FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Danish: Andre lægemidler (fx ranitidin, cimetidin) udskilles kun delvist ved denne mekanisme og har vist sig ikke at interagere med lamivudin.
English: Overall, the results of the clinical pharmacology studies with DUTREBIS demonstrate similar drug exposures compared to the individual components of lamivudine and raltegravir, including similar variability in raltegravir C12hr and Cmax.
Danish: Overordnet set viser resultaterne fra de kliniske farmakologiske studier med DUTREBIS de samme lægemiddeleksponeringer sammenlignet med enkeltkomponenterne lamivudin og raltegravir, herunder samme variabilitet i raltegravirs C12t og Cmax.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Danish: Muligheden for interaktioner med andre samtidigt administrerede lægemidler bør overvejes, særligt hvis disses udskillelse primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, fx trimethoprim.
English: • you have a history of depression or psychiatric illness.
Danish: • hvis du tidligere har haft en depression eller en psykisk sygdom.
English: Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure.
Danish: Der er også rapporteret om overfølsomhedsreaktioner, som var karakteriseret ved udslæt, konstitutionelle fund og nogle gange organdysfunktion inklusive leversvigt.
English: See a doctor immediately, if you notice any of the side effects above.
Danish: Søg straks læge, hvis du bemærker en eller flere af ovenstående bivirkninger.
English: In general the safety profile of raltegravir in patients with hepatitis B and/or hepatitis C virus co-infection was similar to that in patients without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were somewhat higher in the subgroup with hepatitis B and/or hepatitis C virus co-infection for both treatment groups.
Danish: Generelt var sikkerhedsprofilen for raltegravir hos patienter med hepatitis B- og/eller hepatitis C-viruscoinfektion den samme som hos patienter uden hepatitis B og/eller hepatitis C-virusco-infektion, selvom hyppigheden af uregelmæssigheder vedrørende ASAT og ALAT var noget højere i undergruppen med hepatitis B- og/eller hepatitis C-virusco-infektion i begge behandlingsgrupper.
English: Lamivudine in the fixeddose combination tablet was bioequivalent with the lamivudine (single agent) after administration of the individual component.
Danish: Lamivudin fastdosiskombinationstabletten var bioækvivalent med lamivudin (enkeltpræparat) efter administration af den enkelte komponent.
English: Once absorbed the lamivudine and raltegravir distribution, metabolism, and excretion are similar to those of the reference components administered individually as described in the following paragraphs.
Danish: Når det er absorberet, er fordeling, metabolisme og udskillelse af lamivudin og raltegravir de samme som for referencekomponenterne, når disse administreres individuelt som beskrevet
English: Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32 % of the dose was excreted in faeces and urine, respectively.
Danish: Efter administration af en oral dosis radiomærket raltegravir udskiltes henholdsvis cirka 51% og 32% af dosen i fæces og urin.
English: 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.
Danish: Studiet viste, at fostre, der in utero blev udsat for kombinationsbehandlingen, opretholdt et højere niveau af nukleosid-analogt DNA i flere føtale organer, og de udviste også tegn på øget telomerforkortning i forhold til dem, der kun fik zidovudin.
English: • fever, general feeling of being unwell
Danish: • Feber, generel følelse af ubehag
English: From the clinical studies, a large proportion of patients used atazanavir and / or tenofovir, both agents that result in increases in raltegravir plasma levels, in the optimised background regimens.
Danish: En stor del af patienterne i de kliniske studier fik atazanavir og/eller tenofovir, og begge lægemidler medførte stigning i raltegravirs plasmakoncentrationer i de optimerede baggrundsregimer.
English: Raltegravir at concentrations of 31  20 nM resulted in 95 % inhibition (IC95) of HIV-1 replication (relative to an untreated virus-infected culture) in human T-lymphoid cell cultures infected with the cell-line adapted HIV-1 variant H9IIIB.
Danish: Raltegravir i koncentrationer på 31 ± 20 nM resulterede i 95% hæmning (IC95) af hiv-1 replikation (i forhold til en ubehandlet virusinficeret kultur) i humane T-lymfoide cellekulturer inficeret med cellelinjeadapteret hiv-1 variant H9IIIB.
English: Baseline Characteristics and Efficacy Outcomes at Weeks 24 and 48 from IMPAACT P1066
Danish: Tabel 4 Karakteristika ved baseline og effektresultater ved uge 24 og 48 fra IMPAACT P1066 (2 til 18 år)
English: The NRTIs (e.g. didanosine, zidovudine) are not eliminated by this mechanism and are unlikely to interact with lamivudine.
Danish: NRTIerne (fx didanosin, zidovudin) elimineres ikke ved denne mekanisme og vil sandsynligvis ikke interagere med lamivudin.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in lamivudine exposure at therapeutic doses.
Danish: En interaktion med trimethoprim, der er en af bestanddelene i co-trimoxazol, medfører en stigning på 40% i eksponeringen for lamivudin ved terapeutiske doser.
English: Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Danish: Lamivudin har ingen indvirkning på trimethoprims eller sulfamethoxazols farmakokinetik.
English: If you take more DUTREBIS than you should Do not take more tablets than the doctor recommends.
Danish: Tag ikke flere tabletter, end lægen anbefaler.
English: Raltegravir achieved virologic responses (using Not Completer=Failure approach) of HIV RNA < 50 copies/ml in 61.7 % of patients at Week 16, in 62.1 % at Week 48 and in 57.0 % at Week 96.
Danish: Raltegravir opnåede virologisk respons (med Non-Completer = Failure-analysen) for hiv-RNA <50 kopier/ml hos 61,7% af patienterne ved uge 16, hos 62,1% ved uge 48 og hos 57,0% ved uge 96.
English: • Swallow the tablet whole (do not crush or chew).
Danish: • Slug tabletten hel (lad være med at knuse den eller tygge den).
English: Talk to your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain, tenderness or weakness while taking this medicine.
Danish: Kontakt straks lægen, apotekspersonalet eller sundhedspersonalet, hvis du oplever uforklarlige muskelsmerter, -ømhed eller -svaghed, mens du tager dette lægemiddel.
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-følsomhed af hiv over for lamivudin og det kliniske respons på lamivudinholdig behandling undersøges fortsat.
English: Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
Danish: Administration af høje doser lamivudin i dyretoksicitetsstudier var ikke forbundet med nogen større organtoksicitet.
English: Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Danish: Lamivudin er en nukleosid revers-transkriptasehæmmer (NRTI), som virker mod humant immundefektvirus (hiv) og hepatitis B-virus (HBV).
English: Safety profiles in the subgroup of patients in Phase III studies taking proton pump inhibitors or H2 antagonists were comparable with those who were not taking these antacids.
Danish: Sikkerhedsprofilen for subgruppen af patienter i fase III, som tog protonpumpehæmmere eller H2-antagonister, var den samme som hos dem, der ikke tog disse lægemidler.
English: The treatment difference (raltegravir- efavirenz) was 4.2 % with an associated 95 % CI of (-1.9, 10.3) establishing that raltegravir is non-inferior to efavirenz (p-value for non-inferiority < 0.001).
Danish: Behandlingsdifferencen (raltegravir - efavirenz) var 4,2% med associeret 95% konfidensinterval (-1,9; 10,3), hvilket fastslog, at raltegravir er non-inferior til efavirenz (p-værdi for non-inferioritet <0,001).
English: It contains the active substances lamivudine and raltegravir:
Danish: Det indeholder de aktive stoffer lamivudin og raltegravir:
English: Prior to randomization, OBT were selected by the investigator based on the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance testing.
Danish: Før randomisering blev OBT valgt af investigator på baggrund af patientens behandlingsanamnese, samt testning af genotypisk og fænotypisk virusresistens ved baseline.
English: The following adverse reactions have been reported during therapy for HIV disease with lamivudine and/or raltegravir (alone or in combination with other ART).
Danish: Følgende bivirkninger er rapporteret under hiv-behandling med lamivudin og/eller raltegravir (alene eller i kombination med andre ART).
English: The pharmacokinetics of lamivudine after administration to patients over 65 years of age have not been studied; however, there was no clinically meaningful effect of age on raltegravir pharmacokinetics over the age range studied (19 to 71 years, with few (8) subjects over the age of 65).
Danish: Dosisjustering af DUTREBIS er ikke nødvendig på baggrund af alder. Lamivudins farmakokinetik efter administration til patienter over 65 år er ikke undersøgt; der var dog ingen klinisk betydningsfuld virkning på grund af alder på raltegravirs farmakokinetik i det undersøgte aldersinterval (19 til 71 år, med kun få (8) forsøgspersoner over 65 år).
English: There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) for
Danish: Der var ingen klinisk betydningsfulde farmakokinetiske forskelle på grund af køn, race eller BMI (Body Mass Index) for raltegravir hos voksne.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Danish: Selvom ætiologien anses for at være multifaktoriel (inklusive kortikosteroid anvendelse, alkoholforbrug, svær immunsuppression, højere body mass index (BMI)), er tilfælde af osteonekrose blevet observeret især blandt patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for CART.
English: In these 96 children and adolescents, frequency, type and severity of drug related adverse reactions through Week 48 were comparable to those observed in adults.
Danish: Hos disse 96 børn og unge var bivirkningernes frekvens, type og sværhedsgrad til og med uge 48 de
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Danish: M184V-mutanter udviser markant reduceret følsomhed over for lamivudin og udviser mindsket viral replikationskapacitet in vitro.
English: A carcinogenicity study of raltegravir in mice did not show any carcinogenic potential.
Danish: Et karcinogenicitetsstudie med raltegravir i mus viste ingen potentiel karcinogenicitet.
English: The dosing regimen of the lamivudine component of DUTREBIS in the paediatric population is the same as the dosing regimen of the individual component (EPIVIR).
Danish: Doseringsregimet for lamivudinkomponenten i DUTREBIS i den pædiatriske population er det samme som for den enkelte komponent (EPIVIR).
English: Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown.
Danish: Rifampicin reducerer raltegravirs plasmakoncentration; indvirkningen på raltegravirs virkning er ukendt.
English: In a comparison of 30 subjects receiving raltegravir with *28/*28 genotype to 27 subjects with wild-type genotype, the geometric mean ratio (90 % CI) of AUC was 1.41 (0.96, 2.09) and the geometric mean ratio of C12 hr was 1.91 (1.43, 2.55).
Danish: I en sammenligning af 30 forsøgspersoner, der fik raltegravir, med *28/*28 genotype med 27 forsøgspersoner med vildtype genotype var den geometriske middelratio (90% CI) af AUC 1,41 (0,96; 2,09) og den geometriske middelratio af C12t var 1,91 (1,43; 2,55).
English: If DUTREBIS 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.
Danish: Hvis DUTREBIS seponeres hos patienter, der samtidigt er inficeret med hepatitis Bvirus, anbefales periodisk monitorering af leverfunktionsprøver og markører for HBV-replikation, da seponering af lamivudin kan medføre en akut forværring af hepatitis.
English: Excipient with known effect: Each tablet contains 39.70 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 39,70 mg lactose (som monohydrat).
English: Abacavir maintains its antiretroviral activities against lamivudine resistant HIV-1 harbouring only the M184V mutation.
Danish: Abacavir beholder den antiretrovirale aktivitet over for lamivudinresistent hiv-1, der kun har M184V-mutationen.
English: 48 Weeks
Danish: 48 uger
English: Given that raltegravir is metabolised primarily via UGT1A1, caution should also be used when co-administering DUTREBIS with other strong inducers of UGT1A1.
Danish: Forudsat at raltegravir primært metaboliseres via UGT1A1, bør der udvises forsigtighed, når DUTREBIS administreres sammen med andre stærke inducere af UGT1A1.
English: • high doses of co-trimoxazole - used to treat infections.
Danish: • høje doser af cotrimoxazol - anvendes til behandling af infektioner.
English: Of the 126 patients, 96 received the recommended dose of raltegravir (see section 4.2).
Danish: Af de 126 patienter fik 96 den anbefalede dosis raltegravir (se pkt.
English: Because lamivudine is substantially excreted by the kidney and older people are more likely to have decreased renal function, renal function should be monitored.
Danish: Da lamivudin hovedsageligt udskilles via nyrerne, og ældre har større sandsynlighed for at have nedsat nyrefunktion, skal nyrefunktionen monitoreres.
English: Although in vitro studies indicated that raltegravir is not an inhibitor of the UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, one clinical study has suggested that some inhibition of UGT1A1 may occur in vivo based on effects observed on bilirubin glucuronidation.
Danish: Selvom in vitro-studier indikerede, at raltegravir ikke er en hæmmer af UDP- glucuronosyltransferaserne (UGTerne) 1A1 og 2B7, har ét klinisk studie vist, at nogen hæmning af UGT1A1 kan forekomme in vivo baseret på virkninger, der er observeret ved bilirubinglucuronidering.
English: This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids.
Danish: Dette er mest sandsynligt ved langtidsbehandling mod hiv, alvorlig skade på immunsystemet, overvægt eller alkoholforbrug eller brug af lægemidler, der hedder kortikosteroider (binyrebarkhormon).
English: Pharmacokinetic parameters were not altered by diminishing hepatic function; therefore, no dose adjustment for lamivudine is required for patients with impaired hepatic function.
Danish: De farmakokinetiske parametre ændredes ikke ved aftagende leverfunktion; dosisjustering er derfor ikke nødvendig hos patienter med nedsat leverfunktion.
English: Mutations conferring resistance to raltegravir generally also confer resistance to the integrase strand transfer inhibitor elvitegravir.
Danish: Mutationer, som giver resistens over for raltegravir, giver generelt også resistens over for hiv-integrasehæmmeren af gen-overførsel elvitegravir.
English: The pharmacokinetic properties, use in special populations and drug-drug interactions for each of the individual components (lamivudine and raltegravir) are applicable to
Danish: De farmakokinetiske egenskaber, anvendelse i særlige populationer samt lægemiddelinteraktioner for hver af de enkelte komponenter (lamivudin og raltegravir) er gældende for DUTREBIS.
English: The clinical relevance of these findings is not established.
Danish: Klinisk relevans af disse fund er ikke fastlagt.
English: The comparative bioavailability of DUTREBIS (150 mg lamivudine/300 mg raltegravir) fixed-dose combination tablet was assessed relative to individual components administered concomitantly (150 mg of lamivudine and 400 mg of raltegravir) in 108 healthy subjects.
Danish: Den komparative biotilgængelighed af DUTREBIS (150 mg lamivudin/300 mg raltegravir) fastdosiskombinationstablet blev vurderet i forhold til de enkelte komponenter, som blev administreret samtidigt (150 mg lamivudin og 400 mg raltegravir) hos 108 raske forsøgspersoner.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Danish: Hiv-1-resistens over for lamivudin involverer udviklingen af M184V-aminosyreændringer tæt ved den aktive del af den virale revers- transkriptase (RT).
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir, in mice, rats, dogs and rabbits.
Danish: Der er udført præ-kliniske toksikologistudier, inklusive konventionelle studier af sikkerhedsfarmakologien, gentagen dosistoksicitet, genotoksicitet, udviklingstoksicitet og juvenil toksicitet med raltegravir hos mus, rotter, hunde og kaniner.
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, integrase inhibitors).
Danish: Lamivudin er i vid udstrækning blevet anvendt som komponent i antiretroviral kombinationsbehandling i kombination med andre antiretrovirale lægemidler fra samme klasse (NRTIer) eller fra andre klasser (PIer, non-nukleoside revers-transkriptasehæmmere, integrasehæmmere).
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Danish: Kliniske studier har vist, at lamivudin plus zidovudin forsinker fremkomsten af zidovudin-resistente isolater hos individer, som ikke tidligere har modtaget antiretroviral behandling.
English: Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with DUTREBIS.
Danish: Mindre potente inducere (fx efavirenz, nevirapin, etravirin, rifabutin, glukokortikoider, perikon, pioglitazon) kan anvendes sammen med DUTREBIS.
English: With respect to the primary efficacy endpoint, the proportion (%) of patients achieving HIV RNA < 50 copies/ml at Week 48 was 241/280 (86.1 %) in the group receiving raltegravir and 230/281 (81.9 %) in the group receiving efavirenz.
Danish: Med hensyn til det primære endepunkt var andelen (%) af patienter, der opnåede hiv-RNA <50 kopier/ml i uge 48, 241/280 (86,1%) i gruppen, der fik raltegravir, og 230/281 (81,9%) i gruppen, der fik efavirenz.
English: DUTREBIS should not be used when co-administered with rifampicin.
Danish: DUTREBIS bør ikke anvendes ved samtidig administration af rifampicin.
English: 119 cells/mm
Danish: 119 celler/mm
English: Treatment with NRTIs should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Danish: Behandling med NRTIer skal seponeres ved symptomatisk hyperlaktatæmi og metabolisk acidose/laktatacidose, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
English: One patient experienced drug related clinical adverse reactions of Grade 3 psychomotor hyperactivity, abnormal behaviour and insomnia; one patient experienced a Grade 2 serious drug related allergic
Danish: En patient fik lægemiddelrelaterede kliniske bivirkninger i form af psykomotorisk hyperaktivitet, abnorm adfærd samt insomni af grad 3; en patient fik alvorligt lægemiddelrelateret allergisk udslæt af grad 2.
English: Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Danish: Zidovudin og stavudin beholder deres antiretrovirale aktivitet over for lamivudinresistent hiv-1.
English: Table 3 Efficacy Outcome at Weeks 48 and 240
Danish: Tabel 3 Effektresultater ved uge 48 og 240
English: There is limited information regarding the use of lamivudine and raltegravir in the elderly (see section 5.2).
Danish: Der foreligger kun begrænset information om brugen af lamivudin og raltegravir til ældre patienter (se pkt.
English: At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was similar to that at the clinical dose of 400 mg twice daily.
Danish: Ved det højeste dosisniveau, 400 mg/kg/dag i hunmus og 250 mg/kg/dag i hanmus, var den systemiske eksponering sammenlignelig med eksponeringen ved kliniske doser på 400 mg to gange dagligt.
English: As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing
Danish: Da lamivudins mutagene aktivitet in vitro ikke kunne bekræftes in vivo, kan det konkluderes, at der ikke skulle være risiko for genotoksicitet hos patienter i behandling med lamivudin.
English: In the second study (n=16), the median cerebrospinal fluid concentration was 3 % (range 1 to 61 %) of the corresponding plasma concentration.
Danish: I det andet studie (n = 16) var den mediane koncentration i cerebrospinalvæsken 3 % (interval: 1 til 61 %) af den tilsvarende plasmakoncentration.
English: Cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents.
Danish: Cancer er rapporteret hos behandlingserfarne og behandlingsnaive patienter, som startede i behandling med raltegravir sammen med andre antiretrovirale lægemidler.
English: Skin and subcutaneous common rash, alopecia
Danish: Hud og subkutane væv Almindelig Udslæt, alopeci
English: No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies conducted with raltegravir.
Danish: Der blev ikke observeret tegn på mutagenicitet eller genotoksicitet i in vitro-mikrobielle mutagentests (Ames' test), in vitro-alkaliske elueringsbestemmelser for DNA-beskadigelse og in vitro- og in vivokromosomafvigelsesstudier med raltegravir.
English: At Week 240, the treatment difference (raltegravir - efavirenz) was 9.5 % with an associated 95 % CI of (1.7, 17.3).
Danish: Ved uge 240 var behandlingsdifferencen (raltegravir - efavirenz) 9,5% med associeret 95% konfidensinterval (1,7; 17,3).
English: • medicines containing raltegravair or emtricitabine - used to treat HIV.
Danish: • medicin, der indeholder raltegravir eller emtricitabin - anvendes til behandling af hiv.