FrancophonIA/ELRC3.0 huggingface dataset:
English: It is normally used in combination with other anti-HIV medicines.
Danish: Det anvendes normalt i kombination med anden medicin mod hiv.
English: When treating HIV infection, it is not always easy to identify what side effects are caused by REYATAZ, by the other medicines you are taking, or by the HIV infection itself.
Danish: Ved behandling af hiv-infektion er det ikke altid let at sige, hvilke bivirkninger der skyldes REYATAZ, anden medicin du tager eller selve hiv-infektionen.
English: Always give your child the medicine within 60 minutes of mixing.
Danish: Du skal altid give barnet denne medicin inden for 60 minutter efter, du har blandet den.
English: These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication.
Danish: Denne slags medicin kontrollerer infektion med human immundefektvirus (hiv) ved at stoppe et protein, som hiv har brug for til at mangfoldiggøre sig.
English: AI424-397 (PRINCE I): In paediatric patients from 3 months to less than 6 years of age
Danish: AI424-397 (PRINCE I): Hos pædiatriske patienter fra 3 måneder til under 6 år
English: In this way REYATAZ reduces the risk of developing illnesses linked to HIV infection.
Danish: På denne måde nedsætter REYATAZ risikoen for at udvikle sygdomme forbundet med hiv-infektion.
English: Additional minor metabolic pathways consist of N-dealkylation and hydrolysis.
Danish: Yderligere mindre metaboliske pathways består af N-dealkylering og hydrolyse.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling bør indledes af en læge med erfaring med behandling af hiv-infektion.
English: d Confidence interval.
Danish: d Konfidensinterval.
English: Serum cholesterol and glucose were minimally to mildly increased in rats but not in mice or dogs.
Danish: Serum-kolesterol og glucose var minimalt til let forhøjet hos rotter, men ikke hos mus eller hunde.
English: An initial dose reduction of diltiazem by 50% is recommended, with subsequent titration as needed and ECG monitoring.
Danish: Initial dosisreduktion af diltiazem på 50% med efterfølgende titrering efter behov samt ekg-monitorering anbefales.
English: REYATAZ capsules may be used by adults and children 6 years of age and older.
Danish: REYATAZ-kapsler kan anvendes af voksne og børn, der er 6 år og ældre.
English: The rash usually disappears within 2 weeks without any change to your REYATAZ treatment.
Danish: Udslættet forsvinder som regel inden for 2 uger uden at REYATAZ-behandlingen ændres.
English: A dose reduction of buprenorphine may be considered.
Danish: Reduktion af buprenorphindosis kan overvejes.
English: Pregnancy and Postpartum
Danish: Graviditet og post partum
English: The 24 hour concentration following a high fat meal was increased by approximately 33% due to delayed absorption; the median Tmax increased from 2.0 to 5.0 hours.
Danish: 24-timerskoncentrationen efter et fedtrigt måltid steg med ca. 33% på grund af forsinket absorption; middel-Tmax steg fra 2,0 til 5,0 timer.
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: The primary endpoint was the time-averaged difference in change from baseline in HIV RNA through 48 weeks (Table 6).
Danish: Det primære endepunkt var den tidsgennemsnitlige forskel i ændring fra baseline i hiv-RNA gennem 48 uger (tabel 6).
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Caution should be used with medicinal products known to induce PR prolongations.
Danish: Der bør udvises forsigtighed ved lægemidler, der vides at inducere PR-forlængelser.
English: REYATAZ is an antiviral (or antiretroviral) medicine.
Danish: REYATAZ er medicin til antiviral (eller antiretroviral) behandling.
English: FC susceptibility in cell culture relative to the wild-type reference was assayed using PhenoSenseTM (Monogram Biosciences, South San Francisco, California, USA)
Danish: FC følsomhed i cellekulturer hvad angår vildtypereference blev testet ved hjælp af PhenoSenseTM (Monogram Biosciences, South San Francisco, Californien, USA)
English: To enhance bioavailability and minimise variability, REYATAZ is to be taken with food.
Danish: For at øge biotilgængelighed og minimere variabilitet, skal REYATAZ tages sammen med et måltid.
English: Analyses of data through 96 weeks of treatment demonstrated durability of antiviral activity (Table 5).
Danish: En analyse af data indsamlet over 96 behandlingsuger viste varigheden af den antivirale aktivitet (tabel 5).
English: Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Danish: Antiviral aktivitet in vitro: Atazanavir udviser anti-hiv-1 (herunder alle testede grupper) og anti-hiv-2 aktivitet i cellekulturer.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Det kan være skadeligt, hvis du har phenylketonuri (PKU, Føllings sygdom), en sjælden genetisk lidelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
English: REYATAZ oral powder should be given within 60 minutes of mixing.
Danish: REYATAZ oralt pulver bør gives inden for 60 minutter efter opblanding.
English: For patients not taking tenofovir, if REYATAZ
Danish: Patienter, der ikke tager tenofovir, hvis REYATAZ
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (som skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
English: Body weight (kg)
Danish: Vægt (kg)
English: Expected: ↔ Atazanavir ↔ Ritonavir
Danish: Forventet: ↔ Atazanavir ↔ Ritonavir
English: Children receiving REYATAZ may require their heart to be monitored.
Danish: Hos børn, der er i behandling med REYATAZ, kan det være nødvendigt at overvåge hjertet.
English: Yellowing of your skin or the white part of your eyes caused by high levels of bilirubin in your blood has been commonly reported.
Danish: Gulfarvning af huden eller det hvide i øjnene på grund af højt indhold af bilirubin i blodet er hyppigt rapporteret.
English: Assessment of adverse reactions for REYATAZ is based on safety data from clinical studies and postmarketing experience.
Danish: Evalueringen af REYATAZ' bivirkninger er baseret på sikkerhedsdata fra kliniske studier og på erfaring efter markedsføring.
English: It should always be used with a low dose of ritonavir and in combination with other anti-HIV medicines.
Danish: Det bør altid anvendes sammen med en lav dosis ritonavir og i kombination med anden hiv-medicin.
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryodevelopment study.
Danish: Der sås hos drægtige kaniner omfattende læsioner i mave og tarm hos døde eller moribunde hunner ved maternelle doser 2 og 4 gange den højeste dosis administreret i den endelige fosterudviklingsstudie.
English: Your doctor has prescribed REYATAZ for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
Danish: Lægen har ordineret REYATAZ til dig, fordi du er smittet med hiv, som fører til aids (acquired immunodeficiency syndrome - erhvervet immundefektsyndrom).
English: Treatment of overdose with REYATAZ should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Danish: Behandling af overdosering med REYATAZ bør bestå af generelt understøttende tiltag, inklusive monitorering af vitale tegn og elektrokardiogram (ekg) samt observation af patientens kliniske status.
English: Your doctor will discuss with you which combination of these medicines with REYATAZ is best for you.
Danish: Lægen vil tale med dig om, hvilken kombination af anden medicin og REYATAZ, der er bedst for dig.
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%-89%).
Danish: Plasmaniveauet af fluticasonpropionat øges signifikant hvorimod intrinsic kortisol-niveauer falder med ca. 86% (90% KI 82%-89%).
English: REYATAZ oral powder should be stored in the original sachet and should not be opened until ready to use.
Danish: REYATAZ oralt pulver bør opbevares i det originale brev og bør ikke åbnes, før lægemidlet skal bruges.
English: Ritonavir is administered immediately following REYATAZ powder administration.
Danish: Ritonavir administreres umiddelbart efter administration af REYATAZ pulver.
English: e Per protocol analysis: Excluding non-completers and patients with major protocol deviations.
Danish: e Per protokol analyse: Undtagen patienter, der ikke fuldførte behandlingen, og patienter med store protokolafvigelser.
English: Aspartame is a source of phenylalanine.
Danish: Aspartam er en phenylalaninkilde.
English: 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: 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: How to take REYATAZ 4.
Danish: Sådan skal du tage REYATAZ 4.
English: Date of latest renewal: 02 March 2009
Danish: Dato for første markedsføringstilladelse: 2. marts 2004 Dato for seneste fornyelse: 2. marts 2009
English: The study assessed 40 infants who received antiretroviral prophylactic treatment (which did not include REYATAZ) and were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.
Danish: I studiet indgik 40 spædbørn, som fik profylaktisk antiretroviral behandling (som ikke omfattede REYATAZ), og som var negative for hiv-1-dna på fødselstidspunktet og/eller i de første 6 måneder efter fødslen.
English: It is recommended that the International Normalised Ratio (INR) be monitored carefully during treatment with REYATAZ, especially when commencing therapy.
Danish: Det anbefales at monitorere International Normaliseret Ratio (INR) omhyggeligt under behandling med REYATAZ, særligt ved behandlingsstart.
English: Put the sachets' content in a small drinking cup.
Danish: Hæld indholdet af brevene i en lille drikkekop.
English: that co-administration with famotidine is not recommended but if required, atazanavir without ritonavir should be administered either 2 hours after famotidine or 12 hours before.
Danish: at administration sammen med famotidin frarådes, men om nødvendigt kan atazanavir uden ritonavir administreres enten 2 timer efter famotidin eller 12 timer før.
English: Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Danish: Ændringer i hjertets måde at slå på (hjerterytmeændringer) kan i nogle tilfælde opstå.
English: There is no specific antidote for overdose with REYATAZ.
Danish: Der findes ingen specifik antidot for overdosering med REYATAZ.
English: REYATAZ given without ritonavir should not be used in pregnant patients given that it could result of suboptimal exposure of particular concern for the mother infection and vertical transmission.
Danish: REYATAZ uden ritonavir bør ikke anvendes til gravide patienter, da det kan medføre suboptimal eksponering, hvilket giver anledning til særlig bekymring for moderens infektion og vertikal transmission.
English: e Number of patients evaluable.
Danish: e Antal evaluerbare patienter.
English: For inclusion in both trials, treatment-naive patients had to have genotypic sensitivity to REYATAZ and two NRTIs, and treatment-experienced patients had to have documented genotypic and phenotypic sensitivity at screening to REYATAZ and at least 2 NRTIs.
Danish: For at blive inkluderet i begge studier skulle behandlingsnaive patienter have genotypisk sensitivitet over for REYATAZ og to NRTI'er, og behandlingserfarne patienter skulle have dokumenteret genotypisk og fænotypisk sensitivitet ved screening over for REYATAZ og mindst 2 NRTI'er.
English: If water is used, food should also be taken at the same time.
Danish: Hvis der anvendes vand, skal det indtages sammen med føde.
English: Patients exposed only to antiretrovirals in utero or intrapartum were considered treatment-naive.
Danish: Patienter, der udelukkende blev eksponeret for antiretrovirale midler in utero eller under fødslen, blev betragtet som behandlingsnaive.
English: REYATAZ contains lactose.
Danish: REYATAZ indeholder lactose.
English: * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Danish: * Der er rapporteret effekt af atazanavir and ritonavir ved den første dosis af glecaprevir og pibrentasvir.
English: Race: a population pharmacokinetic analysis of samples from Phase II clinical trials indicated no effect of race on the pharmacokinetics of atazanavir.
Danish: Race: En befolkningsmæssig farmakokinetisk analyse af prøver fra fase II kliniske afprøvninger indikerede ingen racemæssig indvirkning på farmakokinetikken for atazanavir.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, proteasehæmmere, ATC-kode: J05AE08
English: REYATAZ 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Danish: REYATAZ 300 mg med ritonavir 100 mg giver muligvis ikke tilstrækkelig eksponering for atazanavir, specielt i de tilfælde hvor aktiviteten af atazanavir eller af hele regimet er kompromitteret på grund af resistens.
English: REYATAZ is not a cure for HIV infection.
Danish: REYATAZ er ikke en kur mod hiv-infektion.
English: REYATAZ with food and drink See section 3 How to take REYATAZ.
Danish: Brug af REYATAZ sammen med mad og drikke Se afsnit 3 Sådan skal du tage REYATAZ.
English: Elimination: following a single 400 mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Danish: Elimination: Efter en enkelt dosis på 400 mg 14C-atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
English: Liver problems may uncommonly happen.
Danish: Leverproblemer kan forekomme mindre hyppigt.
English: If REYATAZ oral powder is mixed with water, food should also be taken at the same time.
Danish: Hvis REYATAZ oralt pulver blandes med vand, bør barnet også spise noget samtidig.
English: HIV RNA <50 copies/ml, %f (responder/evaluable) All patients 36 (43/120) 32 (38/120) 42 (52/123) 35 (41/118)
Danish: hiv-RNA <50 kopier/ml, %f (respons/evaluerbar) Alle patienter 36 (43/120) 32 (38/120) 42 (52/123) 35 (41/118)
English: Withdrawal of ritonavir only under restrictive conditions The recommended standard treatment is REYATAZ boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Danish: Seponering af ritonavir udelukkende under restriktive omstændigheder Den anbefalede standardbehandling er REYATAZ boostet med ritonavir, hvilket sikrer optimale farmakokinetiske parametre og et optimalt niveau af virologisk suppression.
English: Studies conducted in HIVinfected patients.
Danish: Studier udført med hivinficerede patienter.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Preparing and giving the medicine with food
Danish: Tilberedning og indgivelse af medicinen sammen med mad
English: f Number of patients evaluable.
Danish: f Antal evaluerbare patienter.
English: Distribution: atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Danish: Fordeling: Atazanavir bindes med cirka 86% til humane serumproteiner over et koncentrationsinterval på 100 til 10.000 ng/ml.
English: Diabetic population
Danish: Diabetespopulation
English: Systemic lidocaine, Quinidine
Danish: Amiodaron Systemisk lidocain Quinidin
English: Age/Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Danish: Alder/køn: Der er gennemført farmakokinetiske studier af atazanavir på 59 raske mandlige og kvindelige forsøgspersoner (29 unge, 30 ældre).
English: Give to your child the recommended dose of ritonavir immediately after giving REYATAZ oral powder.
Danish: Giv barnet den anbefalede dosis ritonavir umiddelbart efter, du har givet REYATAZ oralt pulver.
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Danish: Øget klinisk monitorering og monitorering af laboratorieprøver for hivsuppression er påkrævet.
English: During postpartum: Following a possible decrease in atazanavir exposure during the second and third trimester, atazanavir exposures might increase during the first two months after delivery (see section 5.2).
Danish: Efter et muligt fald i eksponering for atazanavir i andet og tredje trimester kan eksponeringen for atazanavir muligvis øges i de første to måneder efter fødslen (se pkt.
English: REYATAZ oral powder should be taken/given with food (e.g. applesauce or yogurt) or drinks (e.g. milk, infant formula or water) for infants who can drink from a cup.
Danish: REYATAZ oralt pulver skal tages/gives sammen med mad (f.eks. æblemos eller yoghurt) eller drikke (f.eks. mælk, modermælkserstatning eller vand) hos spædbørn, som kan drikke af en kop.
English: Your child's doctor will decide the right dose based on your child's age and weight.
Danish: Dit barns læge vil fastlægge den rigtige dosis ud fra barnets alder og vægt.
English: None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect reemergence 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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 50 mg
English: Metabolism: 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: Biotransformation: 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: Renal impairment: in healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Danish: Nedsat nyrefunktion: Hos raske forsøgspersoner var den renale udskillelse af uomdannet atazanavir cirka 7% af den administrerede dosis.
English: Do not open the sachet until ready to use.
Danish: Du må ikke åbne brevet, før det skal anvendes.
English: One pack size is available: 1 carton with 30 sachets.
Danish: Der findes en pakningsstørrelse: 1 æske med 30 breve.
English: If REYATAZ is co-administered 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 REYATAZ 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: b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Danish: b Ti patienter havde baseline fænotyperesistens over for atazanavir + ritonavir (foldændring [FC]>5,2).
English: 1.3 g of sucrose per sachet.
Danish: 1,3 g saccharose pr. brev.
English: - The active substance is atazanavir.
Danish: - - Aktivt stof: atazanavir.
English: During attempts to overcome the decreased exposure by increasing the dose of REYATAZ 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 REYATAZ, eller andre proteasehæmmere med ritonavir, er der set en høj frekvens af leverreaktioner.
English: A change in dose may occur when switching between oral powder and capsules.
Danish: Det er muligt at dosis skal ændres i forbindelse med et skift fra oralt pulver til kapsler.
English: If you forget to take REYATAZ
Danish: Hvis du har glemt at tage REYATAZ
English: This should be taken into account in patients with diabetes mellitus.
Danish: Diabetespatienter skal tage hensyn hertil.
English: Table 5: Efficacy Outcomes in Study 138 a
Danish: Tabel 5: Effektresultater i Studie 138a
English: If you stop taking REYATAZ Do not stop taking REYATAZ before talking to your doctor.
Danish: Hvis du holder op med at tage REYATAZ Du må ikke holde op med at tage REYATAZ uden at have talt med lægen.
English: Atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
Danish: Atazanavir er en azapeptid hiv-1-proteasehæmmer (PI).
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, REYATAZ/ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Danish: Baseret på data fra andre boostede PI'er og ketoconazol, hvor ketoconazol-AUC viste en 3-fold stigning, forventes REYATAZ/ritonavir at øge ketoconazol- og itraconazolkoncentrationerne.
English: High doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Danish: Høje doser ketoconazol og itraconazol (>200 mg/dag) frarådes.
English: REYATAZ once daily dose ritonavir once daily dose at least 5 to less than 15
Danish: REYATAZ en daglig dosis ritonavir en daglig dosis mindst 5 til under 15
English: Alternative antiretroviral therapy to REYATAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Danish: Anden antiretroviral behandling end REYATAZ kan overvejes såfremt gulsot eller scleral icterus ikke er acceptabelt for patienten.
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: 63 mg of aspartame per sachet.
Danish: 63 mg aspartam pr. brev.