FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Patienterne bør informeres om tegn og symptomer samt monitoreres nøje for hudreaktioner.
English: The resistance in antiretroviral treatment experienced patients mainly occurs by accumulation of the major and minor resistance substitutions described previously to be involved in protease inhibitor resistance.
Danish: Resistensen hos antiretroviralt behandlingserfarne patienter forekommer hovedsageligt ved akkumulering af de større og mindre resistenssubstitutioner beskrevet tidligere som værende involverede i proteasehæmmerresistens.
English: Assessment of adverse reactions for atazanavir is based on safety data from clinical studies and postmarketing experience.
Danish: Evalueringen af atazanavir' bivirkninger er baseret på sikkerhedsdata fra kliniske studier og på erfaring efter markedsføring.
English: Following a possible decrease in atazanavir exposure during the second and third trimester, atazanavir exposures might increase during the first two months after delivery (see section 5.2).
Danish: Efter et muligt fald i eksponering for atazanavir i andet og tredje trimester kan eksponeringen for atazanavir muligvis øges i de første to måneder efter fødslen (se pkt.
English: Clinical results
Danish: Kliniske resultater
English: No teratogenic effects were observed in rats or rabbits at maternally toxic doses.
Danish: Der sås ingen teratogen effekt hos rotter eller kaniner ved maternelle toksiske doser.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer ikke reproduktionstoksicitet (se pkt.
English: For children (6 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Danish: Til børn (mellem 6 og 18 år) vil barnets læge beslutte, hvilken dosis der skal anvendes ud fra barnets vægt.
English: Treatment of overdose with atazanavir should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Danish: Behandling af overdosering med atazanavir bør bestå af generelt understøttende tiltag, inklusive monitorering af vitale tegn og elektrokardiogram (ekg) samt observation af patientens kliniske status.
English: NA = not applicable.
Danish: NA = ikke relevant.
English: Analyses of data through 96 weeks of treatment demonstrated durability of antiviral activity (Table 5).
Danish: En analyse af data indsamlet over 96 behandlingsuger viste varigheden af den antivirale aktivitet (tabel
English: Per protocol analysis: Excluding non-completers and patients with major protocol deviations.
Danish: e Per protokol analyse: Undtagen patienter, der ikke fuldførte behandlingen, og patienter med store protokolafvigelser.
English: The signs may be a mild yellowing of the skin or eyes.
Danish: Symptomerne kan være svag gul-farvning af hud og øjne.
English: Food effect
Danish: Fødepåvirkning
English: Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Danish: Uomdannet lægemiddel udgjorde henholdsvis cirka 20% og 7% af den administrerede dosis i fæces og urin.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af Modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Dose reduction of atazanavir is not recommended because it may result in a loss of therapeutic effect and development of resistance.
Danish: Det kan ikke anbefales at reducere dosis af atazanavir, da det kan medføre tab af terapeutisk virkning og udvikling af resistens.
English: Pregnancy and postpartum
Danish: Graviditet og post partum
English: Caution should be used with medicinal products known to induce PR prolongations.
Danish: Der bør udvises forsigtighed med lægemidler, der er kendt for at inducere PR-forlængelse.
English: Do not open the capsules.
Danish: Kapslerne må ikke åbnes.
English: To enhance bioavailability and minimise variability, atazanavir is to be taken with food.
Danish: For at øge biotilgængelighed og minimere variabilitet, skal atazanavir tages sammen med et måltid.
English: Tell your doctor immediately if you develop any of the following serious side effects:
Danish: Fortæl det straks til lægen, hvis du får en eller flere af følgende bivirkninger:
English: It is important to note that at time of the 96-week analysis, 48 % of patients overall remained on study.
Danish: Det er vigtigt at bemærke, at 48% af det samlede antal patienter i studiet fortsatte efter 96-ugersanalysen.
English: No dosage adjustment is needed.
Danish: Dosisjustering er ikke påkrævet.
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if atazanavir is co-administered with clarithromycin.
Danish: Der kan ikke gives anbefalinger vedrørende dosisreduktion; der bør derfor udvises forsigtighed, hvis atazanavir administreres samtidig med clarithromycin.
English: uncommon: hypertension
Danish: ikke almindelig: hypertension
English: A dose equivalent to famotidine 40 mg twice daily should not be exceeded.
Danish: En dosis, der svarer til 40 mg famotidin 2 gange dagligt bør ikke overskrides.
English: A study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Danish: Der er gennemført farmakokinetisk studier af atazanavir på 59 raske mandlige og kvindelige forsøgspersoner (29 unge, 30 ældre).
English: Two minor metabolites of atazanavir in plasma have been characterised.
Danish: Der er karakteriseret to mindre metabolitter af atazanavir i plasma.
English: Caution is warranted and therapeutic concentration monitoring is recommended when available.
Danish: Der bør udvises forsigtighed, og monitorering af terapeutiske koncentrationer anbefales, hvis dette er muligt.
English: The safety profile in these studies was overall comparable to that seen in previous paediatric and adult studies.
Danish: Sikkerhedsprofilen i disse studier var overordnet set sammenlignelig med den, der blev set i tidligere studier med pædiatriske og voksne patienter.
English: For randomised patients, the mean time of prior antiretroviral exposure was 138 weeks for PIs, 281 weeks for NRTIs, and 85 weeks for NNRTIs.
Danish: For randomiserede patienter var middeltiden for tidligere antiretroviral eksponering 138 uger for PIer, 281 uger for NRTIer og 85 uger for NNRTIer.
English: • Yellowing of your skin or the white part of your eyes caused by high levels of bilirubin in your blood has been commonly reported.
Danish: Gulfarvning af huden eller det hvide i øjnene på grund af højt indhold af bilirubin i blodet er hyppigt rapporteret.
English: If genotyping is not feasible, full monitoring of safety and efficacy should be performed.
Danish: Hvis genotypebestemmelse ikke er mulig, skal der udføres komplet monitorering af virkning og bivirkninger.
English: common: ocular icterus
Danish: almindelig: okulær icterus
English: Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
Danish: Både asymptomatisk atrioventrikulært blok af 1. grad (23%) og 2. grad (1%) blev rapporteret hos pædiatriske patienter.
English: The use of atazanavir in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Danish: Anvendelse af Atazanavir Mylan til børn under 3 måneder og som vejer under 5 kg, er ikke blevet undersøgt på grund af risikoen for alvorlige komplikationer.
English: If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4).
Danish: Hvis behandling med atorvastatin anses for at være absolut nødvendig, skal den lavest mulige dosis af atorvastatin administreres med omhyggelig monitorering af bivirkninger (se pkt.
English: QT prolongation
Danish: QT-forlængelse
English: Atazanavir 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Danish: Atazanavir 300 mg med ritonavir 100 mg giver muligvis ikke tilstrækkelig eksponering for atazanavir, specielt i de tilfælde hvor aktiviteten af atazanavir eller af hele regimet er kompromitteret på grund af resistens.
English: Atazanavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Danish: Atazanavir bør administreres 2 timer før eller 1 time efter antacida eller lægemidler med buffer.
English: Amiodarone, Systemic lidocaine, Quinidine
Danish: Amiodaron Systemisk lidocain Quinidin
English: It is one of a group called protease inhibitors.
Danish: Det tilhører en gruppe lægemidler, der kaldes proteasehæmmere.
English: Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and atazanavir is not expected to significantly alter the exposure of the co-administered medicinal products.
Danish: Baseret på disse data, og fordi ritonavir ikke forventes at have signifikant effekt på NRTI'ernes farmakokinetik, forventes samtidig administration af disse lægemidler og atazanavir ikke at påvirke lægemidlernes eksponering signifikant.
English: The study assessed 40 infants who received antiretroviral prophylactic treatment (which did not include atazanavir) and were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.
Danish: I studiet indgik 40 spædbørn, som fik profylaktisk antiretroviral behandling (som ikke omfattede atazanavir), og som var negative for HIV-1-dna på fødselstidspunktet og/eller i de første 6 måneder efter fødslen.
English: Week 48: 1.7% [-3.8%, 7.1%] Week 96: 6.1% [0.3%, 12.0%]
Danish: Uge 48: 1.7% [-3.8%, 7.1%] Uge 96: 6.1% [0.3%, 12.0%]
English: It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).
Danish: Det er vigtigt at informere lægen, hvis du bruger fluticason eller budesonid (tages gennem næsen eller indåndes, og bruges til at behandle overfølsomhedssymptomer eller astma).
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Danish: Øget klinisk monitorering og monitorering af laboratorieprøver for HIVsuppression er påkrævet.
English: Laboratory abnormalities
Danish: Laboratoriemæssige abnormaliteter
English: A large prospective observational study has shown an association between an increased incidence of chronic kidney disease and cumulative exposure to atazanavir/ritonavir-containing regimen in HIV-infected patients with an initially normal eGFR.
Danish: Et stort prospektivt observationsstudie har vist en sammenhæng mellem øget forekomst af kronisk nyresygdom og kumulativ eksponering for atazanavir/ritonavir-indeholdende behandlingsregimer hos hiv-patienter med initial normal eGFR.
English: Atazanavir given without ritonavir should not be used in pregnant patients given that it could result of suboptimal exposure of particular concern for the mother infection and vertical transmission.
Danish: Atazanavir uden ritonavir bør ikke anvendes til gravide patienter, da det kan medføre suboptimal eksponering, hvilket giver anledning til særlig bekymring for moderens infektion og vertikal transmission.
English: The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinaemia) and therefore is not recommended.
Danish: Brug af højere doser ritonavir kan ændre sikkerhedsprofilen for atazanavir (kardielle virkninger, hyperbilirubinæmi) og kan derfor ikke anbefales.
English: Further dosage reduction of rifabutin to 150 mg twice weekly on set days is recommended for patients in whom the 150 mg dose 3 times per week is not tolerated.
Danish: Yderligere reduktion af rifabutindosis til 150 mg 2 gange ugentligt på fastsatte dage anbefales til patienter, der ikke tolererer 150 mg 3 gange ugentligt.
English: Table 5: Efficacy Outcomes in Study 138
Danish: Tabel 5: Effektresultater i Studie 138a Parameter
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%- 89%).
Danish: Plasmaniveauet af fluticasonpropionat øges signifikant hvorimod intrinsic kortisol-niveauer falder med ca. 86% (90% KI 82%
English: Asymptomatic PR interval prolongation was more frequent in paediatric patients than adults.
Danish: Asymptomatisk forlængelse af PR-intervallet forekom hyppigere hos pædiatriske patienter end hos voksne.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products (see section 4.8).
Danish: I tilfælde af samtidig antiviral behandling ved hepatitis B eller C, henvises der også til de relevante produktresuméer for disse lægemidler (se pkt.
English: Patients co-infected with hepatitis B and/or hepatitis C virus
Danish: Patienter med samtidig hepatitis B- og/eller hepatitis C-virusinfektion
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CI
Danish: Tidsgennemsnitlig forskel ATV/RTV-LPV/RTV [97.5% KId]
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingseffekt, mens der ikke er tydelig evidens for relation mellem vægtøgning og en specifik behandling.
English: The clinical data derived from this study are inadequate to support the use of atazanavir (with or without ritonavir) in children below 6 years of age.
Danish: Der er ikke tilstrækkelige kliniske data fra dette studie til at understøtte brugen af atazanavir (med eller uden ritonavir) hos børn under 6 år.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: Hvis du bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet, skal du straks informere din læge, så du kan få den nødvendige behandling.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
Danish: Der har været rapporter om øget blødning, inklusive spontane hudhæmatomer og hæmarthrose, hos type A og B hæmofile patienter, der havde fået behandling med proteasehæmmere.
English: Atazanavir Mylan should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Danish: Atazanavir Mylan bør ikke anvendes til børn under 3 måneder på grund af problemstillinger vedrørende sikkerhed, især på grund af den potentielle risiko for kernicterus.
English: Tell your doctor if you are using sildenafil for the treatment of erectile dysfunction.
Danish: Fortæl din læge, hvis du tager sildenafil til behandling af erektil dysfunktion.
English: A change in dose may occur when switching between other formulations and capsules.
Danish: Det er muligt at dosis skal ændres i forbindelse med et skift fra andre formuleringer til kapsler.
English: Store below 25ºC.
Danish: Opbevares under 25 ºC.
English: An initial dose reduction of diltiazem by 50% is recommended, with subsequent
Danish: Initial dosisreduktion af diltiazem på 50% med efterfølgende titrering efter behov samt ekgmonitorering anbefales.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede eksisterende leverdysfunktion, inklusive kronisk, aktiv hepatitis, har en øget forekomst af abnorm leverfunktion under antiretroviral kombinationsbehandling og bør monitoreres i overensstemmelse med standardpraksis.
English: A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
Danish: Reduktion af clarithromycindosis kan medføre subterapeutiske koncentrationer af 14-OHclarithromycin.
English: The increased incidence of benign hepatic adenomas in female mice was likely secondary to cytotoxic liver changes manifested by single-cell necrosis and is considered to have no relevance for humans at intended therapeutic exposures.
Danish: Den øgede incidens af benigne hepatiske adenomer hos hunmus var sandsynligvis sekundære til cytotoksiske leverforandringer manifesteret ved enkeltcellenekrose og anses ikke for at være relevante for mennesker ved planlagte terapeutiske doser.
English: The rash usually disappears within 2 weeks without any change to your treatment.
Danish: Udslættet forsvinder som regel inden for 2 uger uden at atazanavir-behandlingen ændres.
English: Intent-to-treat analysis, with missing values considered as failures.
Danish: d Intent-to-treat analyse hvor manglende værdier anses som svigt.
English: Although this study presented some limitations (i.e., unbound drug concentrations not studied), results suggested that the atazanavir pharmacokinetic parameters were decreased by 30% to 50% in patients undergoing haemodialysis compared to patients with normal renal function.
Danish: Selvom dette studie havde nogle begrænsninger (f.eks. blev koncentrationen af ubundet lægemiddel ikke undersøgt), antydede resultaterne at de farmakokinetiske parametre for atazanavir blev nedsat med 30-50% hos patienter i hæmodialysebehandling i forhold til patienter med en normal nyrefunktion.
English: Since atazanavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
Danish: Da atazanavir i udtalt grad metaboliseres i leveren og er udtalt proteinbundet, er det usandsynligt, at dialyse i signifikant grad kan bidrage til fjernelse af dette lægemiddel.
English: A population pharmacokinetic analysis of samples from Phase II clinical trials indicated no effect of race on the pharmacokinetics of atazanavir.
Danish: En befolkningsmæssig farmakokinetisk analyse af prøver fra fase II kliniske afprøvninger indikerede ingen racemæssig indvirkning på farmakokinetikken for atazanavir.
English: Your doctor has prescribed Atazanavir Mylan for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
Danish: Lægen har ordineret Atazanavir Mylan til dig, fordi du er smittet med HIV, som fører til aids (acquired immunodeficiency syndrom - erhvervet immundefektsyndrom).
English: The recommended standard treatment is atazanavir boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Danish: Den anbefalede standardbehandling er atazanavir boostet med ritonavir, hvilket sikrer optimale farmakokinetiske parametre og et optimalt niveau af virologisk suppression.
English: In previous studies, the pharmacokinetics of atazanavir was not altered by rifabutin.
Danish: I tidligere studier blev atazanavirs farmakokinetik ikke ændret af rifabutin.
English: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Danish: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Holland
English: While it may contribute to decreased susceptibility to atazanavir when it occurs with other protease substitutions, in clinical studies N88S by itself does not always lead to phenotypic resistance to atazanavir or have a consistent impact on clinical efficacy.
Danish: Mens det kan bidrage til nedsat følsomhed over for atazanavir, når det forekommer med andre proteasesubstitutioner, har N88S i kliniske studier for sig selv ikke altid medført fænotyperesistens over for atazanavir eller konsekvent påvirket den kliniske effekt.
English: • Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Danish: Ændringer i hjertets måde at slå på (hjerterytmeændringer) kan i nogle tilfælde opstå.
English: Atazanavir was negative in an Ames reverse-mutation assay but did induce chromosomal aberrations in vitro in both the absence and presence of metabolic activation.
Danish: Atazanavir var negativ i Ames reverse-mutationsbestemmelse, men inducerede kromosomale afvigelser in vitro både ved fravær og tilstedeværelse af metabolisk aktivering.
English: Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
Danish: Kronisk nyresygdom hos hiv-inficerede patienter behandlet med atazanavir, med eller uden ritonavir, er blevet rapporteret under post-marketing-overvågning.
English: • that co-administration with famotidine is not recommended but if required, atazanavir without ritonavir should be administered either 2 hours after famotidine or 12 hours before.
Danish: at administration sammen med famotidin frarådes, men om nødvendigt kan atazanavir uden ritonavir administreres enten 2 timer efter famotidin eller 12 timer før.
English: Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem atazanavir og andre lægemidler angives i tabellerne neden for (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”).
English: Store in the originalpackage in order to protect from moisture.
Danish: Opbevares i den originale pakning for at beskytte mod fugt.
English: FC susceptibility in cell culture relative to the wild-type reference was assayed using PhenoSense
Danish: FC følsomhed i cellekulturer hvad angår vildtypereference blev testet ved hjælp af PhenoSenseTM
English: The use of Atazanavir Mylan with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Danish: Brug af Atazanavir Mylan med ritonavir kan overvejes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko.
English: In this way Atazanavir Mylan reduces the risk of developing illnesses linked to HIV infection.
Danish: På denne måde nedsætter Atazanavir Mylan risikoen for at udvikle sygdomme forbundet med HIV-infektion.
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, atazanavir/ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Danish: Baseret på data fra andre boostede PI'er og ketoconazol, hvor ketoconazol-AUC viste en 3-fold stigning, forventes atazanavir /ritonavir at øge ketoconazol- og itraconazol-koncentrationerne.
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of atazanavir is based on data from the open- label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Danish: Vurdering af farmakokinetik, sikkerhed, tolerabilitet og virkning af atazanavir er baseret på data fra et åbent, klinisk multicenterstudie (A1424-020), der blev udført med patienter i alderen 3 måneder til 21 år.
English: Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
Danish: Atazanavir øgede opaciteten af bovine corneae i et in vitro okulær irritationsstudie, hvilket tyder på at det kan være en okulær irritant ved direkte kontakt med øjet.