FrancophonIA/ELRC3.0 huggingface dataset:
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Kivexa.
Danish: Husk at fortælle det til lægen eller på apoteket, hvis du begynder at tage anden medicin, mens du er i behandling med Kivexa.
English: The combination of abacavir and lamivudine has demonstrated antiviral activity in cell culture against non-subtype B isolates and HIV-2 isolates with equivalent antiviral activity as for subtype B isolates.
Danish: Kombinationen af abacavir og lamivudin har i cellekulturer demonstreret antiviral aktivitet mod nonsubtype B-isolater og hiv-2-isolater med samme antivirale aktivitet som for subtype B-isolater.
English: Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
Danish: Elimination af abacavir sker via hepatisk metabolisme med efterfølgende udskillelse af metabolitterne primært i urinen.
English: If you have stopped taking Kivexa for any reason - especially because you think you are having side effects, or because you have other illness:
Danish: Hvis du er holdt op med at tage Kivexa af en eller anden grund - særligt hvis det er, fordi du mener, du har bivirkninger, eller fordi du har en anden sygdom:
English: Symptoms can occur at any time during treatment with ABC, but usually occur within the first 6 weeks of therapy.
Danish: Symptomerne kan forekomme på et hvilket som helst tidspunkt under behandling med ABC, men forekommer normalt indenfor de første 6 uger af behandlingen.
English: Intravenous studies with abacavir and lamivudine showed that the mean apparent volume of distribution is 0.8 and 1.3 l/kg respectively.
Danish: Intravenøse studier med abacavir og lamivudin viste, at det gennemsnitlige fordelingsvolumen er henholdsvis 0,8 og 1,3 l/kg.
English: Abacavir is rapidly and well absorbed from oral formulations when administered to children.
Danish: Orale formuleringer af abacavir absorberes godt og hurtigt, når det administreres til børn.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Danish: Den observerede halveringstid for lamivudin er 5 til 7 timer.
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 abacavir behandling og risiko for myokardieinfarkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information WARNING!
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Afriv vedlagte oplysningskort, det indeholder vigtige oplysninger om sikkerheden ADVARSEL!
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 36%).
Danish: Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset binding til plasmaprotein in vitro (< 36 %).
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain.
Danish: Fremstiller Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spanien.
English: Importantly, such symptoms may lead to misdiagnosis of HSR as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
Danish: Disse symptomer kan føre til fejldiagnosticering af overfølsomhed som respiratorisk sygdom (pneumoni, bronkitis, faryngitis) eller gastroenteritis.
English: Overall, these data support the use of lamivudine 300 mg and abacavir 600 mg once daily for the treatment of HIV-infected patients.
Danish: Disse data støtter brugen af lamivudin 300 mg og abacavir 600 mg én gang daglig til behandling af hiv-inficerede patienter.
English: • if you have moderate or severe liver disease
Danish: • hvis du har en middelsvær eller svær leversygdom
English: Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases.
Danish: Abacavir og lamivudin triphosphater viser signifikant mindre affinitet for værtscelle-DNA-polymeraser.
English: Kivexa should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Danish: Kivexa må ikke tages samtidig med andre lægemidler indeholdende lamivudin eller lægemidler indeholdende emtricitabin.
English: Baseline CD4 category <50
Danish: Baseline-CD4-kategori < 50
English: Metabolism of lamivudine is a minor route of elimination.
Danish: Metabolismen af lamivudin sker ved en mindre elimination.
English: Almost all HSR to abacavir include fever and/or rash.
Danish: Næsten alle overfølsomhedsreaktioner over for abacavir omfatter feber og/eller udslæt.
English: Abacavir-resistant isolates of HIV-1 have been selected in-vitro in wild-type strain HIV-1 (HXB2) and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115).
Danish: Abacavir-resistente isolater af hiv-1 er blevet selekteret in vitro i vildtype-stammer af hiv-1 (HXB2) og er associeret med specifikke genotypiske ændringer i RT-codonregionen (codon M184V, K65R, L74V og Y115).
English: Write your doctor's details below:
Danish: Skriv oplysningerne om din læge her:
English: Kivexa contains the azo colouring agent sunset yellow, which may cause allergic reactions.
Danish: Kivexa indeholder azo-farvestoffet sunset yellow, der kan forårsage allergiske reaktioner.
English: Talk to your doctor if any of these apply to you before using Kivexa.
Danish: Tal med lægen, hvis noget af ovenstående gælder for dig, før du tager Kivexa.
English: The results of an in vivo rat micronucleus test with abacavir and lamivudine in combination were negative.
Danish: Resultaterne af en in vivo rotte micronucleustest med abacavir og lamivudin i kombination var negative.
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 inkluderede nedsat fostervægt, føtale ødemer og øget antal skeletale variationer/misdannelser, tidlig intrauterin død og dødsfødsler.
English: In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Danish: Ved langtidskarcinogenicitetsundersøgelser hos rotter og mus viste lamivudin intet karcinogent potentiale.
English: Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Danish: Myalgi, sjældent myolyse, artralgi, forhøjet kreatinkinase
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Danish: Metabolitter og uomdannet abacavir i urinen udgør ca. 83 % af den administrerede dosis abacavir.
English: If you are hypersensitive to Kivexa, return all your unused Kivexa tablets for safe disposal.
Danish: Hvis du er overfølsom over for Kivexa, skal du returnere alle dine Kivexa tabletter, så de kan blive destrueret korrekt.
English: The results are summarised below:
Danish: Resultaterne er sammenfattet nedenfor:
English: In vivo resistance (Therapy-naïve patients)
Danish: In vivo-resistens (behandlingsnaive patienter)
English: Passage with a zidovudine resistant clinical isolate RTMC also selected for the 184V mutation.
Danish: Tilførsel af det zidovudin-resistente kliniske isolat RTMC resulterede også i selektion af 184V-mutationen.
English: • HLA-B*5701 status must always be documented prior to initiating therapy.
Danish: • HLA-B*5701-status skal altid være dokumenteret før initiering af behandling
English: Talk to your doctor before you start again.
Danish: Tal med lægen, inden du begynder at tage Kivexa igen.
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 begrænsede tilfælde af myokardieinfarkt, og der kunne ikke afvises en let forøget risiko.
English: Therapy-naïve patients
Danish: Behandlingsnaive patienter
English: Both abacavir and lamivudine are metabolised sequentially by intracellular kinases to the respective 5'-triphosphate (TP) which are the active moieties.
Danish: Både abacavir og lamivudin bliver metaboliseret sekventielt ved intracellulære kinaser til de respektive 5'-triphosphater (TP), som er de aktive dele.
English: Both abacavir and lamivudine have been shown to inhibit replication of laboratory strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood lymphocytes (PBLs) and monocyte/macrophages.
Danish: Både abacavir og lamivudin er vist at hæmme replikation af laboratoriestammer og kliniske isolater af hiv i en række celletyper, herunder transformerede T-cellelinjer, linjer stammende fra monocytter/makrofager og primærkulturer af aktiverede perifere blodlymfocytter (PBLs) og monocytter/makrofager.
English: Studies in animals showed that neither abacavir nor lamivudine had any effect on fertility (see section
Danish: Dyreforsøg har vist, at hverken abacavir eller lamivudin påvirker fertiliteten (se pkt.
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Danish: • nedsat antal af de blodceller, der har betydning for blodets evne til at størkne (trombocytopeni).
English: When concomitant administration with co-trimoxazole is warranted, patients should be monitored clinically.
Danish: Når samtidig behandling med sulfa/trim er påkrævet, bør patienten monitoreres klinisk.
English: 1 Major IAS-USA defined mutations to Abacavir or Lamivudine and multi-NRTI resistance associated mutations
Danish: 1 Major IAS-USA definerede mutationer rettet mod abacavir eller lamivudin og multi-NRTI-resistens-associerede mutationer
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 blisterdannelse og hudafskalning, særligt omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnsons syndrom) og i alvorlige tilfælde med hudafskalning på mere end 30 %
English: A small amount of the ingredients in Kivexa can also pass into your breast milk.
Danish: Indholdsstofferne i Kivexa kan også udskilles i små mængder i modermælken.
English: If lamivudine is being used concomitantly for the treatment of HIV and hepatitis B virus (HBV), additional information relating to the use of lamivudine in the treatment of hepatitis B infection can be found in the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV.
Danish: Hvis lamivudin bliver anvendt samtidigt til behandling af hiv og hepatitis B-virus (HBV), kan mere information relateret til anvendelse af lamivudin i behandlingen af hepatitis B-infektion findes i produktresumeerne for produkter, som indeholder lamivudin, og som er indiceret til behandling af HBV.
English: - The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Danish: - Risikoen for virologisk svigt ved anvendelse af Kivexa kan være højere end ved anvendelse af andre behandlingsregimer (se pkt.
English: If you forget to take Kivexa
Danish: Hvis du har glemt at tage Kivexa
English: No definitive recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure.
Danish: En definitiv anbefaling for dosisreduktion til patienter med let nedsat leverfunktion kan ikke gives på grund af en betydelig variation i eksponeringen af abacavir.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir and lamivudine.
Danish: Kliniske studier har vist, at der ikke er klinisk signifikante interaktioner mellem abacavir og lamivudin.
English: Some people taking Kivexa or other combination treatments for HIV are more at risk of serious side effects.
Danish: Nogle personer, der tager Kivexa eller andre kombinationsbehandlinger mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: TAMs might be selected when thymidine analogs are associated with abacavir.
Danish: TAM'er kan opstå, når thymidinanaloger anvendes sammen med abacavir.
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 inden genopstart af behandling med abacavir hos patienter med ukendt HLA-B*5701-status, som tidligere tolererede behandling med abacavir.
English: KIVEXA TABLETS ALERT CARD SIDE 1
Danish: KIVEXA TABLETTER OPLYSNINGSKORT
English: Combivir is a fixed dose combination of lamivudine and zidovudine 2.
Danish: Combivir er en fastdosiskombination af lamivudin og zidovudin 2.
English: The fixed-dose combination tablet of abacavir/lamivudine (FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately.
Danish: Fastdosiskombinationstabletten af abacavir/lamivudin (FDC) er vist at være bioækvivalent med lamivudin og abacavir administreret separat.
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Danish: K65R blev ikke fundet, og L74V og Y115F forekom sjældent (≤ 3 %).
English: Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors.
Danish: Der er påvist klinisk signifikant reduktion af følsomhed over for abacavir i kliniske isolater fra patienter med ukontrolleret virusreplikation, som tidligere er behandlet med, og nu er resistente over for, andre nukleosidinhibitorer.
English: The combination of abacavir and lamivudine as a once daily regimen is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Danish: Kombinationen af abacavir og lamivudin som et én gang dagligt regime er støttet af et 48 ugers multicenter, dobbeltblindet, kontrolleret studie (CNA30021) med 770 hiv-inficerede, behandlingsnaive voksne.
English: There was also no clinically significant food effect observed between administration of FDC in the fasted or fed state.
Danish: Der blev heller ikke observeret klinisk signifikant effekt af fødeindtagelse ved indgift af FDC til fastende eller med fødeindtagelse.
English: There was a low, similar overall incidence of virologic failure (viral load > 50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Danish: Der var en lav, ensartet virusbyrde (udgangsværdi > 50 kopier/ml) i både én gang daglig og to gange daglig behandlingsgrupperne (henholdsvis 10 % og 8 %).
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 g/ml eller 0,26 M, når der gives 600 mg abacavir 2 gange daglig.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours.
Danish: Hos patienter der får lamivudin 300 mg én gang daglig, er den terminale intracellulære halveringstid for lamivudin-TP forlænget med 16-19 timer, sammenlignet med en lamivudin plasmahalveringstid på 5-7 timer.
English: Similar clinical success (point estimate for treatment difference: -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Danish: Ensartet klinisk succes (punktestimat for behandlingsforskel: 1,7; 95 % CI: -8,4; 4,9) blev observeret for begge regimer.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle personer, der tager medicin mod hiv-infektioner, får andre bivirkninger, der kan være alvorlige.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1RNA [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 NRTI-resistens-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: Hypersensitivity reactions (see also section 4.8 )
Danish: Overfølsomhedsreaktioner (Se også pkt.
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 basis af kliniske fund, skal ABC seponeres permanent og ikke opstartes igen, uanset resultatet af HLAB*5701-screening.
English: Kivexa is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg.
Danish: Kivexa anvendes til behandling af hiv-infektioner (humant immundefektvirus) hos voksne, unge og børn, der vejer mindst 25 kg.
English: The Data Safety Monitoring Board (DSMB) recommended that consideration be given to change in the therapeutic management of all subjects in the high viral load stratum due to the efficacy differences observed.
Danish: Komiteen til overvågning af datasikkerhed (DSMB) anbefalede, at det på baggrund af de observerede effektforskelle blev overvejet at ændre i behandlingsregimet for alle patienter i gruppen med høj virusbyrde.
English: Tablet Core magnesium stearate microcrystalline cellulose sodium starch glycollate
Danish: Tabletkerne magnesiumstearat mikrokrystallinsk cellulose natriumstivelsesglycolat
English: Elevated creatinine, renal failure
Danish: Forhøjet kreatinin, nyresvigt
English: Efficacy Outcome at Week 48 in CNA30021 by baseline HIV-1 RNA and CD4 Categories (ITTe TLOVR ART naïve subjects).
Danish: Effektudbytte ved uge 48 i CNA30021 ved baseline-hiv-1-RNA og CD4-kategorier (ITTe TLOVR ART-naive patienter).
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Danish: Methadon / abacavir (40-90 mg én gang daglig i 14 dage / 600 mg enkeltdosis, derefter 600 mg 2 gange daglig i 14 dage)
English: Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Danish: Vigtigste symptomer forbundet med ABC-overfølsomhedsreaktion er feber (~80 %), udslæt (~70 %), gastrointestinale symptomer (> 50 %) som f.eks. kvalme, abdominalsmerter, opkastning og diarré, generel utilpashed, træthed, og hovedpine (~50 %) og andre symptomer (~30 %) som f.eks. respiratoriske, slimhinde-, og muskuloskeletale symptomer.
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Danish: I en metaanalyse med seks kliniske studier sås ingen TAM'er i behandlingsregimerne med abacavir uden zidovudin (0/127), men der blev påvist TAM'er i behandlingsregimerne indeholdende abacavir og thymidinanalogen zidovudin
English: • if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - (e.g. Trizivir, Triumeq or Ziagen), lamivudine or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4.
Danish: • hvis du er allergisk (overfølsom) over for abacavir (eller anden medicin, der indeholder abacavir f.eks. Trizivir, Triumeq eller Ziagen), lamivudin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) Læs grundigt alle oplysninger om overfølsomhedsreaktioner under punkt 4 Tal med lægen, hvis du mener, at noget af ovenstående gælder for dig.
English: A similar virologic response was observed for both regimens (point estimate for treatment difference at week 48: 0.39%, 95% CI: -6.63, 7.40).
Danish: Samme virologiske respons blev set ved begge behandlingsregimer (punktestimat for behandlingsforskel ved uge 48: 0,39 %; 95 % CI: -6,63; 7,40).
English: They were randomised to receive either abacavir (ABC) 600 mg once daily or 300 mg twice daily, in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily.
Danish: De blev randomiseret til at få enten abacavir (ABC) 600 mg én gang daglig eller 300 mg 2 gange daglig i kombination med lamivudin 300 mg én gang daglig og efavirenz 600 mg én gang daglig.
English: Driving and using machines Kivexa may cause side effects which could affect your ability to drive or use machines.
Danish: Kivexa kan give bivirkninger der kan påvirke din evne til at køre bil eller betjene maskiner.
English: NAME OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ViiV Healthcare BV
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Danish: Desuden er der ikke hos mennesker observeret autoinduktion af metabolismen af abacavir eller induktion af metabolismen af andre stoffer, som metaboliseres i leveren.
English: The combination of lamivudine with cladribine is not-recommended (see section 4.5).
Danish: Kombination af lamivudin med cladribin anbefales ikke (se pkt.
English: Regardless of HLA-B*5701 status, patients who are diagnosed with a hypersensitivity reaction must discontinue abacavir immediately.
Danish: Uanset udfaldet af HLA-B*5701-status, skal patienter, som diagnosticeres med en overfølsomhedsreaktion, omgående seponere behandlingen med abacavir.
English: HLA-B*5701 status must always be documented and explained to the patient prior to initiating therapy.
Danish: HLA-B*5701status skal altid dokumenteres og forklares til patienten før behandlingen initieres.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents:didanosine, nevirapine and zidovudine).
Danish: Der blev ikke observeret nogen antagonistisk effekt ved lamivudin og andre antiretrovirale lægemidler in vitro (lægemidler testet: abacavir, didanosin, nevirapin og ziduvodin).
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh score 5-6) er omhyggelig monitorering påkrævet, herunder monitorering af plasmakoncentrationen af abacavir, hvis det er muligt (se pkt.
English: There is no evidence from clinical studies that abacavir is hepatotoxic.
Danish: Fra kliniske studier er der ingen tegn på, at abacavir skulle være hepatotoksisk.
English: The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function.
Danish: Farmakokinetikken af abacavir hos patienter med nyresvigt svarer til den hos patienter med normal nyrefunktion.
English: Do not take this medicine after the expiry date shown on the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.