FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020) Parameter
Danish: Tabel 7: Effektparametre (pædiatriske patienter fra 6 år til under 18 år) ved uge 48 ( A1424020 studie)
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The pharmacokinetics of atazanavir exhibit a non-linear disposition.
Danish: Farmakokinetik for atazanavir udviser en ikke-lineær disposition.
English: Frequency de novo PI substitution (n=35)
Danish: Hyppighed de novo PI substitution (n=35)a,b
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienterne skal informeres om at søge læge, hvis de oplever ømme og smertende led, ledstivhed eller bevægelsesbesvær.
English: The mechanism of interaction between atazanavir and tenofovir disoproxil fumarate is unknown.
Danish: Interaktionsmekanismen mellem atazanavir og tenofovirdisoproxilfumarat er ukendt.
English: Atazanavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Danish: Atazanavir bør ikke anvendes i kombination med lægemidler, der er CYP3A4-substrater, og som har et snævert terapeutisk indeks.
English: Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of atazanavir with sildenafil.
Danish: Se også PULMONAL ARTERIEL HYPERTENSION i denne tabel for yderligere information om samtidig administration af atazanavir og sildenafil.
English: Fluvastatin is partially metabolised by CYP2C9.
Danish: Fluvastatin metaboliseres delvist af CYP2C9.
English: • if you have moderate to severe liver problems.
Danish: hvis du har moderate eller svære leverproblemer.
English: In healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Danish: Hos raske forsøgspersoner var den renale udskillelse af uomdannet atazanavir cirka 7% af den administrerede dosis.
English: The N88S substitution has been rarely observed in patients with virologic failure on atazanavir (with or without ritonavir).
Danish: N88S-substitution er i sjældne tilfælde set hos patienter med virologisk svigt ved atazanavirbehandling (med eller uden ritonavir).
English: 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.
Danish: 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.
English: uncommon: dyspnoea
Danish: ikke almindelig: dyspnø
English: 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.
Danish: 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.
English: PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Danish: PULMONAL ARTERIEL HYPERTENSION PDE5-hæmmere
English: 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.
Danish: Det vides ikke, om Atazanavir Mylan med ritonavir administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Danish: Studier på mennesker og in vitro-studier med brug af humane levermikrosomer har vist, at atazanavir hovedsagelig metaboliseres til oxygenerede metabolitter af CYP3A4-isozymer.
English: 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.
Danish: 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.
English: Concentrations of atazanavir (when given with ritonavir) were not significantly affected.
Danish: Atazanavir-koncentrationen (når det gives med ritonavir) påvirkes ikke signifikant.
English: Atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Danish: Atazanavir bindes med cirka 86% til humane serumproteiner over et koncentrationsinterval på 100 til 10.000 ng/ml.
English: 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.
Danish: 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.
English: The mechanism of this decrease is unknown.
Danish: Mekanismen bag dette fald er ukendt (se pkt.
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Danish: Farmakoterapeutisk klassifikation: Antivirale midler, ATC-kode: J05AE08
English: There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Danish: Der er risiko for manglende terapeutisk effekt og resistensudvikling (se pkt.
English: 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).
Danish: 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).
English: Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Danish: Øget overvågning for rifabutinassocierede bivirkninger inklusive neutropeni og uveitis er påkrævet pga. en forventet øget rifabutineksponering.
English: Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Danish: Atazanavir bindes til både alfa-1-acid glykoprotein (AAG) og albumin i samme udstrækning (henholdsvis 89% og 86% ved 1.000 ng/ml).
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under HIV-behandling kan der forekomme vægtstigning samt forhøjede niveauer af lipider og glucose i blodet.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Danish: Data vedrørende samtidig brug af parenteral midazolam og andre proteasehæmmere tyder på en mulig 3-4 gange stigning i midazolamplasmaniveauet.
English: ANTIEPILEPTICS Carbamazepine
Danish: ANTIEPILEPTIKA Carbamazepin
English: 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.
Danish: 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.
English: Mylan Hungary Kft H-2900 Komárom, Mylan utca 1 Hungary
Danish: Mylan Hungary Kft H-2900 Komárom, Mylan utca 1 Ungarn
English: Children receiving Atazanavir Mylan may require their heart to be monitored.
Danish: Hos børn, der er i behandling med Atazanavir Mylan, kan det være nødvendigt at overvåge hjertet.
English: 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).
Danish: 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).
English: No dose adjustment required for raltegravir.
Danish: Dosisjustering er ikke nødvendig for raltegravir.
English: 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).
Danish: 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).
English: No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Danish: Der er ikke set signifikant effekt på atazanavir-koncentrationen ved samtidig administration af enteroovertrukken didanosin, men administration sammen med mad reducerer didanosin-koncentrationen.
English: 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.
Danish: I den præ- og postnatale udviklingsvurdering hos rotter, frembragte atazanavir en forbigående reduktion i legemsvægten hos afkommet ved en maternel toksisk dosis.
English: • Liver problems may uncommonly happen.
Danish: Leverproblemer kan forekomme mindre hyppigt.
English: 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.
Danish: Rifampicin er en kraftig CYP3A4induktor og er vist at reducere atazanavirs AUC med 72%, hvilket kan medføre virologisk svigt og resistensudvikling.
English: Atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
Danish: Atazanavir er en azapeptid HIV-1-proteasehæmmer (PI).
English: Elevation in ALT levels were more frequently reported in paediatric patients in these studies than in adults.
Danish: I disse studier blev forhøjede ALAT-niveauer rapporteret hyppigere hos pædiatriske patienter end hos voksne.
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af lipider og glucose i blodet refereres til eksisterende behandlingsguidelines for HIV.
English: Atazanavir has been detected in human milk.
Danish: Atazanavir er påvist i human mælk.
English: Of importance, many studies were conducted with unboosted atazanavir, which is not the recommended regimen of atazanavir (see section 4.4).
Danish: Det er vigtigt at nævne, at mange studier er udført med ikke-boostet atazanavir, hvilket ikke er det anbefalede atazanavir-regime (se pkt.
English: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Hungary
Danish: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Ungarn
English: In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
Danish: I nogle tilfælde er nefrolitiasis blevet forbundet med akut nyresvigt eller nyreinsufficiens.
English: ANTIPSYCHOTICS Quetiapine
Danish: ANTIPSYKOTIKA Quetiapin
English: The M184I/V substitution emerged in 5/26 Atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Danish: M184I/V substitution opstod hos henholdsvis 5/26 atazanavir/ritonavir og 7/26 lopinavir/ritonavir patienter med virologisk svigt.
English: If necessary, monitor carbamazepine serum concentrations and adjust the dose accordingly.
Danish: Om nødvendigt bør serumkoncentrationen af carbamazepin monitoreres og dosis justeres i henhold hertil.
English: If necessary, monitor lamotrigine concentrations and adjust the dose accordingly.
Danish: Om nødvendigt bør koncentrationen af lamotrigin monitoreres og dosis justeres i henhold hertil.
English: Rash and associated syndromes
Danish: Udslæt og relaterede syndromer
English: There is no specific antidote for overdose with atazanavir.
Danish: Der findes ingen specifik antidot for overdosering med atazanavir.
English: Atazanavir + saquinavir was shown to be inferior to lopinavir + ritonavir.
Danish: Atazanavir + saquinavir er vist at være ringere end lopinavir + ritonavir.
English: Close monitoring of patient's virologic response should be exercised.
Danish: Patientens virologiske respons bør følges tæt.
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir.
Danish: Data fra anvendelse af atazanavir hos et begrænset antal gravide kvinder (mellem 300-1000) indikerer ingen misdannelser.
English: Manufacturer
Danish: Producent
English: Recommendations concerning co-administration
Danish: Anbefalinger ved samtidig administration
English: Interaction
Danish: Interaktion
English: If the patient has developed SJS or DRESS associated with the use of atazanavir, atazanavir may not be restarted.
Danish: Hvis patienten har udviklet SJS eller DRESS under behandling med atazanavir, bør atazanavir-behandling ikke genoptages.
English: 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.
Danish: 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.
English: Potential cardiac effects of this product in humans cannot be ruled out (see sections 4.4 and 4.8).
Danish: Potentielle kardielle virkninger ved dette produkt hos mennesker kan ikke udelukkes (se pkt.
English: Ritonavir 100 mg once daily is used as a booster of atazanavir pharmacokinetics.
Danish: Ritonavir 100 mg 1 gang dagligt anvendes som booster for atazanavirs farmakokinetik.
English: Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Danish: Middelværdien for udskillelse i urinen af uomdannet lægemiddel var 7% efter 2 ugers dosering ved 800 mg én gang dagligt.
English: Medicinal products by therapeutic area
Danish: Lægemidler efter terapeutisk område
English: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Danish: Mødre med hivinfektion frarådes at amme, da virus kan overføres gennem mælken.
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Danish: Tilsvarende atazanavirkoncentrationer øgede den potentielle virkningsvarighed (ADP90) med 13% i et studie af Purkinjefibre hos kaniner.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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,.
English: In the majority of patients, a reduction in both voriconazole and atazanavir exposures are expected.
Danish: Hos størstedelen af patienterne forventes en nedsat eksponering for både voriconazol og atazanavir.
English: 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.
Danish: Atazanavirs minimumkoncentration var ca. 2 gange højere i post partum perioden sammenlignet med værdierne observeret historisk hos HIV-smittede ikke-gravide patienter.
English: 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.
Danish: Proteasehæmmere: Samtidig administration af atazanavir /ritonavir og andre proteasehæmmere er ikke undersøgt, men forventes at øge eksponeringen for andre proteasehæmmere.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported;
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering.
English: Lurasidone
Danish: Lurasidon
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som er behandlet med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt dødelige leverreaktioner.
English: Generics [UK] Ltd Tel: +44 1707 853000
Danish: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000
English: Atazanavir Mylan is an antiviral (or antiretroviral) medicine.
Danish: Atazanavir Mylan er medicin til antiviral (eller antiretroviral) behandling.
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Danish: På baggrund af data for andre CYP3A4-hæmmere forventes plasma-koncentrationen af midazolam at være betydeligt højere, hvis midazolam administreres oralt.
English: Some people will need special care before or while taking Atazanavir Mylan.
Danish: Visse mennesker har behov for særlige hensyn, før eller mens de tager Atazanavir Mylan .
English: The mean half-life of atazanavir in hepatically impaired subjects was 12.1 hours compared to 6.4 hours in healthy subjects.
Danish: Atazanavirs gennemsnitlige halveringstid hos forsøgspersoner med nedsat leverfunktion var 12,1 timer i forhold til 6,4 timer hos raske forsøgspersoner.
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4).
Danish: Regelmæssig overvågning af patienternes nyrefunktion bør opretholdes igennem hele behandlingsforløbet (se pkt.
English: During this time, postpartum patients should follow the same dose recommendation as for non-pregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Danish: I denne periode skal post partum-patienter følge de samme dosisanbefalinger som ikke-gravide, inklusive anbefalingerne for samtidig administration af lægemidler, der er kendt for at påvirke atazanavireksponeringen (se pkt.
English: Atazanavir (pm): all administered with food
Danish: Atazanavir (aften): alle administreret med mad
English: Talk to your doctor immediately if you get dizzy, lightheaded or if you suddenly faint.
Danish: Tal straks med din læge, hvis du bliver svimmel, ør, eller hvis du pludseligt besvimer.
English: Therefore, postpartum patients should be closely monitored for adverse reactions.
Danish: Derfor skal post partumpatienter monitoreres nøje for bivirkninger.
English: The mean AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Danish: Gennemsnitlig AUC(0-∞) var 42% højere hos forsøgspersoner med nedsat leverfunktion end hos raske forsøgspersoner.
English: They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Danish: Medicinen nedsætter mængden af HIV i kroppen og styrker derved immunforsvaret.
English: Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Danish: Ud af de 60 isolater fra patienter behandlet med enten atazanavir eller atazanavir + ritonavir viste 18 (30%) I50L-fænotypen tidligere beskrevet hos patienter, der ikke tidligere havde været behandlet.
English: There was an increase in the maximum PR interval compared to atazanavir alone.
Danish: Der sås forlængelse af det maksimale PRinterval sammenlignet med atazanavir alene.
English: Tell your doctor at once if any of these apply to you.
Danish: Fortæl det altid til lægen, hvis noget af ovenstående gælder for dig.
English: The safety and efficacy of atazanavir has not been established in patients with significant underlying liver disorders.
Danish: Sikkerhed og effekt af atazanavir er ikke bestemt hos patienter med signifikante underliggende leverforstyrrelser.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).
Danish: Reduktion af glukokortikoiddosis bør overvejes, og patienten bør monitoreres tæt for lokale og systemiske bivirkninger eller skiftes til et glukokortikoid, som ikke er substrat for CYP3A4 (f.eks. beclomethason).
English: Driving and using machines If you feel dizzy or lightheaded, do not drive or use machines and contact your doctor immediately.
Danish: Hvis du føler dig svimmel eller uklar, må du ikke køre bil eller betjene maskiner, og du skal skal du straks kontakte lægen.