FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of atazanavir with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and cmax by approximately 25% compared to the fasting state.
Danish: Administration af atazanavir og ritonavir sammen med et let eller et fedtrigt måltid nedsatte variationskoefficienten for AUC og Cmax med ca. 25% sammenlignet med i fastende tilstand.
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations co-administration of fluticasone and atazanavir without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with atazanavir without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Danish: Enkeltdosis af famotidin bør aldrig overstige 20 mg, og den totale daglige dosis af famotidin bør ikke overstige 40 mg. - at det er nødvendigt at tage højde for, at - samtidig administration af voriconazol og atazanavir uden ritonavir kan påvirke koncentrationen af atazanavir - samtidig administration af fluticason og atazanavir uden ritonavir kan øge koncentrationen af fluticason i forhold til administration af fluticason alene - ved samtidig administration af et oralt kontraceptivum og atazanavir uden ritonavir, anbefales det, at det orale kontraceptivum indeholder højst 30 µg ethinylestradiol - dosisjustering af lamotrigin ikke er nødvendig
English: f,g
Danish: a,b
English: Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Danish: Atazanavir Krka-kapsler, administreret sammen med en lav dosis ritonavir, er indiceret til behandling af hiv-1-infektion hos voksne og børn fra 6 år og ældre i kombination med andre antiretrovirale lægemidler (se pkt.
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co- administered with protease inhibitors.
Danish: Selvom det ikke er undersøgt, er der risiko for en øget pravastatin- eller fluvastatineksponering ved administration sammen med proteasehæmmere.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Krka.
Danish: PDE5-hæmmere ved behandling af erektil dysfunktion: Der bør udvises særlig forsigtighed ved ordinering af PDE5-hæmmere (sildenafil, tadalafil eller vardenafil) til behandling af erektil dysfunktion hos patienter, der får Atazanavir Krka.
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: There was no evidence of pathologic jaundice and six of 40 infants in this study received phototherapy for a maximum of 4 days.
Danish: 40 spædbørn i dette studie fik lysbehandling i maksimalt 4 dage.
English: Stop taking Atazanavir Krka and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules).
Danish: Stop straks med at tage Atazanavir Krka og tal med lægen, hvis du får alvorligt udslæt eller udslæt med influenzalignende symptomer, blærer, feber, forkølelsessår, muskel- eller ledsmerter, hævelse i ansigtet, øjenbetændelse, som forårsager røde øjne (konjunktivitis), smertefulde, varme eller røde knuder.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Coinfected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Danish: Patienter med samtidig hepatitis B- og/eller hepatitis C-virusinfektion Blandt 1.151 patienter, der fik 400 mg atazanavir én gang dagligt, var 177 patienter samtidig inficeret med kronisk hepatitis B eller C, og blandt 655 patienter, der fik 300 mg atazanavir én gang dagligt med 100 mg ritonavir én gang dagligt, var 97 patienter samtidig inficeret med kronisk hepatitis B eller C. Samtidigt inficerede patienter havde større sandsynlighed for forhøjede levertransaminaser ved baseline end de, der ikke havde kronisk viral hepatitis.
English: Do not take sildenafil with Atazanavir Krka when sildenafil is used for the treatment of pulmonary arterial hypertension.
Danish: Du må ikke tage sildenafil sammen med Atazanavir Krka, hvis sildenafil anvendes til behandling af pulmonal arteriel hypertension.
English: At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Danish: Ved høje doser, som kan medføre højt lægemiddeloptag, kan der observeres gulsot på grund af indirekte (ukonjugeret) hyperbilirubinæmi (uden dermed forbundne ændringer i leverfunktionstest) eller forlængelse af PR-interval (se pkt.
English: Capsule contents: lactose monohydrate, crospovidone (type A) and magnesium stearate.
Danish: Kapselindhold: lactosemonohydrat, crospovidon (type A) og magnesiumstearat.
English: 50 to <100 cells/mm3
Danish: 50 til <100 celler/mm3
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
English: The withdrawal of ritonavir from the boosted regimen of Atazanavir Krka is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions: - absence of prior virologic failure - undetectable viral load during the last 6 months under current regimen - viral strains not harbouring HIV resistance associated mutations (RAMs) to current regimen.
Danish: Seponering af ritonavir fra det boostede Atazanavir Krka-regime frarådes, men en dosis på 400 mg Atazanavir Krka én gang dagligt sammen med føde kan overvejes hos voksne patienter under følgende kombinerede restriktive forhold: - intet tidligere virologisk svigt - udetekterbar virusbelastning i de seneste 6 måneder med det nuværende regime - virusstammer, som ikke har hiv-resistensassocierede mutationer (RAM) på det nuværende regime.
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: Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir.
Danish: Der er rapporteret alvorligt hududslæt, herunder Stevens-Johnsons syndrom hos patienter, der tager atazanavir.
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 irinotecan-metabolismen og medføre øget irinotecan-toksicitet.
English: The content of the capsule is yellowishwhite to yellow-white powder.
Danish: Kapselindholdet er gullig-hvidt til gul-hvidt pulver.
English: Amiodarone,
Danish: Amiodaron
English: Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
Danish: Atazanavir (uden ritonavir) er blevet undersøgt hos voksne forsøgspersoner med moderat til alvorligt nedsat leverfunktion (14 forsøgspersoner med Child-Pugh klasse B og 2 forsøgspersoner med Child-Pugh klasse C) efter en enkelt 400 mg dosis.
English: The decrease in AUC, cmax, and cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Danish: Faldet i AUC, Cmax, and Cmin var ikke mindre, når en øget dosis af atazanavir/ritonavir (400/100 mg én gang dagligt) blev forskudt fra omeprazol med
English: Due to phenytoin/phenobarbital inducing effect, a reduction in atazanavir exposure cannot be ruled out.
Danish: På grund af phenytoins/phenobarbitals inducerende effekt kan nedsat eksponering for atazanavir ikke udelukkes.
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: 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: 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: 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: If you take more Atazanavir Krka 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 Krka.
Danish: Gulfarvning af huden/øjnene (gulsot) og uregelmæssig hjerterytme (QTc-forlængelse) kan forekomme, hvis du eller dit barn har taget for meget Atazanavir Krka.
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 ikke-boostet atazanavir og hos 1 forsøgsperson i atazanavir + ritonavir-gruppen.
English: Efficacy Atazanavir/ritonavir is not effective in viral strains harbouring multiple mutations of resistance.
Danish: Virkning Atazanavir/ritonavir er ikke effektivt over for virale stammer med multiresistensmutationer.
English: The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Danish: Valg af Atazanavir Krka til behandlingserfarne voksne og pædiatriske patienter bør baseres på en individuel, viral resistenstest og patientens behandlingsanamnese (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 hiv-inficerede mødre ikke ammer deres spædbørn.
English: potassium hydroxide
Danish: kaliumhydroxid
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
Danish: Patienterne bør advares om risikoen for disse bivirkninger ved brug af PDE5-hæmmere mod erektil dysfunktion samtidig med atazanavir (se pkt.
English: Coadministration of diltiazem and atazanavir /ritonavir has not been studied.
Danish: Samtidig administration af diltiazem og atazanavir/ritonavir er ikke undersøgt.
English: No drug interaction study has been performed for the coadministration 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 én gang dagligt.
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 44.185 (51%) ng•t/ml.
English: The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Krka and ritonavir.
Danish: Produktresuméet for ritonavir bør kontrolleres, inden behandling med Atazanavir Krka og ritonavir initieres.
English: The dose of Atazanavir Krka capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Danish: Dosis af Atazanavir Krka kapsler til børn beregnes ud fra barnets vægt og skal tages én gang dagligt sammen med mad og 100 mg ritonavir som vist i tabellen nedenfor:
English: Atazanavir concentrations were greatly decreased when coadministered with didanosine (buffered tablets) and stavudine.
Danish: Atazanavirkoncentrationen faldt betydeligt ved samtidig administration af didanosin (tabletter med buffer) og stavudin.
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: 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 hiv-kontrol.
English: Buprenorphine AUC ↑67% Buprenorphine cmax ↑37% Buprenorphine cmin ↑69%
Danish: Buprenorphin Cmax ↑37% Buprenorphin Cmin ↑69%
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 ikke-boostet atazanavir sammenlignet med gruppen med atazanavir + ritonavir (hos henholdsvis 18 og 28 forsøgspersoner).
English: - It is not recommended to use Atazanavir Krka with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist.
Danish: - Atazanavir Krka med ritonavir anbefales ikke til gravide, der både anvender tenofovirdisoproxil og en H2-receptorantagonist.
English: When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil, atazanavir concentrations are expected to be additionally decreased by about
Danish: Sammenlignet med atazanavir 300 mg med ritonavir 100 mg uden tenofovirdisoproxil forventes koncentrationen af atazanavir at falde yderligere med ca. 20%.
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: Paediatric patients (less than 3 months of age) Atazanavir Krka should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Danish: Atazanavir Krka bør ikke anvendes til børn under 3 måneder på grund af problemstillinger vedrørende sikkerhed, især på grund af den potentielle risiko for kernicterus.
English: Co-administration 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: uncommon: torsades de pointes a rare: QTc prolongationa, oedema, palpitation
Danish: ikke almindelig: torsades de pointes a sjælden: QTc-forlængelsea, ødem, palpitation
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: 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: Take Atazanavir Krka capsules with food (a meal or a substantial snack).
Danish: Tag Atazanavir Krka sammen med mad (et måltid eller et større mellemmåltid).
English: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a
Danish: almindelig: gulsot ikke almindelig: hepatitis, cholelithiasis a, kolestase a sjælden: hepatosplenomegali, cholecystitisa
English: The body and the cap of the capsule are brownish-orange colour.
Danish: Kapslens krop og hætte er brun-orange.
English: Particular caution should be used when prescribing Atazanavir Krka 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 Krka 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: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
Danish: Der er set reversible forhøjelser i indirekte (ukonjugeret) bilirubin relateret til hæmning af UDP-glucuronosyltransferase (UGT) hos patienter i behandling med atazanavir (se pkt.
English: When Atazanavir Krka and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Danish: Ved samtidig administration af Atazanavir Krka og ritonavir kan ritonavirs metaboliske lægemiddelinteraktionsprofil dominere, idet ritonavir er en mere potent CYP3A4-hæmmer end atazanavir.
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: 200 mg hard capsules: 60 hard capsules: EU/1/19/1353/002
Danish: 200 mg hårde kapsler: 60 hårde kapsler: EU/1/19/1353/002
English: Sildenafil, tadalafil and vardenafil are metabolised by CYP3A4.
Danish: Sildenafil, tadalafil og vardenafil metaboliseres af CYP3A4.
English: Atazanavir, the active substance of Atazanavir Krka, is excreted in human milk.
Danish: Atazanavir, det aktive stof i Atazanavir Krka, udskilles i modermælk.
English: f Intent-to-treat analysis, with missing values considered as failures.
Danish: f Intent-to-treat-analyse hvor manglende værdier anses for svigt.
English: 30 hard capsules: EU/1/19/1353/003 90 (3 x 30) hard capsules: EU/1/19/1353/004
Danish: 30 hårde kapsler: EU/1/19/1353/003 90 (3 x 30) hårde kapsler: EU/1/19/1353/004
English: Atazanavir Krka capsules must be taken with ritonavir and have to be taken with food.
Danish: Atazanavir Krka kapsler skal tages sammen med ritonavir og i forbindelse med et måltid.
English: No significant effect on methadone concentrations was observed.
Danish: Der er ikke set signifikant påvirkning af methadonkoncentrationen.
English: 150 mg hard capsules: 60 hard capsules: EU/1/19/1353/001
Danish: 150 mg hårde kapsler: 60 hårde kapsler: EU/1/19/1353/001
English: Your doctor may adjust the dose of Atazanavir Krka according to your anti-HIV therapy.
Danish: Lægen kan vælge at justere dosis af Atazanavir Krka, hvis det er relevant i forhold til din hiv-behandling.
English: boceprevir AUC ↔5% boceprevir cmax ↔7% boceprevir cmin ↔18%
Danish: boceprevir Cmax ↔7% boceprevir Cmin ↔18%
English: CD4 Mean Change from Baseline, cells/mm All patients
Danish: CD4 Middelændring fra baseline, celler/mm3 Alle patienter
English: If you forget to take Atazanavir Krka
Danish: Hvis du har glemt at tage Atazanavir Krka
English: Three of 20 infants (15%) born to women treated with atazanavir /ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with atazanavir /ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Danish: 3 ud af 20 spædbørn (15%) født af kvinder i behandling med atazanavir/ritonavir 300/100 mg og 4 ud af 20 spædbørn (20%) født af kvinder i behandling med atazanavir/ritonavir 400/100 mg oplevede grad 3-4 bilirubin.