FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, combination of bedaquiline with ritonavir should be avoided.
Danish: Kombination af bedaquilin med ritonavir bør derfor undgås.
English: For older children it may be feasible to substitute tablets for the maintenance dose of other pharmaceutical forms.
Danish: Til ældre børn er det muligt at udskifte den orale vedligeholdelsesdosis af andre lægemiddelformuleringer med tabletter.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Der er rapporteret om tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
English: The most frequently used nucleosides in this study were zidovudine, stavudine, didanosine and zalcitabine.
Danish: De oftest anvendte nukleosider i dette studie var zidovudin, stavudin, didanosin og zalcitabin.
English: Monitor for ADRs related to abemaciclib.
Danish: Monitorer for bivirkningerer relateret til abemaciclib.
English: The Summary of Product Characteristics of other protease inhibitors or official continuous updates should be consulted for specific information regarding protease mutations associated with reduced response to these agents.
Danish: Produktresuméet for andre proteasehæmmere eller andre officielle opdateringer bør konsulteres med hensyn til konkrete oplysninger vedrørende proteasemutationer associeret med nedsat respons på disse stoffer.
English: In contrast to long-term administration of ritonavir, there was no significant interaction with bupropion after short-term administration of low doses of ritonavir (200 mg twice daily for 2 days), suggesting reductions in bupropion concentrations may have onset several days after initiation of ritonavir co-administration.
Danish: I modsætning til langtidsadministration af ritonavir sås ingen signifikant interaktion med bupropion efter kort tids administration af lave doser ritonavir (200 mg to gange dagligt i 2 dage), hvilket tyder på reduktion af bupropion-koncentrationer kan begynde adskillige dage efter initiering af samtidig administration af ritonavir.
English: Lipid-modifying agents
Danish: Lipid-modificerende agenter
English: Kidney (renal) disease, since your doctor may need to check the dose of your other medicines (such as protease inhibitors).
Danish: nyresygdom, da det kan være nødvendigt for din læge at kontrollere dosis af den anden medicin (f.eks. proteasehæmmere).
English: In patients who are already taking digoxin when ritonavir is introduced, the digoxin dose should be reduced to one-half of the patients' normal dose and patients need to be followed more closely than usual for several weeks after initiating co-administration of ritonavir and digoxin.
Danish: Hos patienter, som allerede tager digoxin, når behandling med ritonavir påbegyndes, bør digoxindosis reduceres til halvdelen af patientens normale dosis, og patienterne bør følges tættere end normalt i adskillige uger efter påbegyndelse af samtidig indgift af ritonavir og digoxin.
English: Hyperplasia of the retinal pigment epithelium (RPE) and retinal degeneration have been seen in all of the rodent studies conducted with ritonavir, but have not been seen in dogs.
Danish: Hyperplasi af nethindens pigmentepitel og nedbrydning af nethinden er forekommet i alle de undersøgelser på gnavere, der er foretaget med ritonavir, men er ikke set i hunde.
English: Ritonavir concentrations in this study were highly variable and somewhat lower than those obtained in adults receiving 600 mg (approximately 330 mg/m2) twice daily.
Danish: De opnåede koncentrationer af ritonavir i dette studie var meget variable og noget lavere end de koncentrationer, der blev opnået hos voksne, som fik 600 mg (ca. 330 mg/m²) to gange dagligt.
English: Based on interaction studies with the ritonavir boosted protease inhibitors (lopinavir/ritonavir, atazanavir), concurrent administration of omeprazole or ranitidine does not significantly modify ritonavir efficacy as a pharmacokinetic enhancer despite a slight change of exposure (about 6 - 18%).
Danish: Baseret på interaktionsstudie med ritonavir boostet proteasehæmmere (lopinavir/ritonavir, atazanavir) ændrer samtidig administration af omeprazol eller ranitidin ikke signifikant ritonavirs effekt som farmakokinetisk forstærker, selv om der sker en mindre ændring af eksponering (omkring 6-18 %).
English: Ritonavir should be started at 250 mg/m and increased at 2 to 3 day intervals by 50 mg/m twice daily.
Danish: Ritonavir bør påbegyndes med 250 mg/m og øges med 2 til 3 dages mellemrum med 50 mg/m to gange dagligt.
English: The effects of ritonavir (alone or combined with other antiretroviral agents) on biological markers of disease activity such as CD4 cell count and viral RNA were evaluated in several studies involving HIV-1 infected patients.
Danish: Ritonavirs virkning (alene eller sammen med andre antiretrovirale stoffer) på biologiske markører på sygdomsaktivitet, f.eks. CD4-celletælling og viralt RNA, blev vurderet i flere studier, hvori der indgik hiv-1-inficerede patienter.
English: Diabetes, as there have been reports of worsening of or the development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
Danish: sukkersyge (diabetes), da der har været rapporteret om forværring eller udvikling af diabetes (diabetes mellitus) hos nogle patienter i behandling med proteasehæmmere.
English: If Ritonavir Mylan is taken in combination with other antiretroviral medicines, it is important that you also carefully read the leaflets that are provided with these other medicines.
Danish: Hvis Ritonavir Mylan tages i kombination med anden antiretroviral medicin, er det vigtigt, at du også omhyggeligt læser de indlægssedler, som følger med den anden medicin.
English: Ritonavir Mylan should be administered by physicians who are experienced in the treatment of HIV infection.
Danish: Ritonavir Mylan skal ordineres af en læge, der har erfaring med behandling af hiv-infektion.
English: For a description of the mechanisms and potential mechanisms contributing to the interaction profile of the PIs, see section 4.5.
Danish: For en beskrivelse af de mekanismer og potentielle mekanismer, der bidrager til proteasehæmmernes interaktionsprofil henvises til pkt.
English: C-labelled ritonavir in rats showed the liver, adrenals, pancreas, kidneys and thyroid to have the highest concentrations of ritonavir.
Danish: C-mærket ritonavir i rotter har vist, at lever, binyrer, pankreas, nyrer og thyreoidea indeholdt den højeste koncentration af ritonavir.
English: If a side effect is preventing you from taking Ritonavir Mylan as directed, tell your doctor straight away.
Danish: Hvis en bivirkning forhindrer dig i at tage Ritonavir Mylan efter anvisningerne, skal du straks kontakte lægen.
English: For selected medicinal products (e.g. alprazolam) the inhibitory effects of ritonavir on CYP3A4 may decrease over time.
Danish: For udvalgte lægemidler (f.eks. alprazolam) kan ritonavirs hæmmende effekt på CYP3A4 aftage med tiden.
English: For patients who have completed the ramp-up phase and are on a steady daily dose of venetoclax, reduce the venetoclax dose by at least 75% when used with strong CYP3A inhibitors (refer to the venetoclax SmPC for dosing instructions).
Danish: Hos patienter, der har gennemført titreringsfasen og får en fast daglig dosis venetoclax, skal dosis af venetoclax reduceres med mindst 75%, når det anvendes sammen med potente CYP3A-hæmmere (se produktresuméet for venetoclax for dosisvejledning).
English: You must not take ritonavir with colchicine if you have kidney and/or liver problems (see also ‘Do not take Ritonavir Mylan' above).
Danish: Du må ikke tage ritonavir sammen med colchicin, hvis du har problemer med nyre og/eller lever (se også ‘Tag ikke Ritonavir Mylan' ovenfor).
English: Concomitant administration of glecaprevir/pibrentasvir and ritonavir is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.
Danish: Samtidig administration af glecaprevir/pibrentasvir og ritonavir frarådes på grund af en øget risiko for ALT-elevationer associeret med øget glecaprevireksponering.
English: There are some medicines you cannot take at all with ritonavir.
Danish: Der er nogle lægemidler, som du slet ikke må tage sammen med ritonavir.
English: Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity.
Danish: Der er grund til særlig bevågenhed hos patienter, der samtidig er inficeret med kronisk hepatitis B eller hepatitis C, da disse patienter har en øget risiko for levertoksicitet.
English: Talk to your doctor before you take any cholesterol-reducing medicines with ritonavir (see also ‘Do not take Ritonavir Mylan' above).
Danish: Tal med din læge, inden du tager nogen former for kolesterolsænkende lægemidler sammen med ritonavir (se også punktet ‘Tag ikke Ritonavir Mylan' ovenfor).
English: When used in combination with delavirdine, dose reduction of ritonavir may be considered.
Danish: Når ritonavir anvendes i kombination med delavirdin, kan dosisreduktion af ritonavir overvejes.
English: Co-administration of voriconazole and ritonavir dosed as a pharmacokinetic enhancer should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Danish: Samtidig anvendelse af voriconazol og ritonavir doseret som farmakokinetisk forstærker bør undgås, medmindre en vurdering af benefit/risk-forholdet for patienten berettiger brugen af voriconazol.
English: Also read the list of medicines under ‘Other medicines and Ritonavir Mylan' for use with certain other medicines which require special care.
Danish: Læs også listen over lægemidler under punktet ‘Brug af anden medicin sammen med Ritonavir Mylan', hvis du skal anvende ritonavir sammen med visse andre lægemidler, som kræver, at der udvises særlig forsigtighed.
English: Although rifampicin may induce metabolism of ritonavir, limited data indicate that when high doses of ritonavir (600 mg twice daily) is co-administered with rifampicin, the additional inducing effect of rifampicin (next to that of ritonavir itself) is small and may have no clinical relevant effect on ritonavir levels in high-dose ritonavir therapy.
Danish: Selvom rifampicin kan inducere ritonavirs metabolisme, tyder begrænsede data på, at høje doser ritonavir (600 mg to gange dagligt) administreret med rifampicin kun har en lille inducerende effekt (ved siden af ritonavirs egen) og ikke har nogen klinisk relevant virkning på ritonavir-niveauer i højdosis behandling med ritonavir.
English: developing viral resistance (in HIV-postive infants) and (3) serious adverse reactions in a breastfed infant, HIV infected women should not breast feed their infants under any circumstances if they are receiving ritonavir.
Danish: På grund af risikoen for 1) hiv-overførsel (hos hiv-negative nyfødte), 2) udvikling af virusresistens (hos hiv-positive spædbørn) og 3) alvorlige bivirkninger hos det nyfødte barn bør hiv-inficerede kvinder ikke under nogen omstændigheder amme deres nyfødte barn, hvis kvinden behandles med ritonavir.
English: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Danish: Generics [UK] Limited Station Close, Potters Bar Hertfordshire, EN6 1TL Storbritannien
English: If trazodone is co-administered with ritonavir, the combination should be used with caution, initiating trazodone at the lowest dosage and monitoring for clinical response and tolerability.
Danish: Hvis trazodon anvendes samtidig med ritonavir, bør kombinationen gives med forsigtighed, således at behandling med trazodon initieres med laveste dosis og med overvågning af klinisk respons og tolerabilitet.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression (plasma cortisol levels were noted to be decreased 86% in the above study) have been reported in patients receiving ritonavir and inhaled or intranasal fluticasone propionate; similar effects could also occur with other corticosteroids metabolised by CYP3A e.g., budesonide and triamcinolone.
Danish: Systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (i ovennævnte studie blev der registreret fald i plasmakortisolniveauer på 86 %), er rapporteret hos patienter, der får ritonavir og inhaleret eller intranasal fluticasonpropionat; lignende virkninger kan også forekomme med andre kortikosteroider, som metaboliseres via CYP3A, f.eks. budesonid og triamcinolon.
English: In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of ≤ 400 copies/ml at Week 16 and 104, respectively.
Danish: I intent-to-treat analyser opnåede 72 % og 36 % af patienterne reduktion i plasma hiv-1 RNA på < 400 kopier/ml i henholdsvis uge 16 og 104.
English: Patients who exhibit these signs or symptoms should be evaluated and ritonavir therapy should be discontinued if a diagnosis of pancreatitis is made (see section 4.8).
Danish: Patienter med disse tegn eller symptomer bør vurderes, og behandlingen med ritonavir bør seponeres, hvis diagnosen pankreatit stilles (se pkt.
English: Saquinavir/ritonavir should not be given together with rifampicin, due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three medicines are given together (see section 4.5).
Danish: Saquinavir/ritonavir bør ikke gives sammen med rifampicin på grund af risikoen for alvorlig levertoksicitet (viser sig ved forhøjede leveraminotransferaser), hvis de tre lægemidler gives sammen (se afsnit 4.5).
English: For some products, contraindications may be more relevant when ritonavir is used as an antiretroviral agent than when ritonavir is used as a pharmacokinetic enhancer (e.g. rifabutin and voriconazole):
Danish: For nogle lægemidler kan kontraindikationer være mere relevante, når ritonavir anvendes som antiretroviralt lægemiddel end, når ritonavir anvendes som farmakokinetisk forstærker (f.eks. rifabutin og voriconazol):
English: Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis (see section 4.4).
Danish: Patienter med fremskreden hivsygdom kan have en risiko for forhøjede triglyceridværdier og pankreatit (se pkt.
English: The relatively high frequency of diarrhoea during treatment with ritonavir may compromise the absorption and efficacy (due to decreased compliance) of ritonavir or other concurrent medicinal products.
Danish: Den relativt hyppige forekomst af diarré under ritonavirbehandling kan hæmme optagelsen og virkningen (på grund af nedsat compliance) af ritonavir eller andre samtidigt administrerede lægemidler.
English: Hepatitis B or C and are being treated with a combination of antiretroviral agents, as you are at a greater risk of a severe and potentially life threatening reaction because of the effect on the liver.
Danish: hepatitis B eller C og er i behandling med en kombination af antiretrovirale lægemidler, da du i så fald har større risiko for at få en alvorlig og muligvis livstruende reaktion på grund af påvirkning af leveren.
English: Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
Danish: Pankreatit bør overvejes, hvis der optræder kliniske symptomer (kvalme, opkastning, mavesmerter) eller unormale laboratorieværdier (f.eks. forhøjede serumlipase- eller amylaseværdier), som kan tyde på pankreatit.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under hiv-behandling kan der forekomme vægtstigning samt forhøjet indhold af lipider og glucose i blodet.
English: The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (e.g. digoxin and fexofenadine-see table “Ritonavir effects on non-antiretroviral medicinal products” below).
Danish: Ritonavirs hæmmende effekt (med eller uden proteasehæmmere) på P-gp aktiviteten kan aftage med tiden (f.eks. digoxin og fexofenadin - se tabel ”Ritonavirs virkning på ikkeantiretrovirale lægemidler” nedenfor).
English: The mean average change from baseline over 16 weeks for HIV RNA levels was -0.79 log10 (maximum mean decrease: 1.29 log10) in the ritonavir group versus -0.01 log10 in the control group.
Danish: Den gennemsnitlige ændring fra baseline i løbet af 16 uger for hiv-RNA-niveauerne var -0,79 log10 (gennemsnitlig maksimalt fald: 1,29 log10) i ritonavirgruppen sammenlignet med -0,01 log10 i kontrolgruppen.
English: Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope).
Danish: Derved øges den potentielle risiko for sildenafilassocierede bivirkninger (inklusive hypotension og synkope).
English: Interactions between ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below.
Danish: Interaktioner mellem ritonavir og proteasehæmmere, antiretrovirale stoffer på nær proteasehæmmere og andre ikke-antiretrovirale lægemidler er opført i listen nedenfor.
English: In an open label trial completed in 1998 in HIV infected, clinically stable children there was a significant difference (p = 0.03) in the detectable RNA levels in favour of a triple regimen (ritonavir, zidovudine and lamivudine) following 48 weeks treatment.
Danish: I et åbent studie afsluttet i 1998 med hiv-inficerede, klinisk stabile børn ses en signifikant forskel (p = 0,03) i de påviselige RNA-niveauer efter en 48 ugers triple-behandling (ritonavir + zidovudin + lamivudin).
English: Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases.
Danish: Ritonavir er et oralt aktivt, peptidomimetisk stof, der hæmmer hiv-1 og hiv-2 aspartylprotease.
English: Immunosuppressants Cyclosporine, tacrolimus, everolimus
Danish: Ciclosporin, tacrolimus, everolimus
English: Multipack: 90 (3 bottles of 30) film-coated tablets
Danish: Multipakning: 90 (3 beholdere med 30) filmovertrukne tabletter
English: Taking Ritonavir Mylan as recommended should give you the best chance of delaying resistance to the medicines.
Danish: Ved at tage Ritonavir Mylan som det er ordineret af lægen, har du størst chance for at forsinke udviklingen af resistens mod medicinen.
English: Tell your doctor if you are taking any of the medicines listed below, as special care should be taken.
Danish: Fortæl det til lægen, hvis du tager et eller flere af nedenstående lægemidler, da der i så fald skal udvises særlig forsigtighed.
English: As ritonavir is recommended to be taken with food and didanosine should be taken on an empty stomach, dosing should be separated by 2.5 h. Dose alterations should not be necessary.
Danish: Da det anbefales, at ritonavir indtages sammen med et måltid, og didanosin bør indtages på tom mave, bør intervallet mellem doseringerne være 2,5 time.
English: 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 30 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses.
Danish: Følgende hiv-1-proteasehæmmere er godkendt til brug med ritonavir som en farmakokinetisk forstærker ved de angivne doser.
English: Ritonavir has a high affinity for several cytochrome P450 (CYP) isoforms and may inhibit oxidation with the following ranked order: CYP3A4 > CYP2D6.
Danish: Ritonavir har stor affinitet til flere cytokrom P450 (CYP)-isoformer og kan hæmme oxidation i følgende aftagende rækkefølge: CYP3A4 > CYP2D6.
English: Ritonavir is recommended for children 2 years of age and older.
Danish: Ritonavir anbefales til børn i alderen 2 år og derover.
English: Induction of CYP1A2 and CYP2C9 lead to decreased levels of R-warfarin while little pharmacokinetic effect is noted on S-warfarin when co-administered with ritonavir.
Danish: Induktion af CYP1A2 og CYP2C9 giver lavere koncentrationer af Rwarfarin, mens der kun er registreret en lille farmakokinetisk virkning i forbindelse med S-warfarin ved samtidig administration af ritonavir.
English: Animal studies do not indicate harmful effects of ritonavir on fertility (see section 5.3).
Danish: Dyrestudier viser ingen skadelige virkninger på fertiliteten (se pkt.
English: Atorvastatin is less dependent on CYP3A for metabolism.
Danish: Atorvastatin er mindre afhængig af CYP3A med hensyn til metabolisme.
English: Hepatic transaminase elevations exceeding five times the upper limit or normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretrovirals.
Danish: Stigning i levertransferaser udover 5 gange den øvre normalgrænse, klinisk hepatit og gulsot er set hos patienter, som fik ritonavir alene eller i kombination med andre retrovirale lægemidler.
English: One patient in clinical trials took ritonavir 1,500 mg/day for two days and reported paraesthesia, which resolved after the dose was decreased.
Danish: I et klinisk studie tog en patient ritonavir i en dosis på 1.500 mg/dag i to dage og meldte om paræstesi, der svandt efter at dosis blev sat ned.
English: • muscle aches (pain), tenderness or weakness
Danish: • ømhed i muskler (smerte), ømhed eller svækkelse
English: Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200 mg once daily could be considered.
Danish: Kun når atazanavir med ritonavir administreres sammen med efavirenz, kan en dosisøgning af ritonavir til 200 mg en gang dagligt overvejes.
English: Immune reconstitution inflammatory syndrome
Danish: Immunreaktiveringssyndrom syndrom
English: Low doses of ritonavir have shown profound effects on the pharmacokinetics of other protease inhibitors (and other products metabolised by CYP3A4) and other protease inhibitors may influence the pharmacokinetics of ritonavir (see section 4.5).
Danish: Lave doser af ritonavir har vist sig at have betydelig virkning på andre proteasehæmmeres farmakokinetik (og andre produkter metaboliseret via CYP3A4), og andre proteasehæmmere kan påvirke ritonavirs farmakokinetik (se pkt.
English: Ritonavir effects on non-antiretroviral co-administered medicinal products
Danish: Ritonavirs virkning på ikke-antiretrovirale lægemidler
English: Hormonal contraceptives containing ethinylestradiol as ritonavir may reduce the effectiveness of these medicines.
Danish: Hormonelle præventionsmidler, som indeholder ethinylestradiol, da ritonavir kan mindske disse lægemidlers virkning.
English: In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations.
Danish: In vitro- og in vivo-studier har vist, at ritonavir er en potent hæmmer af CYP3A- og CYP2D6-medierede biotransformationer.
English: Hypersensitivity including urticaria, and face oedema
Danish: Overfølsomhed inklusive arthritis urticaria og ansigtsødem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON MED MULTIPAKKE (MED BLÅ BOKS)
English: The Day 3 ritonavir exposure was approximately 1.5 fold higher than that observed with the 600 mg twice daily dose at steady state.
Danish: Eksponering for ritonavir på dag 3 var ca. 1,5 gange højere end den, som blev set med en dosis på 600 mg to gange dagligt ved steady state.
English: Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as serious liver damage can occur when taken with ritonavir.
Danish: Rifampicin og saquinavir (til behandling af henholdsvis tuberkulose og hiv), da der kan forekomme alvorlig leverskade, når de tages sammen med ritonavir.