FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased plasma concentrations of lovastatin or simvastatin may cause myopathy, including rhabdomyolysis.
Danish: Øgede plasmakoncentrationer af lovastatin eller simvastatin kan forårsage myopati, herunder rhabdomyolyse.
English: Tenofovir alafenamide ↔ Tenofovir ↑
Danish: Tenofoviralafenamid ↔ Tenofovir ↑
English: Dose adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Det bør overvejes at justere midazolamdosis, især hvis der administreres mere end en enkelt dosis midazolam.
English: The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as Darunavir Krka
Danish: Kombinationsproduktet lopinavir/ritonavir denne medicin mod hiv tilhører samme klasse som Darunavir Krka
English: Other tablet strengths and formulations of darunavir are available.
Danish: Andre styrker og formuleringer af darunavir er tilgængelige.
English: Rifabutin 150 mg once every other day rifabutin AUC rifabutin Cmin
Danish: Rifabutin 150 mg hver anden dag rifabutin AUC rifabutin Cmin
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Tegnene på osteonekrose omfatter: Stivhed, ømhed og smerter i led (især hofter, knæ og skuldre) samt problemer med at bevæge sig.
English: Of the 44 patients taking ritonavir oral solution, 27 switched to the 100 mg capsule formulation and exceeded the weightbased ritonavir dose without changes in observed safety.
Danish: Ud af de 44 patienter, der fik ritonavir oral opløsning, skiftede 27 til 100 mg kapselformuleringen og overskred derved den vægtbaserede ritonavirdosis uden observerede ændringer i sikkerhed.
English: Cobicistat decreases the estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Danish: Cobicistat reducerer den estimerede kreatinin-clearance på grund af hæmning af den tubulære kreatinin-sekretion.
English: These are: muscle pain, tenderness or weakness.
Danish: Disse omfatter: - muskelsmerter, -ømhed eller svaghed.
English: Some side effects are typical for anti-HIV medicines in the same family as Darunavir Krka.
Danish: Nogle bivirkninger er typiske for hiv-medicin i samme gruppe som Darunavir Krka.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response NC=F
Danish: I henhold til TLOVR-algoritmen Baseret på en normal approksimation af forskellen i % respons c
English: The increased exposure was likely at least partly due to immaturity of the drug-metabolising enzymes in juvenile animals.
Danish: Det er sandsynligt, at den øgede eksponering i hvert fald til dels skyldtes, at de lægemiddelmetaboliserende enzymer ikke er fuldt udviklede hos unge rotter.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Danish: Darunavir metaboliseres i udstrakt grad via det hepatiske CYP-system og næsten udelukkende via isozym-CYP3A4.
English: ART-experienced adult patients
Danish: ART-erfarne voksne patienter
English: Data on comparison with a 150 mg once daily reference dose is lacking.
Danish: Der mangler data på sammenligning med en referencedosis på 150 mg en gang daglig.
English: Poly(vinyl alcohol) Macrogol
Danish: Polyvinylalkohol Macrogol
English: In repeated-dose toxicology studies in mice, rats and dogs, there were only limited effects of treatment with darunavir.
Danish: I toksikologistudier med gentagne doser til mus, rotter og hunde var der kun begrænset virkning af behandling med darunavir.
English: Sildenafil to treat high blood pressure in the pulmonary circulation
Danish: Sildenafil til behandling af for højt blodtryk i lungekredsløbet
English: Darunavir in combination with ritonavir caused a reduction in the number of pups that exhibited the startle response on day 15 of lactation and a reduced pup survival during lactation.
Danish: Darunavir i kombination med ritonavir medførte et fald i antallet af unger, der udviste forskrækkelsesrespons på dag 15 af diegivningen og en reduceret overlevelse for ungerne i dieperioden.
English: * 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: * disse bivirkninger har ikke været indberettet i forbindelse med de kliniske studier med darunavir/cobicistat, men har været bemærket under behandling med darunavir/ritonavir, og kan også forventes med darunavir/cobicistat.
English: The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with ritonavir.
Danish: De farmakokinetiske steady-stateparametre for darunavir var sammenlignelige, når der blev boostet med ritonavir.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis B eller C, har en øget risiko for at få leverfunktionsanomalier, hvilket kan omfatte alvorlige og potentielt dødelige leverbivirkninger.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take Darunavir Krka.
Danish: Din læge kan vurdere, hvor alvorlig din leversygdom er, inden han eller hun beslutter, om du kan tage Darunavir Krka.
English: No post weaning functions were affected with darunavir alone or in combination with ritonavir.
Danish: Ingen funktioner efter fravænning blev påvirket af darunavir alene eller i kombination med ritonavir.
English: 15 kg to < 20 kg N=16
Danish: 15 kg til <20 kg N=16
English: These are mentioned above under the heading ‘Do not combine Darunavir Krka with any of the following medicines:'
Danish: Disse er nævnt ovenfor under overskriften ”Du må ikke tage Darunavir Krka sammen med følgende medicin”.
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: 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 metadondosis ved samtidig administration over en længere periode.
English: Darunavir Krka with food and drink See section 3 ‘How to take Darunavir Krka.'
Danish: Brug af Darunavir Krka sammen med mad og drikke Se punkt 3 ”Sådan skal du tage Darunavir Krka”
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Danish: Patienter, der får hormonerstatningsbehandling med østrogen, skal monitoreres klinisk for tegn på østrogenmangel.
English: Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).
Danish: - Fortæl din læge, hvis du er allergisk over for sulfonamider(anvendes f.eks. til behandling af visse infektioner).
English: The effects of other medicines might be influenced if you take Darunavir Krka.
Danish: Virkningen af anden medicin kan blive påvirket, hvis du tager Darunavir Krka.
English: Darunavir Krka works by reducing the amount of HIV in your body.
Danish: Darunavir Krka virker ved at reducere mængden af hiv i kroppen.
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: not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Danish: ikke kendt toksisk epidermal nekrolyse*, akut generaliseret eksantematøs pustulose*
English: Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs.
Danish: Der er blevet udført toksikologiske dyrestudier ved eksponeringer op til kliniske eksponeringsniveauer med darunavir administreret alene til mus, rotter og hunde og i kombination med ritonavir til rotter og hunde.
English: In clinical trials, rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing.
Danish: I kliniske studier var udslættet for det meste mildt til moderat og debuterede ofte i løbet af de første fire ugers behandling, hvorefter det fortog sig under den fortsatte behandling.
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Danish: Begge behandlingsarme brugte et fast baggrundsregime bestående af tenoforvirdisoproxilfumarat 300 mg en gang dagligt og emtricitabin 200 mg en gang dagligt.
English: Take your other HIV medicines used in combination with Darunavir Krka and ritonavir as recommended by your doctor.
Danish: - Tag din anden hiv-medicin, der skal bruges sammen med Darunavir Krka og ritonavir, som din læge anbefaler det.
English: Pregnant or breast-feeding mothers should not take Darunavir Krka with ritonavir unless specifically directed by the doctor.
Danish: Gravide eller ammende mødre bør ikke tage Darunavir Krka sammen med ritonavir, medmindre lægen specifikt har foreskrevet det.
English: Do not combine Darunavir Krka with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Danish: Du må ikke tage Darunavir Krka sammen med følgende medicin Hvis du tager et af disse lægemidler, skal du tale med din læge om at skifte til en anden medicin
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Danish: Den intravenøse clearance af darunavir alene (150 mg) og ved tilstedeværelse af lavdosis ritonavir var henholdsvis 32,8 l/t og 5,9 l/t.
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: The decreased susceptibility to darunavir of the emerging viruses in the selection experiment could not be explained by the emergence of these protease mutations.
Danish: Den reducerede følsomhed for darunavir, som vira fremkommet under studiet udviste, kunne ikke forklares med forekomsten af disse proteasemutationer.
English: ANAESTHETIC Alfentanil
Danish: ANÆSTETIKA Alfentanil
English: Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Danish: Darunavir var ikke mutagent eller genotoksisk i et sæt in vitro- og in vivo-analyser, herunder bakteriel revers mutation (Ames), kromosomafvigelse i humane lymfocytter og in vivo mikronukleustest hos mus.
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Danish: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V og L89V
English: Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Danish: Patienter med hæmofili skal derfor oplyses om muligheden for øget blødningstendens.
English: Patients with severe (Child-Pugh Class C) hepatic impairment.
Danish: Patienter med svært (Child-Pugh klasse C) nedsat leverfunktion.
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 en bivirkning.
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 hiv-inficerede kvinder i forhold til mænd.
English: Infections and infestations uncommon herpes simplex
Danish: Infektioner og parasitære sygdomme ikke almindelig herpes simplex
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Danish: Ellers var der ingen virkninger på parring eller fertilitet ved darunavirbehandling med op til 1.000 mg/kg/dag og eksponeringsniveauer under det humane niveau ved den klinisk anbefalede dosis (½ AUC).
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Danish: De observerede hepatocellulære tumorer og tumorer i skjoldbruskkirtlen hos gnavere anses for at være af begrænset relevans for mennesker.
English: Dose (once daily with food)
Danish: Dosis (en gang daglig i forbindelse med et måltid)
English: Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
Danish: Enkeltdoser op til 3.200 mg darunavir som oral opløsning alene og op til 1.600 mg som tabletformulering af darunavir i kombination med ritonavir er blevet givet til raske, frivillige forsøgspersoner uden nogen utilsigtede, symptomatiske virkninger.
English: The table below shows the efficacy data of the 48-week and 96-week analyses from the pooled POWER 1 and POWER 2 trials.
Danish: Tabellen nedenfor viser virkningsdataene fra 48-ugers- og 96-ugers-analyserne fra de samlede POWER 1- og POWER 2-studier.
English: (MATE1 inhibition)
Danish: (MATE1-hæmning)
English: Tablets of lower strengths are available to construct the appropriate dosing regimen.
Danish: Der er tabletter med lavere styrker tilgængelige til at kunne sammensætte den passende dosis til børn.
English: (Rifabutin is an inducer and substrate of CYP3A.)
Danish: (Rifabutin er en induktor af og substrat for CYP3A.)
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes, darunavir with low dose ritonavir should not be used in paediatric patients below 3 years of age.
Danish: På grund af usikkerheden omkring udviklingshastigheden af den humane blod-hjernebarriere og leverenzymer bør darunavir med lavdosis ritonavir ikke bruges til pædiatriske patienter under 3 år.
English: 800 milligram
Danish: 800 mg
English: When the recommendation is the same for darunavir when co-administered with a low dose ritonavir or cobicistat, the term “boosted darunavir” is used.
Danish: Når anbefalingen er den samme for darunavir, uanset om det co-administreres med en lav dosis ritonavir eller cobicistat, anvendes termen ”boostet darunavir”.
English: Amiodarone Bepridil Dronedarone Ivabradine Quinidine Ranolazine
Danish: Amiodaron Bepridil Dronedaron Ivabradin Kinidin Ranolazin
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter åbning af lægemidlet, se pkt.
English: If switching the pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with darunavir/cobicistat, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer.
Danish: Hvis den farmakokinetiske forstærker ændres fra ritonavir til cobicistat, skal der udvises forsigtighed i de første to uger af behandlingen med darunavir/cobicistat, især hvis doser af samtidigt administrerede lægemidler er blevet titreret eller justeret under brugen af ritonavir som farmakoforstærker.
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-RNAniveau på mindst 1,0 log10 i forhold til baseline.
English: Several of the interaction studies have been performed with darunavir at lower than recommended doses.
Danish: Adskillige af interaktionsstudierne er blevet udført med darunavir ved lavere doser end anbefalet.
English: A dose reduction of the co-administered drug may be needed in these cases.
Danish: Dosisreduktion af det samtidigt administrerede lægemiddel kan være påkrævet i disse tilfælde.
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 bruges til behandling af allergi, astma, betændelseslignende tilstande (inflammation) i tarm, øjne, led- og muskler samt andre inflammatoriske tilstande.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Danish: Virkningerne af høj systemisk eksponering for fluticason på plasmaniveauerne af ritonavir kendes endnu ikke.
English: Refer to section 4.4 if creatinine clearance is used for dose adjustment of emtricitabine or lamivudine.
Danish: 4.4, hvis kreatinin-clearance benyttes ved dosisjustering af emtricitabin eller lamivudin.
English: There is no specific antidote for overdose with darunavir.
Danish: Der findes ingen specifik antidot mod darunavir.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Danish: Der er blevet rapporteret systemiske kortikosteroidvirkninger, herunder Cushings syndrom og adrenal suppression, hos patienter, der får ritonavir samt inhaleret eller intranasalt administreret fluticason.
English: Other severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).
Danish: Andre alvorlige bivirkninger var diabetes (almindelig) og betændelse i bugspytkirtlen (ikke almindelig).
English: Cisapride to treat some stomach conditions
Danish: Cisaprid til behandling af visse mavelidelser
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 for samtidig brug af parenteral midazolam med andre proteasehæmmere peger på en mulig 3-4 gange forøgelse af midazolams plasmaniveau.
English: The dosage of other medicines might need to be changed since either their own or Darunavir Krka's therapeutic effect or side effects may be influenced when combined.
Danish: Doseringen af anden medicin skal muligvis ændres, da behandlingsvirkningen eller bivirkninger af enten denne eller Darunavir Krka kan blive påvirket, når de kombineres.
English: The child must take the appropriate doses of Darunavir Krka and ritonavir two times per day or once a day.
Danish: - Barnet skal tage den beregnede dosis af Darunavir Krka og ritonavir 2 gange dagligt eller en gang dagligt.
English: Lovastatin, simvastatin and lomitapide to lower cholesterol levels
Danish: Lovastatin, simvastatin og lomitapid til nedsættelse af kolesterol i blodet
English: The dose of other pharmacokinetic enhancer to be used with darunavir in children less than 18 years of age has not been established.
Danish: Dosis af den andre farmakokinetiske forstærker til administration sammen med darunavir hos børn under 18 år, er ikke blevet fastlagt.
English: Your doctor will advise you how to deal with your symptoms or whether Darunavir Krka must be stopped.
Danish: Din læge vil rådgive dig om, hvad du skal gøre ved symptomerne, eller om du skal holde op med at tage Darunavir Krka.
English: Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Danish: Op til det samme dosisniveau var der ingen teratogenicitet med darunavir administreret alene hos rotter og kaniner og heller ikke hos mus, når de blev behandlet i kombination med ritonavir.
English: Rash considered by the investigator to be drug-related occurred at similar rates.
Danish: Udslæt, der af investigator ansås for at være lægemiddelrelateret, forekom med samme hyppighed.
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking Darunavir Krka.
Danish: Du må ikke betjene maskiner eller køre bil, hvis du føler dig svimmel efter indtagelse af Darunavir Krka
English: Skin rash (more often when used in combination with raltegravir), itching.
Danish: Hududslæt (ses oftere ved kombination med raltegravir), kløe.
English: Limited information is available in this population, and therefore, darunavir should be used with caution in this age group (see sections 4.4 and 5.2).
Danish: Der foreligger kun begrænsede oplysninger om denne population, og darunavir skal derfor anvendes med forsigtighed til denne aldersgruppe (se pkt.
English: The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
Danish: Virkningen på co-administrerede lægemidler er derfor muligvis undervurderet, og klinisk sikkerhedsmonitorering kan være indiceret.
English: CCR5 ANTAGONIST Maraviroc
Danish: CCR5-HÆMMER Maraviroc
English: Some clinical studies suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Danish: Nogle kliniske studier tyder på, at raltegravir kan forårsage et beskedent fald i darunavirs plasmakoncentration.
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 tager antiretroviral kombinationsmedicin, kan udvikle en knoglesygdom, hvor knoglevævet dør på grund af manglende blodforsyning til knoglen (osteonekrose).
English: These patients received darunavir/ritonavir 800/100 mg once daily in combination with other antiretroviral agents.
Danish: Disse patienter fik darunavir/ritonavir 800/100 mg en gang dagligt i kombination med andre antiretrovirale lægemidler.
English: TITAN Week 48
Danish: TITAN Uge 48
English: Even when you feel better, do not stop taking Darunavir Krka.
Danish: Selvom du har det bedre, må du ikke stoppe med at tage Darunavir Krka.
English: Darunavir is approximately 95% bound to plasma protein.
Danish: Darunavir binder sig til plasmaprotein med ca. 95 %.
English: One dose is between 15 and 30 kilograms
Danish: En dosis er mellem 15 og 30 kg
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straβe 5, 27472 Cuxhaven, Germany
Danish: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien TAD Pharma GmbH, Heinz-Lohmann-Straβe 5, 27472 Cuxhaven, Tyskland
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 tenofovirdisoproxil.
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 coadministreret med cobicistat.
English: 100 milligram more than 40 kilograms
Danish: 100 mg mere end 40 kg
English: ART-naïve adult patients
Danish: ART-naive voksne patienter