FrancophonIA/ELRC3.0 huggingface dataset:
English: This indicates a low likelihood for interactions with other medicinal products through plasma protein binding displacement.
Danish: Dette indikerer en lille sandsynlighed for interaktioner med andre lægemidler ved fortrængning af plasmaproteinbinding.
English: Routine risk minimisation activities
Danish: Rutinemæssige risikominimeringsaktiviteter
English: Tell your doctor if you are taking methadone.
Danish: Tal med lægen, hvis du tager methadon.
English: Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Danish: De symptomer, der er rapporteret hos mindst 10 % af patienterne med en overfølsomhedsreaktion, er skrevet med fed skrift.
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 pneumocystis jirovecii pneumoni (ofte omtalt som PCP).
English: Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction.
Danish: Abacavir kan forårsage en alvorlig allergisk reaktion, kendt som en overfølsomhedsreaktion.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, der er hiv-positive, må ikke amme deres børn, da hiv-infektionen kan overføres til barnet gennem mælken.
English: Abacavir and lamivudine 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 og lamivudin bliver ikke metaboliseret signifikant af cytokrom P450-enzymer (såsom CYP 3A4, CYP 2C9, CYP 2D6), og de hverken hæmmer eller inducerer dette enzymsystem.
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 concentrations.
Danish: Lamivudin var ikke genotoksisk in vivo ved doser, der medførte plasmakoncentrationer op til 40-50 gange højere end kliniske plasmakoncentrationer.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided
Danish: Høje doser af trimethoprim/sulfamethoxazol til behandling af Pneumocystis jirovecii pneumoni (PCP) og toksoplasmose er ikke undersøgt og bør undgås.
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Danish: De tilgængelige kliniske data er meget begrænsede og udelukker konklusioner.
English: Swallow the tablets whole, with some water.
Danish: Tabletterne skal synkes hele med vand.
English: Due to similarities, Kivexa should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Danish: Pga. ligheder bør Kivexa ikke administreres samtidig med andre cytidin-analoger, så som emtricitabin.
English: You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene).
Danish: Du har større risiko for at få sådan en overfølsomhedsreaktion, hvis du har et gen, som kaldes HLAB*5701 (men du kan også få en reaktion, selvom du ikke har dette gen).
English: • aches and pains (especially in the hip, knee or shoulder)
Danish: • smerter (særligt i hofterne, knæene eller skuldrene)
English: You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Kivexa.
Danish: Du skal straks kontakte din læge, hvis du tror, du har en overfølsomhedsreaktion over for Kivexa.
English: Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Danish: Symptomerne fremkom normalt indenfor de første seks uger (mediantid til debut var 11 dage) efter behandlingsstart med abacavir, selvom disse reaktioner kan opstå på et hvilket som helst tidspunkt under behandlingen.
English: No pharmacokinetic data are currently available in patients over 65 years of age.
Danish: Der foreligger på nuværende tidspunkt ingen farmakokinetiske data for patienter over 65 år.
English: (see reverse of card)
Danish: (se bagsiden)
English: After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation.
Danish: Efter start af behandling, bliver immunforsvaret stærkere, og kan angribe infektionerne, hvilket kan give symptomer på infektion og betændelse.
English: There are no data available on the safety of abacavir and lamivudine when administered to babies less than three months old.
Danish: Der foreligger ingen data om sikkerheden af abacavir og lamivudin hos børn under 3 måneder.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Kivexa 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 Kivexa uden at tale med lægen først, da det kan få din hepatitis til at blusse op igen)
English: Selection for the M184V mutation occurred first and resulted in a two fold increase in IC50.
Danish: Selektion for M184V-mutation forekom først og resulterede i en fordobling af IC50.
English: The carcinogenic potential of a combination of abacavir and lamivudine has not been tested.
Danish: Det karcinogene potentiale af en kombination af abacavir og lamivudin er ikke blevet testet.
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Danish: Observationsstudier har vist en association mellem myokardieinfarkt og brugen af abacavir.
English: The results are summarised by subgroup in the table below:
Danish: Resultaterne er sammenfattet i undergrupper i tabellen nedenfor:
English: No pharmacokinetic data are available in patients over 65 years of age.
Danish: Ingen farmakokinetiske data er tilgængelige for patienter over 65 år.
English: 30% of the body surface (toxic epidermal necrolysis).
Danish: af kroppens overflade (toksisk epidermal nekrolyse)
English: Among the 104 patients who received Kivexa, including the ones who were between 40 kg and 25 kg, the viral suppression was similar
Danish: Blandt de 104 patienter, som fik Kivexa, inklusive dem, der vejede mellem 40 kg og 25 kg, sås samme niveau af viral suppression.
English: 1 Major IAS-USA (Dec 2009) defined mutations for Abacavir or Lamivudine
Danish: 1 Major IAS-USA (dec 2009) definerede mutationer rettet mod abacavir eller lamivudin
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 ◦C
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the currently approved EU SPC:
Danish: Hovedelementer i uddannelsesmaterialet for at øge forståelsen for og opmærksomheden på ABCoverfølsomhedsreaktion og udvide informationen, som allerede er inkluderet i det nuværende godkendte EU produktresumé:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Danish: Antal forsøgspersoner med ≥1 thymidinanaloge mutationer (TAM'er)
English: Keep in touch with your doctor, and do not stop taking Kivexa without your doctor's advice.
Danish: Hold kontakt med lægen, og stop ikke med at tage Kivexa uden at tale med lægen først.
English: In the small sample size for genotypic analysis, there was a trend toward a higher rate of NRTI-associated mutations in the once daily versus the twice daily abacavir regimens.
Danish: I den lille sample størrelse for genotypeanalyse var der en tendens mod en større frekvens af NRTI-associerede mutationer i én gang daglig versus to gange daglig abacavir regimet.
English: The majority of these tumours occurred at the highest abacavir dose of 330 mg/kg/day in mice and 600 mg/kg/day in rats.
Danish: Størstedelen af tumorerne opstod ved den højeste dosis af abacavir på 330 mg/kg/dag hos mus og 600 mg/kg/dag hos rotter.
English: These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
Danish: Disse overfølsomhedsreaktioner er set oftere hos patienter, som tager medicin, der indeholder abacavir.
English: In vivo resistance
Danish: In vivo-resistens
English: The special warnings and precautions relevant to abacavir and lamivudine are included in this section.
Danish: De særlige advarsler og forsigtighedsregler, der er relevante for abacavir og lamivudin, er inkluderet i dette afsnit.
English: Those studied were mainly antiretroviral experienced patients.
Danish: I disse studier udgjordes patientgruppen hovedsageligt af behandlingserfarne antiretrovirale patienter.
English: Abacavir + lamivudine + PI (or PI/ritonavir)
Danish: Abacavir + lamivudin + PI (eller PI/ritonavir)
English: Abacavir increases the rate at which methadone is removed from the body.
Danish: Abacavir øger den hastighed, hvormed methadon udskilles fra kroppen.
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: The most common symptoms are:
Danish: De almindeligste symptomer er:
English: Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.
Danish: Orange, filmovertrukne, modificerede kapselformede tabletter præget GS FC2 på den ene side.
English: Analysis of the data from subjects in the low viral load stratum showed no demonstrable difference between the nucleoside backbones in the proportion of patients free of virological failure at week 96.
Danish: Analyse af data fra patienter i gruppen med lav virusbyrde viste ingen påviselig forskel mellem nukleosid backbones hos andelen af patienter, der ikke havde virologisk svigt ved uge 96.
English: Paediatric population: The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established.
Danish: Pædiatrisk population: Kivexas sikkerhed og virkning hos børn under 25 kg er ikke klarlagt.
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 overdosis, skønt dette ikke er undersøgt.
English: The frequency of this is unknown (see section 4.4).
Danish: Frekvensen heraf er ukendt (se pkt.
English: Kivexa contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen).
Danish: Kivexa indeholder abacavir (der også er et aktivt stof i medicin som Trizivir, Triumeq og Ziagen).
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: • manglende dannelse af nye røde blodceller i knoglemarven (pure red cell aplasi).
English: • palpitations (rapid or irregular heartbeat) or tremor
Danish: • hjertebanken (hurtig eller uregelmæssig hjerterytme) eller rysten
English: Mechanism of action: Abacavir and lamivudine are NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2 (LAV2 and EHO) replication.
Danish: Virkningsmekanisme: Abacavir og lamivudin er NRTI'er og er potente selektive hæmmere af hiv-1 og hiv-2 (LAV2 og EHO) replikation.
English: Kivexa contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine.
Danish: Kivexa indeholder to aktive stoffer, der anvendes til at behandle hiv-infektioner: abacavir og lamivudin.
English: Data show that abacavir and lamivudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Danish: Data viser, at abacavir og lamivudin penetrerer centralnervesystemet (CNS) og når ud i cerebrospinalvæsken (CSF).
English: • presence of skin rash; OR
Danish: • forekomst af hududslæt, ELLER
English: Drug susceptibility scores were assigned for each patient's viral genotype utilising the ANRS 2009 HIV-1 genotypic drug resistance algorithm.
Danish: Bestemmelse af lægemiddelfølsomhed blev udført for hver patients virale genotype ved hjælp af ANRS 2009 hiv-1-genotypiske algoritme for lægemiddelresistens.
English: With the exception of a negative in vivo rat micronucleus test, there are no data available on the effects of the combination of abacavir and lamivudine in animals.
Danish: Med undtagelse af en negativ in vivo rotte-micronucleus-test er der ingen tilgængelige data for effekten af kombinationen mellem abacavir og lamivudin i dyr.
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 til et ikke-detekterbart niveau når det ammede barn når en alder på 24 uger.
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 ikke var nogen effekt hos mus og rotter, svarede til 3 og 7 gange den systemiske eksponering hos mennesker under behandling.
English: Each susceptible drug in the regimen received a score of 1 and drugs for which the ANRS algorithm predicts resistance were ascribed the value ‘0'.
Danish: Hvert følsomt lægemiddel i regimet blev tildelt en score på 1, og lægemidler, hvor ANRS-algoritmen forudsagde resistens, blev tildelt værdien ‘0'.
English: INFORMATION IN BRAILLE kivexa
Danish: INFORMATION I BRAILLE-SKRIFT kivexa
English: Kivexa is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments.
Danish: Kivexa er en fastdosistablet og bør ikke gives til patienter, der har brug for dosisjusteringer.
English: Your doctor may advise you to stop taking Kivexa.
Danish: Lægen kan råde dig til at stoppe behandlingen med Kivexa.
English: Cross-resistance between abacavir or lamivudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Danish: Krydsresistens mellem abacavir eller lamivudin og antiretroviraler fra andre grupper, f.eks. PI'er eller NNRTI'er, er usandsynlig.
English: The concentration of drug necessary to effect viral replication by 50% (EC50) or 50% inhibitory concentration (IC50) varied according to virus and host cell type.
Danish: Den lægemiddelkoncentration, der var nødvendig for at påvirke viral replikation med 50 % (EC50) eller opnå 50 % hæmmende koncentration (IC50), varierede afhængigt af virus og værtscelletype.
English: Abacavir and its metabolites are excreted into the milk of lactating rats.
Danish: Abacavir og dets metabolitter udskilles i mælk hos diegivende rotter.
English: Very rarely cases of erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Danish: Der er meget sjældent rapporteret om erythema multiforme, Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse, hvor overfølsomhed over for abacavir ikke kunne udelukkes.
English: Kivexa should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced.
Danish: Kivexa bør ikke gives til børn, der vejer under 25 kg, da det er en fastdosistablet, der ikke kan dosisreduceres.
English: People with advanced HIV infection (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: No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Kivexa is not recommended unless judged necessary.
Danish: Der foreligger ingen kliniske data for patienter med moderat og svært nedsat leverfunktion, hvorfor Kivexa ikke bør anvendes, medmindre det vurderes nødvendigt.
English: These medicines should not be used with Kivexa:
Danish: Følgende lægemidler må ikke tages sammen med Kivexa:
English: The GSS was obtained from the Monogram reports with susceptible virus ascribed the values ‘1-4' based upon the numbers of drugs in the regimen and with virus with reduced susceptibility ascribed the value ‘0'.
Danish: GSS blev skaffet fra Monogramrapporter, hvor følsomme vira er tildelt værdierne ‘1-4' baseret på antallet af lægemidler i regimet, og vira med nedsat følsomhed er tildelt værdien ‘0'.
English: Clinical experience
Danish: Kliniske erfaringer
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 for at forårsage kromosomskader in vitro og in vivo ved høje testkoncentrationer.
English: Lamivudine-TP and carbovir-TP (the active triphosphate form of abacavir) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Danish: Lamivudin-TP og carbovir-TP (den aktive triphosphatform af abacavir) er substrater for og kompetitive hæmmere af hiv revers transkriptase (RT).
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-infektion.
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: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Kivexa or other medicines you are taking, or an effect of the HIV disease itself.
Danish: Når du bliver behandlet for hiv, kan det være svært at afgøre, om dine symptomer skyldes Kivexa eller anden medicin, eller om de skyldes hiv-sygdommen i sig selv.
English: This recurrence is usually more severe than on initial presentation, and may include life-threatening hypotension and death.
Danish: Denne tilbagevenden er sædvanligvis alvorligere end ved den initiale præsentation og kan inkludere livstruende hypotension og død.
English: HLA-B*5701 is the only identified pharmacogenetic marker that is consistently associated with clinical diagnosis of an ABC HSR reaction.
Danish: HLA-B*5701 er den eneste identificerede farmakogenetiske markør, der konsekvent er associeret med klinisk diagnosticering af en ABC-overfølsomhedsreaktion.
English: The IC50 for wild-type HXB2 is 0.24 to 0.6 µM, while the IC50 for M184V containing HXB2 is >100 to 500 µM.
Danish: IC50 for vildtype HXB2 er 0,24 - 0,6 M, mens IC50 for M184V med HXB2 er > 100 til 500 M.
English: The safety and efficacy of Kivexa has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og effekten af Kivexa er ikke blevet klarlagt hos patienter med betydende, underliggende leversygdom.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig behandling af hepatitis B eller C med antivirale lægemidler henvises til relevant produktinformation for disse lægemidler.
English: The recommended dose of Kivexa for adults, adolescents and children weighing 25 kg or more is one tablet once a day.
Danish: Den sædvanlige dosis af Kivexa til voksne, unge og børn, som vejer mindst 25 kg, er én tablet én gang daglig.
English: - Triple nucleoside therapy: There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen.
Danish: - Tripel nukleosidterapi: Der er rapporteret om høj frekvens af virologisk svigt og forekomst af resistens på et tidligt stadie, når abacavir og lamivudin kombineres med tenofovirdisoproxilfumerat som et én gang dagligt regime.
English: People may be more likely to get this condition:
Danish: Du har større risiko for at få denne sygdom:
English: The active ingredients of Kivexa may inhibit cellular DNA replication and abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Danish: De aktive indholdsstoffer i Kivexa kan eventuelt hæmme cellulær DNA-replikation og abacavir er vist at være carcinogent i dyremodeller (se pkt.5.3).
English: Pharmacogenetic Testing
Danish: Farmakogenetisk test
English: Abacavir + lamivudine + NNRTI
Danish: Abacavir + lamivudin + NNRTI
English: • difficulty in sleeping (insomnia)
Danish: • søvnproblemer (insomni)
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 tilførsel af øget lægemiddelkoncentration resulterede i selektion af dobbelt RT-mutanter 65R/184V og 74V/184V eller tredobbelt RT-mutant 74V/115Y/184V.
English: Important information about some of the other ingredients of Kivexa tablets Kivexa contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Kivexa tabletter Kivexa indeholder farvestoffet sunset yellow (E110), der kan forårsage overfølsomhedsreaktioner hos nogle mennesker.
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 for en øgning af tidlig fosterdød i kaniner efter en relativ lille systemisk eksponering; sammenligneligt med hvad der set i mennesker.
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) at week 48 were also similar in each group (ITT population).
Danish: Forholdet mellem hiv-1-RNA  50 kopier/ml (50 % versus 47 %) og  400 kopier/ml (54 % versus 57 %) ved uge 48 var ligeledes ensartet i hver gruppe (ITT population).
English: Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Danish: Almindelig: Udslæt (uden systemiske reaktioner) Meget sjælden: Erythema multiforme, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
English: For the CNA109586 (ASSERT) and CNA30021 studies in treatment-naïve patients, genotype data was obtained for only a subset of patients at screening or at baseline, as well as for those patients who met virologic failure criteria.
Danish: For studierne CNA109586 (ASSERT) og CNA30021 hos behandlingsnaive patienter blev genotype-data kun opnået for en undergruppe af patienterne ved screening eller ved baseline, samt for de patienter, der faldt indenfor kriterierne for virologisk svigt.