FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may advise you to stop taking Ziagen.
Danish: Lægen vil muligvis bede dig stoppe med at tage Ziagen.
English: In pregnant women, more than 800 outcomes after first trimester exposure and more than 1000 outcomes after second and third trimester exposure indicate no malformative and foetal/neonatal effect of abacavir.
Danish: Hos gravide kvinder, i flere end 800 tilfælde efter eksponering i første trimester og i flere end 1.000 tilfælde efter eksponering i andet og tredje trimester, var der ingen indikationer af malformative og føto/neonatal virkning af abacavir.
English: There are no data available on the safety of abacavir when administered to babies less than three months old.
Danish: Der foreligger ingen oplysninger om sikkerheden af abacavir givet til spædbørn under 3 måneder.
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 overordnet forekomst af virologisk svigt (viral load > 50 kopier/ml) både i én gang daglig og 2 gange daglig behandlingsgrupperne (henholdsvis 10 % og 8 %).
English: In patients with high viral load (>100,000 copies/ml) the choice of a triple combination with abacavir, lamivudine and zidovudine needs special consideration (see section 5.1).
Danish: Hos patienter med høj virusbyrde (> 100.000 kopier/ml) kræver valget af en tripelkombination med abacavir, lamivudin og zidovudin særlig overvejelse (se pkt.
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Danish: Nukleosid- og nukleotidanaloger in vitro og in vivo har påvist at kunne forårsage en variabel grad af mitokondriel skade.
English: Contents of the pack and other information What Ziagen contains
Danish: Pakningsstørrelser og yderligere oplysninger Ziagen indeholder
English: The safety and efficacy of Ziagen has not been established in patients with significant underlying liver disorders.
Danish: Ziagens sikkerhed og virkning er ikke blevet klarlagt hos patienter med betydende, underliggende leversygdom.
English: 1.Combivir is a fixed dose combination of lamivudine and zidovudine 2.Includes three non-virological failures and four unconfirmed virological failures.
Danish: 1 Combivir er en fastdosiskombination af lamivudin og zidovudin 2 Omfatter tre ikke-virologiske svigt og fire ubekræftede, virologiske svigt
English: These findings are not considered clinically significant.
Danish: Disse fund anses for at være uden klinisk betydning.
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Danish: Metabolitterne og uomdannet abacavir udgør ca. 83 % af den administrerede dosis abacavir i urinen.
English: Tell your doctor.
Danish: Tal med lægen.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir, zidovudine, and lamivudine.
Danish: Kliniske studier har vist, at der ikke er klinisk betydende interaktioner mellem abacavir, zidovudin og lamivudin.
English: No additional adverse reactions to those reported for normal doses were reported.
Danish: Der blev ikke rapporteret bivirkninger ud over dem, som er set efter normal dosis.
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: Abacavir is metabolised intracellularly to the active moiety, carbovir 5'- triphosphate (TP).
Danish: Abacavir bliver metaboliseret intracellulært til den aktive del, carbovir 5'- triphosphat (TP).
English: Based on limited experience Ziagen should be avoided in patients with end-stage renal disease.
Danish: Baseret på begrænset erfaring bør Ziagen undgås til patienter med nyresvigt.
English: Abacavir has also been shown in vitro not to inhibit CYP 3A4, CYP2C9 or CYP2D6 enzymes at clinically relevant concentrations.
Danish: Det er desuden vist in vitro, at abacavir ikke hæmmer CYP3A4, CYP2C9 eller CYP2D6 enzymerne i klinisk relevante koncentrationer.
English: 2 if you get symptoms from at least 2 of the following groups:
Danish: 2) du får et eller flere symptomer fra mindst TO af følgende grupper
English: Cross-resistance between abacavir and antiretrovirals from other classes (e.g. PIs or NNRTIs) is unlikely.
Danish: Der er sandsynligvis ingen krydsresistens mellem abacavir og antiretroviraler fra andre grupper (f.eks. PI'er eller NNRTI'er).
English: Ethanol: the metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%.
Danish: Metabolismen af abacavir ændres ved tilstedeværelse af ethanol, hvilket medfører en øgning i AUC af abacavir på ca. 41 %.
English: No definitive recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the 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: Dosing according to weight bands is recommended for Ziagen tablets.
Danish: Dosering af Ziagen-tabletter ud fra vægtgrupper anbefales.
English: Studies in animals showed that abacavir had no effect on fertility (see section 5.3).
Danish: Dyrestudier har vist, at abacavir ikke har nogen virkning på fertiliteten (se pkt.
English: A plastic adapter and oral dosing syringe are provided for accurate measurement of the prescribed dose of oral solution.
Danish: En plastikadapter og en doseringssprøjte er vedlagt til nøjagtig afmåling af den foreskrevne dosis oral opløsning.
English: Pharmacotherapeutic group: nucleoside reverse transcriptase inhibitors, ATC Code: J05AF06
Danish: Farmakoterapeutisk klassifikation: Nukleosid revers transkriptasehæmmere, ATC-kode: J05AF06.
English: Induction of hepatic metabolism has not been observed in clinical studies.
Danish: Der er ikke set induktion af levermetabolisme i kliniske studier.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1 RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies), showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Danish: Den logistiske regressionsmodel for den prædiktive værdi af genotype (justeret for baseline plasma hiv-1-RNA [vRNA], CD4+-celletal, antal og varighed af tidligere antiretrovirale behandlinger) viste, at tilstedeværelsen af 3 eller flere 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: Symptoms of infection and inflammation Old infections may flare up
Danish: Symptomer på infektion eller betændelseslignende reaktioner (inflammation) Gamle infektioner kan blusse op
English: Keep in touch with your doctor, and do not stop taking Ziagen without your doctor's advice.
Danish: Hold kontakt med lægen, og stop ikke med at tage Ziagen uden at tale med lægen først.
English: Hypersensitivity reactions can start at any time during treatment with Ziagen, but are more likely during the first 6 weeks of treatment.
Danish: Du kan få en overfølsomhedsreaktion på et hvilket som helst tidspunkt under behandlingen med Ziagen, men risikoen er størst i de første 6 uger af behandlingen.
English: P450 does not play a major role in the metabolism of abacavir, and abacavir does not inhibit metabolism mediated by CYP 3A4.
Danish: P450 spiller ikke en større rolle i metabolismen af abacavir, og abacavir hæmmer ikke metabolisme forårsaget af CYP 3A4.
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 klinisk grundlag, skal ABC seponeres permanent og ikke genstartes, uanset resultatet af HLAB*5701-screening.
English: The calorific value of sorbitol is 2.6 kcal/g.
Danish: Energiværdien af sorbitol er 11 kJ (2,6 kcal)/g.
English: ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/3TC/EFV vs ZDV/3TC/ABC.
Danish: ACTG5095 var et randomiseret (1:1:1), dobbeltblindet, placebokontrolleret studie med 1.147 antiretrovirale naive hiv-1-inficerede voksne, som sammenlignede tre behandlingsregimer: zidovudin (ZDV), lamivudin (3TC), abacavir (ABC) og efavirenz (EFV) versus ZDV/3TC/EFV versus ZDV/3TC/ABC.
English: The most common symptoms are: • fever (high temperature) and skin rash
Danish: De almindeligste symptomer er: • feber (høj kropstemperatur) og udslæt.
English: Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.
Danish: Screening anbefales også før re-initiering af abacavir hos patienter med ukendt HLA-B*5701-status, der tidligere har tolereret abacavir.
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Danish: Patienter bør derfor følges tæt af læger med erfaring i behandling af disse sygdomme, som ledsager hiv.
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Ziagen 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 Ziagen eller anden medicin, eller om de skyldes hiv-sygdommen i sig selv.
English: Ziagen oral solution also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Danish: Ziagen oral opløsning indeholder også methylparahydroxybenzoat og propylparahydroxybenzoat, som kan give allergiske reaktioner (muligvis forsinket).
English: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Danish: For at sikre optagelse af hele dosis bør tabletterne synkes hele og ikke knuses.
English: Summary of Stead-State Plasma Abacavir AUC (0-24) (µg.h/ml) and Statistical Comparisons for Once and Twice-Daily Oral Administration Across Studies
Danish: Opsummering af steady state abacavir-AUC (0-24) (µg∙time/ml) i plasma og statistiske sammenligninger af dosering én gang daglig og 2 gange daglig på tværs af studier
English: Ziagen is also available as a tablet formulation.
Danish: Ziagen forefindes også i tabletform.
English: The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Danish: Pakningen indeholder desuden et tilpasningsstykke af polyethylen samt en 10 ml doseringssprøjte bestående af et kammer af polypropylen (med angivelse af ml) og et stempel af polyethylen.
English: Do not take this medicine after the expiry date which is stated 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.
English: Discard oral solution two months after first opening.
Danish: Kasseres to måneder efter første åbning.
English: A small amount of the ingredients in Ziagen can also pass into your breast milk.
Danish: Indholdsstofferne i Ziagen kan også udskilles i små mængder i mælken.
English: Pancreatitis has been reported, but a causal relationship to abacavir treatment is uncertain.
Danish: Pancreatitis Pancreatitis er rapporteret, men kausal sammenhæng med abacavir er usikker.
English: Children less than three months of age: the experience in children aged less than three months is limited (see section 5.2).
Danish: Børn under tre måneder Erfaring med behandling af børn under tre måneder er begrænset (se pkt.
English: Artificial strawberry and banana flavours Purified water
Danish: Syntetisk jordbær- og banansmagsstof Renset vand
English: Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes
Danish: Antal forsøgspersoner Antal virologiske svigt
English: Abacavir was not mutagenic in bacterial tests but showed activity in vitro in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the in vivo micronucleus test.
Danish: Abacavir var ikke mutagent i bakterietests, men viste aktivitet in vitro i kromosomafvigelsesprøven med humane lymfocytter, muselymfomcelletesten og i in vivo mikronukleustesten.
English: Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the reverse transcriptase (RT) codon region (codons M184V, K65R, L74V and Y115F).
Danish: In vitro-resistens: Der er påvist abacavirresistente isolater af hiv-1 in vitro, som er forbundet med specifikke genotypeforandringer i revers transkriptase (RT)-codonregionen (codoner M184V, K65R, L74V og Y115F).
English: The bottle contains 240 ml (20 mg abacavir/ml) of solution.
Danish: Flasken indeholder 240 ml (20 mg abacavir/ml) opløsning.
English: Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: Abacavir tilhører en gruppe af lægemidler, der kaldes nukleosidanalog revers transkriptasehæmmere (NRTI'er).
English: If you have stopped taking Ziagen 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 Ziagen af en eller anden grund - særligt hvis det er, fordi du mener, at du har bivirkninger, eller fordi du har en anden sygdom:
English: Abacavir is not recommended in patients with moderate or severe hepatic impairment.
Danish: Abacavir anbefales ikke til patienter med moderat og svært nedsat leverfunktion.
English: When taken according to the dosage recommendations each 15 ml dose contains approximately 5 g of sorbitol.
Danish: Tages den orale opløsning efter doseringsanbefalingerne, indeholder hver dosis på 15 ml ca. 5 g sorbitol.
English: Additionally, the efficacy and safety of abacavir given once daily has been demonstrated in a pivotal clinical study (CNA30021See section 5.1 Clinical experience).
Danish: Derudover er effekten og sikkerheden af abacavir, givet én gang daglig, blevet demonstreret i et pivotalt klinisk studie (CNA30021- se pkt.
English: Myocardial Infarction
Danish: Myokardieinfarkt
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 30% of the body surface (toxic epidermal necrolysis)
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 % af kroppens overflade (toksisk epidermal nekrolyse)
English: Hypersensitivity to abacavir or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for abacavir eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
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: Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution.
Danish: Ziagen oral opløsning findes i high density polyethylenflasker med børnesikret låg, som indeholder 240 ml.
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Ziagen tablets
Danish: For at undgå genoptagelse af abacavir-behandling bør patienter, der har oplevet en formodet overfølsomhedsreaktion, instrueres i at bortskaffe deres resterende Ziagen-tabletter.
English: If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Danish: Hvis abacavir bruges til patienter med let nedsat leverfunktion er omhyggelig monitorering påkrævet, herunder monitorering af plasmakoncentrationen af abacavir, hvis det er muligt (se pkt.
English: If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered.
Danish: Hvis behandling med 2 daglige doser er uhensigtsmæssig, kan behandling med én daglig dosis (16 mg/kg) overvejes.
English: The mean (CV) AUC over a dosing interval of 12 hours was 6.02 µg.h/ml (29%), equivalent to a daily AUC of approximately 12.0 µg.h/ml.
Danish: Den gennemsnitlige (CV) AUC over et doseringsinterval på 12 timer var 6,02 µg·time/ml (29 %), ækvivalent med en daglig AUC på ca. 12,0 µg·time/ml.
English: Clinical relevance in human of these data is unknown.
Danish: Klinisk relevans af disse data hos mennesker er ikke kendt.
English: In reproductive toxicity studies, embryo and foetal toxicity have been observed in rats but not in rabbits.
Danish: I reproduktionstoksicitetsstudier blev der observeret embryo- og føtal-toksicitet hos rotter, men ikke hos kaniner.
English: Ziagen oral solution is clear to yellowish in colour which may turn into a brown colour over time with strawberry/banana flavouring.
Danish: Ziagen oral opløsning er en klar til gullig opløsning, der kan blive brunlig over tid, og som har jordbær/banansmag.
English: Metabolism and nutrition disorders Common: anorexia Very rare: lactic acidosis
Danish: Metabolisme og ernæring Almindelig: Appetitmangel Meget sjælden: Laktacidose
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 abacavirbehandling og risiko for myokardieinfarkt.
English: The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623' on both sides.
Danish: Gule, bikonvekse, kapselformede tabletter med delekærv, der er præget ”GX 623” på begge sider.
English: Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours.
Danish: Karcinogenicitetsstudier hos mus og rotter af oralt administreret abacavir viste en stigning i forekomsten af ond- og godartede tumorer.
English: Your doctor may need to monitor you while you are taking Ziagen.
Danish: Lægen vil eventuelt holde ekstra øje med dig, så længe du tager Ziagen.
English: A randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Danish: Randomiseret sammenligning af en behandling, som indeholdt dosering med abacavir og lamivudin én gang daglig vs. dosering 2 gange daglig blev foretaget indenfor et randomiseret, multicenter, kontrolleret studie med HIV-inficerede pædiatriske patienter.
English: Animal studies have shown toxicity to the developing embryo and foetus in rats, but not in rabbits (see section 5.3).
Danish: Dyrestudier har vist toksicitet over for det udviklende embryon og foster hos rotter, men ikke hos kaniner (se pkt.
English: -2.3% (95% CI -9.3% to +4.7%), p=0.52
Danish: -2,3 % (95 % CI -9,3 % - +4,7 %), p=0,52
English: • Therapy experienced adults
Danish: • Tidligere behandlede voksne
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Danish: Fremstiller: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Storbritannien.
English: Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW (Observed Analysis)
Danish: Virologisk respons baseret på HIV-1-RNA under 80 kopier/ml plasma ved uge 48 og uge 96 ved én gang daglig versus 2 gange daglig dosering af abacavir + lamivudin; randomisering af ARROW (observationsanalyse)
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63%, 80% and 86% for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Danish: Ved uge 48 var andelen af patienter med hiv-RNA < 50 kopier/ml 63 %, 80 % og 86 % for henholdsvis ZDV/3TC/ABC, ZDV/3TC/EFV og ZDV/3TC/ABC/EFV.
English: Triple nucleoside therapy
Danish: Tripel nukleosidterapi
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Danish: Brug doseringssprøjten til oral administration, der ligger i pakningen, til at afmåle den nøjagtige dosis.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TABLET BLISTER FOIL TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
English: After 36 weeks on a regimen including twice daily abacavir and lamivudine, 669 eligible subjects were randomised to either continue twice daily dosing or switch to once daily abacavir and lamivudine for at least 96 weeks.
Danish: Efter 36 uger på et behandlingsregime indeholdende abacavir og lamivudin 2 gange daglig blev 669 egnede patienter randomiseret til enten at fortsætte med dosering 2 gange daglig eller skifte til abacavir og lamivudin én gang daglig i minimum 96 uger.
English: Push the plastic adapter into the neck of the bottle
Danish: Sæt tilpasningsstykket af plastik i flaskehalsen.
English: In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary.
Danish: Der foreligger ingen kliniske data for patienter med moderat og svært nedsat leverfunktion, hvorfor abacavir ikke bør anvendes, medmindre det vurderes nødvendigt.
English: Children (weighing less than 25 kg):
Danish: Børn (som vejer under 25 kg):
English: Package leaflet: Information for the user Ziagen 300 mg Film-coated tablets
Danish: Indlægsseddel: Information til brugeren Ziagen 300 mg filmovertrukne tabletter
English: If you forget to take Ziagen
Danish: Hvis du har glemt at tage Ziagen
English: Ziagen film-coated tablets are engraved with ‘GX 623' on both sides.
Danish: Ziagen filmovertrukne tabletter er præget med 'GX 623' på begge sider og forsynet med delekærv.
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Danish: I et farmakokinetisk studie (PENTA 15) skiftede fire virologisk kontrollerede patienter under 12 måneder fra abacavir plus lamivudin oral opløsning to gange daglig til dosering én gang daglig.
English: Remove the syringe from the adapter Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Danish: Placer sprøjten i munden med spidsen mod indersiden af kinden.
English: Combination therapy including Ziagen may cause other conditions to develop during HIV treatment.
Danish: Kombinationsbehandling såsom Ziagen kan forårsage udvikling af andre sygdomme under behandlingen af hiv.
English: When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.
Danish: Ved skift tilbage til 2 daglige doser skal patienten tage den første af de to anbefalede daglige doser ca. 24 timer efter den sidste dosis.