FrancophonIA/ELRC3.0 huggingface dataset:
English: In an interaction study of single-dose bedaquiline and multiple dose lopinavir/ritonavir, the AUC of bedaquiline was increased by 22%.
Danish: I et interaktionsstudie med enkeltdosis bedaquilin og flerdosis lopinavir/ritonavir blev AUC for bedaquilin øget med 22 %.
English: Ritonavir is principally metabolised and eliminated by the liver.
Danish: Ritonavir metaboliseres og elimineres primært af leveren.
English: Increased amylase, decreased free and total thyroxin
Danish: Forhøjet amylase, nedsat fri og totalthyroxin
English: Trough concentrations of ritonavir decrease over time, possibly due to enzyme induction, but appeared to stabilise by the end of 2 weeks.
Danish: De laveste koncentrationer af ritonavir falder med tiden, muligvis på grund af enzyminduktion, men synes at stabilisere sig efter 2 uger.
English: If you are currently taking any of these medicines, ask your doctor about switching to a different medicine while you are taking Ritonavir Mylan.
Danish: Hvis du i øjeblikket tager et eller flere af disse lægemidler, skal du rådføre dig med din læge om at skifte til et andet lægemiddel, mens du tager Ritonavir Mylan.
English: PR interval prolongation
Danish: Forlængelse af PR-intervallet
English: Adjustment to the dose of buprenorphine or ritonavir may therefore not be necessary when the two are dosed together.
Danish: Tilpasning af buprenorphins eller ritonavirs dosis er derfor muligvis unødvendig, når disse doseres sammen.
English: Ultrastructural evidence suggests that these retinal changes may be secondary to phospholipidosis.
Danish: Ultrastrukturelle tegn antyder, at disse ændringer i nethinden kan være en følge af fosfolipidose.
English: The maximum mean (95% upper confidence bound) difference in QTcF from placebo was 5.5 (7.6) for 400 mg twice daily ritonavir.
Danish: De maksimale gennemsnitlige (95% øvre konfidensgrænse) forskelle i QTcF fra placebo var 5,5 (7,6) for 400 mg ritonavir to gange dagligt.
English: Ritonavir Mylan is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
Danish: Ritonavir Mylan bruges til børn på 2 år og derover, unge og voksne, som er inficeret med hiv, den virus som forårsager AIDS.
English: The apparent volume of distribution (VB/F) of ritonavir is approximately 20 - 40 l after a single 600 mg dose.
Danish: Det tilsyneladende fordelingsvolumen af ritonavir (VB/F) er ca. 20-40 l efter en enkelt 600 mg dosis.
English: • increase in cholesterol
Danish: • forhøjet kolesterol
English: Methadone1
Danish: Methadon1
English: Hydroxypropylcellulose Talc
Danish: Hydroxypropylcellulose Talcum
English: Maraviroc may be given with ritonavir to increase the maraviroc exposure.
Danish: Maraviroc kan gives sammen med ritonavir for at øge eksponeringen for maraviroc.
English: Therefore, the use of ritonavir is not recommended in patients receiving rivaroxaban.
Danish: Derfor anbefales brug af ritonavir ikke til patienter, som får rivaroxaban.
English: Ritonavir is not recommended in children below 2 years of age due to lack of data on safety and efficacy.
Danish: Ritonavir bør ikke anvendes til børn under 2 år pga. utilstrækkelige data vedrørende sikkerhed og virkning.
English: Sulfamethoxazole/Trimethoprim2
Danish: Sulfamethoxazol+trimethoprim2
English: After ritonavir use for 10 days, no inhibitory effect of ritonavir was observed.
Danish: Efter anvendelse af ritonavir i 10 dage blev der ikke set nogen hæmmende effekt på ritonavir.
English: Food slightly decreases the bioavailability of the ritonavir tablet.
Danish: Føde nedsætter biotilgængeligheden af ritonavir-tabletten en smule.
English: The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Danish: Brug af højere doser af ritonavir kan ændre sikkerhedsprofilen for kombinationen og anbefales derfor ikke.
English: Saquinavir should only be given in combination with ritonavir.
Danish: Saquinavir bør kun indgives i kombination med ritonavir.
English: Gradually increasing the dose of ritonavir when initiating therapy may help to improve tolerance.
Danish: Gradvis dosisforøgelse af ritonavir i behandlingens begyndelse kan medvirke til at øge tolerancen.
English: • coldness in the hands and feet
Danish: • kuldefølelse i hænder og fødder
English: Adverse reactions in clinical studies and post-marketing in adult patients System Order Class
Danish: Bivirkninger i kliniske studier og efter markedsføring hos voksne patienter
English: Administration of a single 100 mg dose of ritonavir tablet with a moderate fat meal (857 kcal, 31% calories from fat) or a high fat meal (907 kcal, 52% calories from fat) was associated with a mean decrease of 20-23% in ritonavir AUC and Cmax.
Danish: Administration af en enkelt 100 mg ritonavir-tablet efter et måltid med moderat fedtindhold (857 kcal, 31 % kalorier fra fedt) eller et måltid med højt fedtindhold (907 kcal, 52% kalorier fra fedt) blev sat i forbindelse med et gennemsnitlig fald på 20-23% i ritonavir AUC og Cmax.
English: Human studies with radiolabelled ritonavir demonstrated that the elimination of ritonavir was primarily via the hepatobiliary system; approximately 86% of radiolabel was recovered from stool, part of which is expected to be unabsorbed ritonavir.
Danish: Humane studier med radiomærket ritonavir har vist, at udskillelsen af ritonavir hovedsagelig sker via lever- eller galdesystemet; ca. 86 % af radiomærkningen blev genfundet i fæces, hvoraf en del anses for at være uabsorberet ritonavir.
English: Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only.
Danish: Kontraindiceret, når det anvendes til behandling af pulmonal arteriel hypertension (PAH).
English: The mean changes from baseline in PR interval ranged from 11.0 to 24.0 msec in the 12 hour interval post dose.
Danish: De gennemsnitlige ændringer i PR-interval fra baseline spænder fra 11,0 til 24,0 msek i et interval på 12 timer efter dosis.
English: If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Danish: Hvis fordelen vurderes at vægte tungere end risikoen, og ritonavir skal anvendes, skal ibrutinib-dosis reduceres til 140 mg, og patienten skal monitoreres tæt for toksicitet.
English: • if your doctor prescribes a full dose, adults may be started on a dose of 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 6 tablets twice daily (totalling 1,200 mg per day).
Danish: • Hvis din læge ordinerer en fuld dosis, kan voksne patienter begynde med en dosis på 3 tabletter om morgenen og 3 tabletter 12 timer senere, hvilket gradvist øges i en periode på højst 14 dage til den fulde dosis på 6 tabletter to gange dagligt (i alt 1.200 mg pr. dag).
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde fundet evidens for en behandlingseffekt, mens der ikke er tydelig evidens for relationen mellem vægtøgning og en specifik behandling.
English: There is no specific antidote for overdose with ritonavir.
Danish: Der er ingen specifik modgift mod overdosering med ritonavir.
English: Inform your doctor as soon as possible if you experience any symptoms that suggest an allergic reaction after taking Ritonavir Mylan such as rash, hives or breathing difficulties.
Danish: Fortæl det straks til din læge, hvis du oplever symptomer, som tyder på en allergisk reaktion, efter indtagelse af Ritonavir Mylan, f.eks. udslæt, nældefeber eller åndedrætsbesvær.
English: • severe or life threatening skin reaction including blisters (Stevens Johnson syndrome, toxic epidermal necrolysis)
Danish: • alvorlig eller livstruende hudreaktion, herunder blærer (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse)
English: Your doctor may need to adjust the dose of digoxin and monitor you while you are taking digoxin and Ritonavir Mylan in order to avoid heart problems.
Danish: Din læge kan være nødt til at justere din digoxin-dosis og følge dig nøje, mens du tager digoxin og ritonavir for at undgå, at du får hjerteproblemer.
English: Across dose groups, ritonavir oral clearance (CL/F/m2) was approximately 1.5 to 1.7 times faster in paediatric patients above 2 years of age than in adult subjects.
Danish: På tværs af dosisgrupper var oral clearance (CL/F/m2) af ritonavir ca. 1,5 til 1,7 gange hurtigere hos pædiatriske patienter over 2 år end hos voksne forsøgspersoner.
English: However, these warnings may also apply when Ritonavir Mylan is used in lower doses (a booster) with other medicines.
Danish: Advarslerne kan dog også gælde i tilfælde, hvor Ritonavir Mylan tages i lavere doser (boosterdoser) sammen med andre lægemidler.
English: Yellow, capsule shaped film-coated tablet, approximately 19.1 mm x 10.2 mm, debossed with ‘M163' on one side and plain on the other side.
Danish: Gul, kapselformet, filmovertrukket tablet, ca. 19,1 mm x 10,2 mm, præget med “M163” på den ene side, den anden side er uden prægning.
English: People taking ritonavir may still develop infections or other illnesses associated with HIV infection or AIDS.
Danish: Personer, der tager ritonavir, kan stadig få infektioner eller andre sygdomme forbundet med hivinfektion eller AIDS.
English: Ritonavir binds to both human alpha 1-acid glycoprotein (AAG) and human serum albumin (HSA) with comparable affinities.
Danish: Ritonavir binder til både humant surt alfa 1-glykoprotein (AAG) og humant serumalbumin (HSA) med sammenlignelig affinitet.
English: Digoxin levels should be monitored more intensively than usual during this period, with dose adjustments made, as necessary, based on clinical, electrocardiographic and digoxin level findings.
Danish: Digoxinkoncentrationerne bør overvåges mere intensivt end normalt i denne periode, med dosisjusteringer efter behov, baseret på kliniske og elektrokardiografiske resultater og fundne digoxinkoncentrationer.
English: Co-administration with ritonavir may cause a large increase in the concentration of this benzodiazepine.
Danish: Samtidig administration af ritonavir kan forårsage en stor stigning i koncentrationen af dette benzodiazepin.
English: These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.
Danish: Disse data refererer overvejende til eksponering, hvor ritonavir blev anvendt i kombinationsbehandling og ikke ved terapeutiske ritonavir doser men ved lavere doser som farmakokinetisk forstærker af andre PI'er.
English: Patients receiving ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Danish: Patienter, der får ritonavir eller anden antiretroviral behandling, kan fortsat udvikle opportunistiske infektioner og andre komplikationer til hiv-1-infektion.
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Danish: Hæmofilipatienter skal derfor være opmærksomme på muligheden for øget blødningsrisiko.
English: Co-administration of tipranavir with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation including some fatalities.
Danish: Samtidig administration af tipranavir og 200 mg ritonavir er blevet associeret med rapporterede tilfælde af klinisk hepatit og hepatisk dekompensation, herunder dødsfald.
English: Sedatives/hypnotics
Danish: Sedativa/hypnotika
English: Co-administration of saquinavir and ritonavir has led to severe adverse reactions, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease.
Danish: Samtidig administration af saquinavir og ritonavir har ført til alvorlige bivirkninger, hovedsagelig diabetisk ketoacidose og leversygdomme, især hos patienter med en allerede eksisterende leversygdom.
English: Caution must also be exercised and reduced doses should be considered if ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A.
Danish: Der skal også udvises forsigtighed, og mindskede doser skal overvejes, hvis ritonavir anvendes samtidig med atorvastatin, som i mindre udstrækning metaboliseres af CYP3A.
English: Four ritonavir metabolites have been identified in man.
Danish: Der er identificeret fire metabolitter af ritonavir hos mennesker.
English: Hepatitis (including increased AST, ALT, GGT), blood bilirubin increased (including jaundice)
Danish: Hepatitis inklusive øget ASAT, ALAT, GGT), forhøjet bilirubin i blodet (inklusive gulsot)
English: Dasatinib, nilotinib, vincristine, vinblastine
Danish: Dasatinib, nilotinib, vincristin, vinblastin
English: Serious persistent vomiting and/or diarrhoea associated with ritonavir use might also compromise renal function.
Danish: Alvorlig, vedvarende opkastning og/eller diarré associeret med ritonavir kan også påvirke nyrefunktionen.
English: Across dose groups, ritonavir oral clearance (CL/F/m2) declined with age with median values of 9.0 L/h/m2 in children less than 3 months of age, 7.8 L/h/m2 in children between 3 and 6 months of age and 4.4 L/h/m2 in children between 6 and 24 months of age.
Danish: På tværs af dosisgrupper faldt oral clearance (CL/F/m2) af ritonavir med alder med middelværdier på 9,0 l/t/m2 hos børn på under 3 måneder, 7,8 l/t/m2 hos børn på mellem 3 og 6 måneder og 4,4 l/t/m2 hos børn på mellem 6 og 24 måneder.
English: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).
Danish: Ritonavir er indiceret sammen med andre antiretrovirale lægemidler til behandling af hiv-1-inficerede patienter (voksne og børn i alderen 2 år og ældre).
English: Pancreatitis has been observed in patients receiving ritonavir therapy, including those who developed hypertriglyceridemia.
Danish: Pankreatit er observeret hos patienter i behandling med ritonavir, herunder patienter, der udviklede hypertriglyceridæmi.
English: In these studies renal elimination was not found to be a major route of elimination of ritonavir.
Danish: I disse studier fandtes udskillelse via nyrerne ikke at være en vigtig vej til udskillelse af ritonavir.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3 - 4 fold increase in midazolam plasma levels.
Danish: Data fra samtidig anvendelse af parenteral midazolam og andre proteasehæmmere tyder på en mulig stigning på 3 - 4 gange i plasmaniveauerne for midazolam.
English: Insomnia, anxiety, confusion, disturbance in attention, syncope, seizure
Danish: Søvnløshed, angst, konfusion, opmærksomhedsforstyrrelser, synkope, krampeanfald
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Danish: Baseret på data fra andre CYP3A4-hæmmere forventes plasmakoncentrationerne af midazolam at være signifikant højere, når midazolam gives oralt.
English: Hepatic changes involved hepatocellular, biliary and phagocytic elements and were accompanied by increases in hepatic enzymes.
Danish: Leverforandringer omfattede hepatocellulære, biliære og fagocyterende elementer og ledsagedes af en stigning i leverenzymer.
English: Refer to the Summary of Product Characteristics for atazanavir for further details.
Danish: Se produktresuméet for atazanavir for yderligere detaljer.
English: Hypertension, hypotension including orthostatic hypotension, peripheral coldness
Danish: Hypertension, hypotension inklusive ortostatisk hypotension, perifer kuldefølelse
English: Modest prolongation of the PR interval was also noted in subjects receiving ritonavir in the same study on Day 3.
Danish: På dag 3 blev der også set en beskeden forlængelse af PR-intervallet hos forsøgspersoner, som fik ritonavir i det samme studie.
English: Higher doses of ritonavir have been shown to be associated with an increased incidence of adverse reactions.
Danish: Højere doser af ritonavir har vist sig at være forbundet med en øget forekomst af bivirkninger.
English: Tell your doctor if you experience:
Danish: Fortæl det til lægen, hvis du får:
English: Ritonavir Mylan film-coated tablets are available in plastic bottles with screw caps containing 30, 90 or 100 tablets and in multipacks of 90 tablets comprising 3 bottles, each containing 30 tablets.
Danish: Ritonavir Mylan filmovertrukne tabletter fås i en plastikbeholder med skruelåg med 30, 90 eller 100 tabletter og i multipakninger af 90 tabletter bestående af 3 beholdere, hver indeholdende 30 tabletter.
English: Lipid-modifying agents Lomitapide
Danish: Lipid-modificerende agenter Lomitapide
English: All thyroid changes were reversible upon discontinuation of ritonavir.
Danish: Alle thyreoidea-forandringer var reversible efter seponering af ritonavir.
English: Concurrent administration of bupropion with repeated doses of ritonavir is expected to decrease bupropion levels.
Danish: Samtidig administration af bupropion med gentagne doser af ritonavir forventes at formindske bupropion-niveauer.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, har en øget forekomst af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Danish: 4.4 og 4.5 vedrørende samtidig indgift af sildenafil til patienter med erektil dysfunktion.
English: If ritonavir 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 ritonavir administreres samtidig med parenteral midazolam, bør det gøres på en intensivafdeling eller under lignende forhold, der sikrer tæt klinisk monitorering og passende medicinsk behandling i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Increased glucose, increased magnesium, increased alkaline phosphatase
Danish: Ikke almindelig Forhøjet glucose, forhøjet magnesium, forhøjet alkalisk fosfatase
English: Alprazolam metabolism was inhibited following the introduction of ritonavir.
Danish: Metabolismen af alprazolam blev hæmmet efter introduktion af ritonavir.
English: There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.
Danish: Der foreligger ingen oplysninger om ritonavirs effekt på det ammede barn eller på mælkeproduktionen.
English: Plasma concentrations of ritonavir after administration of a single 100 mg dose tablet are similar to the 100 mg soft gelatin capsule under fed conditions.
Danish: Plasmakoncentrationen af ritonavir efter administration af en enkelt 100 mg tablet er den samme som efter en 100 mg blød gelatinekapsel efter fødeindtagelse.
English: Renal changes including tubular degeneration, chronic inflammation and proteinurea were noted in rats and are felt to be attributable to species-specific spontaneous disease.
Danish: Nyreforandringer, herunder tubulær degeneration, kronisk inflammation og proteinuri er påvist i rotter og menes at være forårsaget af en artsspecifik, spontan sygdom.
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
Danish: QTcF-intervallet blev evalueret i et randomiseret, aktivt (moxifloxacin 400 mg en gang dagligt) kontrolleret overkrydsnings-placebostudie hos 45 raske voksne med 10 målinger over 12 timer på dag 3.
English: In patients who are already taking ritonavir when digoxin is introduced, digoxin should be introduced more gradually than usual.
Danish: Hos patienter, der allerede tager ritonavir, når behandling med digoxin påbegyndes, bør digoxin introduceres mere gradvist end normalt.
English: Ritonavir also has a high affinity for P-glycoprotein and may inhibit this transporter.
Danish: Ritonavir har også stor affinitet til P-glykoprotein og kan hæmme dette transportprotein.
English: The following warnings apply when Ritonavir Mylan is taken as a full dose.
Danish: Følgende advarsler gælder, når Ritonavir Mylan tages i fuld dosis.
English: Limited published data reports that ritonavir is present in human milk.
Danish: Amning Begrænsede data viser, at ritonavir er til stede i modermælk.
English: In general, pregnant mothers received ritonavir after the first three months of pregnancy at a lower dose (booster) along with other protease inhibitors.
Danish: Efter de første tre måneder af graviditeten fik gravide kvinder gennemgående ritonavir i en lavere dosis (boosterdosis) sammen med andre proteasehæmmere.
English: Ritonavir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection.
Danish: Ritonavir anvendes i kombination med andre lægemidler mod hiv (antiretrovirale lægemidler) til at kontrollere hiv-infektion.
English: 14-OH clarithromycin metabolite
Danish: Clarithromycin 14-OH-clarithromycin metabolit
English: If you are affected do not drive or use machinery.
Danish: Hvis du bliver svimmel, må du ikke køre bil eller motorcykel eller betjene maskiner.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).
Danish: Det bør overvejes at reducere dosis af glukokortikoidet samtidig med tæt monitorering af lokale og systemiske bivirkninger eller at skifte til et glukokortikoid, som ikke er et substrat for CYP3A4 (f.eks. beclomethason).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection.
Danish: Denne hæmning af hiv-proteasen bevirker, at enzymet bliver ude af stand til at danne gag-pol polyproteinprecursor, hvorved der dannes hiv-partikler med umoden morfologi, der er ude af stand til at starte en ny omgang infektion.
English: Dose of Ritonavir (mg)
Danish: Dosis af ritonavir (mg)
English: The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and therefore is not recommended.
Danish: Brug af højere doser af ritonavir kan ændre sikkerhedsprofilen for atazanavir (hjertepåvirkning, hyperbilirubinæmi) og anbefales derfor ikke.
English: So it is important that you carefully read the side effects section of the leaflets that are provided with these other medicines.
Danish: Det er derfor vigtigt at læse afsnittet om bivirkninger omhyggeligt i de indlægssedler, der er vedlagt de andre lægemidler.
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Danish: CYP3A4-inhibitorer øger eksponeringen af lomitapid, hvor stærke inhibitorer øger eksponeringen ca. 27 gange.
English: If you realise you have taken more Ritonavir Mylan than you were supposed to, contact your doctor or the Accident and Emergency Department of your nearest hospital straight away.
Danish: Hvis du bliver klar over, at du har taget mere Ritonavir Mylan, end du skulle, skal du straks kontakte din læge eller skadestuen på det nærmeste hospital.