FrancophonIA/ELRC3.0 huggingface dataset:
English: This potential difference is sufficiently small to draw an overall conclusion of noninferiority of abacavir once daily over abacavir twice daily.
Danish: Denne potentielle forskel er tilstrækkelig lille til at drage en overordnet konklusion om ikke-inferioritet af abacavir én gang daglig over for abacavir 2 gange daglig.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion spredes ved seksuel kontakt med en person, der har infektionen, eller via smittet blod (f.eks. ved at dele nåle).
English: The absolute bioavailability of oral abacavir in adults is about 83%.
Danish: Den absolutte orale biotilgængelighed af abacavir hos voksne er ca. 83 %.
English: There was no significant difference in the time to first virologic failure (p=0.73, log-rank test) between the 2 arms.
Danish: Der var ingen signifikant forskel i tiden indtil første virologiske svigt (p = 0,73; log- rank test) mellem de to arme.
English: Hold the bottle firmly.
Danish: Hold godt fast om flasken.
English: From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Danish: Ud fra disse resultater kan det konkluderes med 95 % konfidens at den sande forskel ikke er større end 8.4 % til fordel for 2 gange daglig regimet.
English: The degree of benefit as part of a new combination regimen will depend on the nature and duration of prior therapy which may have selected for HIV-1 variants with cross-resistance to abacavir.
Danish: Hvor stor fordelen er som del af et nyt kombinationsregime vil afhænge af arten og varigheden af forudgående behandling, som eventuelt har selekteret for hiv-1-varianter med krydsresistens over for abacavir.
English: ALERT CARD TEXT SIDE 1
Danish: TEKST PÅ OPLYSNINGSKORT SIDE 1
English: If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Danish: Hvis din læge ikke træffes, skal du hurtigst muligt søge anden lægehjælp (f.eks. skadestuen på det nærmeste hospital).
English: Many of the adverse reactions have not been treatment limiting.
Danish: Mange af bivirkningerne var ikke begrænsende for behandlingen.
English: Important information about some of the other ingredients of Ziagen oral solution
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Ziagen oral opløsning
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: It also increases the CD4 cell count in your blood.
Danish: Ziagen øger også antallet af CD4-celler i dit blod.
English: You need to know about important signs and symptoms to look out for while you are taking Ziagen.
Danish: Du skal kende til vigtige tegn og symptomer, du skal holde øje med, mens du tager Ziagen.
English: Overall, these data support the use of abacavir 600 mg once daily for the treatment of HIV infected patients.
Danish: Disse data støtter brugen af abacavir 600 mg én gang daglig til behandling af hiv-inficerede patienter.
English: Ziagen helps to control your condition.
Danish: Ziagen hjælper med at holde din sygdom under kontrol.
English: Therefore Ziagen can be taken with or without food.
Danish: Derfor kan Ziagen tages med eller uden mad.
English: Long term data with abacavir used as a once daily regimen (beyond 48 weeks) are currently limited.
Danish: Langsigtede data med abacavir brugt som et én gang daglig regime (over 48 uger) er for tiden begrænsede.
English: The following convention has been used for their classification: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000) very rare (<1/10,000).
Danish: Følgende termer er anvendt til klassifikation: 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: After first opening the container: 2 months
Danish: Efter første åbning af flasken: 2 måneder.
English: No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
Danish: Der blev ikke observeret yderligere sikkerhedsproblemer hos pædiatriske patienter, som fik én eller 2 daglige doser, sammenlignet med voksne.
English: 2 to 12 years (N=14) PENTA 15 3 to 36 months (N=18)
Danish: 3 til 12 år (N=14) PENTA 15 3 til 36 måneder (N=18)
English: The data are displayed in the table below:
Danish: Disse data er vist i tabellen nedenfor:
English: If your doctor advises that you can start taking Ziagen 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 Ziagen 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: There are insufficient safety data to recommend the use of Ziagen in infants less than three months old.
Danish: Der er ikke tilstrækkelige sikkerhedsdata til at anbefale brugen af Ziagen til børn under tre måneder.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR´er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Ziagen.
Danish: Du skal straks kontakte din læge, hvis du tror, du har en overfølsomhedsreaktion over for Ziagen.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læge og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: When prescribing Ziagen, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Ved ordinering af Ziagen bør man så vidt muligt forsøge at minimere samtlige påvirkelige risikofaktorer (såsom rygning, hypertension og hyperlipidæmi).
English: However, no effects on neuropsychological performance were seen when it was administered to patients with AIDS dementia complex.
Danish: Der er dog ikke set nogen effekt på den neuropsykologiske tilstand ved administration af stoffet til patienter med aids demens kompleks.
English: Do not store above 30°C Discard two months after first opening
Danish: Må ikke opbevares ved temperaturer over 30 °C Kasseres 2 måneder efter første åbning
English: Abacavir has no effect on the metabolism of ethanol.
Danish: Abacavir har ingen indvirkning på metabolismen af ethanol.
English: Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Danish: Retinoider elimineres via alkoholdehydrogenase.
English: The results are summarised in the table below:
Danish: Resultaterne er opsummeret i tabellen nedenfor.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Danish: Ydermere kan 69-indsættelseskomplekset eller Q151M-mutationen, sædvanligvis fundet i kombination med A62V, V751, F77L og F116Y, forårsage et højt niveau af resistens over for abacavir.
English: Once Daily N (%)
Danish: Én gang daglig N (%)
English: However, both analyses were compatible with a conclusion of non-inferiority between both treatment arms.
Danish: Begge analyser var dog sammenlignelige med en konklusion af ikke-inferioritet mellem begge behandlingsarme.
English: The changes in abacavir pharmacokinetics are not considered clinically relevant.
Danish: Ændringerne af abacavirs farmakokinetik betragtes ikke som klinisk relevant.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Danish: Når sådanne personer starter behandlingen, kan gamle, skjulte infektioner blusse op igen og medføre tegn og symptomer på betændelse.
English: Other possible side effects of combination therapy for HIV
Danish: Andre bivirkninger ved kombinationsbehandling af hiv
English: As a general rule, when deciding to use antiretroviral agents for the treatment HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, both animal data as well as clinical experience in pregnant women should be taken into account.
Danish: Som en generel regel skal der, ved stillingtagen til anvendelse af antiretrovirale lægemidler ved behandling af hiv-infektion hos gravide kvinder og dermed ved reduktion af risikoen for hivoverførsel til barnet, tages højde for både dyreforsøg og klinisk erfaring hos gravide kvinder.
English: If you get any symptoms of infection while you are taking Ziagen: Tell your doctor immediately.
Danish: Hvis du får symptomer på en infektion, mens du tager Ziagen: Kontakt straks lægen.
English: Sodium hydroxide and/or hydrochloric acid for pH adjustment.
Danish: Natriumhydroxid og/eller saltsyre til justering af pH
English: In this study abacavir increased the mean methadone systemic clearance by 22%.
Danish: I studiet øgede abacavir den gennemsnitlige systemiske clearance for methadon med 22 %.
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 at danne 5′-carboxylsyre og 5′-glucuronid, som udgør ca. 66 % af den administrerede dosis.
English: Elderly No pharmacokinetic data are currently available in patients over 65 years of age.
Danish: Ældre Der foreligger på nuværende tidspunkt ingen farmakokinetiske data for patienter over 65 år.
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: 240 ml oral solution
Danish: 240 ml oral opløsning
English: Therapy Abacavir + Combivir1
Danish: Abacavir + Combivir1
English: Of note, from this study clinical data were not available for children under one year old.
Danish: Bemærk, at der fra dette studie ikke er data tilgængelige for patienter under 1 år.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Danish: CD4-celler er en type hvid blodcelle, der spiller en vigtig rolle, når kroppen skal bekæmpe infektioner.
English: If you are caring for a child who is being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction.
Danish: Hvis du plejer et barn, der er i behandling med Ziagen, er det vigtigt, at du forstår oplysningerne om overfølsomhedsreaktioner.
English: Child-resistant foil blister packs (polyvinyl chloride/aluminium/paper) containing 60 tablets.
Danish: Børnesikrede folie-blisterpakninger (polyvinylchlorid/aluminium/papir) indeholdende 60 tabletter.
English: Studies in HIV infected patients have shown good penetration of abacavir into the CSF, with a CSF to plasma AUC ratio of between 30 to 44%.
Danish: Studier af hiv-inficerede patienter har vist god penetration af abacavir til cerebrospinalvæsken (CSF) med et fordelingsforhold mellem CSF og plasma AUC på mellem 30 og 44 %.
English: These results indicate that abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high test concentrations.
Danish: Resultaterne indikerer, at abacavir har et svagt potentiale for at forårsage kromosomskader både in vitro og in vivo ved høje testkoncentrationer.
English: This medicine contains the sweetener sorbitol (approximately 5g in each 15 ml dose), which may have a mild laxative effect.
Danish: Denne medicin indeholder sødestoffet sorbitol (ca. 5 g i en 15 ml dosis), der kan have en mild afførende virkning.
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 (aids) har et svækket immunsystem og har større risiko for at få alvorlige infektioner (opportunistiske infektioner).
English: Ziagen should be prescribed by physicians experienced in the management of HIV infection.
Danish: Ziagen bør ordineres af læger med erfaring i behandling af hiv-infektion.
English: The metabolites are excreted in the urine.
Danish: Metabolitterne bliver udskilt i urinen.
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Danish: 3 Antal forsøgspersoner med ≥1 thymidinanaloge mutationer (TAM'er)
English: There are no differences observed between the AUC for the tablet or solution.
Danish: Der er ikke observeret forskelle mellem AUC for tabletten eller den orale opløsning.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Afriv vedlagte oplysningskort, det indeholder vigtige oplysninger om sikkerheden
English: IMPORTANT - ALERT CARD ZIAGEN (abacavir) tablets Carry this card with you at all times
Danish: VIGTIGT − OPLYSNINGSKORT ZIAGEN (abacavir) tabletter Hav altid dette kort med dig
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 højere hyppighed af NRTI-associerede mutationer i én gang daglig versus 2 gange daglig abacavir regimet.
English: Contact your doctor immediately:
Danish: Kontakt straks lægen:
English: Nervous system disorders Common: headache
Danish: Nervesystemet Almindelig: Hovedpine
English: The scored tablets are yellow and capsule-shaped and are provided in blister packs containing 60 tablets.
Danish: Tabletterne er gule og kapselformede og fås i blisterpakninger med 60 tabletter.
English: Patients being treated with methadone and abacavir should be monitored for evidence of withdrawal symptoms indicating under dosing, as occasionally methadone re-titration may be required.
Danish: Patienter i behandling med methadon og abacavir bør monitoreres for tegn på abstinenser, der indikerer underdosering, da det af og til kan være nødvendigt at dosistitrere methadon igen.
English: Therefore, there is little potential for interactions with antiretroviral PIs and other medicinal products metabolised by major P450 enzymes.
Danish: Derfor er der et lille potentiale for interaktioner med antiretrovirale PI'er og andre lægemidler, som metaboliseres af betydende P450-enzymer.
English: • Therapy naïve adults
Danish: • Behandlingsnaive voksne
English: Ziagen contains the active ingredient abacavir.
Danish: Ziagen indeholder det aktive stof abacavir.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations of abacavir is about 1.5 hours for the tablet formulation and about 1.0 hour for the solution formulation.
Danish: Efter oral administration er den gennemsnitlige tid (tmax) til maksimale serumkoncentrationer af abacavir ca. 1,5 time for tabletterne og ca. 1,0 time for den orale opløsning.
English: Twice Daily N (%)
Danish: 2 gange daglig N (%)
English: The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Danish: Én gang daglig regimet med abacavir støttes af et 48 ugers multicenter, dobbeltblindet, kontrolleret studie (CNA30021) af 770 hiv-inficerede, behandlingsnaive voksne.
English: The pharmacokinetics of abacavir has not been studied in patients over 65 years of age.
Danish: Ældre Farmakokinetikken af abacavir er ikke undersøgt hos patienter over 65 år.
English: Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Danish: Potente enzymatiske induktorer som rifampicin, phenobarbital og phenytoin kan eventuelt nedsætte plasmakoncentrationer af abacavir lidt via deres indvirkning på UDP-glucuronyltransferaser.
English: Pregnancy Ziagen is not recommended for use during pregnancy.
Danish: Graviditet Det anbefales ikke at tage Ziagen under graviditet.
English: No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6).
Danish: Det er ikke muligt at give en definitiv doseringsanbefaling til patienter med let nedsat leverfunktion (Child-Pugh score 5-6).
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ziagen.
Danish: Husk at fortælle det til lægen eller på apoteket, hvis du begynder at tage anden medicin, mens du er i behandling med Ziagen.
English: Glyceryl triacetate
Danish: Glyceryltriacetat
English: Abacavir and its metabolites are excreted into the milk of lactating rats.
Danish: Abacavir og metabolitter heraf udskilles i mælken hos diegivende rotter.
English: You are more likely to develop such a reaction if you have the HLA-B*5701 gene (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: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when abacavir was combined with tenofovir disoproxil fumarate and lamivudine as a once daily regimen.
Danish: Der er rapporteret om høj hyppighed af virologisk svigt og forekomst af resistens på et tidligt stadie, når abacavir kombineres med tenofovirdisoproxilfumerat og lamivudin som et én gang daglig regime.
English: Some people taking Ziagen for HIV are more at risk of serious side effects.
Danish: Nogle personer, der tager Ziagen mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: Following intravenous administration, the apparent volume of distribution was about 0.8 l/kg, indicating that abacavir penetrates freely into body tissues.
Danish: Efter intravenøs administration var det tilsyneladende fordelingsvolumen ca. 0,8 l/kg, hvilket tyder på, at abacavir nemt trænger ud i kropsvæv.
English: The Cmax value for the oral solution is slightly higher than the tablet.
Danish: Cmax værdien for den orale opløsning er lidt højere end for tabletten.
English: Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen 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 Ziagen til patienter i kliniske studier.
English: Children less than three months of age: The clinical experience in children aged less than three months is limited and are insufficient to propose specific dosage recommendations (see section 5.2).
Danish: Børn under tre måneder: Den kliniske erfaring med behandling af børn under tre måneder er begrænset og utilstrækkelig til at foreslå specifikke doseringsanbefalinger (se pkt.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Danish: Amning Kvinder, der er hiv-positive, må ikke amme deres børn, da hiv-infektionen kan overføres til barnet gennem mælken.
English: When full, the syringe contains 10 ml of solution.
Danish: Når sprøjten er fuld, indeholder den 10 ml opløsning.
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) were also similar in each group (ITT population).
Danish: Forholdene mellem hiv-1 < 50 kopier/ml (50 % versus 47 %) og < 400 kopier/ml (54 % versus 57 %) var ligeledes ensartet i hver gruppe (ITT population).
English: If you know you have this gene, tell your doctor before you take Ziagen.
Danish: Hvis du ved, at du har dette gen, skal du fortælle det til lægen, før du begynder at tage Ziagen.
English: The limited data available indicate that an oral solution dose of 2 mg/kg in neonates less than 30 days old provides similar or greater AUCs, compared to the 8 mg/kg oral solution dose administered to older children.
Danish: De begrænsede tilgængelige data indikerer, at en dosis på 2 mg/kg oral opløsning til nyfødte, der er under 30 dage gamle, giver lignende eller større AUC'er, sammenlignet med en dosis på 8 mg/kg oral opløsning givet til ældre børn.
English: Pharmacokinetic data were derived from 3 pharmacokinetic studies (PENTA 13, PENTA 15 and ARROW PK substudy) enrolling children under 12 years of age.
Danish: Farmakokinetiske data blev beregnet fra 3 farmakokinetiske studier (PENTA 13, PENTA 15 og ARROW PK substudie), som inkluderede børn under 12 år.
English: Swallow the tablets with some water.
Danish: Tabletterne skal synkes hele med vand.
English: If you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN
Danish: Hvis du stopper med at tage Ziagen på grund af en overfølsomhedsreaktion, må du ALDRIG MERE
English: Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48.
Danish: Tre patienter havde ikke-detekterbar virusmængde og én havde HIV-RNA på 900 kopier/ml plasma ved uge 48.
English: Check with your doctor if you think this applies to you.
Danish: Tal med lægen, hvis du mener, at ovenstående gælder for dig.
English: Abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Danish: Abacavir er vist at være karcinogent i dyremodeller (se pkt.
English: Subgroup analyses testing for heterogeneity of once vs twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Danish: Subgruppe-analyse for heterogenicitet af én daglig dosis vs. 2 daglige doser viste ingen signifikant effekt af køn, alder eller virusmængde ved randomisering.
English: This conclusion is based on the physiochemical and pharmacokinetic data, assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Danish: Dette er baseret på fysiskkemiske og farmakokinetiske data og forudsætter, at patienten opblander hele tabletten og at hele mængden indtages straks.
English: Patients receiving Ziagen or any other antiretroviral therapy may still develop opportunistic infections and other complications of HIV infection.
Danish: Patienter, der får Ziagen eller anden antiretroviral behandling, kan fortsat få opportunistiske infektioner eller andre komplikationer af hiv-infektionen.
English: Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and
Danish: Ziagen er indiceret til antiretroviral kombinationsbehandling af humant immundefektvirus (hiv)infektion hos voksne, unge og børn (se pkt.
English: For many adverse reactions reported, it is unclear whether they are related to Ziagen, to the wide range of medicinal products used in the management of HIV infection or as a result of the disease process.
Danish: For mange rapporterede bivirkninger er det uklart, om de skyldes Ziagen, den vide udstrækning af lægemidler, der bruges ved behandling af hiv-infektion, eller er et resultat af sygdomsprocessen.