FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Data for anvendelse hos et stort antal gravide kvinder, som fik lamivudin (mere end 1.000) indikerer dog ingen malformativ toksicitet.
English: Similar AUC values for fed vs. fasted and somewhat lower Cmax values (23 % for raltegravir and 21 % for lamivudine) were observed with DUTREBIS.
Danish: 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.
English: However, raltegravir is secreted in the milk of lactating rats.
Danish: Raltegravir udskilles dog i mælken hos diegivende rotter.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: In addition, caution should also be used when co-administering DUTREBIS with other strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1.
Danish: Desuden skal der udvises forsigtighed ved samtidig administration af DUTREBIS og andre stærke inducere af uridindiphosphat glucuronyltransferase (UGT) 1A1.
English: • muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity.
Danish: • muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
English: The rashes observed in clinical studies were mild to moderate in severity and did not result in discontinuation of therapy (see section 4.4).
Danish: Sværhedsgraden af udslæt set i kliniske studier var let til moderat og medførte ikke seponering af behandlingen (se pkt.
English: 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.
Danish: 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.
English: Do not stop taking DUTREBIS without your doctor's advice.
Danish: Du må ikke holde op med at tage Dutrebis uden at have talt med lægen om det.
English: 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.
Danish: 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.
English: One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which
Danish: En patient oplevede lægemiddelrelaterede abnorme laboratorieværdier, ASAT grad 4 og ALAT grad 3,
English: 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.
Danish: 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
English: However, unless the patient has renal impairment, no dosage adjustment of DUTREBIS is necessary (see section 4.2).
Danish: Men medmindre patienten har nedsat nyrefunktion, er dosisjustering ikke nødvendig for DUTREBIS (se pkt.
English: 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.
Danish: I nogle studier medførte samtidig administration af raltegravir og darunavir en beskeden stigning i darunavirs plasmakoncentration; mekanismen bag denne virkning er ukendt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Pharmacokinetic Interaction Data between the Individual Components of DUTREBIS and
Danish: Farmakokinetiske interaktionsdata mellem de enkelte komponenter i DUTREBIS og andre
English: Raltegravir readily crossed the placenta in rats, but did not penetrate the brain to any appreciable extent.
Danish: Raltegravir passerede uden besvær placenta hos rotter, men penetrerede ikke blod-hjernebarrieren i
English: Less potent UGT1A1 inhibitors (e.g., indinavir, saquinavir) may also increase plasma levels of raltegravir, but to a lesser extent compared with atazanavir.
Danish: Mindre potente UGT1A1-hæmmere (fx indinavir, saquinavir) kan også øge raltegravirs plasmakoncentration, men i mindre grad end atazanavir.
English: DUTREBIS is used to treat HIV (Human Immunodeficiency Virus).
Danish: Dutrebis anvendes til behandling af hiv (humant immundefekt-virus).
English: • The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose.
Danish: • Øvrige indholdsstoffer: hypromellose (2910), croscarmellosenatrium, lactosemonohydrat, siliciumdioxid (kolloid), magnesiumstearat og mikrokrystallinsk cellulose.
English: No dosage adjustment is necessary for DUTREBIS based on gender, race, or BMI.
Danish: Dosisjustering af DUTREBIS er ikke nødvendig på grund af køn, race eller BMI.
English: No animal studies have been conducted with DUTREBIS.
Danish: Der er ikke udført dyrestudier med DUTREBIS.
English: 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.
Danish: 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.
English: As DUTREBIS contains lamivudine and raltegravir, any interactions that have been identified with these agents individually, may occur with DUTREBIS.
Danish: Da DUTREBIS indeholder lamivudin og raltegravir, kan alle interaktioner identificeret for et af disse lægemidler, forekomme med DUTREBIS.
English: Additionally, renal insufficiency was evaluated in the composite pharmacokinetic analysis.
Danish: Desuden blev nedsat nyrefunktion vurderet i den samlede farmakokinetiske analyse.
English: 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.
Danish: 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.
English: Studies with raltegravir in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier med raltegravir har vist reproduktionstoksicitet (se pkt.
English: • Lamivudine belongs to a group of medicines called nucleoside analogue reverse transcriptase
Danish: • Lamivudin tilhører en gruppe af lægemidler kaldet nukleosidanaloge revers-transkriptasehæmmere
English: DUTREBIS should not be used during pregnancy.
Danish: DUTREBIS bør ikke anvendes under graviditet.
English: Durable outcomes (Week 48 and Week 96) for patients on the recommended dose raltegravir 400 mg twice daily from the pooled studies BENCHMRK 1 and BENCHMRK 2 are shown in Table 2.
Danish: Holdbare resultater (uge 48 og uge 96) for patienter, der fik den anbefalede dosis raltegravir 400 mg to gange dagligt, fra de poolede studier BENCHMRK 1 og BENCHMRK 2, fremgår af tabel 2.
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Danish: Studier med patienter med nedsat nyrefunktion viser, at udskillelse af lamivudin påvirkes af renal dysfunktion.
English: • trimethoprim - used to treat infections.
Danish: • trimethoprim - anvendes til behandling af infektioner
English: The following data are based on findings in separate studies with the individual components of DUTREBIS (lamivudine and raltegravir).
Danish: Følgende data er baseret på fund i individuelle studier med de enkelte komponenter i DUTREBIS (lamivudin og raltegravir).
English: 156 cells/mm
Danish: 156 celler/mm
English: Efavirenz 600 mg at bedtime (N = 282)
Danish: Efavirenz 600 mg ved sengetid (N = 282)
English: DUTREBIS can cause some side effects that you need to talk to your doctor, pharmacist or nurse about.
Danish: Dutrebis kan give bivirkninger, som du skal drøfte med lægen, apotekspersonalet eller sundhedspersonalet.
English: Percent HIV-RNA < 50 copies/ml (95 % CI)
Danish: Procent hiv-RNA < 50 kopier/ml (95% CI)
English: Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Danish: Administration af cotrimoxazol sammen med lamivudin til patienter med nedsat nyrefunktion bør vurderes omhyggeligt.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Danish: Krydsresistens overført af M184V revers transkriptase er begrænset inden for nukleosidinhibitorklassen af antivirale stoffer.
English: Studies using isoform-selective chemical inhibitors and cDNA-expressed UDP-glucuronosyltransferases (UGT) show that UGT1A1 is the main enzyme responsible for the formation of raltegravir-glucuronide.
Danish: Studier med anvendelse af isoformselektive kemiske hæmmere og UDP-glucuronosyltransferaser (UGT) udtrykt via cDNA viser, at UGT1A1 er det enzym, der hovedsageligt er ansvarligt for dannelsen af raltegravir-glucuronid.
English: In clinical studies, the number of HIV patients taking raltegravir who developed cancer was similar to that of patients taking other HIV medicines.
Danish: I kliniske studier var antallet af hiv-patienter, der fik raltegravir, og som fik cancer, det samme som for patienter, der fik anden
English: In rats, tumours (squamous cell carcinoma) of the nose/nasopharynx were identified at 300 and 600 mg/kg/day in females and at 300 mg/kg/day in males.
Danish: Hos rotter blev der identificeret tumorer (planocellulært karcinom) i næsen/nasopharynx ved doser på 300 og 600 mg/kg/dag hos hunrotter og 300 mg/kg/dag hos hanrotter.
English: Raltegravir400 mg twice daily + OBT (N = 462)
Danish: Raltegravir 400 mg to gange dagligt + OBT (N = 462)
English: DUTREBIS is not recommended for use in combination with emtricitabine containing products, since both lamivudine (in DUTREBIS) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Danish: DUTREBIS bør ikke anvendes sammen med lægemidler, der indeholder emtricitabin, da både lamivudin (i DUTREBIS) og emtricitabin er cytidinanaloger (dvs der er risiko for intracellulær interaktion) (se pkt.
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Autoimmune lidelser (såsom Graves sygdom) er også set i forbindelse med immunreaktiveringen; udbrudstidspunktet er dog mere variabelt og kan være mange måneder efter initiering af behandling (se pkt.
English: As waste and fluids accumulate, other body systems are affected, potentially leading to complications
Danish: Efterhånden som affaldsstoffer og væske ophobes, bliver andre kropsfunktioner påvirket.
English: Grade 2-4 creatine kinase laboratory abnormalities were observed in subjects treated with raltegravir.
Danish: Der blev observeret abnorme laboratorieværdier for kreatinkinase, grad 2-4, hos forsøgspersoner, der blev behandlet med raltegravir.
English: High density polyethylene (HDPE) bottle with a child-resistant closure (HDPE) with foil induction seal
Danish: Højdensitetspolyethylen (HDPE) flaske med børnesikker lukning (HDPE) og folieforsegling.
English: When DUTREBIS is administered, raltegravir is absorbed with a Tmax of approximately 1 hour in the fasted state.
Danish: Ved administration af DUTREBIS absorberes raltegravir med Tmax på cirka 1 time under faste.
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Danish: Ved de højeste doser sås en mindre påvirkning af indikatorer for lever- og nyrefunktion samt af og til reduktioner af levervægt.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In Phase III studies with raltegravir, treatment-experienced patients (N = 114/699 or 16 %; HBV=6 %, HCV=9 %, HBV+HCV=1 %) and treatment-naïve patients (N = 34/563 or 6 %; HBV=4 %, HCV=2 %, HBV+HCV=0.2 %) with chronic (but not acute) active hepatitis B and/or hepatitis C co-infection were permitted to enrol provided that baseline liver function tests did not exceed 5 times the upper limit of normal.
Danish: Patienter koinficeret med hepatitis B- og/eller hepatitis C-virus Behandlingserfarne patienter (N = 114/699 eller 16%; HBV = 6%, HCV = 9%, HBV+HCV = 1%) og behandlingsnaive patienter (N = 34/563 eller 6%; HBV = 4%, HCV = 2%, HBV+HCV = 0,2%) med kronisk (men ikke akut) aktiv hepatitis B- og/eller hepatitis C-co-infektion fik adgang til at deltage i faseIII studier, forudsat at leverfunktionsprøverne ved baseline ikke oversteg 5 gange den øvre normalgrænse.
English: The signature mutations decrease viral susceptibility to raltegravir and addition of other mutations results in a further decrease in raltegravir susceptibility.
Danish: Signaturmutationerne reducerer den virale modtagelighed over for raltegravir, og tilkomst af andre mutationer medfører en yderligere reduktion af raltegravirs modtagelighed.
English: Viruses harbouring a mutation at amino acid 148, along with one or more other raltegravir resistance mutations, may also have clinically
Danish: Vira, som har en mutation ved aminosyre 148 sammen med en eller flere andre raltegravir resistensmutationer, kan også have klinisk signifikant resistens over for dolutegravir.
English: Achieved ≥1 log10 HIV RNA drop from baseline or
Danish: Opnået ≥1 log10 hiv-RNA fald ift.
English: • interferons taken with or without ribavirin - used to treat hepatitis.
Danish: • interferoner (immunstimulerende midler), som tages med eller uden ribavirin - anvendes til behandling af hepatitis.
English: Rash considered by the investigator to be drug-related occurred at similar rates.
Danish: Udslæt, som investigator anså for at være lægemiddelrelateret, forekom med samme frekvens.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Danish: Tal med lægen om, hvilke forholdsregler der er nødvendige for at undgå at
English: In the first study (n=18), the median cerebrospinal fluid concentration was 5.8 % (range 1 to 53.5 %) of the corresponding plasma concentration.
Danish: I det ene studie (n = 18) var den mediane koncentration i cerebrospinalvæsken 5,8 % (interval: 1 til 53,5 %) af den tilsvarende plasmakoncentration.
English: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis; increased levels of sugar and fats (triglycerides and cholesterol) in the blood; resistance to insulin (so if you are diabetic, you may have to change your insulin dose to control your blood sugar).
Danish: • forhøjet indhold af mælkesyre i blodet, som i sjældne tilfælde kan føre til mælkesyreforgiftning, forhøjet indhold af sukker og fedt (triglycerider og kolesterol) i blodet, resistens over for insulin (hvis du er diabetiker, skal din insulindosis måske ændres for at regulere blodsukkeret).
English: Plasma HIV-1 RNA (log10 copies/ml), mean [range]
Danish: Plasma hiv-1 RNA (log10 kopier/ml), middelværdi [interval]
English: Based on in vitro and in vivo studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway.
Danish: Baseret på in vitro- og in vivo-studier elimineres raltegravir hovedsageligt ved metabolisme via UGT1A1medieret glucuronidering.
English: Depression, including suicidal ideation and behaviours, has been reported with raltegravir, particularly in patients with a pre-existing history of depression or psychiatric illness.
Danish: Der er rapporteret om depression, herunder selvmordstanker og -adfærd, med raltegravir, især hos patienter med depression eller psykisk sygdom i anamnesen.
English: • blood test showing failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
Danish: • Blodprøver som viser, at knoglemarven ikke kan danne nye røde blodlegemer (aplasi med umodne røde blodlegemer (pure red cell aplasia eller PRCA))
English: Raltegravir 400 mg twice daily (N = 281)
Danish: Raltegravir 400 mg to gange dagligt (N = 281)
English: Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of lamivudine in plasma are 1.2 μg/ml (24 %) and 0.09 μg/ml (27 %), respectively.
Danish: Baseret på data udtrukket fra et studie af raske frivillige ved en terapeutisk dosis på 150 mg 2 gange dagligt, er middelværdien af (CV) Cmax og Cmin i plasma af lamivudin ved steady state henholdsvis 1,2 µg/ml (24 %) og 0,09 µg/ml (27 %).
English: The SWITCHMRK 1 & 2 (Protocols 032 & 033) studies evaluated HIV-infected patients receiving suppressive (screening HIV RNA < 50 copies/ml; stable regimen > 3 months) therapy with lopinavir 200 mg (+) ritonavir 50 mg 2 tablets twice daily plus at least 2 nucleoside reverse transcriptase inhibitors and randomized them 1:1 to continue lopinavir (+) ritonavir 2 tablets twice daily (n=174 and n=178, respectively) or replace lopinavir (+) ritonavir with raltegravir 400 mg twice daily (n=174 and n=176, respectively).
Danish: SWITCHMRK 1- og 2-studierne (Protokol 032 og 033) vurderede hiv-inficerede patienter, der fik suppressiv (screening hiv-RNA <50 kopier/ml; stabilt regime >3 måneder) behandling med lopinavir 200 mg (+) ritonavir 50 mg 2 tabletter to gange dagligt plus mindst 2 nukleoside revers-transkriptasehæmmere og randomiserede dem 1:1 til at fortsætte med lopinavir (+) ritonavir 2 tabletter to gange dagligt (n = henholdsvis 174 og 178) eller erstatte lopinavir (+) ritonavir med raltegravir 400 mg to gange dagligt (n = henholdsvis 174 og 176).
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Danish: Tidlige symptomer (symptomatisk hyperlaktatæmi) omfatter godartede fordøjelsessymptomer (kvalme, opkastning og mavesmerter), uspecifik utilpashed, manglende appetit, vægttab, luftvejssymptomer (hurtig og/eller dyb vejrtrækning) eller neurologiske symptomer (herunder motorisk svækkelse).
English: Thus the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.
Danish: Data indikerer således, at raltegravirs væsentligste clearance-mekanisme hos mennesker er UGT1A1-medieret
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Danish: Frekvensen af udslæt (af alle årsager), justeret i forhold til eksponering, var henholdsvis 10,9; 4,2 og 3,8 pr. 100 patientår; og for lægemiddelrelateret udslæt var den henholdsvis 2,4; 1,1 og 2,3 pr. 100 patientår.
English: Tell your doctor if you notice any of the following signs of osteonecrosis:
Danish: Fortæl det straks til lægen, hvis du bemærker tegn på osteonekrose:
English: In clinical studies, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral load and increase CD4 cell count.
Danish: Kliniske studier har vist, at lamivudin i kombination med zidovudin kan reducere hiv-1-virusbelastningen samt øge CD4-celletallet.
English: Interactions between the components of DUTREBIS and co-administered medicinal products are listed
Danish: Interaktioner mellem komponenterne i DUTREBIS og samtidigt administrerede lægemidler er oplistet i
English: Co-administration of DUTREBIS with high doses of co-trimoxazole for the treatment of Pneumocystis carinii pneumonia (PCP) and toxoplasmosis should be avoided.
Danish: Samtidig administration af DUTREBIS og høje doser af co-trimoxazol til behandling af pneumoni forårsaget af pneumocystis carinii og toksoplasmose frarådes.
English: Considerable inter- and intra-individual variability was observed in the pharmacokinetics of raltegravir.
Danish: Der er observeret betydelig inter- og intra-individuel variabilitet i raltegravirs farmakokinetik.
English: Tell your doctor, pharmacist or nurse immediately if you notice any symptoms of infection or other symptoms such as:
Danish: Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker symptomer på infektion eller andre symptomer, såsom:
English: Of the 126 patients, 96 received the recommended dose of
Danish: Af de 126 patienter fik 96 den anbefalede dosis raltegravir.
English: DUTREBIS is an antiretroviral medicine used to treat infection with human immunodeficiency virus (HIV).
Danish: Dutrebis er et antiretroviralt lægemiddel, der anvendes til behandling af infektion med humant immundefekt-virus (hiv).
English: Dosing in children less than 6 years of age and those weighting less than 30 kg requires weight based dose adjustments for the individual components of DUTREBIS.
Danish: Dosering til børn, der er under 6 år eller vejer under 30 kg, kræver vægtbaseret dosisjustering af de enkelte komponenter i DUTREBIS.
English: It is important that you take DUTREBIS exactly as your doctor has instructed.
Danish: Hvis du holder op med at tage Dutrebis Det er vigtigt, at du tager Dutrebis nøjagtigt, som din læge har anvist.