FrancophonIA/ELRC3.0 huggingface dataset:
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: The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age.
Danish: Der er ikke tilstrækkelige kliniske data fra dette studie til at understøtte brugen af atazanavir kapsler (med eller uden ritonavir) hos børn under 6 år.
English: Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Danish: a Antal patienter med parvise genotyper, der er klassificeret som virologisk svigt (hiv-RNA ≥400 kopier/ml).
English: Some people will need special care before or while taking Atazanavir Krka.
Danish: Visse mennesker har behov for særlige hensyn, før eller mens de tager Atazanavir Krka.
English: G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
Danish: A71, G73, V82, 184 og L90 (0-2, 3, 4 eller flere) ved baseline.
English: Atazanavir, simultaneous administration with ddI+d4T (fasted)
Danish: Atazanavir, samtidig administration af ddI+d4T (fastende)
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: 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: Other formulations of this medicine may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms).
Danish: Der fås muligvis andre formuleringer af dette lægemiddel til pædiatriske patienter, som er mindst 3 måneder gamle og vejer mindst 5 kg (se relevant produktresumé for alternative formuleringer).
English: It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).
Danish: Det er vigtigt at informere lægen, hvis du tager fluticason eller budesonid (tages gennem næsen eller indåndes, og bruges til at behandle overfølsomhedssymptomer eller astma).
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 ca. 86% til humane serumproteiner over et koncentrationsinterval på 100 til 10.000 ng/ml.
English: During postpartum:
Danish: Post partum:
English: - Yellowing of your skin or the white part of your eyes caused by high levels of bilirrubin 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: *Ritonavir capsules, tablets or oral solution may be used.
Danish: *Ritonavir-kapsler, -tabletter eller oral opløsning kan anvendes.
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Danish: Stoffet blokerer bearbejdningen af virale gag-pol-proteiner i hiv-1 inficerede celler og hindrer dermed dannelsen af modne virioner og infektion af andre celler.
English: 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 ca. 7% af den administrerede dosis.
English: The N88S substitution has been rarely observed in patients with virologic failure on atazanavir (with or without ritonavir).
Danish: N88S-substitution er i sjældne tilfælde set hos patienter med virologisk svigt ved atazanavir-behandling (med eller uden ritonavir).
English: bSee description of selected adverse reactions for more details.
Danish: b Se Beskrivelse af udvalgte bivirkninger for yderligere oplysninger.
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, atazanavir /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 atazanavir/ritonavir at øge ketoconazol- og itraconazolkoncentrationerne.
English: No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Danish: Der er ikke set signifikant effekt på atazanavirkoncentrationen ved samtidig administration af enteroovertrukken didanosin, men administration sammen med mad reducerer didanosinkoncentrationen.
English: Do not take Atazanavir Krka: - if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Atazanavir Krka: hvis du er allergisk over for atazanavir eller et af de øvrige indholdsstoffer i Atazanavir Krka (angivet i punkt 6).
English: In this way Atazanavir Krka reduces the risk of developing illnesses linked to HIV infection.
Danish: På denne måde nedsætter Atazanavir Krka risikoen for at udvikle sygdomme forbundet med hiv-infektion.
English: Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
Danish: Pædiatriske patienter (fra 6 år til under 18 år og med en legemsvægt på mindst 15 kg) Doseringen af atazanavir-kapsler til pædiatriske patienter bestemmes ud fra legemsvægten som vist i tabel 1 og bør ikke overskride den anbefalede dosis for voksne.
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Danish: Rifampicin er en kraftig CYP3A4-induktor og er vist at reducere atazanavirs AUC med 72%, hvilket kan medføre virologisk svigt og resistensudvikling.
English: The use of Atazanavir Krka with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Danish: Brug af Atazanavir Krka med ritonavir kan overvejes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko.
English: Atazanavir Krka 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: Atazanavir Krka 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: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Danish: Mødre med hiv-infektion frarådes at amme, da virus kan overføres gennem modermælken.
English: Study conducted in HIV infected patients
Danish: Studier udført med hiv-inficerede patienter.
English: Your doctor has prescribed Atazanavir Krka for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS).
Danish: Lægen har ordineret Atazanavir Krka til dig, fordi du er smittet med hiv, som fører til aids (acquired immunodeficiency syndrome - erhvervet immundefektsyndrom).
English: Concentrations of atazanavir (when given with ritonavir) were not significantly affected.
Danish: Atazanavirkoncentrationen (når det gives med ritonavir) påvirkes ikke signifikant.
English: Therefore, postpartum patients should be closely monitored for adverse reactions.
Danish: Derfor skal post partum-patienter monitoreres nøje for bivirkninger.
English: Shelf life after first opening is 2 months, stored below 25°C.
Danish: Holdbarhed efter første åbning er 2 måneder ved opbevaring ved temperaturer under 25°C.
English: It is not known whether atazanavir with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Danish: Det vides ikke, om atazanavir med ritonavir administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn.
English: The safety and efficacy of atazanavir has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og virkningen af atazanavir er ikke bestemt hos patienter med signifikante underliggende leverforstyrrelser.
English: The M184I/V substitution emerged in 5/26 atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Danish: M184I/V substitution opstod hos henholdsvis 5/26 atazanavir/ritonavir og 7/26 lopinavir/ritonavir patienter med virologisk svigt.
English: Withdrawal of ritonavir only under restrictive conditions The recommended standard treatment is Atazanavir Krka boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Danish: Seponering af ritonavir udelukkende under restriktive omstændigheder Den anbefalede standardbehandling er Atazanavir Krka boostet med ritonavir, hvilket sikrer optimale farmakokinetiske parametre og et optimalt niveau af virologisk suppression.
English: - During this time, postpartum patients should follow the same dose recommendation as for non- pregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Danish: - I denne periode skal post partum-patienter følge de samme dosisanbefalinger som ikke-gravide, inklusive anbefalingerne for samtidig administration af lægemidler, der er kendt for at påvirke atazanavireksponeringen (se pkt.
English: Your doctor will discuss with you which combination of these medicines with Atazanavir Krka is best for you.
Danish: Lægen vil tale med dig om, hvilken kombination af anden medicin og Atazanavir Krka, der er bedst for dig.
English: De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks)
Danish: De novo substitutioner hos behandlingserfarne patienter med svigt i behandling med atazanavir + ritonavir (studie 045, 48 uger)
English: 300 mg hard capsules:
Danish: 300 mg hårde kapsler:
English: b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Danish: b 10 patienter havde baseline fænotyperesistens over for atazanavir + ritonavir (foldændring [FC]>5,2).
English: There is no specific antidote for overdose with Atazanavir Krka.
Danish: Der findes ingen specifik antidot for overdosering med Atazanavir Krka.
English: Co-administration of alfuzosin concentrations which can result in hypotension.
Danish: Risiko for øget alfuzosinkoncentration, som kan medføre hypotension.
English: AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Danish: Gennemsnitlig AUC(0-∞) var 42% højere hos forsøgspersoner med nedsat leverfunktion end hos raske forsøgspersoner.
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance aThese adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir in randomised controlled and other available clinical trials (n = 2321).
Danish: almindelig: træthed ikke almindelig: brystsmerter, ubehag, pyreksi, asteni sjælden: gangforstyrrelser a Disse bivirkninger blev identificeret under post-marketing-overvågning, men hyppigheden er dog estimeret ud fra en statistisk beregning baseret på det totale antal patienter, der har været eksponeret for atazanavir i randomiserede, kontrollerede og andre tilgængelige kliniske studier (n = 2.321).
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Danish: På baggrund af data for andre CYP3A4-hæmmere forventes plasmakoncentrationen af midazolam at være betydeligt højere, hvis midazolam administreres oralt.
English: See section 2 "Atazanavir Krka contains lactose monohydrate".
Danish: Se punkt 2 “Atazanavir Krka indeholder lactosemonohydrat”.
English: Protease inhibitors: The co-administration of atazanavir /ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Danish: Proteasehæmmere: Samtidig administration af atazanavir/ritonavir og andre proteasehæmmere er ikke undersøgt, men forventes at øge eksponeringen for andre proteasehæmmere.
English: Four subjects in the unboosted atazanavir group and 2 in the atazanavir + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Danish: 4 forsøgspersoner i gruppen med ikke-boostet atazanavir og 2 forsøgspersoner i gruppen med atazanavir + ritonavir havde hiv-RNA >500 kopier/ml i vedligeholdelsesfasen.
English: If available, 90% confidence intervals (CI) are shown in parentheses.
Danish: Hvis tilgængelige angives 90% konfidensintervaller
English: If the patient has developed SJS or DRESS associated with the use of Atazanavir Krka, Atazanavir Krka may not be restarted.
Danish: Hvis patienten har udviklet SJS eller DRESS under behandling med Atazanavir Krka, bør Atazanavir Krka-behandling ikke genoptages.
English: Pregnancy and Postpartum During the second and third trimesters of pregnancy:
Danish: Graviditetens andet og tredje trimester:
English: Some medicines may interact with ritonavir, a medicine that is taken with Atazanavir Krka.
Danish: Noget medicin kan påvirkes af ritonavir, som er et lægemiddel, der tages sammen med Atazanavir Krka.
English: ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil
Danish: EREKTIL DYSFUNKTION PDE5-hæmmere Sildenafil, tadalafil, vardenafil
English: Co-administration of atazanavir with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir.
Danish: Samtidig administration af atazanavir med produkter indeholdende voxilaprevir forventes at øge koncentrationen af voxilaprevir.
English: Atazanavir Krka is an antiviral (or antiretroviral) medicine.
Danish: Atazanavir Krka er medicin til antiviral (eller antiretroviral) behandling.
English: RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Danish: RNA-niveauet var 4.4 log10 kopier/ml (område: 2,6 til 5,88 log10 kopier/ml).
English: If you accidentally take more Atazanavir Krka capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Danish: Hvis du ved en fejltagelse har taget for mange Atazanavir Krka kapsler, skal du kontakte din hiv-læge eller nærmeste hospital og bede om råd.
English: 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.
Danish: 15 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.
English: Food effect: co-administration of atazanavir and ritonavir with food optimises the bioavailability of atazanavir.
Danish: Fødepåvirkning: samtidig indtag af atazanavir og ritonavir og mad optimerer biotilgængeligheden af atazanavir.
English: Children receiving Atazanavir Krka may require their heart to be monitored.
Danish: Hos børn, der er i behandling med Atazanavir Krka, kan det være nødvendigt at overvåge hjertet.
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Danish: Voksne patienter, der tidligere har været i antiretroviral behandling Hos antiretroviralt behandlingserfarne patienter fra studie 009, 043 og 045 blev 100 isolater fra patienter angivet som virologisk svigt under behandling, der omfattede enten atazanavir, atazanavir + ritonavir eller atazanavir + saquinavir og blev fastsat til at have udviklet resistens over for atazanavir.
English: Co-administration with atazanavir may cause a large increase in the concentration of these benzodiazepines.
Danish: Administration sammen med atazanavir kan medføre en stor stigning i koncentrationen af disse benzodiazepiner.
English: 30 hard capsules
Danish: 30 hårde kapsler
English: The pharmacokinetic data from HIV-infected pregnant women receiving atazanavir capsules with ritonavir are presented in Table 8.
Danish: De farmakokinetiske data fra hiv-smittede gravide kvinder, der fik atazanavir kapsler med ritonavir, er beskrevet i tabel 8.
English: The atazanavir /ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
Danish: Atazanavir/ritonavir-armen viste antiviral effekt svarende til lopinavir/ritonavir-armen (non-inferiør) vurderet ved andelen af patienter med hiv-RNA <50 kopier/ml ved uge 48 (tabel 5).
English: Talk to your doctor or pharmacist before taking Atazanavir Krka and make sure your doctor knows: - if you have hepatitis B or C - if you develop signs or symptoms of gall stones (pain at the right side of your stomach) - if you have type A or B haemophilia - if you require haemodialysis
Danish: Kontakt lægen eller apotekspersonalet, før du tager Atazanavir Krka, og vær sikker på, at din læge ved det: - hvis du har hepatitis B eller C - hvis du får tegn eller symptomer på galdesten (smerter i højre side af maven) - hvis du har type A- eller B-blødersygdom - hvis du er i hæmodialysebehandling.
English: Alternative antiretroviral therapy to Atazanavir Krka may be considered if jaundice or scleral icterus is unacceptable to a patient.
Danish: Anden antiretroviral behandling end Atazanavir Krka kan overvejes såfremt gulsot eller scleral icterus ikke er acceptabelt for patienten.
English: 2nd Trimester (n=9)
Danish: 2. trimester (n=9)
English: QT prolongation: Dose related asymptomatic prolongations in PR interval with atazanavir have been observed in clinical studies.
Danish: QT-forlængelse: Der er i kliniske studier observeret dosisrelaterede, asymptomatiske forlængelser i PR-intervallet med atazanavir.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristic d
Danish: Uge 48: -3% [-7,6%, 1,5%] Uge 96: 2,2% [-2,3%, 6,7%] hiv-RNA <50 kopier/ml, % ved baseline karakteristika d hiv-RNA <100.000 kopier/ml
English: Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the cmax was within 11% of fasting values.
Danish: Samtidig indtag af fedtrigt måltid påvirkede ikke AUC for atazanavir i forhold til i fastende tilstand, og Cmax lå inden for 11% i forhold til faste-værdierne.
English: The mechanism of interaction between atazanavir/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Danish: Interaktionsmekanismen mellem atazanavir/ritonavir og sofosbuvir/velpatasvir/voxilaprevir er hæmning af OATP1B, Pgp, og CYP3A.
English: LIST OF EXCIPIENTS Contains also lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactosemonohydrat.
English: Also see PULMONARY ARTERIAL HYPERTENSION in this table for futher information regarding co- administration of atazanavir with sildenafil.
Danish: Se også PULMONAL ARTERIEL HYPERTENSION i denne tabel for yderligere information om samtidig administration af atazanavir og sildenafil.
English: During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at cmax in humans.
Danish: Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro-studier ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
English: When atazanavir/ritonavir is coadministered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Danish: Når atazanavir/ritonavir administreres sammen med phenytoin eller phenobarbital, kan det være nødvendigt at justere dosis af phenytoin eller phenobarbital.
English: In a multiple-dose study in HIVinfected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Danish: I et flerdosis-studie med hiv-inficerede patienter, der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
English: If you stop taking Atazanavir Krka Do not stop taking Atazanavir Krka before talking to your doctor.
Danish: Hvis du holder op med at tage Atazanavir Krka Du må ikke holde op med at tage Atazanavir Krka uden at have talt med lægen.
English: Atazanavir Krka is not a cure for HIV infection.
Danish: Atazanavir Krka er ikke en kur mod hiv-infektion.
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Danish: Hvis det vurderes nødvendigt, bør samtidig administration kun ske efter individuel vurdering hos patienter med supprimeret hiv-virusbelastning og med hiv-virusstamme uden formodet resistens over for hiv-behandlingen.
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg
Danish: Tabel 8: Steady state farmakokinetik af atazanavir med ritonavir hos hiv-smittede gravide kvinder efter fødeindtagelse atazanavir 300 mg med ritonavir 100 mg
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Danish: Andre markante, kliniske laboratoriemæssige abnormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende atazanavir og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/serum-glutamin-pyrudrue transaminase (ALAT/SGPT) (5%), lav neutrofiltælling (5%), forhøjet aspartataminotransferase/serum-glutamin-oxalsyretransaminase (ASAT/SGOT) (3%) og forhøjet lipase (3%).
English: Other side effects reported for patients treated with atazanavir are the following: Common (may affect up to 1 in 10 people): - headache - vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia
Danish: Følgende andre bivirkninger er rapporteret hos patienter, som har været behandlet med atazanavir: Almindelige (kan forekomme hos op til 1 ud af 10 personer): - hovedpine - opkastning, diarré, smerter i maven (ubehagelige mavesmerter), kvalme, fordøjelsesbesvær - voldsom træthed