natgillin/translations-raw huggingface dataset:
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;
Patienter med kronisk hepatitis B eller C, som er behandlet med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt dødelige leverreaktioner.
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.
Atazanavir Mylan er medicin til antiviral (eller antiretroviral) behandling.
Atazanavir Mylan is an antiviral (or antiretroviral) medicine.
På baggrund af data for andre CYP3A4-hæmmere forventes plasma-koncentrationen af midazolam at være betydeligt højere, hvis midazolam administreres oralt.
Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Visse mennesker har behov for særlige hensyn, før eller mens de tager Atazanavir Mylan .
Some people will need special care before or while taking Atazanavir Mylan.
Atazanavirs gennemsnitlige halveringstid hos forsøgspersoner med nedsat leverfunktion var 12,1 timer i forhold til 6,4 timer hos raske forsøgspersoner.
The mean half-life of atazanavir in hepatically impaired subjects was 12.1 hours compared to 6.4 hours in healthy subjects.
Regelmæssig overvågning af patienternes nyrefunktion bør opretholdes igennem hele behandlingsforløbet (se pkt.
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4).
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.
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).
Atazanavir (aften): alle administreret med mad
Atazanavir (pm): all administered with food
Tal straks med din læge, hvis du bliver svimmel, ør, eller hvis du pludseligt besvimer.
Talk to your doctor immediately if you get dizzy, lightheaded or if you suddenly faint.
Derfor skal post partumpatienter monitoreres nøje for bivirkninger.
Therefore, postpartum patients should be closely monitored for adverse reactions.
Gennemsnitlig AUC(0-∞) var 42% højere hos forsøgspersoner med nedsat leverfunktion end hos raske forsøgspersoner.
The mean AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Medicinen nedsætter mængden af HIV i kroppen og styrker derved immunforsvaret.
They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
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.
Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Der sås forlængelse af det maksimale PRinterval sammenlignet med atazanavir alene.
There was an increase in the maximum PR interval compared to atazanavir alone.
Fortæl det altid til lægen, hvis noget af ovenstående gælder for dig.
Tell your doctor at once if any of these apply to you.
Sikkerhed og effekt af atazanavir er ikke bestemt hos patienter med signifikante underliggende leverforstyrrelser.
The safety and efficacy of atazanavir has not been established in patients with significant underlying liver disorders.
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).
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).
Hvis du føler dig svimmel eller uklar, må du ikke køre bil eller betjene maskiner, og du skal skal du straks kontakte lægen.
Driving and using machines If you feel dizzy or lightheaded, do not drive or use machines and contact your doctor immediately.
I toksicitetsstudier med gentagne doser på mus, rotter og hunde var atazanavirrelaterede fund generelt begrænset til leveren og omfattede generelt minimale til milde forhøjelser af serum bilirubin og leverenzymer, hepatocellulær vacuolation og hypertrofi, og kun i hunmus hepatisk enkeltcellenekrose.
In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Hvis du bemærker et eller flere af disse symptomer, skal du informere lægen.
If you notice any of these symptoms please inform your doctor.
4 forsøgspersoner i gruppen med ikke-boostet atazanavir og 2 forsøgspersoner i gruppen med atazanavir + ritonavir havde HIVRNA > 500 kopier/ml i vedligeholdelsesfasen.
Four subjects in the unboosted atazanavir group and 2 in the atazanavir + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Afvigelsesestimate [95% KI]
Difference estimate [95% CI]
Hyppigheden af behandlingsrelateret hepatitis eller transaminaseforhøjelser hos samtidigt inficerede patienter var sammenlignelig mellem atazanavir og sammenlignelige regimer (se pkt.
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Anden antiretroviral behandling end Atazanavir Mylan kan overvejes såfremt gulsot eller scleral icterus ikke er acceptabelt for patienten.
Alternative antiretroviral therapy to Atazanavir Mylan may be considered if jaundice or scleral icterus is unacceptable to a patient.
b Ti patienter havde baseline fænotyperesistens over for atazanavir + ritonavir (foldændring [FC]>5,2).
Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Selvom det ikke er undersøgt, er der risiko for en øget pravastatin- eller fluvastatineksponering ved administration sammen med proteasehæmmere.
Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Hvis du ved en fejltagelse har taget for mange Atazanavir Mylan -kapsler, skal du kontakte din HIVlæge eller nærmeste hospital og bede om råd.
If you accidentally take more Atazanavir Mylan capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
3. trimester (n=20)
3rd Trimester (n=20)
Dosisjustering er ikke påkrævet hos patienter med nedsat nyrefunktion.
No dosage adjustment is needed in patients with renal impairment.
Lægen vil tale med dig om, hvilken kombination af anden medicin og Atazanavir Mylan , der er bedst for dig.
Your doctor will discuss with you which combination of these medicines with Atazanavir Mylan is best for you.
Femten ud af 120 (13%) patienter i atazanavir + ritonavir-behandlingsarmen og 17 ud af 123 (14%) patienter i lopinavir + ritonavir-armen havde fire eller flere af PI-substitutionerne L10, M46, I54, V82, I84 og L90.
Fifteen of 120 (13%) patients in the atazanavir + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
H2-receptorantagonister
ACID REDUCING AGENTS H2-Receptor antagonists
Det vides endnu ikke, hvordan høj systemisk fluticasoneksponering påvirker ritonavir-plasmaniveauet.
The effects of high fluticasone systemic exposure on ritonavir plasma levels are yet unknown.