FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes three non-virological failures and four unconfirmed virological failures.
Danish: Omfatter tre ikke-virologiske svigt og fire ubekræftede, virologiske svigt 3.
English: Therefore the following should be adhered to:
Danish: Derfor bør følgende overholdes:
English: A similar effect was not seen in rats even at very high systemic exposure.
Danish: En lignende effekt er ikke set hos rotter selv efter meget høj systemisk eksponering.
English: It cannot be excluded that abacavir may increase the risk of having a heart attack.
Danish: Det kan ikke udelukkes, at abacavir kan øge risikoen for at få et hjertetilfælde.
English: These have been identified either from clinical studies or post marketing surveillance.
Danish: De er blevet identificeret enten i kliniske studier eller fra postmarketing overvågning.
English: • methadone, used as a heroin substitute.
Danish: • methadon, der anvendes som erstatning for heroin.
English: However, as there were only moderately experienced patients included in this study with an imbalance in baseline viral load between the arms, these results should be interpreted with caution.
Danish: Da der imidlertid kun var moderat erfarne patienter inkluderet i dette studie, med en uligevægt i baseline virusbyrde mellem armene, skal disse resultater tolkes med forsigtighed.
English: Symptoms usually include fever, plus some of the following:
Danish: Symptomer omfatter som regel feber, samt nogle af følgende:
English: Neurological/Psychiatry
Danish: Neurologiske/psykiatriske
English: In these cases the physician should refer to the individual product information for these medicinal products.
Danish: I disse tilfælde bør lægen referere til produktinformationerne for disse lægemidler.
English: The educational material includes 3 model case studies to demonstrate different clinical scenarios and their management.
Danish: Uddannelsesmaterialet indeholder 3 modelcasestudier for at vise forskellige kliniske scenarier, og hvordan de håndteres.
English: These were primarily asymptomatic HIV infected patients (CDC stage A).
Danish: Disse var primært asymptomatiske hiv-inficerede patienter (CDC-stadie A).
English: The primary efficacy analysis was performed at week 48 with study continuation to week 96 and demonstrated non-inferiority.
Danish: Den primære effektanalyse blev foretaget ved uge 48 med fortsættelse af studieforløbet indtil uge 96 og demonstrerede non-inferioritet.
English: Date of latest renewal: 17 November 2014
Danish: Dato for første markedsføringstilladelse: 17. december 2004 Dato for seneste fornyelse: 17. november 2014
English: Detach this card and keep it with you at all times.
Danish: Tag kortet ud og hav det altid på dig.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body
Danish: • svaghed, der starter i hænderne og fødderne og efterfølgende bevæger sig ind mod kroppen.
English: Rare: Rises in serum amylase.
Danish: Sjælden: Stigning i serum amylase.
English: ATC code: J05AR02.
Danish: ATC-kode: J05A R02.
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Danish: Den systemiske eksponering svarede til 7-24 gange den forventede systemiske eksponering hos mennesker.
English: If you have taken Kivexa 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 Kivexa under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
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: Frekvenser er defineret som: meget almindelig (> 1/10), almindelig (> 1/100 til < 1/10), ikke almindelig (> 1/1.000 til < 1/100), sjælden (> 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: This potential difference is sufficiently small to draw an overall conclusion of non-inferiority of abacavir once daily over abacavir twice daily.
Danish: Denne potentielle forskel er tilstrækkelig lille til at drage en overordnet konklusion om non-inferioritet af abacavir én gang daglig over for abacavir 2 gange daglig.
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Danish: Symptomer på autoimmune forstyrrelser kan opstå mange måneder efter, at du er startet med at tage medicin til behandling af din hiv-infektion.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværring i leversygdommen hos disse patienter, skal afbrydelse eller ophør med behandlingen overvejes.
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Danish: Sådanne infektioner kan have været 'stille' og ikke opdaget af det svækkede immunforsvar før behandlingens start.
English: Not everyone responds to treatment with Kivexa in the same way.
Danish: Ikke alle reagerer ens på behandlingen med Kivexa.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis du også tager betændelseshæmmende medicin, kaldet kortikosteroider
English: You need to know about important signs and symptoms to look out for while you are taking Kivexa.
Danish: Du skal kende til vigtige tegn og symptomer, du skal holde øje med, mens du tager Kivexa.
English: Kivexa does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Kivexa helbreder ikke hiv-infektionen, men nedsætter mængden af virus i kroppen og holder den på et lavt niveau.
English: ABC HSR Education Programme has been in place since the first approval of ABC as the single active preparation, ZIAGEN (USA December 1998, EU July 1999).
Danish: Uddannelsesprogrammet for ABC-overfølsomhedsreaktion har eksisteret siden den første godkendelse af ABC i enkeltstof-præparatet Ziagen (USA december 1998, EU juli 1999).
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Danish: Den gennemsnitlige fordeling af CSF/serum lamivudin koncentrationer 2-4 timer efter oral administration var ca. 12 %.
English: For many of these adverse reactions it is unclear whether they are related to the active substance, the wide range of other medicinal products used in the management of HIV infection, or whether they are a result of the underlying disease process.
Danish: For mange af disse bivirkninger er det uklart, om de er relaterede til den aktive substans, den vide udstrækning af andre lægemidler, der anvendes i behandlingen af hiv-infektion, eller om de er et resultat af den underliggende sygdomsproces.
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 patienterne informeres om omgående at kontakte deres læge for at fastlægge, hvorvidt de skal stoppe med at tage abacavir, ved:
English: Unknown 8/14 (57%) 6/14 (43%) 2/14 (14%) 0 All
Danish: Ikke kendt 8/14 (57%) 6/14 (43%) 2/14 (14%) 0 Alle
English: The recommended dose of Kivexa is one tablet once daily.
Danish: Den anbefalede dosis af Kivexa er én tablet én gang daglig.
English: The remainder is eliminated in the faeces.
Danish: Resten elimineres i fæces.
English: While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Danish: Så længe den kliniske relevans af disse fund er ukendt, indikerer disse data, at den karcinogene risiko hos mennesker opvejes af de potentielle kliniske fordele.
English: If your doctor advises that you can start taking Kivexa again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Danish: Hvis lægen vurderer, at du kan begynde at tage Kivexa igen, bliver du muligvis bedt om at tage de første doser på et sted, hvor du hurtigt kan få lægehjælp, hvis det skulle blive nødvendigt.
English: Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Danish: Zidovudin, didanosin, stavudin og tenofovir fastholder deres antiretrovirale aktiviteter mod sådanne hiv-1-varianter.
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 det til 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 sukkersyge.
English: There are no additional precautions and warnings relevant to Kivexa.
Danish: Der er ingen yderligere advarsler og forsigtighedsregler der er relevante for Kivexa.
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Danish: Hvis du gør det, kan du inden for få timer få et alvorligt blodtryksfald, der kan medføre død.
English: (Inhibition of alcohol dehydrogenase)
Danish: (Hæmning af alkoholdehydrogenase).
English: The absolute bioavailability of lamivudine (approximately 58 to 66%) was lower and more variable in paediatric patients under 12 years of age.
Danish: Den absolutte biotilgængelighed af lamivudin (ca. 58-66 %) var lavere og mere variabel hos pædiatriske patienter under 12 år.
English: • phenytoin, for treating epilepsy.
Danish: • phenytoin, til behandling af epilepsi.
English: Kivexa helps to control your condition.
Danish: Kivexa hjælper med at holde din sygdom under kontrol.
English: Genotypic sensitivity scores were not obtained for all patients at baseline.
Danish: Genotypisk sensitivitetsscore ved baseline kunne ikke skaffes for alle patienter.
English: Restarting abacavir in such patients must be done in a setting where medical assistance is readily available.
Danish: Genstart af abacavir hos disse patienter skal foregå under omstændigheder, hvor medicinsk assistance er hurtig tilgængelig.
English: Methadone: CL/F ↑22%
Danish: Methadon: CL/F  22 %
English: Summary of the safety profile
Danish: Sammendrag af sikkerhedsprofilen.
English: There are no data on the use of Kivexa in pregnancy, however the malformative risk is unlikely in humans based on those data.
Danish: Der foreligger ingen data om anvendelse af Kivexa under graviditet, men risikoen for misdannelse er usandsynlig hos mennesker baseret på disse data.
English: These metabolites are excreted in the urine.
Danish: Disse metabolitter udskilles i urinen.
English: Talk to your doctor about your ability to drive or operate machines while taking Kivexa.
Danish: Tal med lægen om din evne til at køre bil eller betjene maskiner når du tager Kivexa.
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
Danish: Sorbitol opløsning (3,2 g, 10,2 g, 13,4 g) / lamivudin
English: Very rare: Cases of peripheral neuropathy (or paraesthesia) have been reported
Danish: Meget sjælden: Tilfælde af perifer neuropati (eller paræstesi) er rapporteret
English: It is important that you follow this advice.
Danish: Det er vigtigt, at du følger lægens råd.
English: Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir.
Danish: Efter multiple orale doser af abacavir 300 mg 2 gange daglig er der ingen betydende akkumulering af abacavir.
English: Patients co-infected with chronic hepatitis B or C virus
Danish: Patienter co-inficeret med kronisk hepatitis B eller C
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogle anbefalinger vedrørende dosering.
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Danish: Klinisk diagnosticering af mistænkt overfølsomhed over for ABC er fortsat grundlaget for at tage kliniske beslutninger.
English: Antiviral Activity in vitro
Danish: Antiviral in vitro-aktivitet
English: What Kivexa contains
Danish: Kivexa indeholder
English: The mean half-life of abacavir is about 1.5 hours.
Danish: Den gennemsnitlige halveringstid af abacavir er ca. 1,5 time.
English: • hyperactivity (excessive restlessness and movement)
Danish: • hyperaktivitet (voldsom rastløshed og bevægelse)
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 to år.
English: Signs of osteonecrosis include:
Danish: Symptomer på osteonekrose omfatter:
English: The true extent of CNS penetration of lamivudine and its relationship with any clinical efficacy is unknown.
Danish: Det sande omfang af CNS penetrationen for lamivudin og dets sammenhængen med klinisk effekt er ukendt.
English: These may affect up to 1 in 100 people and may show up in blood tests:
Danish: Disse kan forekomme hos op til 1 ud af 100 personer og kan ses i blodprøver:
English: The absolute bioavailability of oral abacavir and lamivudine in adults is about 83% and 80-85% respectively.
Danish: Den absolutte biotilgængelighed af oral abacavir og lamivudin hos voksne er henholdsvis omkring 83 % og 8085 %.
English: Risk of heart attack
Danish: Risiko for hjertetilfælde
English: Abbreviations: ↑ = Increase; ↓ = decrease; ↔ = no significant change; AUC = area under the concentration versus time curve; Cmax = maximum observed concentration; CL/F = apparent oral clearance
Danish: Forkortelser:  = Stigning;  = Fald;  = Ingen signifikant ændring; AUC = Arealet under kurven koncentration versus tid; Cmax= Maksimal observeret koncentration; CL/F = Tilsyneladende oral clearance.
English: Additionally, the efficacy and safety of this combination given once daily has been demonstrated in a pivotal clinical study (CNA30021- See Clinical experience).
Danish: Derudover er effekten og sikkerheden af denne kombination, givet én gang daglig, blevet demonstreret i et pivotalt klinisk studie (CNA30021 - se Klinisk erfaring).
English: Tell your doctor if you are taking phenytoin.
Danish: Tal med lægen, hvis du tager phenytoin.
English: Your methadone dose may need to be changed.
Danish: Det kan være nødvendigt at ændre dosis af methadon.
English: Objective and rationale: Increased understanding and awareness of ABC HSR.
Danish: Formål og rationale: Øget forståelse for og opmærksomhed på ABC-overfølsomhedsreaktion.
English: Virologic Response
Danish: Virologisk respons
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Danish: Patienter bør derfor fortsat være under tæt klinisk observation af læger med erfaring i behandling af disse sygdomme, som ledsager hiv.
English: It also increases the CD4 cell count in your blood.
Danish: Kivexa øger også antallet af CD4-celler i dit blod.
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Danish: I disse tilfælde skal behandling med abacavir ophøre permanent.
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44%.
Danish: Studier med abacavir demonstrerer et fordelingsforhold mellem CSF og plasma AUC på mellem 30 % og 44 %.
English: No studies on the effects on ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Overall response
Danish: Overordnet respons
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Danish: De primære metaboliseringsveje hos mennesker er ved hjælp af alkoholdehydrogenase og glukuronidering til dannelse af 5-carboxylsyre og 5-glucuronid, som udgør ca. 66 % af den administrerede dosis.
English: In the fasted state there was no significant difference in the extent of absorption, as measured by the area under the plasma concentration-time curve (AUC) and maximal peak concentration (Cmax), of each component.
Danish: I det fastende stadie var der ingen signifikant forskel på graden af absorption, målt som arealet under plasmakoncentrationskurven (AUC) og maksimal serumkoncentration (Cmax), for hver komponent.
English: Abacavir is also excreted into human milk.
Danish: Abacavir udskilles også i humant mælk.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er omkring 0,32 l/t/kg, hovedsageligt ved renal clearance (> 70 %) via det organisk kationiske transportsystem.
English: Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase.
Danish: Sjældne bivirkninger, der kan ses i blodprøver: • stigning i mængden af et enzym, som kaldes amylase.
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 blister, og som ligner små målskiver (mørk plet i midten omgivet af et lysere område, omsluttet af en mørk ring) (erythema multiforme)
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 for abacavir som følge af denne embryo- og føtal-toksicitet.
English: The clinical status of the patient and the adverse reaction profile of Kivexa should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Patientens kliniske status og bivirkningsprofilen for Kivexa bør tages i betragtning, når man overvejer patientens evne til at føre motorkøretøj eller betjene maskiner.
English: IMPORTANT - ALERT CARD Kivexa (abacavir / lamivudine) tablets Carry this card with you at all times
Danish: VIGTIGT - OPLYSNINGSKORT Kivexa (abacavir / lamivudin) tabletter Hav altid dette kort med dig
English: Kivexa is not recommended for use during pregnancy.
Danish: Det anbefales ikke at tage Kivexa under graviditet.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Danish: Men deres centrale antivirale aktivitet sker ved inkorporering af monophosphatformen ind i den virale DNA-kæde, resulterende i en kædetermination.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, antivirale midler til behandling af hiv-infektioner, kombinationstyper.
English: Risk of virological failure
Danish: Risiko for virologisk svigt
English: Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Danish: Læge: ……………………………………………….. Tlf.: ………………………………… Hvis din læge ikke træffes, skal du hurtigst muligt søge anden lægehjælp (f.eks. skadestuen på det nærmeste hospital).
English: Ask your doctor or pharmacist for advice.
Danish: Spørg lægen eller apoteket til råds.
English: Adults, adolescents and children weighing at least 25 kg:
Danish: Voksne, unge og børn, der vejer mindst 25 kg:
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Danish: Gruppe O-isolater fra antiviral-naive patienter testet for lamivudin-aktivitet var meget følsomme.
English: When prescribing Kivexa, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Ved ordinering af Kivexa bør man så vidt muligt forsøge at minimere samtlige påvirkelige risikofaktorer (såsom rygning, hypertension og hyperlipidæmi).
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det. Fortsæt derefter behandlingen som før.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle personer, der får kombinationsbehandling mod hiv, udvikler en sygdom, der kaldes osteonekrose.
English: Subgroup analyses testing for heterogeneity of once versus twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Danish: Subgruppe-analyse for heterogenitet af dosering 1 gang daglig versus 2 gange daglig viste ingen signifikant effekt af køn, alder eller virusbelastning ved randomisering.
English: Number of Baseline Mutations1
Danish: Antal baseline-mutationer1
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: Do not take Kivexa:
Danish: Tag ikke Kivexa:
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
Danish: • lavt antal røde blodceller (anæmi) eller lavt antal hvide blodceller (neutropeni)
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 7-8 gange i abacavirs følsomhed, og kombinationer af tre mutationer var nødvendig for at give mere end en 8 gange ændring i følsomhed.
English: Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Danish: Der tilrådes særlig forsigtighed i denne aldersgruppe på grund af aldersbetingede ændringer, såsom den nedsatte nyrefunktion og ændringer i hæmatologiske parametre.
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Kivexa tablets
Danish: • For at undgå genoptagelse af abacavir-behandling bør patienter, der har oplevet en formodet overfølsomhedsreaktion, instrueres i at bortskaffe deres resterende Kivexa-tabletter.
English: Therapy should be prescribed by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør ordineres af en læge med erfaring i behandling af hiv-infektion.
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Danish: Lægen vil undersøge, om dine bivirkninger skyldtes en overfølsomhedsreaktion.
English: Patients should be advised that Kivexa 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 Kivexa eller anden antiretroviral kombinationsbehandling ikke helbreder hiv-infektion og at der fortsat kan udvikles opportunistiske infektioner og andre komplikationer af hivinfektionen.
English: Kivexa contains abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Kivexa.
Danish: Kivexa indeholder abacavir og lamivudin, og derfor er interaktioner, påvist individuelt for disse, relevante for Kivexa.