FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 2nd September 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 2. september 2014 Dato for seneste fornyelse:
English: Current ART N=278 n (%)
Danish: Aktuel ART N=278 n (%)
English: The median time from first starting ART was around 4.5 years.
Danish: Mediantiden fra første ART-behandling var ca. 4,5 år.
English: No additional types of adverse reactions have been observed beyond those characterised for the adult population.
Danish: Der er ikke observeret yderligere bivirkninger ud over dem, der er karakteriseret for den voksne population.
English: People may be more likely to get this condition:
Danish: Du har større risiko for at få denne tilstand:
English: Both of these active ingredients can cause a serious allergic reaction known as a hypersensitivity reaction.
Danish: Begge disse aktive stoffer kan forårsage en alvorlig allergisk reaktion kendt som en overfølsomhedsreaktion.
English: Four subjects had virologic failure none of which had INI resistance at the time of virologic failure.
Danish: 4 personer havde virologisk svigt, hvor ingen af dem var resistente over for INI på tidspunktet for det virologiske svigt.
English: Week 48 outcomes (including outcomes by key baseline covariates) are shown in Table 3.
Danish: Udfaldene ved uge 48 (herunder udfald efter nøglebaseline-kovariater) er vist i tabel 3.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Danish: Påviste og teoretiske interaktioner med udvalgte antiretrovirale og ikke-antiretrovirale lægemidler er anført i tabel 1.
English: Changes in laboratory chemistries
Danish: Ændringer i kemiske laboratorieparametre
English: For abacavir there was a decrease in Cmax with 23% and AUC was unchanged.
Danish: For abacavir var der et fald i Cmax med 23 %, og AUC var uændret.
English: In this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Danish: I denne tilstand dør dele af knoglevævet på grund af nedsat blodtilførsel til knoglerne.
English: While the clinical relevance of these findings is unknown, these data suggest that a potential carcinogenic risk to humans is outweighed by the clinical benefit.
Danish: Selvom den kliniske relevans af disse fund ikke kendes, tyder disse data på, at potentiel karcinogen risiko hos mennesker opvejes af den kliniske fordel.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy, so it is important you take your medicine exactly as your doctor has told you.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi, så det er vigtigt, at du tager din medicin præcis som din læge har fortalt dig.
English: • if their immune systems are very weak
Danish: • hvis dit immunforsvar er meget svækket
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Danish: I disse tilfælde bør lægemidler, der indeholder abacavir, seponeres permanent.
English: • hypersensitivity reaction (see ‘Hypersensitivity reactions' earlier in this section)
Danish: • overfølsomhedsreaktion (se 'Overfølsomhedsreaktioner' tidligere i dette afsnit)
English: TRIUMEQ TABLETS PATIENT ALERT CARD SIDE 1
Danish: TRIUMEQ-TABLETTER PATIENTOPLYSNINGSKORT SIDE 1
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe Triumeq are provided with a health care professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger der forventes at udskrive Triumeq, får en sundhedsfaglig informationpakke, der indeholder følgende:
English: Don't stop taking Triumeq unless your doctor advises you to do so.
Danish: Du må ikke stoppe med at tage Triumeq, medmindre lægen anbefaler dig at gøre det.
English: ATC code: J05AR13
Danish: ATC-kode: J05AR13.
English: These have been identified either from clinical studies or post marketing surveillance.
Danish: Disse er blevet identificeret enten fra kliniske studier eller fra overvågning efter markedsføring.
English: Both the time to viral suppression and change from baseline analyses were pre-specified and adjusted for multiplicity.
Danish: Både analysen af tiden til viral suppression og analysen af ændringen i forhold til baseline var forudspecificeret og justeret for multiplicitet.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare
Danish: Bivirkningernes hyppighed er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000).
English: Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Triumeq helbreder ikke hiv-infektion, men det nedsætter mængden af virus i kroppen og holder den på et lavt niveau.
English: You should also never again take medicines containing dolutegravir.
Danish: Du bør heller aldrig igen tage lægemidler, der indeholder dolutegravir.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion spredes ved seksuel kontakt med en person, der har infektionen, eller ved overførsel af inficeret blod (for eksempel ved at dele injektionsnåle med andre).
English: Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 96 weeks.
Danish: Niveauet af serumkreatinin steg i løbet af den første uge af behandlingen med dolutegravir, og det forblev stabilt igennem 96 uger.
English: → Don't drive or operate machinery unless you are sure your alertness has not been affected.
Danish: → Du må ikke føre motorkøretøjer eller betjene maskiner, medmindre du er sikker på, at din agtpågivenhed ikke er påvirket.
English: The systemic exposures were equivalent to 7 to 21 times the expected systemic exposure in humans.
Danish: Den systemiske eksponering svarede til 7-24 gange den forventede systemiske eksponering hos mennesker.
English: Dolutegravir ↔ (Not studied)
Danish: Dolutegravir ↔ (Ikke undersøgt)
English: This reaction can be life-threatening if treatment with Triumeq is continued.
Danish: Denne reaktion kan være livstruende, hvis behandling med Triumeq fortsættes.
English: You need to be aware of the extra risks:
Danish: Vær opmærksom på en øget risiko:
English: → Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure or diabetes.
Danish: → Fortæl lægen, hvis du har hjerteproblemer, hvis du ryger eller har sygdomme, der kan øge risikoen for at få en hjertesygdom, f.eks. forhøjet blodtryk eller diabetes (sukkersyge).
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
Danish: • leversvigt (tegn kan omfatte gulfarvning af huden og det hvide i øjnene eller usædvanlig mørk urin).
English: Patients were mainly white (66%) or black (28%) of male sex (87%).
Danish: Patienterne var overvejende hvide (66 %) eller sorte (28 %) og af hankøn (87 %).
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Danish: Klinisk diagnosticering af mistænkt overfølsomhed overfor ABC er fortsat grundlaget for at tage kliniske beslutninger.
English: At 96 weeks, the response was 80% vs 72%, respectively.
Danish: Efter 96 uger var responset henholdsvis 80 % vs. 72 %.
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase (abacavircomponent).
Danish: Mulig interaktion på grund af fælles eliminationsvej via alkoholdehydrogenase (abacavirkomponent).
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på pakningen og tabletbeholderen.
English: Triumeq should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Danish: Triumeq bør derfor kun bruges i andet og tredje trimester af en graviditet, hvis de forventede fordele opvejer de potentielle risici for fosteret.
English: It also increases the number of CD4 cells in your blood.
Danish: Triumeq øger også antallet af CD4-celler i dit blod.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selvom effektiv viral suppression med antiretroviral behandling har vist sig at nedsætte risikoen for seksuel overførsel væsentligt, kan en residual risiko ikke udelukkes.
English: Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Hold øje med vigtige symptomer Nogle personer, der tager lægemidler mod hiv-infektion, får andre tilstande, der kan være alvorlige.
English: The absolute bioavailability of oral abacavir and lamivudine in adults is about 83% and 80-85% respectively.
Danish: Den absolutte biotilgængelighed af oralt indgivet abacavir og lamivudin hos voksne er henholdsvis omkring 83 % og 80-85 %.
English: No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Danish: Der kan ikke drages nogen konklusion med hensyn til det teratogene potentiale af abacavir som følge af denne embryo-føtale toksicitet.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis du også tager en form for antiinflammatorisk (betændelsesdæmpende) medicin, der kaldes kortikosteroider
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Danish: Overvej hyppigere overvågning af hiv-1 viusmængde, når vedvarende samtidig administration ikke kan undgås.
English: Main demographics and outcomes are summarised in Table 5.
Danish: De primære demografiske karakteristika og resultater er opsummeret i Tabel 5.
English: Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if:
Danish: Baseret på ovenstående, skal patienter informeres om omgående at kontakte lægen for at fastlægge, hvorvidt de skal stoppe med at tage abacavir, ved:
English: These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
Danish: Disse overfølsomhedsreaktioner er oftere blevet set hos personer, der tager lægemidler, som indeholder abacavir.
English: Due to the potential risk of neural tube defects with dolutegravir, Triumeq should not be used during the first trimester unless there is no alternative.
Danish: På grund af den potentielle risiko for neuralrørsdefekter med dolutegravir, bør Triumeq ikke anvendes i det første trimester, medmindre der ikke findes andre muligheder.
English: If you have taken Triumeq during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Triumeq under din graviditet kan lægen beslutte at tage jævnlige blodprøver og andre diagnostiske tests for at holde øje med dit barns udvikling.
English: If the patient misses a dose of Triumeq, the patient should take it as soon as possible, providing the next dose is not due within 4 hours.
Danish: Hvis patienten glemmer at tage en dosis Triumeq, bør patienten tage den så hurtigt som muligt, forudsat at den næste dosis ikke skal tages inden for 4 timer.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Danish: Lamivudin var ikke teratogent i dyrestudier, men der var indikationer på et øget antal tilfælde af tidlig embryonal død hos kaniner efter en relativt lav systemisk eksponering, sammenlignelig med den der opnås hos mennesker.
English: Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Danish: Let myokardiel degeneration i hjertet hos mus og rotter blev observeret efter administration af abacavir i 2 år.
English: Effects on electrocardiogram
Danish: Effekter på elektrokardiogram
English: Baseline CD4+ (cells/ mm3)
Danish: Baseline-CD4+ (celler/ mm3)
English: Do not discontinue Triumeq without consulting your doctor, as this may harm you and your unborn child.
Danish: Du må ikke ophøre med at tage Triumeq uden først at tale med lægen, da det kan være skadeligt for dig og dit ufødte barn.
English: Outcome Time Point
Danish: Resultat / Tidspunkt
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Danish: Hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid:
English: In the SINGLE study a mean change from baseline of 12.6 µmol/L was observed after 96 weeks of treatment.
Danish: I SINGLE-studiet blev der observeret en gennemsnitlig ændring i forhold til baseline på 12,6 µmol/l efter 96 ugers behandling.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis tegn på forværring af leversygdommen observeres hos disse patienter, skal afbrydelse eller permanent seponering af behandlingen overvejes.
English: The efficacy of Triumeq in HIV-infected, therapy naive subjects is based on the analyses of data from a number of trials.
Danish: Effekten af Triumeq hos hiv-inficerede, behandlingsnaive personer er baseret på analyser af data fra en række studier.
English: Interaction not studied (Inhibition of alcohol dehydrogenase)
Danish: Interaktion ikke undersøgt (hæmning af alkoholdehydrogenase).
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. doseringsenhed, dvs. det er i det væsentlige 'natriumfrit'
English: Patients should be advised that Triumeq or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Danish: Patienterne bør informeres om, at Triumeq eller en hvilken som helst anden antiretroviral behandling ikke kurerer hiv-infektion, og at de stadig kan udvikle opportunistiske infektioner og andre komplikationer fra hiv-infektion.
English: If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: → Tell your doctor immediately.
Danish: Hvis du får symptomer på infektion og betændelse, eller hvis du bemærker nogen af de ovennævnte symptomer: → Fortæl det omgående til lægen.
English: Triumeq is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments.
Danish: Triumeq er en fastdosis-tablet og bør ikke ordineres til patienter, der har brug for dosisjusteringer.
English: Your methadone dose may need to be changed.
Danish: Det kan være nødvendigt at ændre din dosis af methadon.
English: Risk of heart attack The possibility that abacavir increases the risk of having a heart attack cannot be excluded.
Danish: Risiko for hjertetilfælde Muligheden for at abacavir øger risikoen for at få et hjertetilfælde, kan ikke udelukkes.
English: Baseline demographics and outcomes are summarised in Table 4.
Danish: Baseline demografiske karakteristika og resultater er opsummeret i Tabel 4.
English: Non-white
Danish: Ikke-hvid
English: Do not take Triumeq:
Danish: Tag ikke Triumeq:
English: You should never take abacavir or abacavircontaining products again if you have a hypersensitivity reaction: it can be life threatening.
Danish: Du bør aldrig tage abacavir eller abacavirholdige produkter igen, hvis du har en overfølsomhedsreaktion: Det kan være livstruende.
English: Two mutations conferred a 7 to 8-fold change in abacavir susceptibility and combinations of three mutations were required to confer more than an 8-fold change in susceptibility.
Danish: To mutationer gav en ændring på 7 til 8 gange i følsomheden over for abacavir, og kombinationer af tre mutationer var nødvendige for at give mere end en 8 gange ændring i følsomhed.
English: At baseline, median patient age was 35 years, 16% were female, 32% non-white, 7% had hepatitis C coinfection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Danish: Ved baseline var patienternes medianalder 35 år, 16 % var kvinder, 32 % var ikke-hvide, 7 % var co-inficeret med hepatitis C-virus, og 4 % var CDC-klasse C. Disse karakteristika var omtrent de samme mellem behandlingsgrupperne.
English: The use of Triumeq in children under 12 years of age has not yet been studied.
Danish: Brugen af Triumeq til børn under 12 år er endnu ikke undersøgt.
English: • aches and pains (especially in the hip, knee or shoulder)
Danish: • ømhed og smerter i leddene (særligt i hofter, knæ eller skuldre)
English: Main prior transmission routes were homosexual (73%) or heterosexual (29%) contact.
Danish: Den primære smittevej var homoseksuel (73 %) eller heteroseksuel (29 %) kontakt.
English: Patients should be informed that dizziness has been reported during treatment with dolutegravir.
Danish: Patienterne bør informeres om, at svimmelhed er rapporteret under behandling med dolutegravir.
English: insomnia
Danish: Insomni
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Danish: Dolutegravir er i høj grad bundet (> 99 %) til humane plasmaproteiner baseret på in vitro-data.
English: nausea, diarrhoea
Danish: Kvalme, diarré
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Danish: • udslæt, der kan danne blærer, og som ligner små målskiver (mørk plet i midten omgivet af et lysere område, omsluttet af en mørk ring) (erythema multiforme)
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Danish: Den angivelige orale clearance (CL/F) er ca. 1 l/t hos hiv-inficerede patienter baseret på en farmakokinetisk populationsanalyse.
English: → Tell your doctor or pharmacist if you are taking any of these.
Danish: → Fortæl lægen eller apotekspersonalet, hvis du tager nogen af disse lægemidler.
English: Hepatitis B and/or C CDC class C
Danish: Hepatitis B og/eller C CDC-klasse C
English: It is recommended women who are HIV-positive do not breast-feed because HIV infection can be passed on to the baby in breast milk.
Danish: Det anbefales, at kvinder, der er hiv-positive, ikke ammer, da hiv-infektionen kan overføres til barnet gennem mælken.
English: De novo resistance in patients failing therapy in SINGLE, SPRING-2 and FLAMINGO
Danish: De novo-resistens hos patienter med behandlingssvigt i SINGLE, SPRING-2 og FLAMINGO
English: The exposure of lamivudine was similar with and without food.
Danish: Eksponeringen for lamivudin var af samme størrelsesorden med og uden mad.
English: When prescribing Triumeq, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Ved ordinering af Triumeq bør det så vidt muligt forsøges at minimere samtlige påvirkelige risikofaktorer (f.eks. rygning, hypertension og hyperlipidæmi).
English: • an increase in sugar (glucose) in the blood
Danish: • øget niveau af sukker (glucose) i blodet
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Danish: Fosamprenavir/ritonavir reducerer koncentrationen af dolutegravir, men baseret på en begrænset datamængde resulterede dette ikke i reduceret effekt i fase III-studier.
English: Triumeq can also affect how some other medicines work.
Danish: Triumeq kan også påvirke virkningen af andre lægemidler.
English: The concentration of active substance necessary to effect viral replication by 50% (IC50 - half maximal inhibitory concentration) varied according to virus and host cell type.
Danish: Den koncentration af det aktive stof, der var nødvendig for at hæmme viral replikation med 50 % (IC50 - 50 % hæmmende koncentration), varierede afhængigt af virus og værtscelletype.
English: 10.5 (3.1% to 17.8%) [p=0.005].
Danish: 10,5 (3,1 % til 17,8 %) [p=0,005].
English: Triumeq should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced.
Danish: Triumeq bør ikke administreres til voksne eller unge, der vejer under 40 kg, da det er en fastdosistablet, der ikke kan dosisreduceres.
English: Effect of nevirapine on dolutegravir exposure is likely similar to or less than that of efavirenz.
Danish: Effekten af nevirapin på eksponeringen for dolutegravir er sandsynligvis af samme størrelsesorden eller mindre end effekten af efavirenz.
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Danish: Det gennemsnitlige fordelingsforhold mellem lamivudinkoncentrationen i CSF og serum 2-4 timer efter oral administration var ca. 12 %.
English: Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir.
Danish: Efter gentagne orale doser af 300 mg abacavir to gange daglig er der ingen signifikant akkumulering af abacavir.
English: There is no specific treatment for an overdose of Triumeq.
Danish: Der findes ingen specifik behandling mod overdosering med Triumeq.
English: A clinically relevant phenotypic cut-off value (fold change vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Danish: En klinisk relevant fænotypisk skæringsværdi (FC vs. vildtypevirus) er ikke blevet fastlagt; genotypisk resistens var en bedre indikator for udfaldet.
English: Studies with lamivudine show that plasma concentrations (AUC) are increased in patients with renal dysfunction due to decreased clearance.
Danish: Studier med lamivudin viser, at plasmakoncentrationer (AUC) øges hos patienter med nedsat nyrefunktion på grund af nedsat clearance.
English: → Don't take a double dose to make up for a missed dose.
Danish: → Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jirovecii pneumoni (ofte omtalt som PCP).
English: If you know you have this gene, tell your doctor.
Danish: Hvis du ved, at du har dette gen, skal du fortælle det til lægen.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Danish: Denne variant opstår både in vitro og hos hiv-1inficerede patienter, der behandles med antiretrovirale lægemidler, som indeholder lamivudin.
English: Triumeq can make you dizzy and have other side effects that make you less alert.
Danish: Triumeq kan gøre dig svimmel og give andre bivirkninger, som gør dig mindre agtpågivende.
English: No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Triumeq is not recommended unless judged necessary.
Danish: Der er ingen kliniske data tilgængelig om patienter med moderat eller svært nedsat leverfunktion og derfor er anvendelsen af Triumeq ikke anbefalet, medmindre behandling vurderes at være nødvendig.