FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rarely cases of erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Danish: Der er meget sjældne rapporter om erythema multiforme, Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse, hvor overfølsomhed over for abacavir ikke kunne udelukkes.
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i variende grad, hvilket er mest udtalt for stavudin, didanosin og zidovudin.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir (a component of Triumeq) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Danish: Foreløbige data fra et overvågningsstudie peger på øget forekomst af neuralrørsdefekter (0,9 %) hos mødre, der eksponeres for dolutegravir (et af indholdsstofferne i Triumeq) på undfangelsestidspunktet, sammenholdt med mødre, der eksponeres for regimer, som ikke indeholder dolutegravir (0,1 %).
English: Dolutegravir has a <10-fold change against 94% of the 705 clinical isolates.
Danish: Dolutegravir har en FC på < 10 mod 94 % af de 705 kliniske isolater.
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Danish: Klinisk status, herunder niveauet af leveraminotransferaser og bilirubin, bør overvåges.
English: Triumeq is not recommended for use in combination with emtricitabine containing products, since both lamivudine (in Triumeq) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4))
Danish: Det anbefales ikke at anvende Triumeq i kombination med produkter, der indeholder emtricitabin, da både lamivudin (i Triumeq) og emtricitabin er cytidinanaloger (dvs. der er en risiko for intracellulære interaktioner, (se pkt.
English: The analyses included two randomized, international, double-blind, activecontrolled trials, SINGLE (ING114467) and SPRING-2 (ING113086), the international, open-label, active-controlled trial FLAMINGO (ING114915), and the randomized, open-label, active-controlled, multicentre, non-inferiority study ARIA (ING117172).
Danish: Analyserne inkluderede to randomiserede, internationale, dobbeltblinde studier med aktiv kontrol, SINGLE (ING114467) og SPRING-2 (ING113086), det internationale åbne studie med aktiv kontrol FLAMINGO (ING114915) og det randomiserede, åbne, non-inferiore multicenter studie med aktiv kontrol ARIA (ING117172).
English: In patients with prior failed therapies, but naïve to the integrase class (SAILING study), integrase inhibitor substitutions were observed in 4/354 patients (follow-up 48 weeks) treated with dolutegravir, which was given in combination with an investigator selected background regimen (BR).
Danish: Hos patienter med tidligere behandlingssvigt, men som var naïve over for integraseklassen (SAILING-studiet), blev der observeret integrasehæmmer-substitutioner hos 4 ud af 354 patienter (opfølgning på 48 uger), som blev behandlet med dolutegravir kombineret med et af investigator udvalgt baggrundsregime (BR).
English: M184V is associated with about a 2-fold increase in abacavir resistance but does not confer clinical resistance for abacavir.
Danish: M184V er forbundet med en omtrent fordobling af resistensen over for abacavir, men medfører ikke klinisk resistens over for abacavir.
English: Your doctor may decide to adjust your dose or that you need extra checkups.
Danish: Lægen vil beslutte, om din dosis skal ændres, eller om du har brug for flere konsultationer.
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Danish: M184V-mutanter har markant nedsat følsomhed over for lamivudin og udviser mindsket viral replikationskapacitet in vitro.
English: The most common symptoms are: fever (high temperature) and skin rash.
Danish: De almindeligste symptomer er: feber (høj kropstemperatur) og udslæt.
English: When using the lab-strain HIVIII during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F. These mutations were not selected in patients treated with dolutegravir in the clinical studies.
Danish: Når laboratoriestammen HIVIII blev brugt, viste de selekterede mutationer sig langsomt under passage over 112 dage, med substitutioner på position S153Y og F. Disse mutationer blev ikke selekteret hos patienter, der blev behandlet med dolutegravir i de kliniske studier.
English: • an increase in triglycerides (type of fat) in the blood
Danish: • øget niveau af triglycerider (en type fedt) i blodet.
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Danish: Baseret på manglende effekt på in vivo-farmakokinetikken af OAT-substratet tenofovir er in vivohæmning af OAT1 usandsynlig.
English: § Includes reasons such as protocol deviation, lost to follow up, and withdrew consent.
Danish: § Omfatter årsager som f.eks. afvigelse fra protokollen, tabt for opfølgning, tilbagetrækning af samtykke.
English: Don't take other medicines for the infection without your doctor's advice.
Danish: Tag ikke andre lægemidler mod infektionen medmindre lægen har foreskrevet det.
English: The absorption of dolutegravir is reduced by certain anti-acid medicinal products (see Table 1).
Danish: Absorptionen af dolutegravir reduceres af visse syreneutraliserende lægemidler (se tabel 1).
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Danish: Renal clearance af uomdannet aktivt stof er en mindre eliminationsvej for dolutegravir.
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose.
Danish: Farmakokinetikken af abacavir er blevet undersøgt hos patienter med let nedsat leverfunktion (Child-Pugh-score 5-6), der fik en enkelt dosis på 600 mg.
English: IMPORTANT - PATIENT ALERT CARD Triumeq (dolutegravir / abacavir / lamivudine) tablets Carry this card with you at all times
Danish: VIGTIGT - PATIENTOPLYSNINGSKORT Triumeq (dolutegravir/abacavir/lamivudin)-tabletter Hav altid dette kort med dig
English: While the total dolutegravir concentration in plasma was similar, a 1.5 to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Danish: Mens den totale koncentration af dolutegravir i plasma var tilsvarende, blev en 1,5-2-gange øgning i ubundet eksponering for dolutegravir observeret hos patienter med moderat nedsat leverfunktion sammenlignet med raske kontroller.
English: In vitro, abacavir was an inhibitor of MATE1; the clinical consequences are not known.
Danish: In vitro var abacavir en hæmmer af MATE1; de kliniske konsekvenser er ikke kendt.
English: Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
Danish: Data fra kliniske studier viste et begrænset antal tilfælde af myokardieinfarkt, og der kunne ikke afvises en let forøget risiko.
English: Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Danish: 32 % af den samlede orale dosis udskilles i urinen og består af et etherglucuronid af dolutegravir (18,9 % af den samlede dosis), en metabolit, der er dannet ved N-dealkylering (3,6 % af den samlede dosis), og en metabolit, der er dannet ved oxidation ved det benzyliske carbon (3,0 % af den samlede dosis).
English: Hypersensitivity reaction observed for each of these medicinal products (described below) share some common features such as fever and/or rash with other symptoms indicating multi-organ involvement.
Danish: Overfølsomhedsreaktioner observeret for hvert af disse lægemidler (beskrevet nedenfor), har nogle fælles træk, f.eks. feber og/eller udslæt med andre symptomer, som indikerer, at flere organsystemer er involveret.
English: Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.
Danish: Dolutegravir kan muligvis øge plasmakoncentrationen af lægemidler, hvis udskillelse er afhængig af OAT3.
English: Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
Danish: In vitro-studier af plasmaproteinbinding indikerer, at abacavir kun i begrænset til moderat omfang (~ 49 %) bindes til humane plasmaproteiner ved terapeutiske koncentrationer.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies.
Danish: Lamivudin var ikke genotoksisk i studierne udført in vivo.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, bisphosphonates, 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 (herunder kortikosteroidforbrug, bisphosphonater, alkoholforbrug, svær immunosuppression, højere BMI), er der rapporteret tilfælde af osteonekrose, særligt hos patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for CART.
English: Before you are prescribed Triumeq your doctor will arrange a test to find out whether you carry a particular type of gene called HLA-B*5701.
Danish: Før du får ordineret Triumeq, vil lægen foretage en test for at finde ud af, om du har en bestemt type gen, der kaldes HLA-B*5701.
English: • trimethoprim/sulfamethoxazole, an antibiotic to treat bacterial infections
Danish: • trimethoprim/sulfamethoxazol, et antibiotikum til behandling af bakterieinfektioner.
English: As hepatic elimination plays a minor role in the clearance of lamivudine, drug interactions due to inhibition of OCT1 are unlikely to be of clinical significance.
Danish: Da hepatisk eliminering spiller en mindre rolle i clearance af lamivudin, er det usandsynligt, at lægemiddelinteraktioner på grund af hæmning af OCT1 vil have en klinisk betydning.
English: You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you don't have this gene).
Danish: Du har større risiko for at få sådan en overfølsomhedsreaktion, hvis du har et gen, som kaldes HLAB*5701 (men du kan også få en reaktion, selvom du ikke har dette gen).
English: Dolutegravir, abacavir and lamivudine are present in cerebrospinal fluid (CSF).
Danish: Dolutegravir, abacavir og lamivudin er til stede i cerebrospinalvæsken (CSF).
English: Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction.
Danish: Generelt viser tilgængelige data fra kohortestudier og randomiserede studier uoverensstemmelser; således kan der hverken be- eller afkræftes en årsagssammenhæng mellem abacavirbehandling og risiko for myokardieinfarkt.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Danish: Der er ingen tegn på, at almindelige polymorfismer i lægemiddelmetaboliserende enzymer ændrer dolutegravirs farmakokinetik i klinisk betydningsfuldt omfang.
English: Dolutegravir is eliminated mainly through metabolism by uridine diphosphate glucuronosyl transferase (UGT) 1A1.
Danish: Dolutegravir elimineres overvejende gennem metabolisering via uridindiphosphatglucuronosyltransferase (UGT) 1A1.
English: The median time to viral suppression was shorter with ABC/3TC + DTG (28 vs 84 days, p<0.0001).
Danish: Mediantiden til viral suppression var kortere med ABC/3TC + DTG (28 vs. 84 dage, p < 0,0001).
English: • other medicines containing lamivudine, used to treat HIV infection or hepatitis B infection
Danish: • andre lægemidler, der indeholder lamivudin til behandling af hiv-infektion eller hepatitis Binfektion.
English: Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Danish: Symptomerne fremkom sædvanligvis inden for de første 6 uger (gennemsnitligt 11 dage til symptomdebut) efter start af behandlingen med abacavir, skønt reaktionerne kan opstå på et hvilket som helst tidspunkt under behandlingen.
English: These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births.
Danish: Disse fund omfattede nedsat fostervægt, føtale ødemer og et øget antal skeletale variationer/misdannelser, tidlige intrauterine dødsfald og dødfødsler.
English: • presence of skin rash; OR
Danish: • Forekomst af hududslæt, ELLER
English: Manufacturer Glaxo Wellcome, S.A., Avda.
Danish: Fremstiller Glaxo Wellcome, S.A., Avda.
English: Cross-resistance between dolutegravir or abacavir or lamivudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Danish: Krydsresistens mellem dolutegravir eller abacavir eller lamivudin og antriretrovirale lægemidler fra andre klasser, f.eks. PI'er eller NNRTI'er, er usandsynlig.
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Danish: Gruppe O-isolater fra ART-naïve patienter testet for lamivudin-aktivitet var meget følsomme.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Danish: Dolutegravir hæmmer hiv-integrase ved at binde sig til det aktive sted på integrase og blokere strand transfer-trinnet i integrationen af retroviral deoxyribonukleinsyre (DNA), hvilket er essentielt for hiv's replikationscyklus.
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Danish: Når mutationer anført som sekundære integrasehæmmer-relaterede mutationer (for raltegravir/elvitegravir) lægges til primære mutationer (bortset fra ved Q148) i eksperimenter med stedspecifikke mutanter, forbliver følsomheden over for dolutegravir på eller nær vildtype-niveau.
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Danish: AUC i cervicovaginal væske, cervikalt væv og vaginalt væv var 6-10 % af tilsvarende AUC-værdier i plasma ved steady state.
English: There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over.
Danish: Der er en begrænset mængde data tilgængelig om anvendelse af dolutegravir, abacavir og lamivudin hos patienter på 65 år og derover.
English: Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Danish: De tegn og symptomer, der er rapporteret hos mindst 10 % af patienterne med en overfølsomhedsreaktion, er skrevet med fed skrift.
English: No dose adjustment of oral contraceptives is necessary when co-administered with Triumeq.
Danish: Det er ikke nødvendigt at justere dosis af orale kontraceptiva, når de administreres samtidigt med Triumeq.
English: Based on limited available data with the dolutegravir single entity used in combination with other antiretroviral agents to treat adolescents (12 to 17 years), there were no additional types of adverse reactions beyond those observed in the adult population.
Danish: På baggrund af en begrænset mængde data på enkeltkomponenten dolutegravir anvendt i kombination med andre antiretrovirale lægemidler til behandling af unge (12-17 år) sås ingen yderligere bivirkninger ud over dem, der blev set hos den voksne population.
English: Nucleoside reverse transcriptase inhibitors (NRTIs) Tenofovir
Danish: Nukleosid revers transskriptase-hæmmere (NRTI'er) Tenofovir
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Danish: Baseret på mere end 200 mod/barn-par behandlet for hiv er serumkoncentrationen af lamivudin hos ammede børn, hvis mor er behandlet for hiv, meget lav (< 4 % af moderens serumkoncentration) og falder til et ikke-detekterbart niveau når det ammede barn når en alder på 24 uger.
English: Hypersensitivity reactions have been reported in <1% of patients treated with dolutegravir in clinical studies, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Danish: Overfølsomhedsreaktioner er set i <1 % af patienter behandlet med dolutegravir i kliniske studier og var ofte karakteriseret som udslæt, konstitutionelle fund, og sommetider påvirkning af organer, heriblandt alvorlige leverreaktioner.
English: R263K was reported from two individual patients with subtype B and subtype C in the clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
Danish: R263K blev rapporteret fra to individuelle ART-erfarne, INI-naïve patienter med undertyper B og C i det kliniske program, men uden effekt på følsomheden over for dolutegravir in vitro.
English: Arthralgia1, muscle disorders1(including myalgia1)
Danish: Artralgi1, muskelforstyrrelser1(inklusive myalgi1)
English: Clinically significant interaction unlikely.
Danish: Der forventes ingen klinisk signifikant interaktion.
English: Dolutegravir is primarily metabolized via UGT1A1 with a minor CYP3A component (9.7% of total dose administered in a human mass balance study).
Danish: Dolutegravir metaboliseres primært ved glucuronidering via UGT1A1 og i mindre grad via CYP3A (9,7 % af den samlede dosis, der blev administreret i et massebalance-studie hos mennesker).
English: Lamivudine is also substrate of the hepatic uptake transporter OCT1.
Danish: Lamivudin er også substrat for den hepatiske optagstransportør OCT1.
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Triumeq if:
Danish: KONTAKT LÆGEN OMGÅENDE for at få at vide, om du skal stoppe med at tage Triumeq, hvis:
English: Co-administration with nevirapine may decrease dolutegravir plasma concentration due to enzyme induction and has not been studied.
Danish: Administration samtidigt med nevirapin kan muligvis reducere plasmakoncentrationen af dolutegravir på grund af enzyminduktion og er ikke blevet undersøgt.
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160mg/800mg once daily for 5 days/300mg single dose)
Danish: Trimethoprim/sulfamethoxazol (Co-trimoxazol)/lamivudin (160 mg/800 mg én gang daglig i 5 dage/300 mg enkeltdosis)
English: Virologic non response† No virologic data at Weeks 48 window
Danish: Virologisk non-respons† Ingen virologiske data i analysevinduet omkring uge 48
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INTERMEDIÆRE EMBALLAGE INTERMEDIÆR ÆSKE (UDEN BLÅ BOKS - DEL AF MULTIPAKNING)
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 18.
English: Triumeq is used to treat HIV (human immunodeficiency virus) infection in adults and children over 12 years old who weigh at least 40 kg.
Danish: Triumeq anvendes til behandling af hiv (humant immundefektvirus)-infektion hos voksne og børn over 12 år, der vejer mindst 40 kg.
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Danish: Antiretrovirale lægemidler Non-nukleosid revers transskriptase-hæmmere Etravirin uden boostede proteasehæmmere /dolutegravir
English: Lamivudine-TP (an analogue for cytidine) and carbovir-TP (the active triphosphate form of abacavir, an analogue for guanosine) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Danish: Lamivudin-TP (en cytidinanalog) og carbovir-TP (den aktive triphosphatform af abacavir, en guanosinanalog) er substrater for og kompetitive hæmmere af hiv-revers transskriptase (RT).
English: Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.
Danish: Screening anbefales også før re-initiering af abacavir hos patienter med ukendt HLA-B*5701-status, som tidligere har tolereret abacavir.
English: Anti-infective products Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
Danish: Lægemidler mod infektioner Trimethoprim/sulfamethoxazol (Co-trimoxazol)/abacavir
English: Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Danish: Samlet set svarede sikkerhedsprofilen hos patienter, der var co-inficeret med hepatitis B- og/eller C-virus, til den sikkerhedsprofil, der blev observeret hos patienter uden co-infektion med hepatitis B- eller C-virus, selvom raterne af ASAT- og ALATabnormaliteter var højere i undergruppen med co-infektion med hepatitis B- og/eller C-virus for alle behandlingsgrupper.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. metformin) (see Table 1).
Danish: In vivo kan dolutegravir øge plasmakoncentrationen af lægemidler, for hvilke udskillelsen afhænger af OCT2 eller MATE-1 (f.eks. metformin) (se tabel 1).
English: Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
Danish: I meget sjældne tilfælde har patienter, som tidligere er blevet behandlet med lægemidler indeholdende abacavir uden symptomer på overfølsomhed, udviklet overfølsomhedsreaktioner, når de begynder at tage disse lægemidler igen.
English: If you have discontinued Triumeq due to this reaction, YOU MUST NEVER TAKE Triumeq, or any medicine containing abacavir again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Danish: Hvis du er stoppet med Triumeq på grund af en sådan reaktion, MÅ DU ALDRIG TAGE Triumeq eller andre lægemidler indeholdende abacavir igen, da du inden for få timer kan risikere et livstruende fald i blodtrykket eller død.
English: Active renal secretion of lamivudine in the urine is mediated through the organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Danish: Aktiv renal udskillelse af lamivudin via urinen medieres af den organiske kation transporter (OCT) 2 og multilægemiddel og toksin ekstrudering transportere (MATE1 og MATE2-K).
English: Dolutegravir increased metformin concentrations.
Danish: Dolutegravir øger koncentrationen af metformin.
English: Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase
Danish: Sjældne bivirkninger, der kan ses i blodprøver, er: • øget niveau af et enzym, der kaldes amylase.