natgillin/translations-raw huggingface dataset:
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.
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.
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).
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).
Det indeholder de aktive stoffer lamivudin og raltegravir:
It contains the active substances lamivudine and raltegravir:
Før randomisering blev OBT valgt af investigator på baggrund af patientens behandlingsanamnese, samt testning af genotypisk og fænotypisk virusresistens ved baseline.
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.
Følgende bivirkninger er rapporteret under hiv-behandling med lamivudin og/eller raltegravir (alene eller i kombination med andre ART).
The following adverse reactions have been reported during therapy for HIV disease with lamivudine and/or raltegravir (alone or in combination with other ART).
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).
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).
Der var ingen klinisk betydningsfulde farmakokinetiske forskelle på grund af køn, race eller BMI (Body Mass Index) for raltegravir hos voksne.
There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) for
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.
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.
Hos disse 96 børn og unge var bivirkningernes frekvens, type og sværhedsgrad til og med uge 48 de
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.
M184V-mutanter udviser markant reduceret følsomhed over for lamivudin og udviser mindsket viral replikationskapacitet in vitro.
M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Et karcinogenicitetsstudie med raltegravir i mus viste ingen potentiel karcinogenicitet.
A carcinogenicity study of raltegravir in mice did not show any carcinogenic potential.
Doseringsregimet for lamivudinkomponenten i DUTREBIS i den pædiatriske population er det samme som for den enkelte komponent (EPIVIR).
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).
Rifampicin reducerer raltegravirs plasmakoncentration; indvirkningen på raltegravirs virkning er ukendt.
Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown.
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).
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).
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.
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.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 39,70 mg lactose (som monohydrat).
Excipient with known effect: Each tablet contains 39.70 mg lactose (as monohydrate).
Abacavir beholder den antiretrovirale aktivitet over for lamivudinresistent hiv-1, der kun har M184V-mutationen.
Abacavir maintains its antiretroviral activities against lamivudine resistant HIV-1 harbouring only the M184V mutation.
48 uger
48 Weeks
Forudsat at raltegravir primært metaboliseres via UGT1A1, bør der udvises forsigtighed, når DUTREBIS administreres sammen med andre stærke inducere af UGT1A1.
Given that raltegravir is metabolised primarily via UGT1A1, caution should also be used when co-administering DUTREBIS with other strong inducers of UGT1A1.
• høje doser af cotrimoxazol - anvendes til behandling af infektioner.
• high doses of co-trimoxazole - used to treat infections.
Af de 126 patienter fik 96 den anbefalede dosis raltegravir (se pkt.
Of the 126 patients, 96 received the recommended dose of raltegravir (see section 4.2).
Da lamivudin hovedsageligt udskilles via nyrerne, og ældre har større sandsynlighed for at have nedsat nyrefunktion, skal nyrefunktionen monitoreres.
Because lamivudine is substantially excreted by the kidney and older people are more likely to have decreased renal function, renal function should be monitored.
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.
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.
Dette er mest sandsynligt ved langtidsbehandling mod hiv, alvorlig skade på immunsystemet, overvægt eller alkoholforbrug eller brug af lægemidler, der hedder kortikosteroider (binyrebarkhormon).
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.
De farmakokinetiske parametre ændredes ikke ved aftagende leverfunktion; dosisjustering er derfor ikke nødvendig hos patienter med nedsat leverfunktion.
Pharmacokinetic parameters were not altered by diminishing hepatic function; therefore, no dose adjustment for lamivudine is required for patients with impaired hepatic function.
Mutationer, som giver resistens over for raltegravir, giver generelt også resistens over for hiv-integrasehæmmeren af gen-overførsel elvitegravir.
Mutations conferring resistance to raltegravir generally also confer resistance to the integrase strand transfer inhibitor elvitegravir.
De farmakokinetiske egenskaber, anvendelse i særlige populationer samt lægemiddelinteraktioner for hver af de enkelte komponenter (lamivudin og raltegravir) er gældende for DUTREBIS.
The pharmacokinetic properties, use in special populations and drug-drug interactions for each of the individual components (lamivudine and raltegravir) are applicable to
Klinisk relevans af disse fund er ikke fastlagt.
The clinical relevance of these findings is not established.
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.
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.
Hiv-1-resistens over for lamivudin involverer udviklingen af M184V-aminosyreændringer tæt ved den aktive del af den virale revers- transkriptase (RT).
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).
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.
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.
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).
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).
Kliniske studier har vist, at lamivudin plus zidovudin forsinker fremkomsten af zidovudin-resistente isolater hos individer, som ikke tidligere har modtaget antiretroviral behandling.
Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Mindre potente inducere (fx efavirenz, nevirapin, etravirin, rifabutin, glukokortikoider, perikon, pioglitazon) kan anvendes sammen med DUTREBIS.
Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with DUTREBIS.
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.
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.
DUTREBIS bør ikke anvendes ved samtidig administration af rifampicin.
DUTREBIS should not be used when co-administered with rifampicin.
119 celler/mm
119 cells/mm
Behandling med NRTIer skal seponeres ved symptomatisk hyperlaktatæmi og metabolisk acidose/laktatacidose, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
Treatment with NRTIs should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
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.
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
Zidovudin og stavudin beholder deres antiretrovirale aktivitet over for lamivudinresistent hiv-1.
Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Tabel 3 Effektresultater ved uge 48 og 240
Table 3 Efficacy Outcome at Weeks 48 and 240
Der foreligger kun begrænset information om brugen af lamivudin og raltegravir til ældre patienter (se pkt.
There is limited information regarding the use of lamivudine and raltegravir in the elderly (see section 5.2).
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.
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.
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.
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
I det andet studie (n = 16) var den mediane koncentration i cerebrospinalvæsken 3 % (interval: 1 til 61 %) af den tilsvarende plasmakoncentration.
In the second study (n=16), the median cerebrospinal fluid concentration was 3 % (range 1 to 61 %) of the corresponding plasma concentration.
Cancer er rapporteret hos behandlingserfarne og behandlingsnaive patienter, som startede i behandling med raltegravir sammen med andre antiretrovirale lægemidler.
Cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents.
Hud og subkutane væv Almindelig Udslæt, alopeci
Skin and subcutaneous common rash, alopecia
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.
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.
Ved uge 240 var behandlingsdifferencen (raltegravir - efavirenz) 9,5% med associeret 95% konfidensinterval (1,7; 17,3).
At Week 240, the treatment difference (raltegravir - efavirenz) was 9.5 % with an associated 95 % CI of (1.7, 17.3).
• medicin, der indeholder raltegravir eller emtricitabin - anvendes til behandling af hiv.
• medicines containing raltegravair or emtricitabine - used to treat HIV.
Data for anvendelse hos et stort antal gravide kvinder, som fik lamivudin (mere end 1.000) indikerer dog ingen malformativ toksicitet.
There are no adequate data from the use of raltegravir in pregnant women; however, a large amount of data on pregnant women who were administered lamivudine (more than 1,000 exposed outcomes) indicate no malformative toxicity.
Der blev observeret de samme AUC-værdier for de personer, der havde fået mad versus fastet og noget lavere Cmax (23% for raltegravir og 21% for lamivudin) med DUTREBIS.
Similar AUC values for fed vs. fasted and somewhat lower Cmax values (23 % for raltegravir and 21 % for lamivudine) were observed with DUTREBIS.
Raltegravir udskilles dog i mælken hos diegivende rotter.
However, raltegravir is secreted in the milk of lactating rats.
Et åbent, randomiseret, to-perioders cross-over studie med enkeltdosering vurderede virkningen af et måltid med højt fedtindhold på DUTREBIS, når dette blev administreret til 20 raske mandlige og kvindelige forsøgspersoner.
An open-label, single-dose, randomized, two-period crossover study assessed the effect of a high fat meal on DUTREBIS administered to 20 healthy male and female subjects.
Børn, som før fødslen har været eksponeret for nukleosid- og nukleotid-reverstranskriptasehæmmere, også hiv-negative børn, bør følges og monitoreres klinisk og undersøges grundigt for mulig mitokondriel dysfunktion i tilfælde af tegn og symptomer herpå.
Any child exposed in utero to nucleoside and nucleotide reverse transcriptase inhibitors, even HIV-negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Desuden skal der udvises forsigtighed ved samtidig administration af DUTREBIS og andre stærke inducere af uridindiphosphat glucuronyltransferase (UGT) 1A1.
In addition, caution should also be used when co-administering DUTREBIS with other strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1.
• muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
• muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity.
Sværhedsgraden af udslæt set i kliniske studier var let til moderat og medførte ikke seponering af behandlingen (se pkt.
The rashes observed in clinical studies were mild to moderate in severity and did not result in discontinuation of therapy (see section 4.4).
For hver af følgende kliniske bivirkninger rapporteret for raltegravir var der mindst en alvorlig hændelse: genital herpes, anæmi, immunreaktiveringssyndrom, depression, mentale forstyrrelser, selvmordsforsøg, gastritis, hepatitis, nyreinsufficiens, uforsætlig overdosering.
For each of the following clinical adverse reactions reported for raltegravir there was at least one serious occurrence: genital herpes, anaemia, immune reconstitution syndrome, depression, mental disorder, suicide attempt, gastritis, hepatitis, renal failure, accidental overdose.
Du må ikke holde op med at tage Dutrebis uden at have talt med lægen om det.
Do not stop taking DUTREBIS without your doctor's advice.
Desuden hæmmede raltegravir den virale replikation i kulturer af mitogenaktiverede mononukleære celler fra humant perifert blod inficeret med forskellige, primære kliniske isolater af hiv-1, inklusive isolater fra 5 non-B subtyper, og isolater, som var resistente over for revers-transkriptasehæmmere og proteasehæmmere.
In addition, raltegravir inhibited viral replication in cultures of mitogen-activated human peripheral blood mononuclear cells infected with diverse, primary clinical isolates of HIV-1, including isolates from 5 non-B subtypes, and isolates resistant to reverse transcriptase inhibitors and protease inhibitors.
En patient oplevede lægemiddelrelaterede abnorme laboratorieværdier, ASAT grad 4 og ALAT grad 3,
One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which
For patienter, der samtidig er inficeret med hepatitis, og som bliver behandlet med DUTREBIS og efterfølgende bliver gravide, skal risikoen for tilbagevenden af hepatitis overvejes ved seponering af
For patients co-infected with hepatitis who are being treated with DUTREBIS and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of DUTREBIS.
Men medmindre patienten har nedsat nyrefunktion, er dosisjustering ikke nødvendig for DUTREBIS (se pkt.
However, unless the patient has renal impairment, no dosage adjustment of DUTREBIS is necessary (see section 4.2).
I nogle studier medførte samtidig administration af raltegravir og darunavir en beskeden stigning i darunavirs plasmakoncentration; mekanismen bag denne virkning er ukendt.
In some studies, co-administration of raltegravir with darunavir resulted in a modest decrease in darunavir plasma concentrations; the mechanism for this effect is unknown.
Biotilgængeligheden af raltegravirkomponenten i DUTREBIS under faste er cirka 60%, hvilket er højere end biotilgængeligheden af raltegravir i raltegravir poloxamer-formuleringen og forklarer forskellen i raltegravirdosis.
The bioavailablity of the raltegravir component of DUTREBIS in the fasted state is approximately 60 %, which is higher than the bioavailability of raltegravir in the raltegravir poloxamer formulation, and accounts for the difference in raltegravir dose.
Der er ikke set påvirkning af fertiliteten hos han- og hunrotter ved doser af raltegravir på op til 600 mg/kg/dag, hvilket resulterede i en eksponering, der var 3 gange højere end eksponeringen ved den anbefalede dosis til mennesker.
No effect on fertility was seen in male and female rats at doses of raltegravir up to 600 mg/kg/day which resulted in 3-fold exposure above the exposure at the recommended human dose.
Farmakokinetiske interaktionsdata mellem de enkelte komponenter i DUTREBIS og andre
Pharmacokinetic Interaction Data between the Individual Components of DUTREBIS and
Raltegravir passerede uden besvær placenta hos rotter, men penetrerede ikke blod-hjernebarrieren i
Raltegravir readily crossed the placenta in rats, but did not penetrate the brain to any appreciable extent.
Mindre potente UGT1A1-hæmmere (fx indinavir, saquinavir) kan også øge raltegravirs plasmakoncentration, men i mindre grad end atazanavir.
Less potent UGT1A1 inhibitors (e.g., indinavir, saquinavir) may also increase plasma levels of raltegravir, but to a lesser extent compared with atazanavir.
Dutrebis anvendes til behandling af hiv (humant immundefekt-virus).
DUTREBIS is used to treat HIV (Human Immunodeficiency Virus).
• Øvrige indholdsstoffer: hypromellose (2910), croscarmellosenatrium, lactosemonohydrat, siliciumdioxid (kolloid), magnesiumstearat og mikrokrystallinsk cellulose.
• The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose.
Dosisjustering af DUTREBIS er ikke nødvendig på grund af køn, race eller BMI.
No dosage adjustment is necessary for DUTREBIS based on gender, race, or BMI.
Der er ikke udført dyrestudier med DUTREBIS.
No animal studies have been conducted with DUTREBIS.
Lamivudin udviser lav cytotoksicitet over for lymfocytter i perifert blod, over for etablerede lymfocyt- og monocyt-makrofage cellelinjer og over for forskellige progenitorceller i knoglemarven in vitro.
Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Da DUTREBIS indeholder lamivudin og raltegravir, kan alle interaktioner identificeret for et af disse lægemidler, forekomme med DUTREBIS.
As DUTREBIS contains lamivudine and raltegravir, any interactions that have been identified with these agents individually, may occur with DUTREBIS.
Desuden blev nedsat nyrefunktion vurderet i den samlede farmakokinetiske analyse.
Additionally, renal insufficiency was evaluated in the composite pharmacokinetic analysis.
I fæces var kun raltegravir til stede, hvoraf størstedelen sandsynligvis stammer fra hydrolyse af raltegravir-glucuronid udskilt i galden, som det sås i de prækliniske dyrearter.
In faeces, only raltegravir was present, most of which is likely to be derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species.
Dyrestudier med raltegravir har vist reproduktionstoksicitet (se pkt.
Studies with raltegravir in animals have shown reproductive toxicity (see section 5.3).
• Lamivudin tilhører en gruppe af lægemidler kaldet nukleosidanaloge revers-transkriptasehæmmere
• Lamivudine belongs to a group of medicines called nucleoside analogue reverse transcriptase
DUTREBIS bør ikke anvendes under graviditet.
DUTREBIS should not be used during pregnancy.