FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)
Danish: Dosis til voksne, som ikke tidligere har fået hiv-medicin (din læge vil afgøre dette)
English: It is therefore important to talk to your doctor if you develop a rash.
Danish: Derfor er det vigtigt at tale med lægen, hvis du får udslæt.
English: A gradual dose increase of atorvastatin may be tailored to the clinical response.
Danish: Derefter kan dosis af atorvastatin øges gradvist på grundlag af det kliniske respons.
English: If parenteral midazolam is coadministered with darunavir with low dose ritonavir, 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 parenteral midazolam coadministreres med darunavir med lavdosis ritonavir, skal det foregå på en intensivafdeling (ITA) eller i lignende rammer, der sikrer tæt klinisk monitorering og passende medicinsk håndtering i tilfælde af respirationsdepression og/eller forlænget sedation.
English: When administered without food, the relative bioavailability of darunavir in the presence of low dose ritonavir is 30% lower as compared to intake with food.
Danish: Ved administration uden indtagelse af mad er den relative biotilgængelighed af darunavir ved tilstedeværelse af lavdosis ritonavir 30% lavere sammenlignet med administration med mad.
English: α1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Danish: Alfa1-RECEPTOR-ANTAGONISTER Alfuzosin
English: Dose adjustment for buprenorphine may not be necessary when coadministered with boosted darunavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Danish: Dosisjustering af buprenorphin er måske ikke nødvendig ved administration sammen med boostet darunavir, men en omhyggelig klinisk monitorering for tegn på opioidtoksicitet anbefales.
English: (induction of CYP450 enzymes)
Danish: (induktion af CYP450-enzymer)
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Danish: DRESS (hududslæt med eosinofili og systemiske symptomer) og Stevens-Johnsons syndrom er rapporteret i sjældne tilfælde (<0,1 %), og efter markedsføringen er toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose blevet rapporteret.
English: The exposure-adjusted rates of rash (all causality) were 10.9, 4.2, and 3.8 per 100 patient-years (PYR), respectively; and for drug-related rash were 2.4, 1.1, and 2.3 per 100 PYR, respectively.
Danish: Hyppigheden af udslæt (uanset årsagssammenhæng) justeret for eksponering var henholdsvis 10,9, 4,2 og 3,8 pr. 100 patientår, og for lægemiddelrelateret udslæt var hyppigheden henholdsvis 2,4, 1,1 og 2,3 pr. 100 patientår.
English: Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed in case digoxin is given to patients on boosted darunavir therapy.
Danish: Da digoxin har et snævert terapeutisk indeks, anbefales det at starte med at udskrive den lavest mulige dosis digoxin, hvis der skal gives digoxin til patienter i behandling med boostet darunavir.
English: In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Danish: I forbindelse med beslutningen om at påbegynde behandling med darunavir, administreret sammen med lavdosis ritonavir, skal den enkelte patients behandlingsanamnese og de mutationsmønstre, der er forbundet med forskellige lægemidler, overvejes nøje.
English: Exposure to darunavir was higher in HIV-1 infected patients than in healthy subjects.
Danish: Eksponeringen for darunavir var højere hos hiv-1-inficerede patienter end hos raske forsøgspersoner.
English: Sedative/hypnotics are extensively metabolised by CYP3A.
Danish: Sedativa/hypnotika metaboliseres i vid udstrækning af CYP3A.
English: Tablet dimension: 20 x 10 mm.
Danish: Tabletdimension: 20 × 10 mm.
English: ANTIFUNGALS Voriconazole
Danish: ANTIMYKOTIKA Voriconazol
English: The table below shows the efficacy data of the 48 week analysis from the TITAN trial.
Danish: Tabellen nedenfor viser effektdata af 48 ugers-analysen fra TITAN-studiet.
English: For patients with renal impairment the Summary of Product Characteristics for clarithromycin should be consulted for the recommended dose.
Danish: For patienter med nedsat nyrefunktion henvises til produktresuméet for clarithromycin for oplysninger om den anbefalede dosis.
English: This should be taken into consideration if darunavir with cobicistat is administered to patients in whom the estimated creatinine clearance is used to adjust doses of co-administered medicinal products (see section 4.2 and cobicistat SmPC).
Danish: Der skal tages højde for dette, hvis darunavir med cobicistat administreres til patienter, hvor den estimerede kreatinin-clearance benyttes til dosisjustering af samtidigt administrerede lægemidler (se pkt.
English: The rashes observed in clinical studies were mild to moderate in severity and did not result in discontinuation of therapy (see section 4.4).
Danish: De udslæt, der sås i kliniske studier, var lette til moderate og medførte ikke seponering (se pkt.
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Danish: Simeprevirdosis i dette interaktionsstudie var 50 mg ved co-administration med darunavir/ritonavir, sammenlignet med 150 mg i den gruppe, der blev behandlet med simeprevir alene.
English: In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with darunavir co-administered with low dose ritonavir.
Danish: Derudover er der observeret reaktivering af herpes simplex og herpes zoster i kliniske studier med darunavir, co-administreret med lavdosis ritonavir.
English: Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Danish: - Atorvastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
English: Darunavir Krka is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.
Danish: Darunavir Krka anvendes til at behandle voksne og børn fra 3 år og opefter med en legemsvægt på mindst 15 kg, der er inficeret med hiv, og som allerede har været behandlet med anden medicin til behandling af hiv.
English: The concomitant use with boosted darunavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Danish: Samtidig brug med boostet darunavir kan nødvendiggøre nedsættelse af alfentanildosis og kræver monitorering for risici i forbindelse med forlænget eller forsinket respirationsdepression.
English: Dexamethasone (systemic) Not studied.
Danish: Dexamethason (systemisk)
English: Emtricitabine/tenofovir alafenamide
Danish: Emtricitabin/tenofoviralafenamid
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Danish: Efter intravenøs administration var distributionsvolumen for darunavir administreret alene 88,1 + 59,0 l (gennemsnit ±SD) og steg til 131 ± 49,9 l (gennemsnit ±SD) ved tilstedeværelse af 100 mg ritonavir to gange daglig .
English: Oestrogen-based hormonal contraceptives and hormonal replacement therapy.
Danish: - Østrogenholdig prævention og hormonerstatningsbehandling.
English: Baseline DRV FC
Danish: Baseline DARUNAVIR FC
English: Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Danish: Genotype / fænotype ved baseline og virologisk udfald Baseline-genotype og darunavir FC (skift i følsomhed i forhold til reference) blev vist at være en forudsigende faktor for virologisk udfald.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir used in combination with cobicistat or low dose ritonavir and patients should be monitored during treatment.
Danish: Relevante laboratorieundersøgelser bør udføres før indledning af behandling med darunavir anvendt i kombination med cobicistat eller lavdosis ritonavir, og patienterne bør monitoreres under behandlingen.
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Danish: I løbet af det kliniske udviklingsprogram (N=2.613 behandlingserfarne forsøgspersoner, som indledte behandling med darunavir/ritonavir 600/100 mg to gange daglig), fik 51,3 % af deltagerne mindst en bivirkning.
English: Titanium dioxide (E171) Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
Danish: Titandioxid (E171) Talcum (E553b) Jernoxid, gul (E172) Jernoxid, rød (E172)
English: If you get any side effects, talk toyour doctor or pharmacist.This includes any possible side effects not listed in this leaflet.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (P-gp; see sections 4.3 and 4.5).
Danish: Der er indberettet livstruende og letale lægemiddelinteraktioner hos patienter, der blev behandlet med colchicin og stærke CYP3A- og P-glykoprotein (P-gp)-hæmmere (se pkt.
English: OPIOID ANTAGONIST Naloxegol
Danish: OPIOID ANTAGONISTER Naloxegol
English: The combination may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombinationen kan medføre en øget risiko for kardiovaskulære bivirkninger af salmeterol inklusive QT-forlængelse, palpitationer og sinustakykardi.
English: TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA < 400 copies/ml) IAS-USA lists
Danish: TLOVR non-VF censureret algoritme baseret på hiv-1-RNA <50 kopier/ml med undtagelse af TITAN (hiv-1RNA <400 kopier/ml) IAS-USA-lister
English: The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Danish: Den absolutte, orale biotilgængelighed af en enkeltdosis darunavir på 600 mg var ca. 37%, og den steg til ca. 82% ved tilstedeværelse af ritonavir 100 mg to gange daglig.
English: This guidance is based on the half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 24 hours.
Danish: Denne vejledning er baseret på halveringstiden for darunavir i tilstedeværelse af ritonavir og på et anbefalet dosisinterval på ca. 24 timer.
English: ≥ 30 kg to < 40 kg
Danish: ≥30 kg til <40 kg
English: The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting.
Danish: De hyppigste bivirkninger indberettet under kliniske studier og som spontane indberetninger er diarre, kvalme, udslæt, hovedpine og opkastning.
English: Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out (see section 4.5).
Danish: Derfor kan fortrængning af lægemidler, der i udstrakt grad bindes til surt α1-glykoprotein, ikke udelukkes (se pkt.
English: Domperidone to treat nausea and vomiting
Danish: Domperidon til behandling af kvalme og opkastning
English: Based on theoretical considerations boosted darunavir may increase the exposure to glecaprevir and pibrentasvir.
Danish: Baseret på teoretiske overvejelser kan boostet darunavir øge eksponeringen for glecaprevir og pibrentasvir.
English: In addition, patients on a stable dose of these antidepressants who start treatment with darunavir with low dose ritonavir should be monitored for antidepressant response.
Danish: Ydermere skal patienter, der får en stabil dosis af disse antidepressiva, og som starter behandling med darunavir og lavdosis ritonavir, monitoreres for antidepressivt respons.
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
Danish: Rosuvastatin 10 mg en gang daglig rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
English: Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Danish: Ritonavir hæmmer transportørerne P-glykoprotein, OATP1B1 og OATP1B3, og coadministration med substrater for disse transportører kan medføre øgede plasmakoncentrationer af disse stoffer (f.eks. dabigatranetexilat, digoxin, statiner og bosentan - se interaktionstabellen nedenfor).
English: If you forget to take Darunavir Krka If you notice within 6 hours, you must take your missed dose immediately.
Danish: Hvis du har glemt at tage Darunavir Krka Hvis du kommer i tanke om den glemte dosis inden for 6 timer, skal du straks tage en dosis.
English: Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile.
Danish: En alvorlig leverfunktionsnedsættelse kan medføre et øget niveau af darunavir og en forværring af stoffets sikkerhedsprofil.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Danish: Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt.
English: TREATMENT FOR PREMATURE EJACULATION Dapoxetine
Danish: BEHANDLING AF PRÆMATUR EJAKULATION Dapoxetin
English: Imputations according to the TLOVR algorithm d Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation af forskellen i % respons Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter der afbrød behandlingen i utide medregnes med en ændring, der tillægges størrelsen 0.
English: In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is described in the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.
Danish: - Hos alle andre ART-erfarne patienter, eller i tilfælde af, at der ikke foreligger en hiv-1- genotypebestemmelse, er det anbefalede behandlingsregime beskrevet i produktresumeet for Darunavir Krka 600 mg tabletter.
English: Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients receive rifabutin at doses other than 300 mg/day.
Danish: På baggrund af en farmakokinetisk model er det også relevant at reducere dosis med 75% hos patienter, der får rifabutin i andre doser end 300 mg/dag.
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 180 film-coated tablets
Danish: 30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 180 filmovertrukne tabletter
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Danish: Som hovedregel skal såvel dyredata som kliniske erfaringer hos gravide kvinder tages i betragtning, når det besluttes at anvende antiretrovirale lægemidler til behandling af hiv-infektion hos gravide kvinder og dermed til at reducere risikoen for vertikal transmission af hiv til den nyfødte.
English: Strong CYP3A inducers include e.g. carbamazepine, phenobarbital and phenytoin (see sections 4.4 and 4.5).
Danish: Potente CYP3A-induktorer omfatter f.eks. carbamazepin, phenobarbital og phenytoin (se pkt.
English: ANTIMYCOBACTERIALS Rifampicin
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin
English: Medicinal products that may be affected by darunavir boosted with cobicistat
Danish: Lægemidler, som kan blive påvirket af darunavir boostet med cobicistat
English: Outcomes at week 48
Danish: Resultater ved uge 48
English: In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
Danish: Hos rotter medførte kombinationen af darunavir med ritonavir en lille stigning i virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtlen og øget incidens af pankreasfibrose (kun hos hanrotter) sammenlignet med behandling med darunavir alene.
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Danish: De kan omfatte gulfarvning af huden og det hvide i øjnene, mørk (tefarvet) urin, bleg afføring, kvalme, opkastning, appetittab eller smerter, jag eller smerter og ubehag i højre side under ribbenene.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Danish: Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at farmakokinetikken for darunavir ikke var signifikant påvirket hos hiv-inficerede patienter med moderat nedsat nyrefunktion (CrCl mellem 30 og 60 ml/min, n=20) (se pkt.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinations behandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Danish: I løbet af det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) rapporteredes alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4 % af patienterne.
English: ANTIEMETICS Domperidone
Danish: ANTIEMETIKA Domperidon
English: Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Danish: Sekalealkaloider f.eks. ergotamin, dihydroergotamin, ergometrin og methylergonovin til behandling af migræne hovedpine
English: Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
Danish: Din læge vil vurdere, hvilken kolesterolsænkende behandling, der egner sig bedst til dig.
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Danish: ENDOTELINRECEPTOR-ANTAGONISTER Bosentan
English: INHALED BETA AGONISTS Salmeterol
Danish: INHALEREDE  -AGONISTER Salmeterol
English: Coadministration with darunavir/ritonavir may cause a large increase in the concentration of these medicines.
Danish: Co-administration med darunavir/ritonavir kan give anledning til en kraftig forøgelse af koncentrationen af disse lægemidler.
English: However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
Danish: Hvis hivgenotypebestemmelse ikke er gennemførlig, anbefales dosisregimet med darunavir/ritonavir en gang dagligt til hiv-proteasehæmmer-naive pædiatriske patienter, og doseringen to gange dagligt til hivproteasehæmmer-erfarne patienter.
English: There was no effect on mating or fertility with darunavir treatment in rats (see section 5.3).
Danish: Der sås ingen virkning på parring eller fertilitet hos rotter i forbindelse med behandling med darunavir (se pkt.
English: Treatment with darunavir/cobicistat 800/150 mg once daily during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Danish: Det er påvist, at behandling med darunavir/cobicistat 800/150 mg en gang dagligt i det andet og tredje trimester fører til lav eksponering for darunavir med en reduktion i værdierne for Cmin på ca. 90 % (se pkt.
English: Medicinal products that may be affected by darunavir boosted with ritonavir
Danish: Lægemidler, som kan blive påvirket af darunavir boostet med ritonavir
English: Coadministration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
Danish: Co-administration af darunavir/cobicistat med svage til moderate CYP3A-induktorer (f.eks. efavirenz, etravirin, nevirapin, boceprevir, fluticason og bosentan) frarådes (se interaktionstabel nedenfor).
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) I henhold til LOCF (last obervation carried forward) 95% konfidensintervaller.
English: In most cases, Darunavir Krka can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Danish: I de fleste tilfælde kan Darunavir Krka tages sammen med hiv-medicin, der tilhører en anden gruppe (f.eks. NRTI (nukleosid revers-transkriptase-hæmmere), NNRTI (nonnukleosid revers-transkriptasehæmmere), CCR5-antagonister og FI (fusionshæmmere)).
English: Other medicines and Darunavir Krka Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Darunavir Krka Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing darunavir/ritonavir + raltegravir compared to those containing darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
Danish: I det kliniske udviklingsprogram med raltegravir hos behandlingserfarne patienter forekom udslæt uanset årsagssammenhæng hyppigere, når regimet indeholdt darunavir/ritonavir + raltegravir, end når det indeholdt darunavir/ritonavir uden raltegravir eller raltegravir uden darunavir/ritonavir.