FrancophonIA/ELRC3.0 huggingface dataset:
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 hivsygdom og/eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
English: Dose(twice daily with food)
Danish: Dosis (to gange daglig i forbindelse med et måltid)
English: For co-administration with strong CYP3A4 inhibitors, the same recommendations apply independent of whether darunavir is boosted with ritonavir or with cobicistat (see section above).
Danish: Ved administration sammen med potente CYP3A4-hæmmere gælder de samme anbefalinger uafhængigt af, om darunavir er boostet med ritonavir eller med cobicistat (se afsnittet ovenfor).
English: 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: 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: 20 mg once daily
Danish: 20 mg en gang daglig
English: Advice on missed doses
Danish: Rådgivning om glemte doser
English: There are some medicines that you must not combine with Darunavir Krka.
Danish: Nogle typer medicin må du ikke tage sammen med Darunavir Krka.
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Danish: Darunavir udviser antiviral aktivitet in vitro mod en bred række af hiv-1 gruppe M (A, B, C, D, E, F, G) og gruppe O primære isolater med EC50-værdier fra < 0,1 til 4,3 nM.
English: Adverse reactions observed with darunavir/ritonavir in clinical trials and post-marketing
Danish: Bivirkninger, som er observeret med darunavir/ritonavir i kliniske studier og efter markedsføring
English: Ethinylestradiol (3 mg/0.02 mg once daily)
Danish: Ethinylestradiol (3 mg/0,02 mg x 1)
English: For ART-experienced paediatric patients HIV genotypic testing is recommended.
Danish: Bestemmelse af hiv-genotype anbefales hos ART-erfarne pædiatriske patienter.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation af forskellen i % respons Subtype A1, D, F1, G, K, CRF02_AG, CRF12_BF og CRF06_CPX Forskelle i gennemsnit
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/ml).
Danish: Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af hiv-1 og laboratoriestammer af hiv-2 i akut inficerede T-cellelinjer, mononukleare celler fra perifert humant blod og humane monocytter/makrofager med mediane EC50 værdier fra 1,2 til 8,5 nM (0,7 til 5,0 ng/ml).
English: Changes were observed in liver (hepatocyte hypertrophy, vacuolation, increased liver enzymes) and thyroid (follicular hypertrophy).
Danish: Der blev observeret ændringer i leveren (hepatocellulær hypertrofi, vakuolisering, forhøjede leverenzymer) og skjoldbruskkirtlen (follikulær hypertrofi).
English: According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Danish: Ifølge gældende retningslinjer for behandlingen kan samtidig behandling med flere proteasehæmmere generelt ikke anbefales.
English: Both arms used an Optimised Background Regimen (OBR) consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs).
Danish: Begge behandlingsarme brugte et optimeret baggrundsregime (OBR) bestående af mindst 2 antiretrovirale midler (NRTI'er med eller uden NNRTI).
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Danish: I et enkeltarmet studie, som undersøgte darunavir 800 mg en gang daglig i kombination cobicistat 150 mg en gang daglig og andre antiretrovirale midler, afbrød 2,2 % af patienterne behandlingen på grund af udslæt.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set; den rapporterede tid til udbrud er mere variabel, og disse hændelser kan forekomme mange måneder efter initiering af behandling (se pkt.
English: Do not take Darunavir Krka if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6), if you have severe liver problems.
Danish: Tag ikke Darunavir Krka - hvis du er allergisk over for aktive substans eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
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 justere metadondosis ved samtidig administration over en længere periode, på grund af ritonavirs induktion af metabolisme.
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Danish: Gentagen administration af darunavir til rotter forårsagede induktion af mikrosomale enzymer i leveren og øgede eliminationen af skjoldbruskkirtelhormoner, som prædisponerer rotter, men ikke mennesker, for neoplasmer i skjoldbruskkirtlen.
English: Darunavir dose is
Danish: En dosis darunavir er
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: (P-gp, BCRP and/or OATP1B1/3 inhibition)
Danish: (P-gp-, BCRP- og/eller OATP1B1/3-hæmning)
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after boosted darunavir given with food.
Danish: Didanosin skal administreres på tom mave, således at det bliver administreret 1 time før eller 2 timer efter boostet darunavir, taget sammen med mad.
English: The recommended dose of darunavir with low dose ritonavir for paediatric patients is based on body weight and should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Danish: Den anbefalede darunavir-dosis med lavdosis ritonavir til pædiatriske patienter er baseret på legemsvægt og må ikke overstige den anbefalede voksendosering (600/100 mg to gange dagligt eller 800/100 mg en gang dagligt).
English: Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions
Danish: Lurasidon, pimozid, quetiapin eller sertindol til behandling af psykiske lidelser
English: In rodents the target organs identified were the haematopoietic system, the blood coagulation system, liver and thyroid.
Danish: Hos gnavere var de identificerede målorganer det hæmatopoietiske system, blodkoagulationssystemet, lever og skjoldbruskkirtlen.
English: Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat).
Danish: Derfor er samtidig behandling med lægemidler, der ved forhøjet plasmakoncentration sættes i forbindelse med alvorlige og/eller livstruende bivirkninger, kontraindiceret (gælder for darunavir boostet med enten ritonavir eller cobicistat).
English: Response (HIV-1 RNA < 50 copies/ml at week 24) %, n/N
Danish: Respons (hiv1-RNA <50 kopier/ml ved uge 24) %, n/N
English: Take Darunavir Krkawith food.
Danish: - Tag Darunavir Krka med mad.
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 length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Varigheden af antiretroviral kombinationsbehandling, brug af binyrebarkhormoner, alkoholforbrug, alvorlig svækkelse af immunforsvaret og højt Body Mass Index (BMI) kan være nogle af de mange risikofaktorer for udvikling af denne sygdom.
English: Other strengths of Darunavir Krka are available.
Danish: Andre styrker af Darunavir Krka er tilgængelige.
English: C-darunavir could be retrieved in faeces and urine, respectively.
Danish: C-darunavir genfindes i henholdsvis fæces og urin.
English: OTHER LIPID MODIFYING AGENTS Lomitapide
Danish: ANDRE LIPIDMODIFICERENDE MIDLER Lomitapid
English: Ethinylestradiol Norethindrone 35 μg/1 mg once daily
Danish: Ethinylestradiol Norethindron 35 µg/1 mg en gang daglig
English: 14-OH-clarithromycin concentrations were not detectable when combined with darunavir/ritonavir.
Danish: 14-OH-clathromycinkoncentrationerne var ikke målbare ved kombination med darunavir/ritonavir.
English: A clinical study utilising a cocktail of medicinal products that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of darunavir/ritonavir, which may be attributed to the presence of low dose ritonavir.
Danish: Et klinisk studie, hvor der anvendtes flere forskellige lægemidler, der metaboliseres af cytochrom CYP2C9, CYP2C19 og CYP2D6, viste en stigning i CYP2C9- og CYP2C19-aktiviteten og en hæmning af CYP2D6-aktiviteten ved tilstedeværelse af darunavir/ritonavir.
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 TITANstudiet, idet 60,4 % af patienterne i darunavir/ritonavir-armen havde hiv- 1-RNA < 50 kopier/ml sammenlignet med 55,2 % i lopinavir/ritonavir-armen ved uge 96 [forskel: 5,2 %, 95 % CI (-2,8; 13,1)]
English: Darunavir is primarily metabolised and eliminated by the liver.
Danish: Darunavir metaboliseres og elimineres især i leveren.
English: The efficacy and safety of the use of darunavir with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Danish: † Sikkerhed og virkning af darunavir sammen med 100 mg ritonavir og andre hiv-PI (f.eks. (fos)amprenavir, nelfinavir og tipranavir) er ikke klarlagt hos hiv-patienter.
English: Based upon the safety profile of darunavir/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for darunavir/ritonavir.
Danish: På baggrund af sikkerhedsprofilen for darunavir/ritonavir giver denne øgede eksponering af darunavir ved samtidig administration af rifabutin ikke anledning til en justering af dosis for darunavir/ritonavir.
English: ANTI-DIABETICS Metformin
Danish: ANTIDIABETIKA Metformin
English: When darunavir is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Danish: Når darunavir gives sammen med et præparat, der indeholder drospirenon, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
English: Iron oxide, yellow (E172) - only for 400 mg film-coated tablets Iron oxide, red (E172)
Danish: Jernoxid, gul (E172) - kun for 400 mg filmovertrukne tabletter Jernoxid, rød (E172)
English: The doctor will inform you on how many Darunavir Krka tablets and how much ritonavir (capsules, tablets or solution) the child must take.
Danish: Lægen vil fortælle dig, hvor mange Darunavir Krka-tabletter og hvor meget ritonavir (kapsler, tabletter eller opløsning), barnet skal tage.
English: You must take Darunavir Krka every day and always in combination with 100 milligram of ritonavir and with food.
Danish: Du skal tage Darunavir Krka hver dag og altid i kombination med 100 mg ritonavir samt mad.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Danish: En populationsfarmakokinetisk analyse af hiv-inficerede patienter viste, at farmakokinetikken for darunavir ikke er meget anderledes i aldersgruppen 18-75 år vurderet hos hiv-inficerede patienter (n=12, alder ≥65 år) (se pkt.
English: If there is a need to combine darunavir/ritonavir and carbamazepine, patients should be monitored for potential carbamazepine-related adverse events.
Danish: Hvis der er behov for at kombinere darunavir/ritonavir med carbamazepin, skal patienterne monitoreres for potentielle carbamazepinrelaterede bivirkninger.
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Danish: Tabellen nedenfor viser effektdata fra 48 ugers og 96 ugers analyserne af ARTEMISstudiet:
English: The Darunavir Krka 400 or 800 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Danish: Darunavir Krka 400 og 800 mg tabletter må ikke anvendes til børn under 3 år, eller som vejer mindre end 40 kg.
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 CYP3Ahæmning).
English: Co-administration with boosted darunavir may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Danish: Coadministration af boostet darunavir kan medføre en markant stigning i eksponeringen for dabigatran eller ticagrelor.
English: Once daily dosing Weight
Danish: Dosering en gang dagligt Legemsvægt
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-Odesacetyl metabolite) was increased 1.6fold, while Cmax remained comparable.
Danish: Desuden blev AUC for totalt aktivt rifabutin (moderstof + 25-Odesacetyl metabolit) forøget 1,6 gange, mens Cmax forblev sammenlignelig.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with darunavir should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Danish: Derfor skal mærkningen af hvert lægemiddel, som administreres sammen med darunavir, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration.
English: DRESS, Stevens-Johnson syndrome, erythema multiforme, dermatitis, seborrhoeic dermatitis, skin lesion, xeroderma not known toxic epidermal necrolysis, acute generalised exanthematous pustulosis
Danish: DRESS, Stevens-Johnsons syndrom, erythema multiforme, dermatitis, seboroisk dermatitis, hudlæsioner, xeroderma ikke kendt toksisk epidermal nekrolyse, akut generaliseret eksantematøs pustulose
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Danish: Den terminale halveringstid for darunavir var ca. 15 timer, når det blev givet med ritonavir.
English: The doctor will inform you on how much Darunavir Krka tablets and how much ritonavir (capsules, tablets or solution) the child must take.
Danish: Lægen vil fortælle dig, hvor meget Darunavir Krka-tabletter og hvor meget ritonavir (kapsler, tabletter eller opløsning), barnet skal tage.
English: Increasing baseline darunavir fold change in EC50 (FC) was associated with decreasing virologic response.
Danish: Stigende EC50-værdi over for darunavir (målt som FC - fold change) ved baseline var associeret med faldende virologisk respons.
English: Dabigatran, ticagrelor to help stop the clumping of platelets in the treatment of patients with a history of a heart attack
Danish: Dabigatran, ticagrelor som hjælp til at hindre sammenklumpning af blodplader hos patienter, der tidligere har haft et hjerteanfald
English: Endocrine disorders uncommon hypothyroidism, increased blood thyroid stimulating hormone
Danish: Det endokrine system ikke almindelig hypotyroidisme, forhøjet thyroideastimulerende hormon i blodet
English: These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial.
Danish: Disse resultater blev bekræftet ved analyserne af data efter 96 ugers behandling i ARTEMIS-studiet og blev opretholdt i op til 192 ugers behandling i ARTEMIS-studiet.
English: ODIN Week 48
Danish: ODIN Uge 48
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: Sertraline 50 mg once daily
Danish: Sertralin 50 mg en gang daglig
English: Therefore, no special precautions or dose adjustments are required in these patients (see sections 4.2 and 5.2).
Danish: Derfor er der ingen særlige sikkerhedsregler eller dosisjusteringer for disse patienter (se pkt.
English: β-BLOCKERS Carvedilol Metoprolol Timolol
Danish: BETABLOKKERE Carvedilol Metoprolol Timolol
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir.
Danish: Lægemiddelinduceret hepatitis (f.eks. akut hepatitis, cytolytisk hepatitis) er blevet rapporteret efter anvendelse af darunavir.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Danish: Det anbefales at bruge andre trombocythæmmende midler, som ikke påvirkes af CYP-hæmning eller -induktion (f.eks. prasugrel).
English: ANTIDEPRESSANTS Paroxetine
Danish: ANTIDEPRESSIVA Paroxetin
English: Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 36 pregnant women (18 in each arm) during the second and third trimesters, and postpartum.
Danish: Darunavir/ritonavir (600/100 mg to gange dagligt eller 800/100 mg en gang dagligt) i kombination med et baggrundsregime blev evalueret i et klinisk studie med 36 gravide kvinder (18 i hver arm) i andet og tredje trimester samt post partum.
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Danish: Ingen nye sikkerhedsfund blev identificeret i 192-ugers-analysen af behandlingsnaive forsøgspersoner, hvor den gennemsnitlige behandlingstid med darunavir/ritonavir 800/100 mg en gang daglig var 162,5 uger.
English: As limited information is available on the use of darunavir in patients aged 65 and over, caution should be exercised in the administration of darunavir in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Danish: Da der kun foreligger begrænsede oplysninger om brug af darunavir til patienter over 65 år, skal der udvises forsigtighed ved administration af darunavir til ældre patienter, for hvilke der skal tages højde for den højere forekomst af nedsat leverfunktion, samtidige sygdomme og andre behandlinger (se pkt.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Danish: Der har været rapporter om øget blødningstendens, herunder spontane hudhæmatomer og hæmartrose hos patienter med type A- og B-hæmofili, der behandles med PI (proteasehæmmere).
English: If you take more Darunavir Krka than you should Contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du har taget for meget Darunavir Krka Kontakt straks din læge, apotekspersonalet eller sundhedspersonalet.
English: Darunavir FC was less than 10 for 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Danish: Darunavir FC var mindre end 10 for 90 % af 3.309 kliniske isolater, der var resistente over for amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir og/eller tipranavir.
English: Both arms used an optimised background regimen (OBR) of ≥ 2 NRTIs.
Danish: I begge arme anvendes et optimeret baggrundsregime (OBR) med ≥ 2 NRTI'er.
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/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 doseringen til denne population ikke er påvist hos tilstrækkeligt mange patienter (se pkt.
English: Adverse reactions observed with darunavir/cobicistat in adult patients
Danish: Bivirkninger, som er observeret med darunavir/cobicistat hos voksne patienter
English: No treatment related mortalities were noted in juvenile rats dosed at 1,000 mg/kg darunavir (single dose) on day 26 of age or at 500 mg/kg (repeated dose) from day 23 to 50 of age, and the exposures and toxicity profile were comparable to those observed in adult rats.
Danish: Der blev ikke konstateret behandlingsrelateret mortalitet hos unge rotter, der fik en dosis på 1.000 mg/kg darunavir (enkeltdosis) i en alder på 26 dage eller en dosis på 500 mg/kg (gentagen dosis) i alderen fra 23 til 50 dage, og eksponeringen og toksicitetsprofilen var sammenlignelige med dem, der blev observeret hos voksne rotter.
English: In addition, patients on a stable dose of these antidepressants who start treatment with boosted darunavir should be monitored for antidepressant response.
Danish: Ydermere skal patienter, der får en stabil dosis af disse antidepressiva, og som starter behandling med boostet darunavir, monitoreres for antidepressivt respons.
English: ≥ 15 kg to < 30 kg
Danish: ≥15 kg til <30 kg
English: Swallow the tablets with a drink such as water or milk.
Danish: - Synk tabletterne med væske som f.eks. vand eller mælk.