumoni forårsaget af pneumocystis carinii.
English: • medicines containing lamivudine - used to treat HIV or hepatitis B.
Danish: • medicin, der indeholder lamivudin - anvendes til behandling af hiv eller hepatitis B.
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 cirka 0,32 l/t/kg med overvejende renal clearance (>70 %) via det organiske kationiske
English: These results indicate that raltegravir is not an inducer or inhibitor of CYP3A4, and raltegravir is thus not anticipated to affect the pharmacokinetics of medicinal products which are CYP3A4 substrates.
Danish: Disse resultater indikerer, at raltegravir ikke er en inducer eller hæmmer af CYP3A4, og raltegravir forventes således ikke at påvirke farmakokinetikken for lægemidler, som er CYP3A4substrater.
English: Rifampicin may decrease your levels of raltegravir (one of the medicines in DUTREBIS).
Danish: Rifampicin kan nedsætte koncentrationen af raltegravir (et af lægemidlerne i Dutrebis).
English: This is not considered to be of significance to patient safety and therefore no dosage adjustments are necessary.
Danish: Dette vurderes at være uden klinisk betydning for patientsikkerheden, og dosisjustering er derfor ikke nødvendig.
English: DUTREBIS contains two medicines: lamivudine and raltegravir.
Danish: Dutrebis indeholder to lægemidler: lamivudin og raltegravir.
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 resulterede i en stigning på 40 % i lamivudineksponering på grund af trimethoprimkomponenten; sulfamethoxazolkomponenten interagerede ikke.
English: In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not induce CYP3A4 and does not inhibit P-glycoprotein-mediated transport.
Danish: In vitro studier indikerer, at raltegravir ikke er et substrat for cytokrom P450 (CYP) enzymer, ikke hæmmer CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A, ikke inducerer CYP3A4 og ikke hæmmer P-glycoproteinmedieret transport.
English: In addition, higher C12h levels (20 % for raltegravir and 53 % for lamivudine) were observed.
Danish: Desuden sås højere C12t (20% for raltegravir og 53% for lamivudin).
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Danish: Kliniske endepunktsdata indikerer, at lamivudin i kombination med zidovudin medfører en signifikant reduktion i risikoen for sygdomsprogression og dødelighed.
English: Mutations at amino acid 143 confer greater resistance to raltegravir than to elvitegravir, and the E92Q mutation confers greater resistance to elvitegravir than to raltegravir.
Danish: Mutationer ved aminosyre 143 giver større resistens over for raltegravir end over for elvitegravir, og E92Q-mutationen giver større resistens over for elvitegravir end over for raltegravir.
English: Results 48 week and 96 week analyses
Danish: Resultater af uge 48- og 96-ugers analyser
English: The extent to which raltegravir may be dialysable is unknown.
Danish: Det vides ikke, i hvilken grad raltegravir er dialysérbart.
English: The adverse reactions seen in clinical studies and in post-marketing experience are listed below by body system, organ class and absolute frequency.
Danish: De bivirkninger, som er set i kliniske studier og efter markedsføring, er nævnt nedenfor i henhold til systemorganklasse og hyppighed.
English: Apparent total oral clearance (Cl/F) of lamivudine decreased as creatinine clearance decreased.
Danish: Tilsyneladende total oral clearance (C1/F) af lamivudin faldt, når kreatininclearance faldt.
English: In both studies at Week 24, suppression of HIV RNA to less than 50 copies/ml was maintained in 84.4 % of the raltegravir group versus 90.6 % of the lopinavir (+) ritonavir group, (Non-completers = Failure).
Danish: I begge studier i uge 24 blev hæmning af hiv-RNA til under 50 kopier/ml opretholdt hos 84,4% af raltegravirgruppen versus 90,6% af lopinavir (+) ritonavir-gruppen (non-completers = failure).
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 er der set en beskeden stigning i Cmax (28 %), når det blev givet sammen med lamivudin, men den samlede eksponering (AUC) ændredes ikke signifikant.
English: Raltegravir is eliminated primarily by glucuronidation in the liver.
Danish: Raltegravir elimineres primært ved glucuronidering i leveren.
English: IMPAACT P1066 is a Phase I/II open label multicentre study to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of raltegravir in HIV infected children.
Danish: IMPAACT P1066 er et fase-I/II åbent, multicenterstudie til evaluering af raltegravirs farmakokinetiske profil, sikkerhed, tolerabilitet samt effektivitet hos hiv-inficerede børn.
English: For mean CD4 changes, baseline-carry-forward was used for virologic failures.
Danish: Til opgørelsen af gennemsnitlige CD4-ændringer blev baseline-carry-forward anvendt ved analyse af virologisk svigt.
English: Most had a signature mutation at amino acid 155 (N155 changed to H), amino acid 148 (Q148 changed to H, K, or R), or amino acid 143 (Y143 changed to H, C, or R), along with one or more additional integrase mutations (e.g., L74M, E92Q, T97A, E138A/K, G140A/S, V151I, G163R, S230R).
Danish: De fleste havde en signaturmutation ved aminosyre 155 (N155 ændrede sig til H), aminosyre 148 (Q148 ændrede sig til H, K eller R) eller aminosyre 143 (Y143 ændrede sig til H, C eller R) sammen med en eller flere andre integrasemutationer (fx L74M, E92Q, T97A, E138A/K, G140A/S, V151I, G163R, S230R).
English: Randomization was stratified by screening HIV RNA level (≤50,000 copies/ml; and > 50,000 copies/ml) and by hepatitis B or C status (positive or negative).
Danish: Randomisering blev stratificeret ved screening af hiv-RNA-koncentrationen (≤50.000 kopier/ml og 50.000 kopier/ml) og ved hepatitis B- eller C-status (positiv eller negativ).
English: NL-2031 BN Haarlem The Netherlands
Danish: NL-2031 BN Haarlem Holland
English: There is little to no accumulation in AUC and Cmax and evidence of slight accumulation in C12 hr.
Danish: Der er kun beskeden eller ingen akkumulering i AUC og Cmax samt kun tegn på let akkumulering i C12t.
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 μg•h/ml (18 %).
Danish: Det gennemsnitlige (CV) AUC over et doseringsinterval på 12 timer er 4,7 µg•time/ml (18 %).
English: Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Danish: Måling af faste-serumlipider og blodglucose bør overvejes.
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
Danish: Antiretroviral flerstofsbehandling, der inkluderer lamivudin, har vist sig at være effektiv hos antiretroviral-naive patienter såvel som hos patienter, der er smittet med vira, der indeholder M184V
English: In interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir, hormonal contraceptives, methadone, midazolam, or boceprevir.
Danish: I interaktionsstudier havde raltegravir ingen klinisk betydningsfuld virkning på farmakokinetikken for etravirin, maraviroc, tenofovir, hormonel kontraception, methadon, midazolam eller boceprevir.
English: In two studies of HIV-1 infected patients who received raltegravir 400 mg twice daily, raltegravir was readily detected in the cerebrospinal fluid.
Danish: I to studier med hiv-1-inficerede patienter, som fik raltegravir 400 mg to gange dagligt, påvistes raltegravir hurtigt i cerebrospinalvæsken.
English: Adults, adolescents, and children (6 through 11 years of age weighing at least 30 kg) The recommended dosage is one tablet (150 mg lamivudine/300 mg raltegravir) twice daily.
Danish: Voksne, unge og børn (fra 6-11 år og med en vægt på mindst 30 kg) Den anbefalede dosering er en tablet (150 mg lamivudin/300 mg raltegravir) to gange dagligt.
English: Severe skin and hypersensitivity reactions
Danish: Alvorlige hud- og overfølsomhedsreaktioner
English: The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Danish: Af klinisk relevans sås reduktion i antallet af røde blodlegemer og neutropeni.
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 det terapeutiske dosisinterval og viser begrænset binding til plasmaproteinet albumin (<16 % - 36 % til serumalbumin i in vitro-studier).
English: No human data on the effect of DUTREBIS on fertility are available.
Danish: Der er ingen tilgængelige data vedrørende virkningen af DUTREBIS på fertiliteten hos mennesker.
English: • joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving.
Danish: • ledstivhed, ledsmerter (især i hofte, knæ og skulder) samt besvær med at bevæge dig.
English: Limited data show that lamivudine penetrates the central nervous system and reaches the cerebrospinal fluid (CSF).
Danish: Begrænsede data viser, at lamivudin penetrerer centralnervesystemet og når ud i cerebrospinalvæsken.
English: However, the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically meaningful.
Danish: Raltegravirs indvirkning på darunavirs plasmakoncentration synes dog ikke at være af klinisk betydning.
English: Exposure (AUC∞), Cmax, and half-life increased with diminishing renal function (as expressed by creatinine clearance).
Danish: Eksponering (AUC∞), Cmax og halveringstid øgedes med aftagende nyrefunktion (udtrykt ved kreatininclearance).
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 (510 %) og lav plasmaproteinbinding.
English: In rats, at a maternal dose of 600 mg/kg/day, mean active substance concentrations in milk were approximately 3-fold greater than in maternal plasma.
Danish: Hos rotter, der fik en maternel dosis på 600 mg/kg/dag, var den gennemsnitlige koncentration af det aktive indholdsstof i mælken ca. 3 gange højere end i maternelt plasma.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Danish: In vitro-data tyder på, at fortsat anvendelse af lamivudin i et antiretroviralt behandlingsregime, på trods af udvikling af M184V, kan give residual antiretroviral aktivitet (sandsynligvis gennem nedsat ”viral fitness”).
English: Talk to your doctor if you notice changes in your body shape.
Danish: Fortæl det til din læge, hvis du oplever, at din krop ændrer facon.
English: For raltegravir, renal clearance of unchanged drug is a minor pathway of elimination.
Danish: For raltegravir er renal clearance af uomdannet lægemiddel en ubetydelig eliminationsvej.
English: DUTREBIS should not be taken with any other medicinal products containing lamivudine, raltegravir or medicinal products containing emtricitabine.
Danish: DUTREBIS må ikke tages sammen med andre lægemidler, der indeholder lamivudin, raltegravir eller lægemidler, der indeholder emtricitabin.
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Danish: Patienter der samtidigt er inficeret med hepatitis-C og bliver behandlet med alfainterferon og ribavirin kan udgøre en særlig risiko.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this
Danish: Patienter med sjældne, arvelige sygdomme som galactose-intolerance, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucosegalactose malabsorptionssyndrom må ikke tage dette lægemiddel.
English: Treatment with DUTREBIS should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis
Danish: Behandling med DUTREBIS skal straks stoppes, hvis kliniske tegn, symptomer eller unormale laboratorieprøver, som tyder på pankreatitis,
English: Delay in stopping DUTREBIS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
Danish: Forhalet seponering af DUTREBIS eller andre mistænkte lægemidler efter optræden af alvorligt udslæt kan resultere i en livstruende reaktion.
English: Muscle pain, tenderness, or weakness have been reported during treatment with raltegravir.
Danish: Der er set muskelsmerter, -ømhed eller -svaghed i forbindelse med behandling med raltegravir.
English: Therefore no dose adjustment of DUTREBIS is required with use of proton pump inhibitors or H2
Danish: Dosisjustering af DUTREBIS er derfor ikke nødvendig ved anvendelse sammen med protonpumpehæmmere eller H2
English: • allergic rash (including red spots or blotches sometimes with blistering and swelling of
Danish: • Allergisk udslæt (med røde pletter eller skjolder, nogle gange med blærer og hævelse af
English: A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of ART and associated metabolic disturbances.
Danish: En højere risiko for lipodystrofi er blevet sat i forbindelse med individuelle faktorer som højere alder, og med lægemiddelrelaterede faktorer som længere antiretroviral behandlingstid og ledsagende metaboliske forstyrrelser.