FrancophonIA/ELRC3.0 huggingface dataset:
English: Proposed actions: Provision of updated ABC HSR education materials for healthcare professionals to countries where the MAH has marketing authorisation for ABC.
Danish: Foreslåede handlinger: Levering af opdateret uddannelsesmateriale for ABC-overfølsomhedsreaktion til sundhedspersonalet i lande, hvor MAH har markedsføringstilladelse til ABC
English: Patients should be advised that Trizivir 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: Patienter bør orienteres om, at Trizivir eller anden antiretroviral behandling ikke helbreder hivinfektionen, og at de stadig kan få opportunistiske infektioner eller andre komplikationer af hivinfektionen.
English: If your doctor advises that you can start taking Trizivir 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 foreslår, at du genoptager behandlingen med Trizivir, kan det være, at du bliver rådet til at tage første dosis på et sted, hvor du vil have mulighed for hurtigt at få lægehjælp, hvis det skulle blive nødvendigt.
English: In patients with high viral load (> 100,000 copies/ml) choice of therapy needs special consideration (see section 5.1).
Danish: Hos patienter med høj virusbyrde (> 100.000 kopier/ml) kræver valget af behandling særlig overvejelse (se pkt.
English: infection
Danish: infektion
English: The incidence of neutropenia was also increased in those patients whose neutrophil counts, haemoglobin levels and serum vitamin B12 levels were low at the start of zidovudine therapy.
Danish: Forekomsten af neutropeni var ligeledes øget hos de patienter, hvis neutrofiltal, hæmoglobinniveau og serumniveau af vitamin B12 var lavt ved starten af behandlingen med zidovudin.
English: Single doses up to 1,200 mg and daily doses up to 1,800 mg of abacavir have been administered to patients in clinical studies.
Danish: Der er givet enkeltdoser op til 1.200 mg og døgndoser op til 1.800 mg abacavir til patienter i kliniske studier.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Danish: Imidlertid udøves den væsentligste antivirale aktivitet gennem inkorporering af monophosphatformen i den virale DNAkæde, hvorved kædedannelsen afsluttes.
English: When these signs occur, Trizivir should be stopped and your HIV treatment changed.
Danish: Hvis der ses tegn på lipoatrofi, skal behandlingen med Trizivir stoppes og din hiv-behandling ændres.
English: Food decreased the rate of absorption of Trizivir (slight decrease Cmax (mean 18 - 32 %) and increase tmax (approximately 1 hour), but not the extent of absorption (AUC0-∞).
Danish: Fødeindtagelse nedsætter absorptionshastigheden af Trizivir (let nedsat Cmax (i gennemsnit 18-32 %) og øger tmax (ca. 1 time), men ikke omfanget af absorptionen (AUC0-∞).
English: Abacavir, lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Danish: Abacavir, lamivudin og zidovudin bliver ikke metaboliseret signifikant af cytokrom P450-enzymer (såsom CYP3A4, CYP2C9 eller CYP2D6), og de hverken hæmmer eller inducerer dette enzymsystem.
English: The degree of benefit of this nucleoside combination in heavily pre-treated patients will depend on the nature and duration of prior therapy that may have selected for HIV-1 variants with cross-resistance to abacavir, lamivudine or zidovudine.
Danish: Fordelen ved denne nukleosidkombination hos tidligere massivt behandlede patienter vil afhænge af arten og varigheden af den forudgående behandling, som eventuelt har selekteret for hiv-1-varianter med krydsresistens over for abacavir, lamivudin og zidovudin.
English: • pyrimethamine, to treat malaria and other parasitic infections
Danish: • pyrimethamin, til behandling af malaria og andre parasitinfektioner
English: Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care.
Danish: Efter seponering af abacavir skal symptomerne behandles i henhold til lokal standardbehandling.
English: What Trizivir contains
Danish: Trizivir indeholder
English: When prescribing Trizivir, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Ved ordinering af Trizivir bør man så vidt muligt forsøge at minimere samtlige påvirkelige risikofaktorer (såsom rygning, hypertension og hyperlipidæmi).
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med en fremskreden hiv-infektion (aids) har et svagt immunforsvar og har derfor lettere ved at udvikle alvorlige infektioner (opportunistiske infektioner).
English: Anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
Danish: Anæmi, neutropeni og leukopeni (som regel sekundært til neutropeni) kan forventes at forekomme hos patienter, der behandles med zidovudin.
English: Dose reduction or cessation of therapy may become necessary (see section 4.4).
Danish: Dosisreduktion eller seponering af behandling kan blive nødvendig (se pkt.
English: If you are hypersensitive to Trizivir, return all your unused Trizivir tablets for safe disposal.
Danish: Hvis du er overfølsom over for Trizivir, bør du aflevere alle dine ubrugte Trizivir tabletter til destruktion.
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: • Hududslæt i form af blister, som ligner små målskiver (mørk plet omgivet af en næsten farveløs ring med en mørk kant yderst) (erythema multiforme).
English: Virologic success (48 weeks HIV RNA < 50 copies/ml)
Danish: Virologisk succes (48 ugers hiv-RNA < 50 kopier/ml)
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Danish: Observationsstudier har vist en forbindelse mellem myokardieinfarkt og brugen af abacavir.
English: This indicates a low likelihood for interactions with other medicinal products through plasma protein binding displacement.
Danish: Dette indikerer, at sandsynligheden for interaktioner med andre lægemidler ved fortrængning af plasmaproteinbinding er lille.
English: An effect of abacavir is observed on zidovudine (Cmax reduced with 20 %) and on lamivudine (Cmax reduced with 35 %).
Danish: Der ses en påvirkning af abacavir på zidovudin (Cmax er nedsat med 20 %) og på lamivudin (Cmax nedsat med 35 %).
English: Patients receiving Trizivir should be frequently examined and questioned for signs of lipoatrophy.
Danish: Patienter, der behandles med Trizivir, skal jævnligt undersøges og udspørges for tegn på lipoatrofi.
English: Treatment with Trizivir often causes a loss of fat from legs, arms and face (lipoatrophy).
Danish: Behandling med Trizivir resulterer ofte i tab af fedt på benene og armene og i ansigtet (lipoatrofi).
English: This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar doses.
Danish: Dette kombinationspræparat erstatter de tre stoffer (abacavir, lamivudin og zidovudin) brugt separat i tilsvarende doser.
English: Likewise, neither lamivudine nor zidovudine had any effect on fertility.
Danish: Tilsvarende havde hverken lamivudin eller zidovudin nogen effekt på fertiliteten.
English: One year postnatally, there was an increase in the incidence of tumours in the lung, liver and female reproductive tract of offspring exposed to the highest dose level (420 mg/kg term body weight).
Danish: Et år efter fødslen var der en øget forekomst af tumorer i lunger, lever og hunlige reproduktionsorganer hos afkommet, som var udsat for de højeste doseringsniveauer (420 mg/kg kropsvægt ved termin).
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 mor/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 gradvist til et ikke-detekterbart niveau, når det ammede barn når en alder på 24 uger.
English: Do not take other medicines for the infection without your doctor's advice.
Danish: Tag ikke anden medicin mod infektion uden at have talt med lægen om det.
English: Therapy should be prescribed by a physician experienced in the management of HIV infection.
Danish: Behandling bør ordineres af en læge med erfaring i behandling af hiv-infektion.
English: Table 1: Adverse reactions reported with the individual components of Trizivir
Danish: Tabel 1: Bivirkninger, som er rapporteret for de individuelle bestanddele af Trizivir.
English: You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Trizivir.
Danish: Du skal straks kontakte lægen, hvis du tror, du har en overfølsomhedsreaktion over for Trizivir.
English: • other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B
Danish: • anden medicin, der indeholder lamivudin, til behandling af hiv-infektion eller hepatitis B
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 for 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 at doses that gave plasma concentrations up to 40 - 50 times higher than clinical plasma levels.
Danish: Lamivudin var ikke genotoksisk in vivo ved doser, der medførte plasmakoncentrationer op til 40-50 gange højere end kliniske plasmakoncentrationer.
English: 3'-amino-3'deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing.
Danish: 3-amino-3-deoxythymidin (AMT) er identificeret som en metabolit af zidovudin efter intravenøs administration.
English: The 5'-glucuronide of zidovudine is the major metabolite in both plasma and urine, accounting for approximately 50 - 80 % of the administered dose eliminated by renal excretion.
Danish: 5-glucuronidet af zidovudin er hovedmetabolitten i både plasma og urin og udgør ca. 50-80 % af den administrerede dosis, som elimineres ved renal ekskretion.
English: A subsequent intravaginal carcinogenicity study confirmed the hypothesis that the vaginal tumours were the result of long term local exposure of the rodent vaginal epithelium to high concentrations of unmetabolised zidovudine in urine.
Danish: Et efterfølgende intravaginal karcinogenicitetsstudie bekræftede hypotesen om, at de vaginale tumorer hos gnaverne var resultatet af længerevarende lokal eksponering af det vaginale epitel med høje koncentrationer af uomdannet zidovudin i urin.
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 dose excreted in the urine.
Danish: De primære metaboliseringsveje hos mennesker er ved hjælp af alkoholdehydrogenase og glucuronidering at danne 5-carboxylsyre og 5-glucuronid, som udgør ca. 66 % af dosen udskilt i urinen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/156/003
English: Signs of osteonecrosis include:
Danish: Tegnene på osteonekrose omfatter:
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time
Danish: Hvis tidsfristen for en periodisk, opdateret sikkerhedsindberetning (PSUR) og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
Danish: • Ophævet funktion af knoglemarven til at danne nye røde blodlegemer (pure red cell aplasia).
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Trizivir without your doctor's advice, as your hepatitis may come back)
Danish: • hvis du nogensinde har haft en leversygdom, herunder hepatitis B eller C (hvis du har hepatitis Binfektion, må du kun stoppe din Trizivir-behandling efter aftale med lægen, da det kan give tilbagefald af hepatitis)
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Danish: Den systemiske eksponering, hvor der var ingen effekt hos mus og rotter svarede til 3 og 7 gange den systemiske eksponering hos mennesker i behandling.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 36 % serum albumin in vitro).
Danish: Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset binding til det væsentligste plasmaprotein albumin (< 36 % til serumalbumin in vitro).
English: A pilot study has demonstrated that zidovudine is incorporated into leukocyte nuclear DNA of adults, including pregnant women, taking zidovudine as treatment for HIV-1 infection, or for the prevention of mother to child viral transmission.
Danish: Et pilotstudie har vist, at zidovudin findes i leukocyt-nuklear DNA hos voksne, herunder hos gravide, i behandling med zidovudin for hiv-1-infektion eller som forebyggelse af smitte fra mor til barn.
English: Thymidine analogue mutations (TAMs) which are selected by zidovudine (ZDV) were also found (8%).
Danish: Thymidinanaloge mutationer (TAM'er), som ses med zidovudin, blev også påvist (8 %).
English: If concomitant therapy with Trizivir and any of these medicinal products is necessary then extra care should be taken in monitoring renal function and haematological parameters and, if required, the dosage of one or more agents should be reduced.
Danish: Såfremt samtidig behandling med Trizivir og et af disse lægemidler er nødvendig, bør der udvises ekstra omhu med monitorering af nyrefunktion og hæmatologiske parametre, og om nødvendigt bør dosis af ét eller flere af lægemidlerne reduceres.
English: In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Danish: I sjældne tilfælde kan immunforsvaret, når det bliver stærkere, også angribe raskt kropsvæv (autoimmune forstyrrelser).
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Danish: Det kan være, du skal komme hyppigere til kontrol og have taget flere blodprøver, mens du tager medicinen.
English: Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Danish: Abacavir viste toksicitet over for embryoner og fostre hos rotter, men ikke hos kaniner.
English: Treatment with zidovudine has been associated with loss of subcutaneous fat, which has been linked to mitochondrial toxicity.
Danish: Behandling med zidovudin er blevet forbundet med tab af subkutant fedt, hvilket er blevet kædet sammen med mitokondriel toksicitet.
English: ( see reverse of card)
Danish: (se bagsiden)
English: • clarithromycin, an antibiotic If you are taking clarithromycin, take your dose at least 2 hours before or after you take your Trizivir.
Danish: Hvis du tager clarithromycin, skal dosis tages mindst 2 timer før eller efter du tager Trizivir.
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 inkonsistens, således kan der hverken be- eller afkræftes en årsagssammenhæng mellem abacavir behandling og risiko for myokardieinfarkt.
English: The EU RMP of the abacavir (ABC) containing products (Ziagen, Kivexa and Trizivir) includes the following risk minimisation plan in relation to abacavir hypersensitivitiy reaction (HSR), which is an important identified risk:
Danish: EU-RMP'en for præparaterne (Ziagen, Kivexa og Trizivir), der indeholder abacavir (ABC), inkluderer følgende risikominimeringsplan for overfølsomhedsreaktion over for abacavir (ABCoverfølsomhedsreaktion), som er en vigtig identificeret risiko:
English: Your doctor may need to monitor you while you are taking Trizivir.
Danish: Lægen vil muligvis holde ekstra øje med dig, mens du tager Trizivir.
English: As well as the side effects listed below for Trizivir, other conditions can develop during treatment.
Danish: Ud over de bivirkninger, der nævnes nedenfor for Trizivir, kan der forekomme andre tilstande i forbindelse med behandlingen.
English: INFORMATION IN BRAILLE trizivir
Danish: INFORMATION I BRAILLE-SKRIFT trizivir
English: Rare: anxiety, depression
Danish: Sjælden: Angst og depression.
English: No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Trizivir is not recommended unless judged necessary.
Danish: Der foreligger ingen kliniske data for patienter med moderat til svært nedsat leverfunktion, hvorfor Trizivir ikke anbefales, medmindre det vurderes nødvendigt.
English: Treatment with Trizivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Danish: Behandling med Trizivir bør stoppes omgående, hvis der opstår kliniske tegn, symptomer eller unormale laboratoriefund, som tyder på udvikling af pancreatitis.
English: A very rare side effect that may show up in blood tests is:  a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia)
Danish: En meget sjælden bivirkning, som kan ses i dine blodprøver: • Ophævet funktion af knoglemarven til at danne nye røde og hvide blodlegemer (aplastisk anæmi).
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Danish: Fremstiller: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Storbritannien.
English: Zidovudine has no effect on the pharmacokinetics of lamivudine.
Danish: Zidovudin har ingen indvirkning på farmakokinetikken af lamivudin.
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Danish: Da lamivudin kan fjernes ved dialyse, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, skønt det ikke er undersøgt.
English: Methadone and Trizivir
Danish: Methadon og Trizivir
English: The special warnings and precautions relevant to abacavir, lamivudine and zidovudine are included in this section.
Danish: De særlige advarsler og forsigtighedsregler, som er relevante for abacavir, lamivudin og zidovudin, er inkluderet i dette afsnit.
English: Talk to your doctor immediately.
Danish: Tal med lægen om det straks.
English: Screening is also recommended prior to re-initiation 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, der tidligere har tolereret abacavir.
English: All of these belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: Alle disse tilhører en gruppe af antiretrovirale lægemidler, som kaldes nukleosidanalog revers transkriptasehæmmere (NRTI'er).
English: Keep in touch with your doctor, and do not stop taking Trizivir without your doctor's advice.
Danish: Sørg for at holde jævnlig kontakt til lægen, og hold ikke op med at tage Trizivir uden at have talt med lægen om det.
English: The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Danish: De observerede værdier for maksimale plasmakoncentrationer er 9 gange større end IC50 for abacavir, som er 0,08 µg/ml eller 0,26 µM, når der gives 600 mg abacavir 2 gange daglig.
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 myokardieinfarkt, og en let forøget risiko kunne ikke afvises.
English: Clarithromycin/Lamivudine Interaction not studied.
Danish: Clarithromycin / lamivudin Interaktion ikke undersøgt.
English: From studies with intravenous zidovudine, the mean terminal plasma half-life was 1.1 hours and the mean systemic clearance was 1.6 l/h/kg.
Danish: I studier med intravenøst administreret zidovudin var den terminale middel plasmahalveringstid 1,1 time, og den gennemsnitlige systemiske clearance var 1,6 l/time/kg.
English: K65R was absent and L74V and Y115F were uncommon (≤3 %).
Danish: K65R blev ikke fundet, og L74V og Y115F forekom sjældent (≤ 3 %).
English: Blue-green capsule-shaped film-coated tablets engraved with “GX LL1” on one side.
Danish: Blå-grønne, kapselformede, filmovertrukne tabletter præget med ”GX LL1” på den ene side.
English: No specific symptoms or signs have been identified following acute overdose with zidovudine or lamivudine apart from those listed as adverse reactions.
Danish: Der er ikke iagttaget særlige tegn eller symptomer efter akut overdosering med zidovudin eller lamivudin udover dem, der er nævnt under bivirkninger.
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Danish: Studiet viste, at fostre, der in utero udsættes for kombinationsbehandlingen, opretholdte et højere niveau af nukleosid-analogt DNA i multiple føtale organer, og udviste også tegn på kortere telomere end dem der kun fik zidovudin.
English: ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/3TC/EFV vs ZDV/3TC/ABC.
Danish: ACTG5095 var et randomiseret (1:1:1), dobbeltblindet, placebokontrolleret studie med 1147 antiretrovirale naive hiv-1-inficerede voksne, som sammenlignede tre behandlingsregimer: zidovudin (ZDV), lamivudin (3TC), abacavir (ABC) og efavirenz (EFV) versus ZDV/3TC/EFV versus ZDV/3TC/ABC.
English: Rare: pancreatitis
Danish: Sjælden: Pancreatitis.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1 RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Danish: Den logistiske regressionsmodel for den prædiktive værdi af genotype (justeret for baseline-plasma hiv-1-RNA [vRNA], CD4+-celletal, antal og varighed af tidligere antiretrovirale behandlinger) viste, at tilstedeværelsen af 3 eller flere NRTIresistens-forbundne mutationer var forbundet med nedsat respons i uge 4 (p = 0,015) eller 4 eller flere mutationer ved median uge 24 (p ≤ 0,012).
English: Cross-resistance between abacavir, lamivudine or zidovudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Danish: Krydsresistens mellem abacavir, lamivudin eller zidovudin og antiretroviraler fra andre grupper, f.eks. PI'er eller NNRTI'er, er usandsynlig.