FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity reactions have been observed more commonly with abacavir, some of which have been life-threatening, and in rare cases fatal, when not managed appropriately.
Danish: Der er hyppigere set overfølsomhedsreaktioner over for abacavir, hvoraf nogle har været livstruende, og i sjældne tilfælde dødelige, når de ikke er blevet håndteret hensigtsmæssigt.
English: • if you are allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for dolutegravir, abacavir (eller anden medicin, der indeholder abacavir), lamivudin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Danish: Deres centrale antivirale aktivitet sker imidlertid ved inkorporering af monophosphatformen i den virale DNA-kæde, hvilket resulterer i en kædetermination.
English: Time to onset was typically 10-14 days for both abacavir and dolutegravir-associated reactions, although reactions to abacavir may occur at any time during therapy.
Danish: Tiden til debut var typisk 10-14 dage for både abacavir- og dolutegravir-relaterede reaktioner, selvom reaktioner på abacavir kan opstå på et hvilket som helst tidspunkt under behandlingen.
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Danish: Denne kombination kan øge risikoen for laktacidose hos patienter med moderat nedsat nyrefunktion (stadie 3a kreatininclearence [CrCl] 45-59 ml/min), og forsigtighed anbefales.
English: Similar levels of virologic suppression were maintained in both the Early and Late Switch groups at 48 weeks.
Danish: Sammenlignelige niveauer af virologisk suppression blev opretholdt hos gruppen med tidligt og gruppen med sent skift ved 48 uger.
English: Abacavir and lamivudine are potent selective inhibitors of HIV-1 and HIV-2.
Danish: Abacavir og lamivudin er potente selektive hæmmere af hiv-1 og hiv-2.
English: → Talk to your doctor about the risks and benefits of taking Triumeq.
Danish: → Tal med lægen om risici og fordele ved at tage Triumeq.
English: The clinical status of the patient and the adverse reaction profile of Triumeq should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Der skal tages hensyn til patientens kliniske status og Triumeqs bivirkningsprofil ved vurdering af patientens evne til at føre motorkøretøjer og betjene maskiner.
English: People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med fremskreden hiv-infektion eller AIDS har et svækket immunforsvar og har større risiko for at udvikle alvorlige infektioner (opportunistiske infektioner).
English: Therapy should be prescribed by a physician experienced in the management of HIV infection.
Danish: Behandlingen skal ordineres af en læge med erfaring i behandling af hiv-infektion.
English: If your doctor advises that you can start taking Triumeq again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Danish: Hvis lægen vurderer, at du kan begynde at tage Triumeq igen, bliver du muligvis bedt om at tage de første doser på et sted, hvor du hurtigt kan få lægehjælp, hvis det skulle blive nødvendigt.
English: rhabdomyolysis1
Danish: Rhabdomyolyse1
English: Children and adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.
Danish: Børn og unge i alderen mellem 12 og 17 år, som vejer mindst 40 kg, kan tage den samme dosis som voksne på 1 tablet én gang daglig.
English: These mutations have been selected in patients with pre-existing raltegravir resistance and who were then treated with dolutegravir (listed as secondary mutations for dolutegravir).
Danish: Disse mutationer blev selekteret hos patienter med præeksisterende raltegravir-resistens, som efterfølgende blev behandlet med dolutegravir (anført som en sekundær mutation for dolutegravir).
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Danish: De primære metaboliseringsveje hos mennesker er ved hjælp af alkoholdehydrogenase og glucuronidering til dannelse af 5′-carboxylsyre og 5′-glucuronid, som udgør ca. 66 % af den administrerede dosis.
English: Some people taking Triumeq or other combination treatments for HIV are more at risk of serious side effects than others.
Danish: Nogle personer, der tager Triumeq eller andre kombinationsbehandlinger mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Danish: Særlig forsigtighed er tilrådet hos denne aldersgruppe på grund af aldersrelaterede ændringer som nedsat nyrefunktion og ændring af hæmatologiske parametre.
English: Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high tested concentrations.
Danish: Abacavir har et svagt potentiale til at forårsage kromosomskader både in vitro og in vivo ved høje testkoncentrationer.
English: Dolutegravir has not been studied in patients on dialysis, though differences in exposure are not expected.
Danish: Dolutegravir er ikke blevet undersøgt hos patienter i dialysebehandling, men forskel i eksponering forventes ikke.
English: Uncommon side effects that may show up in blood tests are:
Danish: Ikke almindelige bivirkninger, der kan ses i blodprøver, er:
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Danish: Det vides ikke, om alt eller dele af dette skyldes ikke-absorberet aktivt stof eller biliær udskillelse af glucuronidkonjugatet, som kan blive yderligere nedbrudt til moderforbindelsen i tarmlumen.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Triumeq without your doctor's advice, as your hepatitis may come back)
Danish: • hvis du tidligere har haft en leversygdom, herunder hepatitis B eller C (hvis du har hepatitis B, må du ikke stoppe med at tage Triumeq uden at tale med lægen først, da det kan få din hepatitis til at blusse op igen)
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Danish: • rifampicin til behandling af tuberkulose (TB) og andre bakterieinfektioner.
English: Triumeq is recommended to be administered 2 hours before or 6 hours after these medicinal products (see section
Danish: Det anbefales at administrere Triumeq 2 timer før eller 6 timer efter disse lægemidler (se pkt.
English: erythema multiform1, Stevens-Johnson syndrome1, toxic epidermal necrolysis1
Danish: Erythema multiforme1, Stevens-Johnsons syndrom1, toksisk epidermal nekrolyse1
English: The adjusted difference in proportion and 95% CI [ABC/DTG/3TC vs current ART] were 3.4%; 95% CI: [-9.1, 2.4].
Danish: Den justerede forskel i andel og 95 % CI [ABC/DTG/3TC vs aktuelle ART] var 3,4 %; 95 % CI: [-9,1, 2,4].
English: Write your doctor's details below: Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Danish: Læge: .......................…………………… Tlf.: ...................………… Hvis lægen ikke træffes, skal du hurtigst muligt søge anden lægehjælp (f.eks. skadestuen på det nærmeste hospital).
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er ca. 0.32 l/t/kg, hovedsageligt ved renal clearance (> 70 %) via systemet til transport af organiske kationer.
English: Metabolism of lamivudine is a minor route of elimination.
Danish: Metabolisering af lamivudin er en mindre betydelig eliminationvej.
English: Your doctor may advise you to stop taking Triumeq.
Danish: Lægen vil muligvis råde dig til at stoppe med at tage Triumeq.
English: Other medicines and Triumeq Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Triumeq Fortæl lægen, hvis du tager, for nylig har taget eller vil tage andre lægemidler.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Danish: • lægemidler (oftest opløsninger), der indeholder sorbitol eller andre sukkeralkoholer (som f.eks. xylitol, mannitol, lactitol eller maltitol), hvis de anvendes regelmæssigt
English: No relevant effects were seen on the QTc interval, with doses of dolutegravir exceeding the clinical dose by approximately 3-fold.
Danish: Der blev ikke set nogen relevante effekter på QTc-intervallet med doser af dolutegravir, som var ca. 3 gange den kliniske dosis.
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
Danish: Hos tidligere ubehandlede patienter, som fik dolutegravir + 2 NRTI'er i fase IIb og fase III, blev der ikke set udvikling af resistens over for integraseklassen eller over for NRTI-klassen (n = 876, opfølgning på 48-96 uger).
English: Continued passage in increasing concentrations of drug resulted in selection for double RT mutants 65R/184V and 74V/184V or triple RT mutant 74V/115Y/184V.
Danish: Fortsat passage med stigende lægemiddelkoncentrationer resulterede i selektion for dobbelt-RT-mutanterne 65R/184V og 74V/184V eller tripel-RT-mutanten 74V/115Y/184V.
English: Notes: DTG = dolutegravir, RAL = raltegravir.
Danish: DTG = dolutegravir, RAL = raltegravir.
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Danish: Meget sjældne bivirkninger, der kan ses i blodprøver, er: • manglende dannelse af nye røde blodceller i knoglemarven (pure red cell aplasia).
English: If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis den næste dosis skal tages inden for 4 timer, bør patienten ikke tage den glemte dosis, men blot genoptage den sædvanlige doseringsplan.
English: Dolutegravir, abacavir and lamivudine are rapidly absorbed following oral administration.
Danish: Dolutegravir, abacavir og lamivudin absorberes hurtigt efter oral administration.
English: Abacavir can cause a hypersensitivity reaction (a serious allergic reaction), especially in people who carry a particular type of gene called HLA-B*5701.
Danish: Abacavir kan forårsage en overfølsomhedsreaktion (en alvorlig allergisk reakion), især hos personer, der bærer en bestemt type gen, der kaldes HLA-B*5701.
English: When you're being treated for HIV, it can be hard to tell whether a symptom is a side effect of Triumeq or other medicines you are taking, or an effect of the HIV disease itself.
Danish: Når du bliver behandlet mod hiv-infektion, kan det være svært at afgøre, om et symptom er en bivirkning ved Triumeq eller andre lægemidler, som du tager, eller om symptomet skyldes selve hivsygdommen.
English: In addition, ribavirin had no apparent effect on dolutegravir activity.
Danish: Derudover havde ribavirin ingen umiddelbar virkning på aktiviteten af dolutegravir.
English: Exposure to dolutegravir was generally similar between healthy subjects and HIV-1-infected subjects.
Danish: Eksponeringen for dolutegravir var generelt af samme størrelsesorden hos raske personer og hiv-1inficerede personer.
English: Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high.
Danish: Monoterapi med lamivudin anses generelt ikke som værende tilstrækkelig behandling mod hepatitis B, da risikoen for, at hepatitis B-virus udvikler resistens, er høj.
English: Patients with this gene are at a high risk of developing a serious hypersensitivity (allergic) reaction if they use Triumeq (see ‘hypersensitivity reactions' in section 4).
Danish: Patienter med dette gen har en høj risiko for at udvikle en alvorlig overfølsomhedsreaktion (allergisk reaktion), hvis de får Triumeq (se 'Overfølsomhedsreaktioner' under punkt 4).
English: • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
Danish: • selvmordstanker eller selvmordsadfærd (særligt hos patienter, som tidligere har haft depression eller psykiske problemer).
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44%.
Danish: I studier med abacavir er der påvist et fordelingsforhold mellem AUC i CSF og plasma på mellem 30 % og 44 %.
English: There are no clinical study data on the effects of Triumeq in the paediatric population.
Danish: Der foreligger ingen data fra kliniske studier vedrørende effekterne af Triumeq hos den pædiatriske population.
English: Missing data during window but on study
Danish: Manglende data inden for analysevinduet, men fortsat med i studiet
English: Resistance in vivo: (dolutegravir)
Danish: Resistens in vivo: (dolutegravir)
English: Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Danish: Primære mutationer for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q og T66I) påvirker ikke følsomheden over for dolutegravir in vitro som enkeltvise mutationer.
English: The effect of the Q148-based mutations (H/R/K) was also consistent with in vitro passage experiments with site directed mutants.
Danish: Effekten af de Q148-baserede mutationer (H/R/K) var også i overensstemmelse med effekten i passage-eksperimenter in vitro med stedspecifikke mutanter.
English: Importantly, such symptoms may lead to misdiagnosis of HSR as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
Danish: Vigtigt er det, at sådanne symptomer kan føre til fejldiagnosticering af overfølsomhed som respiratorisk sygdom (pneumoni, bronkitis, pharyngitis) eller gastroenteritis.
English: INFORMATION IN BRAILLE triumeq
Danish: INFORMATION I BRAILLESKRIFT triumeq
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than
Danish: • udbredt udslæt med blæredannelse og hudafskalning, særligt omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnsons syndrom) og i alvorlige tilfælde med hudafskalning på mere end
English: HIV-1 resistance to lamivudine involves the development of a M184I or M184V amino acid change close to the active site of the viral RT.
Danish: Hiv-1-resistens over for lamivudin involverer udviklingen af en M184I eller M184V aminosyreændring tæt ved den aktive del af viral RT.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Osteonekrose Der er rapporteret tilfælde af osteonekrose, særligt hos patienter med kendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for CART.
English: De novo resistance was not detected to the integrase class or the NRTI class in any patients who were treated with dolutegravir + abacavir/lamivudine in the three studies mentioned.
Danish: Der blev ikke set de novo-resistens over for integraseklassen eller NRTI-klassen hos nogen af de patienter, der blev behandlet med dolutegravir + abacavir/lamivudin i de tre nævnte studier.
English: Metformin is eliminated renally and therefore it is of importance to monitor renal function when co-treated with dolutegravir.
Danish: Metformin elimineres renalt, og det er derfor vigtigt at monitorere nyrefunktionen ved administration sammen med dolutegravir.
English: Medicinal products that induce those enzymes or transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Danish: Lægemidler, der inducerer disse enzymer eller transportere, kan reducere plasmakoncentrationen af dolutegravir og reducere den terapeutiske effekt af dolutegravir (se tabel 1).
English: If you could get pregnant while receiving Triumeq, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Danish: Hvis du kan blive gravid, mens du får Triumeq, skal du bruge sikker prævention i form af en barrieremetode (f.eks. kondom) sammen med en anden præventionsmetode, herunder p-piller eller andre hormonelle præventionsmidler (fx implantat, injektion) for at undgå graviditet.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Danish: Den observerede halveringstid af lamivudin er 5-7 timer.
English: Some medicines can affect how Triumeq works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af Triumeq eller gøre det mere sandsynligt, at du får bivirkninger.
English: If Triumeq is used in patients co-infected with hepatitis B an additional antiviral is, therefore, generally needed.
Danish: Hvis Triumeq anvendes hos patienter, der er co-inficeret med hepatitis B-virus, er der derfor generelt behov for yderligere antiviral behandling.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Afriv vedlagte oplysningskort, det indeholder vigtige oplysninger om sikkerheden.
English: These results indicate that Triumeq can be taken with or without food.
Danish: Disse resultater indikerer, at Triumeq kan tages sammen med eller uden mad.
English: • lack of energy (fatigue)
Danish: • manglende energi (træthed).
English: Anyone taking Triumeq could develop a hypersensitivity reaction, which could be life threatening if they continue to take Triumeq.
Danish: Alle, der tager Triumeq, kan få en overfølsomhedsreaktion, der kan være livstruende, hvis de fortsætter med at tage Triumeq.
English: • emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
Danish: • emtricitabin, etravirin, efavirenz, nevirapin eller tipranavir/ritonavir til behandling af hivinfektion.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was 16 to 19 hours.
Danish: Hos patienter, der fik 300 mg lamivudin én gang daglig, var den terminale intracellulære halveringstid af lamivudin-TP 16-19 timer.
English: Trimethoprim (an inhibitor of these drug transporters) has been shown to increase lamivudine plasma concentrations, however the resulting increase was not clinically significant (see Table 1).
Danish: Trimethoprim (en hæmmer af disse lægemiddelstoftransportører) har vist sig at øge plasmakoncentrationen af lamivudin; den resulterende forøgelse var imidlertid ikke klinisk signifikant (se tabel 1).
English: Resistance in vitro and in vivo: (abacavir and lamivudine) Abacavir-resistant isolates of HIV-1 have been selected in vitro and in vivo and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Danish: Resistens in vitro og in vivo (abacavir og lamivudin): Abacavir-resistente isolater af hiv-1 er blevet selekteret in vitro og in vivo og er forbundet med specifikke genotypiske ændringer i RT-codonregionen (codon M184V, K65R, L74V og Y115F).
English: anorexia1
Danish: Anoreksi1
English: Abacavir and lamivudine may inhibit cellular DNA replication and abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Danish: Abacavir og lamivudin kan hæmme cellulær DNA-replikation, og abacavir har vist sig at være karcinogent i dyremodeller (se pkt.5.3).
English: If ABC hypersensitivity cannot be ruled out on clinical grounds, ABC should be permanently discontinued and should not be restarted, regardless of the results of HLA-B*5701 screening.
Danish: Hvis ABC-overfølsomhed ikke kan udelukkes på klinisk grundlag, skal ABC seponeres permanent og ikke genstartes, uanset resultatet af HLA-B*5701-screening.
English: Similar studies were not conducted with either abacavir or lamivudine.
Danish: Der blev ikke udført lignende undersøgelser med hverken abacavir eller lamivudin.
English: Other key symptoms include gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise.
Danish: Andre kendetegnende symptomer omfatter gastrointestinale, respiratoriske eller konstitutionelle symptomer som svær udmatning og utilpashed.
English: Dolutegravir had no Pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Danish: Dolutegravir havde ingen farmakodynamisk virkning på luteiniseringshormon (LH), follikelstimulerende hormon (FSH) og progesteron.
English: The effect of a high fat meal on the Triumeq tablet was evaluated in a subgroup of subjects in this study (n=12).
Danish: Effekten af et måltid med højt fedtindhold på biotilgængeligheden af Triumeq-tabletten blev vurderet hos en undergruppe af personerne i dette studie (n = 12).
English: Since Triumeq contains abacavir some patients taking Triumeq may develop a hypersensitivity reaction (serious allergic reaction).
Danish: Da Triumeq indeholder abacavir, kan nogle patienter, der tager Triumeq, udvikle en overfølsomhedsreaktion (alvorlig allergisk reaktion).
English: Isolates resistant to abacavir may also show reduced sensitivity to lamivudine.
Danish: Isolater, der er resistente over for abacavir, kan også have nedsat følsomhed over for lamivudin.
English: In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of dolutegravir was evaluated in combination regimens in HIV-1 infected infants, children and adolescents.
Danish: I et ublindet multicenterfase I/II-studie af 48 ugers varighed (P1093/ING112578) blev dolutegravirs farmakokinetiske parametre, sikkerhed, tolerabilitet og effekt vurderet i kombinationsregimer hos hiv1-inficerede, spædbørn, børn og unge.
English: - In order to avoid restarting abacavir and dolutegravir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Triumeq tablets.
Danish: - For at undgå genoptagelse af behandling med abacavir og dolutegravir, bør patienter der har oplevet en formodet overfølsomhedsreaktion instrueres til at bortskaffe resterende Triumeq tabletter.
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitet, graviditet og amning Fertile kvinder
English: The most frequently reported adverse reactions considered possibly or probably related to dolutegravir and abacavir/lamivudine were nausea (12%), insomnia (7%), dizziness (6%) and headache (6%).
Danish: De hyppigst rapporterede bivirkninger, der blev anset for muligvis eller sandsynligvis at være relateret til dolutegravir og abacavir/lamivudin var kvalme (12 %), insomni (7 %), svimmelhed (6 %) og hovedpine 6 %.