natgillin/translations-raw huggingface dataset:
d Intent-to-treat analyse hvor manglende værdier anses som svigt. 
Intent-to-treat analysis, with missing values considered as failures.
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. 
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.
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. 
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.
En befolkningsmæssig farmakokinetisk analyse af prøver fra fase II kliniske afprøvninger indikerede ingen racemæssig indvirkning på farmakokinetikken for atazanavir. 
A population pharmacokinetic analysis of samples from Phase II clinical trials indicated no effect of race on the pharmacokinetics of atazanavir.
Lægen har ordineret Atazanavir Mylan til dig, fordi du er smittet med HIV, som fører til aids (acquired immunodeficiency syndrom - erhvervet immundefektsyndrom). 
Your doctor has prescribed Atazanavir Mylan for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
Den anbefalede standardbehandling er atazanavir boostet med ritonavir, hvilket sikrer optimale farmakokinetiske parametre og et optimalt niveau af virologisk suppression. 
The recommended standard treatment is atazanavir boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
I tidligere studier blev atazanavirs farmakokinetik ikke ændret af rifabutin. 
In previous studies, the pharmacokinetics of atazanavir was not altered by rifabutin.
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Holland 
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands
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. 
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.
Ændringer i hjertets måde at slå på (hjerterytmeændringer) kan i nogle tilfælde opstå. 
• Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Atazanavir var negativ i Ames reverse-mutationsbestemmelse, men inducerede kromosomale afvigelser in vitro både ved fravær og tilstedeværelse af metabolisk aktivering. 
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.
Kronisk nyresygdom hos hiv-inficerede patienter behandlet med atazanavir, med eller uden ritonavir, er blevet rapporteret under post-marketing-overvågning. 
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
at administration sammen med famotidin frarådes, men om nødvendigt kan atazanavir uden ritonavir administreres enten 2 timer efter famotidin eller 12 timer før. 
• 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.
Interaktioner mellem atazanavir og andre lægemidler angives i tabellerne neden for (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”). 
Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Opbevares i den originale pakning for at beskytte mod fugt. 
Store in the originalpackage in order to protect from moisture.
FC følsomhed i cellekulturer hvad angår vildtypereference blev testet ved hjælp af PhenoSenseTM 
FC susceptibility in cell culture relative to the wild-type reference was assayed using PhenoSense
Brug af Atazanavir Mylan med ritonavir kan overvejes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko. 
The use of Atazanavir Mylan with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
På denne måde nedsætter Atazanavir Mylan risikoen for at udvikle sygdomme forbundet med HIV-infektion. 
In this way Atazanavir Mylan reduces the risk of developing illnesses linked to HIV infection.
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. 
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.
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. 
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.
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. 
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.
Tabel 7: Effektparametre (pædiatriske patienter fra 6 år til under 18 år) ved uge 48 ( A1424020 studie) 
Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020) Parameter
A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE 
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Farmakokinetik for atazanavir udviser en ikke-lineær disposition. 
The pharmacokinetics of atazanavir exhibit a non-linear disposition.
Hyppighed de novo PI substitution (n=35)a,b 
Frequency de novo PI substitution (n=35)
Patienterne skal informeres om at søge læge, hvis de oplever ømme og smertende led, ledstivhed eller bevægelsesbesvær. 
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Interaktionsmekanismen mellem atazanavir og tenofovirdisoproxilfumarat er ukendt. 
The mechanism of interaction between atazanavir and tenofovir disoproxil fumarate is unknown.
Atazanavir bør ikke anvendes i kombination med lægemidler, der er CYP3A4-substrater, og som har et snævert terapeutisk indeks. 
Atazanavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Se også PULMONAL ARTERIEL HYPERTENSION i denne tabel for yderligere information om samtidig administration af atazanavir og sildenafil. 
Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of atazanavir with sildenafil.
Fluvastatin metaboliseres delvist af CYP2C9. 
Fluvastatin is partially metabolised by CYP2C9.
hvis du har moderate eller svære leverproblemer. 
• if you have moderate to severe liver problems.
Hos raske forsøgspersoner var den renale udskillelse af uomdannet atazanavir cirka 7% af den administrerede dosis. 
In healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
N88S-substitution er i sjældne tilfælde set hos patienter med virologisk svigt ved atazanavirbehandling (med eller uden ritonavir). 
The N88S substitution has been rarely observed in patients with virologic failure on atazanavir (with or without ritonavir).
Stoffet blokerer bearbejdningen af virale gag-pol-proteiner i HIV-1 inficerede celler og hindrer dermed dannelsen af modne virioner og infektion af andre celler. 
The compound selectively inhibits the virusspecific processing of viral Gag-Pol proteins in HIV- 1 infected cells, thus preventing formation of mature virions and infection of other cells.
ikke almindelig: dyspnø 
uncommon: dyspnoea
Pædiatriske patienter (fra 6 år til under 18 år og med en legemsvægt på mindst 15 kg): Doseringen af atazanavir -kapsler til pædiatriske patienter bestemmes ud fra legemsvægten som vist i tabel 1 og bør ikke overskride den anbefalede dosis for voksne. 
Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg): The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
PULMONAL ARTERIEL HYPERTENSION PDE5-hæmmere 
PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Det vides ikke, om Atazanavir Mylan med ritonavir administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn. 
It is not known whether Atazanavir Mylan with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Studier på mennesker og in vitro-studier med brug af humane levermikrosomer har vist, at atazanavir hovedsagelig metaboliseres til oxygenerede metabolitter af CYP3A4-isozymer. 
Studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Under forsøg på at kompensere for den nedsatte eksponering ved at øge dosis af atazanavir, eller andre proteasehæmmere med ritonavir, er der set en høj frekvens af leverreaktioner. 
During attempts to overcome the decreased exposure by increasing the dose of atazanavir or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Atazanavir-koncentrationen (når det gives med ritonavir) påvirkes ikke signifikant. 
Concentrations of atazanavir (when given with ritonavir) were not significantly affected.
Atazanavir bindes med cirka 86% til humane serumproteiner over et koncentrationsinterval på 100 til 10.000 ng/ml. 
Atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Ingen af de novo substitutionerne (se tabel 4) er specifikke for atazanavir og kan være et tegn på tilbagevendende forekomst af arkiveret resistens over for atazanavir + ritonavir i den behandlingserfarne population fra studie 045. 
None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect re-emergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population.
Mekanismen bag dette fald er ukendt (se pkt. 
The mechanism of this decrease is unknown.
Farmakoterapeutisk klassifikation: Antivirale midler, ATC-kode: J05AE08 
Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Der er risiko for manglende terapeutisk effekt og resistensudvikling (se pkt. 
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
En risiko for yderligere fald i eksponering for atazanavir er forventelig, når atazanavir administreres sammen med lægemidler, der er kendt for at reducere dets eksponering (f.eks. tenofovirdisoproxil eller H2-receptorantagonister). 
The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Øget overvågning for rifabutinassocierede bivirkninger inklusive neutropeni og uveitis er påkrævet pga. en forventet øget rifabutineksponering. 
Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Atazanavir bindes til både alfa-1-acid glykoprotein (AAG) og albumin i samme udstrækning (henholdsvis 89% og 86% ved 1.000 ng/ml). 
Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Under HIV-behandling kan der forekomme vægtstigning samt forhøjede niveauer af lipider og glucose i blodet. 
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Data vedrørende samtidig brug af parenteral midazolam og andre proteasehæmmere tyder på en mulig 3-4 gange stigning i midazolamplasmaniveauet. 
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
ANTIEPILEPTIKA Carbamazepin 
ANTIEPILEPTICS Carbamazepine
Hvis atazanavir administreres sammen med parenteral midazolam, bør dette foregå på en intensivafdeling eller tilsvarende afdeling, som sikrer tæt klinisk monitorering og relevant behandling i tilfælde af respirationsdepression og/eller forlænget sedering. 
If atazanavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Mylan Hungary Kft H-2900 Komárom, Mylan utca 1 Ungarn 
Mylan Hungary Kft H-2900 Komárom, Mylan utca 1 Hungary
Hos børn, der er i behandling med Atazanavir Mylan, kan det være nødvendigt at overvåge hjertet. 
Children receiving Atazanavir Mylan may require their heart to be monitored.
På baggrund af eksisterende virologiske og kliniske data for voksne patienter forventes der ikke gavnlig effekt hos patienter med stammer, der er resistente over for flere proteasehæmmere (4 PImutationer). 
Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).
Dosisjustering er ikke nødvendig for raltegravir. 
No dose adjustment required for raltegravir.
almindelig: træthed ikke almindelig: brystsmerter, ubehag, pyreksi, asteni sjælden: gangforstyrrelser a Disse bivirkninger blev identificeret under post-marketing-overvågning, men hyppigheden er dog estimeret ud fra en statistisk beregning baseret på det totale antal patienter, der har været eksponeret for atazanavir i randomiserede, kontrollerede og andre tilgængelige kliniske studier (n = 2.321). 
common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir in randomised controlled and other available clinical trials (n = 2321).
Der er ikke set signifikant effekt på atazanavir-koncentrationen ved samtidig administration af enteroovertrukken didanosin, men administration sammen med mad reducerer didanosin-koncentrationen. 
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
I den præ- og postnatale udviklingsvurdering hos rotter, frembragte atazanavir en forbigående reduktion i legemsvægten hos afkommet ved en maternel toksisk dosis. 
In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Leverproblemer kan forekomme mindre hyppigt. 
• Liver problems may uncommonly happen.
Rifampicin er en kraftig CYP3A4induktor og er vist at reducere atazanavirs AUC med 72%, hvilket kan medføre virologisk svigt og resistensudvikling. 
Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Atazanavir er en azapeptid HIV-1-proteasehæmmer (PI). 
Atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
I disse studier blev forhøjede ALAT-niveauer rapporteret hyppigere hos pædiatriske patienter end hos voksne. 
Elevation in ALT levels were more frequently reported in paediatric patients in these studies than in adults.
Med hensyn til monitorering af lipider og glucose i blodet refereres til eksisterende behandlingsguidelines for HIV. 
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Atazanavir er påvist i human mælk. 
Atazanavir has been detected in human milk.
Det er vigtigt at nævne, at mange studier er udført med ikke-boostet atazanavir, hvilket ikke er det anbefalede atazanavir-regime (se pkt. 
Of importance, many studies were conducted with unboosted atazanavir, which is not the recommended regimen of atazanavir (see section 4.4).
Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Ungarn 
Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Hungary
I nogle tilfælde er nefrolitiasis blevet forbundet med akut nyresvigt eller nyreinsufficiens. 
In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
ANTIPSYKOTIKA Quetiapin 
ANTIPSYCHOTICS Quetiapine
M184I/V substitution opstod hos henholdsvis 5/26 atazanavir/ritonavir og 7/26 lopinavir/ritonavir patienter med virologisk svigt. 
The M184I/V substitution emerged in 5/26 Atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Om nødvendigt bør serumkoncentrationen af carbamazepin monitoreres og dosis justeres i henhold hertil. 
If necessary, monitor carbamazepine serum concentrations and adjust the dose accordingly.
Om nødvendigt bør koncentrationen af lamotrigin monitoreres og dosis justeres i henhold hertil. 
If necessary, monitor lamotrigine concentrations and adjust the dose accordingly.
Udslæt og relaterede syndromer 
Rash and associated syndromes
Der findes ingen specifik antidot for overdosering med atazanavir. 
There is no specific antidote for overdose with atazanavir.
Atazanavir + saquinavir er vist at være ringere end lopinavir + ritonavir. 
Atazanavir + saquinavir was shown to be inferior to lopinavir + ritonavir.
Patientens virologiske respons bør følges tæt. 
Close monitoring of patient's virologic response should be exercised.
Data fra anvendelse af atazanavir hos et begrænset antal gravide kvinder (mellem 300-1000) indikerer ingen misdannelser. 
A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir.
Producent 
Manufacturer
Anbefalinger ved samtidig administration 
Recommendations concerning co-administration
Interaktion 
Interaction
Hvis patienten har udviklet SJS eller DRESS under behandling med atazanavir, bør atazanavir-behandling ikke genoptages. 
If the patient has developed SJS or DRESS associated with the use of atazanavir, atazanavir may not be restarted.
Hvis du har taget for mange Atazanavir Mylan -kapsler Der kan ske gulfarvning af huden/øjnene (gulsot) og uregelmæssig hjerterytme (QTc-forlængelse) kan forekomme, hvis du eller dit barn har taget for meget Atazanavir Mylan. 
If you take more Atazanavir Mylan than you should Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much Atazanavir Mylan.
Potentielle kardielle virkninger ved dette produkt hos mennesker kan ikke udelukkes (se pkt. 
Potential cardiac effects of this product in humans cannot be ruled out (see sections 4.4 and 4.8).
Ritonavir 100 mg 1 gang dagligt anvendes som booster for atazanavirs farmakokinetik. 
Ritonavir 100 mg once daily is used as a booster of atazanavir pharmacokinetics.
Middelværdien for udskillelse i urinen af uomdannet lægemiddel var 7% efter 2 ugers dosering ved 800 mg én gang dagligt. 
Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Lægemidler efter terapeutisk område 
Medicinal products by therapeutic area
Mødre med hivinfektion frarådes at amme, da virus kan overføres gennem mælken. 
It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Tilsvarende atazanavirkoncentrationer øgede den potentielle virkningsvarighed (ADP90) med 13% i et studie af Purkinjefibre hos kaniner. 
Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
I in vivo-studier hos rotter inducerede atazanavir ikke mikronukleus i knoglemarv, dna-beskadigelse i duodenum (comet assay) eller uplanlagt dna-reparation i leveren ved plasma- og vævskoncentrationer, der overskrider dem, der var klastogene in vitro. 
In in vivo studies in rats, atazanavir did not induce micronuclei in bone marrow, DNA damage in duodenum (comet assay), or unscheduled DNA repair in liver at plasma and tissue concentrations exceeding those that were clastogenic in vitro.
Hvis oral kontraception administreres samtidig med atazanavir/ritonavir, anbefales det, at det indeholder mindst 30 μg ethinylestradiol, og at patienten forstår nødvendigheden af omhyggelig compliance med dette kontraceptionsmiddel. 
If an oral contraceptive is administered with atazanavir /ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Totalt fik 182 pædiatriske patienter (81 antiretroviral-naive og 101 antiretroviral-erfarne) i dette studie atazanavir en gang dagligt (kapsler eller pulverformulering) med eller uden ritonavir, i kombination med to NRTI'er. 
Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily atazanavir (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Hos antiretroviralt behandlingserfarne patienter fra studie 009, 043 og 045 blev 100 isolater fra patienter angivet som virologisk svigt under behandling, der omfattede enten atazanavir, atazanavir + ritonavir eller atazanavir + saquinavir og blev fastsat til at have udviklet resistens over for atazanavir,. 
In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Hos størstedelen af patienterne forventes en nedsat eksponering for både voriconazol og atazanavir. 
In the majority of patients, a reduction in both voriconazole and atazanavir exposures are expected.
Atazanavirs minimumkoncentration var ca. 2 gange højere i post partum perioden sammenlignet med værdierne observeret historisk hos HIV-smittede ikke-gravide patienter. 
Atazanavir plasma trough concentrations were approximately 2-fold higher during the postpartum period when compared to those observed historically in HIV infected non-pregnant patients.
Proteasehæmmere: Samtidig administration af atazanavir /ritonavir og andre proteasehæmmere er ikke undersøgt, men forventes at øge eksponeringen for andre proteasehæmmere. 
Protease inhibitors: The co-administration of atazanavir/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering. 
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported;