FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions.
Danish: Disse lægemidler anvendes til behandling af allergier, astma, inflammatoriske tarmsygdomme, inflammatoriske lidelser i øjnene, led og muskler eller andre inflammatoriske lidelser.
English: If prescribed darunavir twice daily the child must take one dose in the morning, and one dose in the evening.
Danish: Hvis darunavir er ordineret to gange dagligt, skal barnet tage en dosis om morgenen og en dosis om aftenen.
English: This protein binding is concentrationdependent indicative for saturation of binding.
Danish: Denne proteinbinding er koncentrationsafhængig, hvilket indicerer, at bindingskapaciteten mættes.
English: Combinations with optimised background regimen (OBRs) other than ≥ 2 NRTIs have not been studied in this population.
Danish: Kombinationer med andre optimerede baggrundsregimer (OBR'er) end ≥ 2 NRTI'er er ikke undersøgt hos denne population.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and on the bottle after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og på flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Danish: På baggrund af observationer kan der være behov for, at carbamazepindoseringen skal reduceres med 25-50% ved samtidig behandling med darunavir/ritonavir.
English: Lurasidone Pimozide Sertindole
Danish: Lurasidon Pimozid Sertindol
English: C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Danish: C-darunavir med ritonavir viste, at ca. 7,7% af den administrerede dosis darunavir udskilles uomdannet i urinen.
English: - Tell your doctor if you have diabetes.
Danish: - Giv din læge besked, hvis du har diabetes.
English: However, adjustment of the methadone dose may be necessary when concomitantly administered for a longer period of time.
Danish: Dog kan det være nødvendigt at justere methadondosis ved samtidig administration over en længere periode.
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Danish: Retningen af pilen ud for hver farmakokinetisk parameter er baseret på 90% konfidensintervallet for den geometriske middelværdi værende inden for (), under () eller over () 80-125% intervallet (ikke fastsat (not determined) som ”ND”).
English: Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen.
Danish: Der findes tabletter med andre styrker, og din læge kan have ordineret en særlig kombination af tabletter til dig for at give dig den helt rigtige dosis.
English: Cold form PVC/Al/OPA-Al blister pack This medicinal product does not require any special storage conditions.
Danish: Koldformet PVC/Al/OPA-Al-blisterpakning Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Psychiatric disorders Common abnormal dreams
Danish: Psykiske forstyrrelser Almindelig unormale drømme
English: Therefore always tell your doctor if you take other antiHIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Danish: Fortæl det derfor altid din læge, hvis du tager andre anti-hiv-lægemidler, og følg din læges anvisninger omhyggeligt i forhold til, hvilke lægemidler der kan kombineres.
English: - Unlike ritonavir, cobicistat does not have inducing effects on enzymes or transport proteins (see section 4.5).
Danish: - Til forskel fra ritonavir har cobicistat ingen inducerende effekt på enzymer eller transportproteiner (se pkt.
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: However, increased methadone dose may be necessary when concomitantly administered for a longer period of time due to induction of metabolism by ritonavir.
Danish: Dog kan det være nødvendigt at øge methadondosis ved samtidig administration over en længere periode, på grund af ritonavirs induktion af metabolisme.
English: 150 mg once every other day rifabutin AUC rifabutin Cmin
Danish: 150 mg hver anden dag rifabutin AUC rifabutin Cmin
English: Baseline genotype or phenotype and virologic outcome Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Danish: Genotype og 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: Glecaprevir/pibrentasvir
Danish: Glecaprevir/pibrentas vir
English: For the treatment of pulmonary arterial hypertension Sildenafil
Danish: Til behandling af pulmonal arteriel hypertension
English: - Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Danish: - Atorvastatin, pravastatin, rosuvastatin (til at sænke kolesterolniveauer).
English: It is important to talk to your doctor if you develop a rash.
Danish: Det er derfor vigtigt at tale med lægen, hvis du udvikler et udslæt.
English: Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Danish: Darunavir Mylan 400 mg og 800 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer til behandling af hiv-1-infektion hos voksne og pædiatriske patienter fra en alder af 3 år og en legemsvægt på mindst 40 kg:
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take darunavir.
Danish: Din læge kan vurdere, hvor alvorlig din leversygdom er, inden han eller hun beslutter, om du kan tage darunavir.
English: What is Darunavir Mylan?
Danish: Hvad er Darunavir Mylan?
English: The effects of darunavir might be reduced if you take any of the following products.
Danish: Darunavir effekt kan reduceres, hvis du tager nogle af følgende produkter.
English: It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
Danish: Det anbefales, at hiv-inficerede kvinder ikke ammer deres børn både pga. risikoen for, at barnet smittes med hiv gennem modermælken og pga. lægemidlets ukendte effekt på barnet.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Symptomer på osteonekrose er ledstivhed, ømhed og smerter (særligt i hoften, knæet og skulderen) og vanskeligheder med at bevæge sig.
English: Pregnant or breast-feeding mothers should not take darunavir with cobicistat.
Danish: Gravide eller ammende mødre bør ikke tage darunavir sammen med cobicistat.
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 dagligt.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: hvis du bemærker nogen symptomer på infektion eller andre sygdomme, f.eks. muskelsvaghed, svaghed der begynder i hænder og fødder og flytter sig mod midten af kroppen, palpitationer, rystelser eller hyperaktivitet, skal du omgående underrette din læge, så du kan få den rette behandling.
English: ● In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA
Danish: ● Hos ART-erfarne patienter uden DRV-RAMs*, som har plasma-hiv-1-RNA
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline.
Danish: Virologisk respons er defineret, som et fald i plasma hiv-1-RNA-niveau på mindst 1,0 log10 i forhold til baseline.
English: 20 mg once daily
Danish: 20 mg en gang dagligt
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-Odesacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Danish: Desuden blev AUC for totalt aktivt rifabutin (moderstof + 25-O-desacetyl metabolit) forøget 1,6 gange, mens Cmax forblev sammenlignelig.
English: - The child must take the appropriate doses of darunavir and ritonavir two times per day or once a day.
Danish: - Barnet skal tage den korrekte dosis darunavir og ritonavir to gange dagligt eller en gang dagligt.
English: <PVC/PE/PVDC-Al blister pack only> Do not store above 25°C.
Danish: <kun PVC/PE/PVDC-Al-blisterpakke> Undgå opbevaring i temperaturer over 25 °C.
English: with darunavir/cobicistat 800/150 mg
Danish: med darunavir/cobicistat 800/150 mg
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/ml.
Danish: Hiv-1-inficerede patienter, som var egnede til deltagelse i dette forsøg, havde en screening-genotype, som ikke udviste nogen darunavir-RAMs og plasma-hiv-1-RNA ≥ 1.000 kopier/ml.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Selvom ætiologien anses for at være multifaktoriel (herunder kortikosteroidbehandling, alkoholforbrug, alvorlig immunsuppression, højt BMI), er der rapporteret tilfælde af osteonekrose, især hos patienter med fremskreden hiv-sygdom og/eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
English: You must eat a meal or a snack within 30 minutes prior to taking your darunavir and cobicistat or ritonavir.
Danish: Du skal spise et måltid eller en snack senest 30 minutter, efter at du har taget din darunavir og cobicistat eller ritonavir.
English: (P-gp, BCRP and/or OATP1B1/3 inhibition)
Danish: (P-gp-, BCRP- og/eller OATP1B1/3hæmning)
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking darunavir co-administered with cobicistat.
Danish: Omhyggelig monitorering af patienten og justering af metformindosis anbefales til patienter, som tager darunavir co-administreret med cobicistat.
English: These are: - muscle pain, tenderness or weakness.
Danish: Det er: - muskelsmerter, ømhed eller svaghed.
English: Refer to section 4.4 if creatinine clearance is used for dose adjustment of tenofovir disoproxil.
Danish: 4.4, hvis kreatinin-clearance benyttes ved dosisjustering af tenofovir.
English: For young children unable to swallow tablets, more suitable formulations containing darunavir should be checked for their availability.
Danish: Til små børn, der ikke er i stand til at synke hele tabletter, skal det undersøges, om der findes bedre egnede formuleringer af darunavir.
English: INHALED BETA AGONISTS Salmeterol
Danish: INHALEREDE -AGONISTER Salmeterol
English: 15 kg to < 20 kg N=16
Danish: 15 kg til < 20 kg N=16
English: Always take with ritonavir and food.
Danish: Tag dem altid med ritonavir og mad.
English: In a pre- and postnatal development assessment in rats, darunavir with and without ritonavir, caused a transient reduction in body weight gain of the offspring pre-weaning and there was a slight delay in the opening of eyes and ears.
Danish: I en vurdering af præ- og postnatal udvikling hos rotter medførte darunavir med og uden ritonavir en forbigående reduktion i vægtstigning hos afkommet inden fravænning, og åbning af øjne og ører skete lidt senere end normalt.
English: Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV infected females compared to males.
Danish: En populationsfarmakokinetisk analyse viste en lidt højere eksponering for darunavir (16,8%)hos hivinficerede kvinder i forhold til mænd.
English: Investigations Common increased blood creatinine these adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Danish: Undersøgelser Almindelig forhøjet kreatinin i blodet * disse bivirkninger har ikke været indberettet i forbindelse med de kliniske forsøg med darunavir/cobicistat, men har været bemærket under behandling med darunavir/ritonavir, og kan også forventes med darunavir/cobicistat.
English: One darunavir dose is
Danish: En dosis Darunavir er
English: Cobicistat has not been studied in patients receiving dialysis, and, therefore, no recommendation can be made for the use of darunavir/cobicistat in these patients.
Danish: Cobicistat er ikke blevet undersøgt hos patienter i dialyse, og der kan derfor ikke gives nogen anbefaling vedrørende brug af darunavir/cobicistat til disse patienter.
English: As darunavir and ritonavir are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da darunavir og ritonavir i høj grad binder sig til plasmaproteiner, er det usandsynligt, at disse lægemidler vil blive fjernet i signifikant grad ved hæmodialyse eller peritonealdialyse.
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Danish: Under det kliniske fase III-studie GS-US-216-130 med darunavir/cobicistat (N=313 behandlingsnaive og behandlingserfarne forsøgspersoner) oplevede 66,5% af forsøgspersonerne mindst én bivirkning.
English: - Take darunavir with food.
Danish: - Tag darunavir sammen med mad.
English: The risk of muscle demage might be increased.
Danish: Risikoen for en muskelskade kan øges.
English: Darunavir is approximately 95% bound to plasma protein.
Danish: Darunavir binder sig til plasmaprotein med ca. 95%.
English: If you take more Darunavir Mylan than you should Contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du tager mere Darunavir Mylan, end du skulle have taget Kontakt omgående din læge, apotekspersonalet eller din sygeplejerske.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment.
Danish: Relevante laboratorieundersøgelser bør udføres før indledning af behandling med darunavir/ritonavir, og patienterne bør monitoreres under behandlingen.
English: - In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: - Foruden opportunistiske infektioner kan autoimmune sygdomme (en tilstand som opstår, når immunsystemet angriber sundt kropsvæv) også opstå, når du begynder at tage lægemidler til behandling af din hiv-infektion.
English: Blood and lymphatic system disorders Uncommon
Danish: Blod og lymfesystem Ikke almindelig
English: - Clarithromycin (antibiotic) - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Danish: - Clarithromycin (antibiotika) - Ciclosporin, everolimus, tacrolimus, sirolimus (til dæmpning af immunforsvaret), da den behandlingsmæssige effekt af eller bivirkningerne fra disse lægemidler kan øges.
English: C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Danish: C-darunavir med ritonavir-dosis på 400/100 mg kunne 79,5% og 13,9% af den administrerede dosis af
English: The dose of cobicistat to be used with Darunavir has not been established in this patient population.
Danish: Dosen af cobicistat til administration sammen med darunavir er ikke blevet fastlagt hos denne patientpopulation.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Danish: Under det kliniske udviklingsprogram med darunavir/ritonavir (N=3.063) rapporteredes hepatitis hos 0,5% af patienterne, der fik antiretroviral kombinationsbehandling med darunavir/ritonavir.
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Danish: Andre kortikosteroider, som er mindre afhængige af CYP3Ametabolisme f.eks. beclomethason til intranasal indgivelse eller inhalering, bør især overvejes til længerevarende brug.
English: - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Danish: 4.5) - triazolam, midazolam administreret oralt (om forsigtighed ved parenteral administration af midazolam, se pkt.
English: Darunavir/ritonavir should not be used in children with a body weight of less than 15 kg as the dose for this population has not been established in a sufficient number of patients (see section 5.1).
Danish: Darunavir/ritonavir bør ikke anvendes til børn med en legemsvægt under 15 kg, da dosis til denne population ikke er påvist hos tilstrækkeligt mange patienter (se pkt.
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after darunavir/ritonavir given with food.
Danish: Didanosin skal administreres på tom mave, således at det bliver administreret 1 time før eller 2 timer efter darunavir /ritonavir, taget sammen med føde.
English: Darunavir/cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Danish: Darunavir/cobicistat kan i modsætning hertil øge plasmakoncentrationen af methadon (se produktresuméet for cobicistat).
English: - if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
Danish: - hvis du er allergisk over for darunavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6) eller over for ritonavir.
English: Sertraline 50 mg once daily
Danish: Sertralin 50 mg en gang dagligt
English: Dose (once daily with food)
Danish: Dosis (en gang dagligt i forbindelse med et måltid)
English: There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
Danish: Der er øget risiko for sildenafil-relaterede bivirkninger (inklusive synsforstyrrelser, hypotension, forlænget erektion og synkope).
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the darunavir/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Danish: Disse resultater blev bekræftet ved analysen af data efter 96 ugers behandling i TITAN-studiet, idet 60,4% af patienterne i darunavir/ritonavir-armen havde hiv-1RNA < 50 kopier/ml sammenlignet med 55,2% i lopinavir/ritonavir-armen ved uge 96 [forskel: 5,2%; 95% CI (-2,8; 13,1)]
English: Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
Danish: Din læge vil evaluere, hvilket lægemiddel der vil være bedst til lige præcis dig til sænkning af kolesterolniveauet.
English: 675 milligram
Danish: 675 mg
English: Voriconazole should not be combined with boosted darunavir unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Danish: Voriconazol bør ikke kombineres med boostet darunavir, medmindre en risk/benefit-vurdering retfærdiggør brug af voriconazol.
English: The dose of cobicistat to be used with darunavir in children less than 18 years of age has not been established.
Danish: Dosis af cobicistat til administration sammen med darunavir hos børn under 18 år, er ikke blevet fastlagt.
English: Endocrine disorders Uncommon hypothyroidism, increased blood thyroid stimulating hormone
Danish: Det endokrine system Ikke almindelig hypotyroidisme, forhøjet thyroideastimulerende hormon i blodet
English: Rare conjunctival hyperaemia, dry eye visual disturbance
Danish: Sjælden konjunktival hyperæmi, tørre øjne synsforstyrrelser
English: In contrast to these data with darunavir/ritonavir, darunavir/cobicistat may increase these antidepressant plasma concentrations (CYP2D6 and/or CYP3A inhibition).
Danish: I kontrast til disse data med darunavir/ritonavir kan darunavir/cobicistat øge plasmakoncentrationen af disse antidepressiva (CYP2D6-og/eller CYP3A-hæmning)
English: C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Danish: C-darunavir-studie med raske, frivillige forsøgspersoner viste, at størstedelen af radioaktiviteten i plasma efter en enkeltdosis darunavir med ritonavir på 400/100 mg skyldtes det aktive moderstof.
English: Amiodarone Bepridil Dronedarone Ivabradine Quinidine Ranolazine
Danish: Amiodaron Bepridil Dronedaron Ivabradin Quinidin Ranolazin
English: Medicinal products that may be affected by darunavir boosted with cobicistat The recommendations for darunavir boosted with ritonavir are adequate also for darunavir boosted with cobicistat with regard to substrates of CYP3A4, CYP2D6, P-glycoprotein, OATP1B1 and OATP1B3 (see contraindications and recommendations presented in the section above).
Danish: Lægemidler, som kan blive påvirket af darunavir boostet med cobicistat Anbefalingerne for darunavir boostet med ritonavir er også gældende for darunavir boostet med cobicistat, hvad angår substrater for CYP3A4, CYP2D6, P-glykoprotein, OATP1B1 og OATP1B3 (se kontraindikationer og anbefalinger i ovenstående afsnit).
English: Uncommon myalgia osteonecrosis*
Danish: Ikke almindelig myalgi osteonekrose*
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der modtager en kombination af antiretrovirale behandlinger, kan udvikle en knoglesygdom, der hedder knoglenekrose (knoglevævet dør pga. mangelfuld blodtilførsel til knoglen).
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to PIs in virologic failures at endpoint in the ARTEMIS, ODIN and TITAN trials.
Danish: Tabellen nedenfor viser udvikling af hiv-1 protease-mutationer og tab af følsomhed for PI'er i forbindelse med virologisk svigt ved endepunktet i studierne ARTEMIS, ODIN og TITAN.
English: Response (HIV-1 RNA < 50 copies/ml at week 24) %, n/N
Danish: Respons (hiv-1RNA < 50 kopier/ml ved uge 24) %, n/N