FrancophonIA/ELRC3.0 huggingface dataset:
English: The evidence of efficacy of raltegravir was based on the analyses of 96-week data from two randomised, double-blind, placebo-controlled studies, (BENCHMRK 1 and BENCHMRK 2, Protocols 018 and 019) in antiretroviral treatment-experienced HIV-1 infected adult patients and the analysis of 240-week data from randomised, double-blind, active-control trial, (STARTMRK, Protocol 021) in antiretroviral treatment-naïve HIV-1 infected adult patients.
Danish: Evidens for klinisk virkning af raltegravir var baseret på analyserne af 96-ugers data fra to randomiserede, dobbeltblindede, placebokontrollerede studier (BENCHMRK 1 og BENCHMRK 2, Protokol 018 og 019) hos antiretrovirale behandlingserfarne hiv-1 inficerede voksne patienter samt analysen af 240-ugers data fra et randomiseret, dobbeltblindet, aktivt kontrolleret studie (STARTMRK, Protokol 021) hos antiretrovirale behandlingsnaive hiv-1 inficerede voksne patienter.
English: • Raltegravir belongs to a group of medicines called HIV integrase strand transfer inhibitors
Danish: • Raltegravir tilhører en gruppe af lægemidler kaldet hiv-integrasehæmmere af gen-overførsel
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Danish: Da lamivudin er dialysérbart, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering,
English: Some people taking DUTREBIS, or similar medicines, may get a side effect called “lactic acidosis” and a swollen liver.
Danish: Nogle personer, der får Dutrebis eller lignende medicin, kan udvikle en bivirkning, der kaldes ”mælkesyreacidose” (mælkesyreforgiftning) og forstørret lever.
English: Co-administration of zidovudine with lamivudine results in a 13 % increase in zidovudine exposure and a 28 % increase in peak plasma levels.
Danish: Samtidig administration af zidovudin og lamivudin resulterer i en stigning på 13 % i eksponeringen for zidovudin og i en stigning på 28 % i den maksimale plasmakoncentration.
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 en gang dagligt er de gennemsnitlige værdier af (CV) Cmax, Cmin og 24 timers AUC ved steady state henholdsvis 2,0 µg/ml (26 %), 0,04 µg/ml (34 %) og 8,9 µg•time/ml (21 %).
English: The results of long-term carcinogenicity studies with lamivudine in rats and mice did not show any carcinogenic potential relevant for humans.
Danish: Resultaterne af langtidskarcinogenicitetsstudier hos rotter og mus viste intet karcinogent potentiale med
English: Myopathy and rhabdomyolysis have been reported with raltegravir.
Danish: Myopati og rhabdomyolyse har været rapporteret ved brugen af raltegravir.
English: A study of the pharmacokinetics of raltegravir was performed in adult patients with severe renal insufficiency.
Danish: Der blev udført et studie af raltegravirs farmakokinetik hos voksne patienter med svært nedsat nyrefunktion.
English: Lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside reverse transcriptase inhibitors (NRTIs), such as lamivudine.
Danish: Der er rapporteret om laktatacidose, som normalt associeres med hepatomegali og hepatisk steatose, ved brugen af nukleoside revers-transkriptasehæmmere (NRTIer), såsom lamivudin.
English: Lamivudine 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.
Danish: Lamivudin fås også som oral opløsning til børn over 3 måneder, som vejer under 14 kg eller til patienter,
English: Myopathy and rhabdomyolysis have been reported.
Danish: Der er rapporteret om myopati og rhabdomyolyse.
English: In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, triacetin, yellow iron oxide, Indigo Carmine (E132) Aluminium Lake, and titanium dioxide.
Danish: Derudover indeholder filmovertrækket følgende inaktive indholdsstoffer: hypromellose, lactosemonohydrat, triacetin, gul jernoxid, indigotin (E132) og titandioxid.
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Danish: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Storbritannien
English: Lactic acidosis is caused by a build-up of lactic acid in the body.
Danish: Mælkeforgiftning skyldes ophobning af mælkesyre i kroppen.
English: The Genotypic Sensitivity Score (GSS) was defined as the total oral ARTs in the optimised background therapy (OBT) to which a patient's viral isolate showed genotypic sensitivity based upon genotypic resistance test. Enfuvirtide use in OBT in enfuvirtide-naïve patients was counted as one active drug in OBT.
Danish: Den genotypiske sensitivitets-score (GSS) defineredes som det totale antal orale antiretrovirale behandlinger i OBT, for hvilke en patients virale isolat viste genotypisk sensitivitet på baggrund af genotypisk resistenstest.
English: Patient demographics (gender, age and race) and baseline characteristics were comparable between the group receiving raltegravir 400 mg twice daily and the group receiving efavirenz 600 mg at bedtime.
Danish: Patientdemografi (køn, alder og race) og karakteristika ved baseline var sammenlignelige for den gruppe, der fik raltegravir 400 mg to gange dagligt og gruppen, der fik efavirenz 600 mg ved sengetid.
English: Nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Danish: Nukleoside/tide reverse transkriptasehæmmere (NRTIer)
English: Raltegravir was administered with an optimized background regimen.
Danish: Raltegravir blev administreret med optimeret
English: Patient demographics (gender, age and race) and baseline characteristics were comparable between the groups receiving raltegravir 400 mg twice daily and placebo.
Danish: Patientdemografi (køn, alder og race) og karakteristika ved baseline var sammenlignelige for de grupper, der fik raltegravir 400 mg to gange dagligt, og placebogrupperne.
English: In clinical studies of treatment-experienced patients receiving raltegravir, rash, irrespective of causality, was more commonly observed with regimens containing raltegravir and darunavir compared to those containing raltegravir without darunavir or darunavir without raltegravir.
Danish: I kliniske studier med behandlingserfarne patienter, der fik raltegravir, sås udslæt oftere, uanset kausalitet, ved behandlingsregimer med raltegravir og darunavir end ved de regimer, der indeholdt raltegravir uden darunavir eller darunavir uden raltegravir.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take:
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager, for nylig har taget eller vil tage:
English: Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during CART and should be monitored according to standard practice.
Danish: Patienter medeksisterende leverdysfunktion, herunder kronisk hepatitis, har øget hyppighed af unormal leverfunktion under antiretroviral kombinationsbehandling (CART) og bør monitoreres i henhold til gældende praksis.
English: Co-administration of raltegravir with a calcium carbonate antacid decreased raltegravir plasma levels; however, this interaction is not considered clinically meaningful.
Danish: Samtidig administration af raltegravir og et calciumcarbonatholdigt antacidum reducerede raltegravirs plasmakoncentration; denne interaktion anses dog ikke for klinisk relevant.
English: Ethinyl Estradiol AUC  2 % Ethinyl Estradiol Cmax ↑ 6 % Norelgestromin AUC ↑ 14 % Norelgestromin Cmax ↑ 29 %
Danish: Ethinylestradiol AUC  2 % Ethinylestradiol Cmax ↑ 6 % Norelgestromin AUC ↑ 14 % Norelgestromin Cmax ↑ 29 %
English: Raltegravir has been studied in 126 antiretroviral treatment-experienced HIV-1 infected children and adolescents 2 through 18 years of age, in combination with other antiretroviral agents in IMPAACT P1066 (see sections 5.1 and 5.2).
Danish: Raltegravir er blevet undersøgt hos 126 antiretroviralt behandlingserfarne hiv-1-inficerede børn og unge i alderen 2 til 18 år i kombination med andre antiretrovirale lægemidler i IMPAACT P1066 (se pkt.
English: Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal
Danish: Laktatacidose har høj dødelighed og associeres med pankreatitis, leversvigt eller nyresvigt.
English: Following oral administration, lamivudine was excreted in breast milk at similar concentrations to
Danish: Efter oral administration blev lamivudin udskilt i human mælk i samme koncentrationer som i serum.
English: Raltegravir in the fixed-dose combination tablet was not bioequivalent with respect to C12, however, based on PK/PD modelling, no clinically meaningful differences in raltegravir exposure are expected following administration of the fixed-dose combination tablet compared to administration of raltegravir as a single agent.
Danish: Raltegravir fastdosis-kombinationstabletten var ikke bioækvivalent med hensyn til C12, men på baggrund af de farmakokinetiske/farmakodynamiske modeller forventes ingen klinisk betydningsfulde forskelle i eksponeringen for raltegravir efter administration af fastdosiskombinationstabletten sammenlignet med administration af raltegravir som enkeltpræparat.
English: In a drug interaction study with DUTREBIS and etravirine, there was no clinically meaningful drug interaction between raltegravir and etravirine, with respect to raltegravir.
Danish: I et interaktionsstudie med DUTREBIS og etravirin var der, med hensyn til raltegravir, ingen klinisk lægemiddelinteraktion af betydning mellem raltegravir og etravirin.
English: The safety and efficacy of lamivudine and raltegravir have not been established in patients with severe underlying liver disorders.
Danish: Hverken lamivudins eller raltegravirs sikkerhed og virkning er klarlagt hos patienter med svær underliggende leversygdom.
English: Limited data are available on the consequences of ingestion of acute overdoses in humans.
Danish: Oplysninger om konsekvenserne af akut overdosering hos mennesker er begrænsede.
English: Clinical studies in patients have not been specifically performed with DUTREBIS.
Danish: Der er ikke udført kliniske studier hos patienter specifikt for DUTREBIS.
English: Overall, considerable variability was observed in the pharmacokinetics of raltegravir.
Danish: Totalt blev der observeret betydelig variabilitet i raltegravirs farmakokinetik.
English: Mean CD4 cell count (%) increase from baseline
Danish: Gennemsnitligt CD4-celletal (%) stigning ift.
English: • If you are allergic to lamivudine, raltegravir or any of the other ingredients in this medicine listed in section 6.
Danish: • hvis du er allergisk over for lamivudin, raltegravir eller eller et af de øvrige indholdsstoffer i
English: • low count of white blood cells that fight infection; pain or swollen glands (lymph nodes) in the neck, armpit and groin
Danish: • Lavt antal hvide blodlegemer, som bekæmper infektion; smerter eller hævede kirtler (lymfeknuder) i halsen, i armhulerne og lysken
English: This enzyme is needed for HIV to make more virus.
Danish: Dette enzym hjælper hiv-virus med at formere sig i kroppen.
English: Merck Sharp & Dohme Ireland (Human Health)
Danish: Merck Sharp & Dohme Ireland (Human Health) Limited
English: Therefore, when DUTREBIS is co-administered with calcium carbonate containing antacids no dose adjustment is required.
Danish: Når DUTREBIS administreres sammen med calciumcarbonat-holdige antacida, er dosisjustering derfor ikke påkrævet.
English: The pharmacokinetic properties of lamivudine have been determined in a small group of HIV-1-infected adults with impaired renal function.
Danish: Lamivudins farmakokinetiske egenskaber er vurderet i en lille gruppe af hiv-1-inficerede voksne med
English: DUTREBIS should not be used in children below 6 years of age or in patients weighing less than 30 kg due to weight based dosing requirements in this patient population.
Danish: DUTREBIS bør ikke anvendes til børn under 6 år eller til patienter, der vejer under 30 kg på grund af kravet om vægtbaseret dosering hos denne patientpopulation.
English: At the NOAEL, systemic exposure was similar to that at the clinical dose of 400 mg twice daily.
Danish: Ved NOAEL (No Observable Adverse Effect Level) var den systemiske eksponering sammenlignelig med eksponeringen ved kliniske doser på 400 mg to gange dagligt.
English: If you notice after 6 hours, then skip the intake and take the next doses as
Danish: Hvis du opdager det efter 6 timer, skal du springe denne tablet over og tage de næste doser som sædvanlig.
English: The raltegravir component in DUTREBIS (300 mg raltegravir) fixed-dose combination tablet was not bioequivalent with respect to C12, however, based on PK/PD modelling, no clinically meaningful differences in raltegravir exposure are expected.
Danish: Raltegravirkomponenten i DUTREBIS (300 mg raltegravir) i fast-dosis kombinationstabletten var ikke bioækvivalent med hensyn til C12, men på baggrund af de farmakokinetiske/farmakodynamiske modeller forventes ingen klinisk betydningsfulde forskelle i eksponeringen for raltegravir.
English: Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 5.2).
Danish: Zidovudin har ingen indvirkning på lamivudins farmakokinetik (se pkt.
English: Caution should be used when administering DUTREBIS in patients with a pre-existing history of depression or psychiatric
Danish: Forsigtighed bør udvises, når DUTREBIS administreres hos patienter med depression eller psykisk sygdom i anamnesen.
English: The pharmacokinetics of DUTREBIS in children under 6 years of age has not been established.
Danish: DUTREBIS' farmakokinetik hos børn under 6 år er ikke fastlagt.
English: Therefore, whenever possible, DUTREBIS should be administered with another active ART to minimise the potential for virological failure and the development of resistance (see section 5.1).
Danish: Derfor bør DUTREBIS, når det er muligt, administreres sammen med et andet aktivt ART for at minimere et potentielt for virologisk svigt og
English: No dosage adjustment required for DUTREBIS or hormonal contraceptives (oestrogen- and/or progesterone-based).
Danish: Dosisjustering af DUTREBIS eller hormonelle antikonceptionsmidler (østrogen- og/eller
English: DUTREBIS 150 mg/300 mg film-coated tablets
Danish: DUTREBIS 150 mg /300 mg filmovertrukne tabletter
English: • abnormal dreams; nightmare; abnormal behaviour; feelings of deep sadness and
Danish: • Unormale drømme, mareridt, unormal adfærd, nedtrykthed og manglende selvværd
English: During your treatment, your doctor will check you for signs of lactic acidosis.
Danish: Undervejs i behandlingen holder lægen øje med tegn på mælkesyreforgiftning.
English: 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).
Danish: Tilfælde af laktatacidose, nogle gange letale, som normalt er forbundet med svær hepatomegali og hepatisk steatose er rapporteret ved anvendelse af nukleosidanaloger (se pkt.
English: Discontinue DUTREBIS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, angioedema).
Danish: DUTREBIS og andre mistænkte lægemidler skal seponeres omgående, hvis der opstår tegn eller symptomer på alvorlige hud- eller overfølsomhedsreaktioner (inklusive, men ikke begrænset til, alvorligt udslæt eller udslæt med feber, generel utilpashed, træthed, muskel- eller ledsmerter, blærer, sår i munden, konjunktivitis, ansigtsødem, hepatitis, eosinofili, angioødem).
English: In HIV-infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: • increased liver blood tests; abnormal white blood cells; increased fat levels in blood (such as cholesterol and triglycerides); increased level of enzyme from salivary glands or pancreas
Danish: • Forhøjede leverværdier ved blodprøver, unormalt antal hvide blodlegemer, øget indhold af fedt i blodet (såsom kolesterol og triglycerider), forhøjede enzymniveauer fra spytkirtler eller bugspytkirtel
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 hos aber sammenlignede zidovudin alene med kombinationen af zidovudin og lamivudin i human-ækvivalente doser.
English: 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.
Danish: Lamivudin var ikke mutagent i bakteriestudier, men viste som mange andre nukleosidanaloger aktivitet i en in vitro-cytogenprøve og i muselymfomcelletesten.
English: • increased appetite; diabetes; high sugar levels in the blood; excessive thirst; severe weight loss; body fat disorder
Danish: • Øget appetit, sukkesyge (diabetes), højt indhold af sukker i blodet, voldsom tørst, alvorligt vægttab, unormal fordeling af kropsfedt
English: DUTREBIS should not be used in children below 6 years of age or in patients weighing less than 30 kg due to weight based dosing requirements in this patient population (see section 5.2).
Danish: DUTREBIS bør ikke anvendes til børn under 6 år eller til patienter, der vejer under 30 kg på grund af kravet om vægtbaseret dosering hos denne patientpopulation (se pkt.
English: • buzzing, hissing, whistling, ringing or other persistent noise in the ears • palpitations; slow heart rate; fast or irregular heart beats
Danish: • Summende, hvislende, fløjtende, ringende eller anden vedvarende støj i ørerne • Hjertebanken, langsom hjerterytme, hurtig eller uregelmæssig hjerterytme
English: STARTMRK (multi-centre, randomised, double-blind, active-control study) evaluated the safety and anti-retroviral activity of raltegravir 400 mg twice daily vs. efavirenz 600 mg at bedtime, in a combination with emtricitabine (+) tenofovir, in treatment-naïve HIV-infected patients with HIV RNA > 5,000 copies/ml.
Danish: STARTMRK (randomiseret, dobbeltblindet, aktivt kontrolleret multicenterstudie) vurderede sikkerhed og antiretroviral aktivitet af raltegravir 400 mg to gange dagligt versus efavirenz 600 mg ved sengetid i en kombination med emtricitabin (+) tenofovir hos behandlingsnaive hiv-inficerede patienter med hiv-RNA >5.000 kopier/ml.
English: DUTREBIS should not be used in children below 6 years of age.
Danish: DUTREBIS bør ikke anvendes til børn under 6 år.
English: • blood test showing decreased count of platelets in blood (a kind of cell that helps blood clot); blood test showing reduced kidney function; increased muscle enzyme in blood; sugar present in urine; red blood cells present in urine; weight gain; increase in waist size; decreased blood protein (albumin); increase in time for blood to clot; blood test showing
Danish: • Blodprøver som viser et fald i antallet af blodplader i blodet (celler der får blodet til at størkne), blodprøver som viser nedsat nyrefunktion, forhøjet mængde muskelenzymer i blodet, sukker i urinen; røde blodlegemer i urinen, vægtøgning; øget taljemål, nedsat blodprotein (albumin), forlængelse af blodets størkningstid, blodprøver som viser et lavt antal røde blodlegemer (anæmi)
English: In adults, there were no clinically important pharmacokinetic differences between patients with moderate hepatic insufficiency and healthy subjects.
Danish: Hos voksne var der ingen klinisk betydningsfulde farmakokinetiske forskelle mellem patienter med moderat nedsat leverfunktion og raske forsøgspersoner.
English: DUTREBIS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
Danish: DUTREBIS er, i kombination med andre antiretrovirale lægemidler, indiceret til behandling af infektion med humant immundefekt-virus (hiv-1) hos voksne, unge og børn fra 6 år, som vejer mindst 30 kg uden nuværende eller tidligere tegn på virusresistens over for antivirale lægemidler af ITI- (hivintegrasehæmmer af genoverførsel) og NRTI-klasserne (nukleosid revers transkriptasehæmmer) (se pkt.
English: Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus
Danish: Raltegravir er en hiv-integrasehæmmer af gen-overførsel, som virker mod humant immundefekt-virus
English: • muscle pain and discomfort, joint pain
Danish: • Muskelsmerter og ubehag, ledsmerter
English: Because the extent to which DUTREBIS may be dialyzable is unknown, dosing before a dialysis session should be avoided (see section 4.2).
Danish: Da det ikke er kendt, i hvor høj grad DUTREBIS er dialysérbart, frarådes dosering før dialyse (se pkt.
English: • DUTREBIS is not recommended in pregnancy.
Danish: • Dutrebis må ikke bruges under graviditet.
English: The most frequently reported adverse reactions during treatment with raltegravir were headache and nausea.
Danish: De hyppigst rapporterede bivirkninger med raltegravir var hovedpine
English: Tell your doctor immediately if you have any of the following signs of lactic acidosis, or any other
Danish: Fortæl det straks til lægen, hvis du har nogen af følgende tegn på mælkesyreforgiftning eller andre
English: 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 aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af CART opstå en inflammatorisk reaktion mod asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomerne.
English: • The active substances are lamivudine and raltegravir.
Danish: • Aktive stoffer: lamivudin og raltegravir.
English: Co-administration of DUTREBIS with antacids containing divalent metal cations may reduce raltegravir absorption by chelation, resulting in a decrease of raltegravir plasma levels.
Danish: Samtidig administration af DUTREBIS og antacida, der indeholder divalente metalkationer, kan reducere absorptionen af raltegravir på grund af chelation, hvilket medfører et fald i raltegravirs plasmakoncetration.
English: Similarly, darunavir use in OBT in darunavir-naïve patients was counted as one active drug in OBT.
Danish: Anvendelse af enfuvirtid i OBT til enfuvirtid-naive patienter blev beregnet som et aktivt lægemiddel i OBT.
English: In a single-cycle infection assay, raltegravir inhibited infection of 23 HIV isolates representing 5 non-B subtypes and 5 circulating recombinant forms with IC50 values ranging from 5 to 12 nM.
Danish: I en infektionstest i enkeltserie hæmmede raltegravir infektion af 23 hiv-isolater, der repræsenterede 5 non-B-subtyper og 5 cirkulerende rekombinante former
English: DUTREBIS is not a cure for HIV infection.
Danish: Dutrebis helbreder ikke hiv-infektion.