FrancophonIA/ELRC3.0 huggingface dataset:
English: Combinations of atazanavir and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Danish: Kombinationer af atazanavir og indinavir er ikke undersøgt, og samtidig administration af disse lægemidler kan ikke anbefales (se pkt.
English: Studies conducted in HIV-infected patients.
Danish: Studier udført med HIVinficerede patienter.
English: Among patients receiving atazanavir 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Danish: Blandt patienter, der fik 300 mg atazanavir med 100 mg ritonavir, var frekvensen af gulsot 19%.
English: Due to carbamazepine inducing effect, a reduction in atazanavir exposure cannot be ruled out.
Danish: På grund af carbamazepins inducerende effekt kan nedsat eksponering for atazanavir ikke udelukkes.
English: uncommon: depression, disorientation, anxiety, insomnia, sleep disorder, abnormal dream
Danish: ikke almindelig: depression, desorientering, ængstelse, søvnløshed, søvnforstyrrelser, abnorme drømme
English: Confidence interval.
Danish: dKonfidensinterval.
English: In clinical trial AI424-182 atazanavir/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Danish: I det kliniske studie AI424-182 blev atazanavir/ritonavir (300/100 mg eller 400/100 mg) administreret samtidig med zidovudin/lamivudin til 41 gravide kvinder i andet og tredje trimester.
English: The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Mylan and ritonavir.
Danish: Produktresumé for ritonavir bør kontrolleres, inden behandling med Atazanavir Mylan og ritonavir initieres.
English: Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Danish: Patienterne skal monitoreres tæt for tenofovirdisoproxilfumaratrelaterede bivirkninger, inklusive nyrefunktionspåvirkning.
English: The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Danish: Det geometriske gennemsnit (CV%) for atazanavir Cmin og AUC var henholdsvis 654 (76%) ng/ml og 44185 (51%) ng•t/ml.
English: CD4 count <50 cells/mm
Danish: CD4-celletal <50 celler/mm3
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: Therefore, such co-administration is not recommended.
Danish: Samtidig administration frarådes derfor.
English: - The other ingredients are lactose monohydrate, crospovidone, magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat, crospovidon, magnesiumstearat.
English: If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Danish: Hvis der opstår tegn eller symptomer på nefrolitiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
English: Atazanavir, the active substance of Atazanavir Mylan, is excreted in human milk.
Danish: Atazanavir, det aktive stof i Atazanavir Mylan, udskilles i modermælk.
English: Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Danish: Atazanavir-koncentrationen faldt betydeligt ved samtidig administration af didanosin (tabletter med buffer) og stavudin.
English: Do not stop taking Atazanavir Mylan before talking to your doctor.
Danish: Du må ikke holde op med at tage Atazanavir Mylan uden at have talt med lægen.
English: Co-administration of atazanavir with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated.
Danish: Samtidig administration af atazanavir og ritonavir i doser over 100 mg én gang dagligt er ikke evalueret klinisk.
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Danish: Itraconazol er, som ketoconazol, en potent CYP3A4-hæmmer såvel som et CYP3A4-substrat.
English: There were no tumorigenic findings in male mice or in rats.
Danish: Der var ingen tumorigene fund hos hanmus eller hos rotter.
English: If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor.
Danish: Hvis du bemærker ændringer i din hjerterytme (puls), skal du informere lægen.
English: Co-administration of lamotrigine and atazanavir/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Danish: Samtidig administration af lamotrigin og atazanavir/ritonavir kan reducere plasmakoncentrationen af lamotrigin på grund af UGT1A4-induktion.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: If atazanavir is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Danish: Hvis atazanavir administreres samtidig med irinotecan, bør patienten monitoreres tæt for irinotecan-relaterede bivirkninger.
English: Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is co-administered with atazanavir, based on these data.
Danish: Lav ritonavirdosis (100 mg 2 gange dagligt) er vist ikke at have signifikant effekt på methadonkoncentrationen, og på baggrund af disse data forventes ingen interaktion ved samtidig administration af methadon og atazanavir.
English: Systemic exposure to atazanavir at doses that resulted in maternal toxicity was at least equal to or slightly greater than that observed in humans given 400 mg once daily.
Danish: Systemisk optagelse af atazanavir i doser, der medførte maternel toksicitet, var mindst lig med, eller en anelse større end den, der blev observeret hos mennesker, der fik 400 mg én gang dagligt.
English: Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for atazanavir + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Danish: Gennem 48 ugers behandling var middelændringerne i HIV-RNA-niveauer fra baseline for atazanavir + ritonavir og lopinavir + ritonavir sammenlignelige (ikke-inferior).
English: If a higher dose of an H2-receptor antagonist is required (e.g., famotidine 40 mg twice daily or equivalent) an increase of the atazanavir/ritonavir dose from 300/100 mg to 400/100 mg can be considered.
Danish: Hvis en højere dosis H2-receptorantagonist er nødvendig (f.eks. famotidin 40 mg 2 gange dagligt eller tilsvarende), kan dosisøgning af atazanavir /ritonavir fra 300/100 mg til 400/100 mg overvejes.
English: Co-administration of atazanavir and ritonavir with food optimises the bioavailability of atazanavir.
Danish: Samtidig indtag af atazanavir og ritonavir og mad optimerer biotilgængeligheden af atazanavir.
English: Sildenafil is also used for the treatment of erectile dysfunction.
Danish: Sildenafil bruges også til behandling af erektil dysfunktion (impotens).
English: Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 ChildPugh Class C subjects) after a single 400 mg dose.
Danish: Atazanavir (uden ritonavir) er blevet undersøgt hos voksne forsøgspersoner med moderat til svært nedsat leverfunktion (14 forsøgspersoner med Child-Pugh klasse B og 2 forsøgspersoner med Child-Pugh klasse C) efter en enkelt 400 mg dosis.
English: Efficacy Atazanavir/ritonavir is not effective in viral strains harbouring multiple mutations of resistance.
Danish: Atazanavir/ritonavir er ikke effektivt over for virale stammer med multiresistensmutationer.
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
Danish: Udslæt er ofte lette til moderate makulopapuløse huderuptioner, der optræder inden for de første 3 uger efter påbegyndelse af atazanavir-behandling.
English: Co-administration of diltiazem and atazanavir /ritonavir has not been studied.
Danish: Samtidig administration af diltiazem og atazanavir/ritonavir er ikke undersøgt.
English: Through 96 weeks of treatment, mean HIV RNA changes from baseline for atazanavir + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases.
Danish: Gennem 96 ugers behandling opfyldte gennemsnitlige HIV-RNA-ændringer fra baseline i uge 96 for atazanavir + ritonavir og lopinavir + ritonavir, kriterierne for ”ikke inferioritet” baseret på observerede tilfælde.
English: ** When compared to rifabutin 150 mg once daily alone.
Danish: ** Sammenlignet med rifabutin 150 mg 1 gang dagligt.
English: The M184V substitution in reverse transcriptase, which confers resistance to lamivudine and emtricitabine, was detected in 2 subjects in the unboosted atazanavir and 1 subject in the atazanavir + ritonavir group.
Danish: Der blev observeret M184V-substitution i revers transkriptase, som medfører resistens over for lamivudin og emtricitabin, hos 2 forsøgspersoner i gruppen med ikkeboostet atazanavir og hos 1 forsøgsperson i atazanavir + ritonavir-gruppen.
English: (See section 4.4, Withdrawal of ritonavir only under restrictive conditions)
Danish: 4.4 Seponering af ritonavir udelukkende under restriktive omstændigheder).
English: ≥ 200 cells/mm
Danish: ≥ 200 celler/mm3
English: No drug interaction study has been performed for the co-administration of atazanavir with benzodiazepines.
Danish: Der er ikke gennemført interaktionsstudier af samtidig administration af atazanavir og benzodiazepiner.
English: Atazanavir (without ritonavir) has been studied in adult patients with severe renal impairment (n=20), including those on haemodialysis, at multiple doses of 400 mg once daily.
Danish: Atazanavir (uden ritonavir) er blevet undersøgt hos voksne patienter med alvorligt nedsat nyrefunktion (n=20), inklusive patienter i hæmodialyse, ved multiple doser på 400 mg en gang dagligt.
English: Atazanavir has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg with ritonavir 100 mg once daily (655 patients, 96°weeks median duration and 108 weeks maximum duration).
Danish: Atazanavir er i kontrollerede kliniske studier evalueret for sikkerhed i kombinationsbehandling med andre antiretrovirale lægemidler hos 1.806 voksne patienter behandlet med atazanavir 400 mg, én gang dagligt (1.151 patienter, 52 ugers middelvarighed og 152 ugers maksimal varighed) eller atazanavir 300 mg med ritonavir 100 mg én gang dagligt (655 patienter, 96 ugers middelvarighed og 108 ugers maksimal varighed).
English: There were no reported cases of kernicterus in neonates.
Danish: Der blev ikke rapporteret kernicterus hos de nyfødte.
English: Combination of rifampicin (see section 4.5).
Danish: Kombination med rifampicin (se pkt.
English: Concomitant use of salmeterol and Atazanavir Mylan may result in increased cardiovascular adverse events associated with salmeterol.
Danish: Samtidig brug af salmeterol og Atazanavir Mylan kan resultere i en øget risiko for salmeterolrelaterede kardiovaskulære bivirkninger.
English: In clinical trials of antiretroviral treatment naive patients treated with boosted atazanavir, the I50L substitution did not emerge in any patient without baseline PI substitutions.
Danish: I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med boostet atazanavir, forekom der ikke I50L substitution hos nogen af patienterne uden baseline PI-substitution.
English: Co-administration with atazanavir has the potential to increase or decrease warfarin concentrations.
Danish: Samtidig administration med atazanavir kan øge eller reducere koncentrationen af warfarin.
English: There was less hyperbilirubinaemia and jaundice in the unboosted atazanavir group compared with the atazanavir + ritonavir group (18 and 28 subjects, respectively).
Danish: Der var færre tilfælde af hyperbilirubinæmi og gulsot i gruppen med ikkeboostet atazanavir sammenlignet med gruppen med atazanavir + ritonavir (hos henholdsvis 18 og 28 forsøgspersoner).
English: Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Danish: Atazanavir hæmmer UGT og kan derfor interferere med irinotecanmetabolismen og medføre øget irinotecan-toksicitet.
English: Lipid disorders should be managed as clinicallly appropriate.
Danish: Tilstande med forhøjet lipid skal behandles som klinisk indiceret.
English: Co-administration of atazanavir /ritonavir with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate has not been studied, and therefore should be avoided.
Danish: Samtidig administration af atazanavir/ritonavir og andre hormonelle kontraceptionsmidler eller orale kontraceptionsmidler indeholdende andre gestagener end norgestimat er ikke blevet undersøgt og bør derfor undgås.
English: Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
Danish: Total rifabutin og 25-O-desacetyl-rifabutin AUC ↑119% (↑78% ↑169%).
English: Adverse reactions were consistent between patients who received atazanavir 400 mg once daily and patients who received atazanavir 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with atazanavir plus ritonavir.
Danish: Bivirkninger var ensartede mellem patienter, der fik 400 mg atazanavir én gang dagligt, og patienter, der fik 300 mg atazanavir med ritonavir 100 mg én gang dagligt, med undtagelse af, at der hyppigere indberettedes gulsot og forhøjede niveauer af totalbilirubin ved atazanavir plus ritonavir.
English: Dose related asymptomatic prolongations in PR interval with atazanavir have been observed in clinical studies.
Danish: Der er i kliniske studier observeret dosisrelaterede, asymptomatiske forlængelser i PR-intervallet med atazanavir.
English: Take Atazanavir Mylan capsules with food (a meal or a substantial snack).
Danish: Tag Atazanavir Mylan sammen med mad (et måltid eller et større mellemmåltid).
English: Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Danish: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil og vardenafil metaboliseres af CYP3A4.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Danish: Vægtstigning og forhøjede lipider og glucose i blodet kan forekomme under antiretroviral behandling.
English: Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine or pain when you urinate.
Danish: Tal straks med lægen, hvis du får symptomer på nyresten, som kan være smerter i lænden eller den nederste del af maven, blod i urinen eller smerter i forbindelse med vandladning.
English: Co-administration of Atazanavir Mylan with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Danish: Samtidig administration af Atazanavir Mylan med disse lægemidler forventes at øge deres koncentration væsentligt og kan resultere i PDE5relaterede bivirkninger såsom hypotension, synsforstyrrelser og priapisme (se pkt.
English: As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV.
Danish: For at undgå overførsel af HIV anbefales det generelt, at HIVinficerede mødre ikke ammer deres spædbørn.
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for atazanavir + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Danish: Ved AT-analyse, hvor manglende værdier blev ekskluderet, var andelen af patienter med HIV-RNA <400 kopier/ml (<50 kopier/ml) for atazanavir+ ritonavir 84% (72%) og for lopinavir + ritonavir 82% (72%).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP 1.
English: In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
Danish: I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med ikke-boostet atazanavir, er I50L-substitutionen, nogle gange i kombination med A71Vændring, den kendetegnende resistenssubstitution for atazanavir.
English: Capsule contents
Danish: Kapselindhold
English: In clinical studies, atazanavir (with or without ritonavir) has been shown to induce dyslipidaemia to a lesser extent than comparators.
Danish: Atazanavir har i kliniske studier (med eller uden ritonavir) vist sig at inducere dyslipidæmi i mindre udstrækning end andre sammenlignelige produkter, der indgik i studierne.
English: Particular caution should be used when prescribing Atazanavir Mylan in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Danish: Man bør udvise særlig forsigtighed, når Atazanavir Mylan ordineres samtidig med lægemidler, som kan forøge QT-intervallet og/eller til patienter med allerede eksisterende risikofaktorer (bradykardi, medfødt langt QT, elektrolytforstyrrelser (se pkt.
English: Subjects without a functional CYP2C19 allele.
Danish: Personer uden en funktionel CYP2C19-allel.
English: The most frequently reported laboratory abnormalities in paediatric patients receiving atazanavir oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Danish: De hyppigst rapporterede laboratoriemæssige anormaliteter hos pædiatriske patienter i behandling med atazanavir oralt pulver var forhøjet total-bilirubin (≥ 2,6 gange ULN, grad 3-4; 16%) og forhøjet amylase (grad 3-4; 33%), generelt ikke udgået fra pancreas.
English: The geometric mean (CV%) for atazanavir Cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Danish: Den geometrisk gennemsnitlige (CV%) atazanavir-Cmin og -AUC var henholdsvis 120 (109) ng/ml og 14.874 (91) ng•t/ml.
English: 36 (43/120) 32 (38/120) 42 (52/123)_ 35 (41/118) NA
Danish: HIV-RNA <50 kopier/ml, %f (respons/evaluerbar) Alle patienter 36 (43/120) 32 (38/120) 42 (52/123) 35 (41/118) NA
English: Co-administration with atazanavir with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Danish: Samtidig administration af atazanavir med ritonavir kræver overvågning for sedation og kognitiv påvirkning.
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose
Danish: Didanosin (tabletter med buffer) 200 mg/stavudin 40 mg, begge som enkeltdoser (atazanavir 400 mg som enkeltdosis)
English: Ritonavir Dose* once daily (mg)
Danish: Ritonavir daglig dosis* (mg)
English: Human experience of acute overdose with atazanavir is limited.
Danish: Der er begrænset erfaring med akut human overdosering med atazanavir.
English: Coadministration of a single 300 mg dose of atazanavir and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Danish: Samtidig indtag af enkeltdosis atazanavir 300 mg og ritonavir 100 mg og et let måltid medførte en stigning i AUC på 33% og en stigning i såvel Cmax som 24-timerskoncentrationen af atazanavir på 40% i forhold til i fastende tilstand.
English: Some medicines may interact with ritonavir, a medicine that is taken with Atazanavir Mylan.
Danish: Noget medicin kan påvirkes af ritonavir, som tages sammen med Atazanavir Mylan.
English: It is important that you take Atazanavir Mylan with food (a meal or a substantial snack) as this helps the body absorb the medicine.
Danish: Brug af Atazanavir Mylan sammen med mad og drikke Det er vigtigt, at du tager Atazanavir Mylan sammen med mad (et måltid eller et større mellemmåltid), da dette hjælper kroppen med at optage medicinen.
English: The most frequently reported laboratory abnormality in paediatric patients receiving atazanavir was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Danish: Den hyppigst rapporterede laboratoriemæssige anormalitet hos pædiatriske patienter i behandling med atazanavir var forhøjet total-bilirubin (≥ 2,6 gange ULN, grad 3-4), som forekom hos 45% af patienterne.
English: Systemic exposures of atazanavir in mice (males), rats, and dogs at doses associated with hepatic changes were at least equal to that observed in humans given 400 mg once daily.
Danish: Systemisk optagelse af atazanavir i mus (hanner), rotter og hunde ved doser forbundet med leverforandringer, var mindst den samme som den, der blev observeret hos mennesker, der kun havde fået 400 mg én gang dagligt.
English: • It is not recommended to use atazanavir with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist.
Danish: Atazanavir med ritonavir anbefales ikke til gravide, der både anvender tenofovirdisoproxil og en H2-receptorantagonist.
English: Concentrations of these antiarrhythmics may be increased when co-administered with atazanavir.
Danish: Koncentrationer af disse antiarytmika kan øges ved samtidig administration af atazanavir.
English: HIV RNA <100,000 copies/ml
Danish: HIV-RNA <100.000 kopier/ml
English: common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
Danish: almindelig: opkastning, diarré, abdominalsmerter, kvalme, dyspepsi; ikke almindelig: pankreatitis, gastritis, abdominal distension, aftøs stomatitis, flatulens, tør mund
English: Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.
Danish: Samtidig administration af atazanavir/ritonavir og boceprevir medførte lavere atazanavireksponering, hvilket kan resultere i lavere effekt og manglende HIVkontrol.
English: High doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Danish: itraconazol (>200 mg/dag) frarådes.
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with atazanavir may result in increased concentrations.
Danish: Simvastatin og lovastatin metaboliseres i høj grad via CYP3A4 og samtidig administration med atazanavir kan medføre øgede koncentrationer.