natgillin/translations-raw huggingface dataset:
Boostet darunavir og didanosin kan administreres uden dosisjusteringer.
Boosted darunavir and didanosine can be used without dose adjustments.
Tredje trimester af graviditeten (n=15)
Third Trimester of pregnancy (n=15)
Tilregning af LOCF (sidste overførte observation)
Last Observation Carried Forward imputation
10 kg til <15 kg N=5
darunavir /ritonavir 10 kg to < 15 kg N=5
Boostet darunavir kan administreres sammen med protonpumpehæmmere uden dosisjusteringer.
Boosted darunavir can be coadministered with proton pump inhibitors without dose adjustments.
Derfor må darunavir kun anvendes i kombination med en farmakokinetisk forstærker (se pkt.
Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Samtidig anvendelse af bosentan og darunavir administreret sammen med lavdosis ritonavir kan øge plasmakoncentrationen af bosentan.
Concomitant use of bosentan and darunavir co-administered with low dose ritonavir may increase plasma concentrations of bosentan.
DELPHI er et åben label fase II studie, hvor farmakokinetikken, sikkerheden, tolerabiliteten og effekten af darunavir med lavdosis ritonavir blev undersøgt hos 80 ART-erfarne hiv-1-smittede pædiatriske patienter i alderen 6 til 17 år og med en vægt på mindst 20 kg.
ART-experienced paediatric patients from the age of 6 to < 18 years and weighing at least 20 kg DELPHI is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 80 ART-experienced HIV-1 infected paediatric patients aged 6 to 17 years and weighing at least 20 kg.
ANTIKOAGULANTIA/TROMBOCYTHÆMMENDE MIDLER Apixaban
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban
Co-administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom metadon) kan resultere i nedsat systemisk eksponering af disse lægemidler, hvilket kan nedsætte eller forkorte deres terapeutiske effekt.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Samtidig brug af everolimus og boostet darunavir frarådes.
Concomitant use of everolimus and boosted darunavir is not recommended.
4.2, 4.3 og 4.4).
6/l (see section 4.2 and 4.4).
Co-administration af darunavir og ritonavir med lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom metadon) kan resultere i nedsat systemisk eksponering af disse lægemidler, hvilket kan nedsætte eller forkorte deres terapeutiske effekt.
Co-administration of darunavir and ritonavir with medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Samtidig brug af everolimus eller irinotecan og boostet darunavir frarådes.
Concominant use of everolimus or irinotecan and boosted darunavir is not recommended.
Samtidig brug af everolimus eller irinotecan og darunavir coadministreret med lavdosis ritonavir frarådes.
Concominant use of everolimus or irinotecan and darunavir coadministered with low dose ritonavir is not recommended.
450 mg darunavir/60 mg ritonavir to gange dagligt
450 mg darunavir /60 mg ritonavir twice daily
Atazanavir: sammenligning af atazanavir/ritonavir 300/100 mg en gang daglig vs atazanavir 300 mg en gang daglig i kombination med darunavir/ritonavir 400/100 mg to gange daglig.
Atazanavir: comparison of atazanavir/ritonavir 300/100 mg once daily vs. atazanavir 300 mg once daily in combination with darunavir/ritonavir 400/100 mg twice daily.
Darunavir Krka 600 mg filmovertrukne tabletter
Darunavir Krka 600 mg film-coated tablets
En dosis ritonavir a er mellem 15 og 30 kg
One ritonavira dose is between 15 and 30 kilograms 600 milligram
Almene symptomer og reaktioner på administrationsstedet Almindelig træthed ikke almindelig asteni
General disorders and administration site conditions common fatigue uncommon asthenia
4.1), kan der anvendes et regime med 800 mg en gang dagligt sammen med ritonavir 100 mg en gang dagligt i forbindelse med et måltid.
(see section 4.1) a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
Kombinationen af avanafil og darunavir med lavdosis ritonavir er kontraindiceret (se pkt.
The combination of avanafil and darunavir with low dose ritonavir is contraindicated (see section 4.3).
Dosisjustering af darunavir/ritonavir er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
No dose adjustment is required for darunavir/ritonavir in patients with renal impairment (see sections 4.4 and 5.2).
Boostet darunavir og rilpivirin kan administreres uden dosisjusteringer.
Boosted darunavir and rilpivirine can be used without dose adjustments.
Darunavir Krka kan øge risikoen for blødning.
Darunavir Krka might increase the risk of bleeding.
Simeprevir simeprevir AUC ↑ 159% simeprevir Cmin ↑ 358% simeprevir Cmax ↑ 79% darunavir AUC ↑ 18% darunavir Cmin ↑ 31%
Simeprevir simeprevir AUC ↑ 159% simeprevir Cmin ↑ 358% simeprevir Cmax ↑ 79%
Etravirin 100 mg to gange daglig etravirin AUC ↓ 37% etravirin Cmin ↓ 49% etravirin Cmax ↓ 32% darunavir AUC ↑ 15%
Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Produktresuméet for cobicistat eller ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med darunavir påbegyndes.
The Summary of Product Characteristics of cobicistat or ritonaviras appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Hos kvinder, der fik 800/100 mg darunavir/ritonavir en gang dagligt i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24t og Cmin for total-darunavir hhv. 33 %, 31 % og 30 % lavere i forhold til post partum.
In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 29%, 32% and 50% lower, respectively, as compared with postpartum.
HIV-proteasehæmmere (PI) - med co-administration af lavdosis ritonavir†
HIV Protease inhibitors (PIs) - with co-administration of low dose ritonavir
Darunavir Krka 400 mg filmovertrukne tabletter Darunavir Krka 800 mg filmovertrukne tabletter
Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets
Darunavir Krka 400 mg filmovertrukne tabletter:
Darunavir Krka 400 mg film-coated tablets:
Klinisk monitorering anbefales ved co-administration af darunavir med lavdosis ritonavir og disse antidepressiva, og det kan være nødvendigt at justere
Clinical monitoring is recommended when co-administering darunavir with low dose ritonavir with these antidepressants and a dose adjustment of the antidepressant may be needed.
Vedrørende yderligere kliniske studieresultater hos ART-naive voksne henvises til produktresumeet for Darunavir Krka 400 mg og 800 mg tabletter.
For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
N=294
once daily N=294
Darunavir skal altid gives oralt sammen med lavdosis ritonavir som en farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler (se pkt.
Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
4.3 og 4.4), og der skal ligeledes udvises forsigtighed i den første tid af behandlingen, hvis den farmakokinetiske forstærker ændres fra ritonavir til cobicistat (se pkt.
The recommendations given for concomitant use of darunavir and other medicinal products may therefore differ depending on whether darunavir is boosted with ritonavir or cobicistat (see sections 4.3 and 4.4), and caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Der er kun begrænset erfaring med akut overdosering af darunavir, co-administreret med lavdosis ritonavir, hos mennesker.
Human experience of acute overdose with darunavir co-administered with low dose ritonavir is limited.
Tredje trimester af graviditeten (n = 6)
Third trimester of pregnancy (n=6)
Hvis efavirenz skal anvendes i kombination med darunavir/ritonavir, bør der anvendes et regime med darunavir/ritonavir 600/100 mg to gange daglig (se pkt.
If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Efter 48 uger blev der påvist non-inferioritet (ved den forud definerede 12% grænse for non-inferioritet) af det virologiske respons, defineret som procentdelen af patienter med plasmahiv-1-RNA < 50 kopier/ml, på behandling med darunavir/ritonavir 800/100 mg en gang dagligt sammenlignet med darunavir/ritonavir 600/100 mg to gange dagligt hos både ITT- og OP-populationer.
At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Darunavir Krka må ikke kombineres med naturlægemidler, der indeholder perikon (Hypericum perforatum).
Do not combine Darunavir Krka with products that contain St John's wort (Hypericum perforatum).
Samtidig brug af everolimus og darunavir co-administreret med lavdosis ritonavir frarådes.
Concomitant use of everolimus and darunavir co-administered with low dose ritonavir is not recommended.
Blødninger hos hæmofilipatienter
Bleeding in haemophiliac patients
Knogler, led, muskler og bindevæv almindelig myalgi ikke almindelig osteonekrose*
Musculoskeletal and connective tissue disorders common myalgia uncommon osteonecrosis*
Boostet darunavir kan forventes at øge plasmakoncentrationen af calciumantagonisterne.
Boosted darunavir can be expected to increase the plasma concentrations of calcium channel
Darunavir kan administreres sammen med lavdosis ritonavir og H2-receptorantagonister uden dosisjusteringer.
Darunavir co-administered with low dose ritonavir can be co-administered with H2-receptor antagonists without dose adjustments.
Samtidig administration af kombinationsproduktet lopinavir/ritonavir (se pkt.
Co-administration with the combination product lopinavir/ritonavir (see section 4.5).
Farmakokinetiske resultater for total-darunavir efter administration af 600/100 mg darunavir/ritonavir to gange dagligt som del af et antiretroviralt regime i andet og tredje trimester af graviditeten og post partum
Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Andet trimester af graviditeten (n = 7)
Second trimester of pregnancy (n=7)
Kombinationen af rifampicin og darunavir med samtidig lavdosis ritonavir er kontraindiceret (se pkt.
The combination of rifampicin and darunavir with concomitant low dose ritonavir is contraindicated (see section 4.3).
Produktresuméet for ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med darunavir påbegyndes.
The Summary of Product Characteristics of ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Kombination af rifampicin og darunavir sammen med lavdosis ritonavir (se pkt.
Combination of rifampicin with darunavir with concomitant low dose ritonavir (see section 4.5).
Darunavir bør derfor kun anvendes i kombination med lavdosis ritonavir som en farmakokinetisk forstærker (se pkt.
Therefore, darunavir must only be used in combination with low dose ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Der kan derfor være forskellige kontraindikationer og anbefalinger for darunavir og samtidige lægemidler afhængigt af, om darunavir er boostet med ritonavir (se pkt.
Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir (see sections 4.3, 4.4 and
Follikelcelleadenomer i skjoldbruskkirtlen blev observeret hos hanrotter.
Thyroid follicular cell adenomas were noted in male rats.
Hiv-1-RNA <50 kopier/ml gennemsnitlig CD4+celletals ændring fra baseline (×10
HIV-1 RNA < 50 copies/ml median CD4+ cell count change from baseline (x 10
Det frarådes at co-administrere boostet darunavir og simeprevir.
It is not recommended to coadminister boosted darunavir and simeprevir.
Den samlede farmakokinetiske, forstærkende effekt af ritonavir medførte en ca. 14fold stigning i den systemiske eksponering for darunavir ved administration af en oral enkeltdosis darunavir på 600 mg i kombination med ritonavir 100 mg to gange daglig.
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily.
Kombinationen af avanafil og boostet darunavir er kontraindiceret (se pkt.
The combination of avanafil and boosted darunavir is contraindicated (see section 4.3).
Darunavir/ritonavir bør kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko (se pkt.
Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Anbefalet dosis af darunavir tabletter og ritonavir a til behandlingsnaive pædiatriske patienter (3 til 17 år)
Recommended dose for treatment-naïve paediatric patients (3 to 17 years) with darunavir and ritonavir
Andet trimester af graviditeten (n=17)
Second trimester of pregnancy (n=17)
lægemidler ved co-administration med boostet darunavir.
concomitantly administered with boosted darunavir.
ELLER - 800 mg Darunavir Krka (2 tabletter a 400 mg Darunavir Krka eller 1 tablet a 800 mg Darunavir Krka) sammen med 100 mg ritonavir en gang dagligt.
800 milligram Darunavir Krka (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
(CYP3A og/eller CYP2D6hæmning)
(CYP3A and/or CYP2D6 inhibition)
Interaktion er ikke undersøgt.
Other corticosteroids: interaction not studied.
375 mg darunavir/50 mg ritonavir to gange dagligt
375 mg darunavir /50 mg ritonavir twice daily
Darunavir/ritonavir
based on published data with darunavir/ritonavir
boostet darunavir og alfuzosin er kontraindiceret (se pkt.
Co-administration of boosted darunavir and alfuzosin is contraindicated (see section 4.3).
Hos kvinder, der fik darunavir/cobicistat i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24t og Cmin for total-darunavir hhv. 49 %, 56 % og 92 % lavere i forhold til post partum.
In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Det anbefales ikke at kombinere saquinavir med darunavir administreret sammen med lavdosis ritonavir.
It is not recommended to combine darunavir co-administered with low dose ritonavir with saquinavir.
Hvis efavirenz skal anvendes i kombination med darunavir, bør der anvendes et regime med darunavir/ritonavir 600/100 mg to gange daglig (se pkt.
If efavirenz is to be used in combination with darunavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.5).
Farmakokinetiske resultater for total-darunavir efter administration af 800/100 mg darunavir/ritonavir en gang dagligt som del af et antiretroviralt regime i andet og tredje trimester af graviditeten og post partum
Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 800/100 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Darunavir Krka 800 mg filmovertrukne tabletter:
Darunavir Krka 800 mg film-coated tablets:
Derfor er samtidig brug af kombinationsproduktet lopinavir/ritonavir og boostet darunavir kontraindiceret (se pkt.
Hence, concomitant use of boosted darunavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Kombinationen af rifampicin og boostet darunavir er kontraindiceret (se pkt.
The combination of rifampicin and boosted darunavir is contraindicated (see section 4.3).
Darunavir/ ritonavir 800/100 mg en gang dagligt N=343
darunavir/ ritonavir 800/100 mg once daily N=343
Baseret på teoretiske overvejelser forventes darunavir at øge plasmakoncentrationerne af alfuzosin (CYP3A-hæmning)
Based on theoretical considerations darunavir is expected to increase alfuzosin plasma concentrations.
Anvisninger for voksne - Tag altid Darunavir Krka sammen med ritonavir.
Take Darunavir Krka always together with ritonavir.
Hver filmovertrukken tablet indeholder 800 mg darunavir.
Each film-coated tablet contains 800 mg darunavir.
100 mg mellem 30 og 40 kg
100 milligram between 30 and 40 kilograms 675 milligram
ART-erfarne pædiatriske patienter (3 til 17 år og legemsvægt mindst 40 kg) Hos ART-erfarne patienter, der ikke har DRV-RAMs*, og som har plasma-hiv-1
ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, hydroxypropylcellulose, silica, kolloid vandfri, silicificeret mikrokrystallinsk cellulose (mikrokrystallinsk cellulose; silica, kolloid vandfri) og magnesiumstearat (E470b) i tabletkernen og polyvinylalkohol, macrogol, titandioxid (E171), talcum (E553b), jernoxid, gul (E172) og jernoxid, rød (E172) i filmovertrækket.
silica, colloidal anhydrous ) and magnesium stearate (E470b)in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172) in film coating.
Darunavir Krka 800 mg filmovertrukne tabletter darunavir
Darunavir Krka 800 mg film-coated tablets darunavir
Darunavir Krka 400 mg filmovertrukne tabletter darunavir
Darunavir Krka 400 mg film-coated tablets darunavir
Carbamazepin AUC ↑ 45% Carbamazepin Cmin ↑ 54% Carbamazepin Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Samtidig administration af darunavir med lavdosis ritonavir og alfuzosin er kontraindiceret (se pkt.
Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Andet trimester af graviditeten (n=12)
Second trimester of pregnancy (n=12)
Darunavir/ ritonavir 800/100 mg en gang dagligt N=294
darunavir/ ritonavir 800/100 mg once daily N=294
Ved 48-ugers-analysen blev non-inferioritet i virologisk respons over for darunavir/ritonavir behandlingen, defineret som procentdelen af patienter med plasma hiv-1-RNA niveau < 50 kopier/ml, blev påvist (ved den forud definerede 12 % noninferioritetsgrænse) hos begge populationer (”Intent-To-Treat” og ”On Protocol”).
Non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Det skal du vide, før du begynder at tage Darunavir Krka Sådan skal du tage Darunavir Krka Bivirkninger
What Darunavir Krka is and what it is used for What you need to know before you take Darunavir Krka How to take Darunavir Krka Possible side effects
Den samlede farmakokinetiske, forstærkende effekt af ritonavir medførte en ca. 14fold stigning i den systemiske eksponering for darunavir ved administration af en oral enkeltdosis darunavir på 600 mg i kombination med 100 mg ritonavir to gange daglig (se pkt.
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
Klinisk monitorering anbefales, når boostet darunavir administreres sammen med lavdosis ritonavir og clonazepam.
Clinical monitoring is recommended when co-administering boosted darunavir and clonazepam.
Darunavir Krka 400 og 800 mg tabletter anvendes kun til at sammensætte en daglig dosis på 800 mg.
Darunavir Krka 400 and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
De farmakokinetiske egenskaber af darunavir i kombination med ritonavir en gang daglig hos 12 ART-naive pædiatriske patienter i alderen 12 til <18 år med en legemsvægt på mindst 40 kg viste, at darunavir/ritonavir 800/100 mg en gang daglig resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 800/100 mg en gang daglig.
The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Sådan skal du tage Darunavir Krka
How to take Darunavir Krka
675 mg darunavir/100 mg ritonavir en gang dagligt
675 mg darunavir/100 mg ritonavir once daily
Darunavir/ritonavir 800/100 mg en gang dagligt hos ART-erfarne patienter bør ikke anvendes til patienter med en eller flere mutationer associeret med darunavirresistens (DRV-RAMs) eller hiv-1 RNA ≥ 100.000 kopier/ml eller CD4+-celletal < 100 x 10 celler/l (se pkt.
Darunavir/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
7,7% af den administrerede dosis darunavir udskilles uomdannet i urinen.
C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Det frarådes at co-administrere darunavir med lavdosis ritonavir simeprevir.
It is not recommended to coadminister darunavir with low dose ritonavir and simeprevir.
Boostet darunavir og raltegravir kan administreres uden dosisjusteringer.
Boosted darunavir and raltegravir can be used without dose adjustments.
DIONE er et åbent fase II-studie til evaluering af farmakokinetik, sikkerhed, tolerabilitet og effekt af darunavir sammen med lavdosis ritonavir hos 12 ART-naive hiv-1-smittede pædiatriske patienter i alderen 12 år til < 18 år med en legemsvægt på mindst 40 kg.
ART-naïve paediatric patients from the age of 12 years to < 18 years, and weighing at least 40 kg DIONE is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.