natgillin/translations-raw huggingface dataset:
EXP Skal anvendes inden for 100 dage efter anbrud.
EXP Once opened, use within 100 days
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
Ethinylestradiol Norethindron 35 g/1 mg x 1
Ethinylestradiol Norethindrone 35 μg/1 mg once daily drospirenone AUC ↑ 58% drospirenone Cmin ND€
Immunsystemet Ikke almindelig immunrekonstitutionsinflammatorisk syndrom (IRIS) , (lægemiddel)overfølsomhed
Uncommon immune reconstitution inflammatory syndrome, (drug) hypersensitivity
Genotype- og fænotypebestemmelse (hvor det er muligt) og behandlingsanamnese skal være vejledende for brugen af darunavir (se pkt.
Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).
hiv-1-RNA < 50 kopier/ml a gennemsnitlig hiv-1-RNAlogændring fra baseline (log10 kopier/ml) gennemsnitlig ændring fra baseline b i CD4+ celletal a
HIV-1 RNA < 50 copies/ml a b median CD4+ cell count change from baseline (x 10
Antal forsøgspersoner med virologisk svigt a og genotypedata, som udvikler mutationer b ved endepunktet, n/N
Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
60 filmovertrukne tabletter 100 filmovertrukne tabletter
60 film-coated tablets 100 film-coated tablets
Det frarådes at co-administrere boostet darunavir og simeprevir.
It is not recommended to co-administer boosted darunavir and simeprevir.
Ved 48 uger blev non-inferioritet i virologisk respons over for darunavir/ritonavirbehandlingen, defineret som procentdelen af patienter med plasma hiv-1-RNA-niveau < 400 og < 50 kopier/ml, påvist (ved den forud definerede 12% grænse for non-inferioritet) hos begge populationer (”Intent-To-Treat” og ”On Protocol”).
At 48 weeks non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 400 and < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both ITT and OP populations.
Darunavir bindes hovedsageligt til surt 1-glykoprotein.
Darunavir binds predominantly to α1-acid glycoprotein.
Derfor kan den samme daglige dosis anvendes til behandlingserfarne unge i alderen 12 til < 18 år med en legemsvægt på mindst 40 kg uden mutationer associeret med darunavirresistens (DRV-RAMs)*, og som har plasma-hiv-1-RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
Therefore the same once daily dosage may be used in treatment-experienced adolescents aged 12 to < 18 years and weighing at least 40 kg without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l (see section 4.2).
800 mg darunavir/100 mg ritonavir en gang dagligt a ritonavir oral opløsning: 80 mg/ml
800 mg darunavir/100 mg ritonavir once daily a ritonavir oral solution: 80 mg/ml
Darunavir skal altid gives oralt med cobicisat eller lavdosis ritonavir som en farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler.
Darunavir must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
600 mg darunavir/100 mg ritonavir to gange dagligt a ritonavir oral opløsning: 80 mg/ml
600 mg darunavir/100 mg ritonavir twice daily a ritonavir oral solution: 80 mg/ml
Øre og labyrint Ikke almindelig
Ear and labyrinth disorders Uncommon vertigo
Darunavir er ikke testet med ritonavir med alle PI'ere (proteasehæmmere) og må ikke anvendes sammen med andre hiv-PI'ere.
Darunavir with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs.
Et
e
påvirkning af lever, nyrer eller lunger] - hjerteanfald, langsom puls, hjertebanken - synsforstyrrelser - kulderystelser, unormal følelse - følelse af forvirring eller desorientering, humørændring, rastløshed - besvimelse, epileptiske anfald, ændring i eller tab af smagsoplevelse - mundsår, opkastning af blod, betændelse i læberne, tørre læber, belagt tunge - snue - beskadigelse af huden, tør hud - stive muskler eller led, ledsmerter med eller uden betændelse - ændringer i visse blodlegemer eller i blodets kemiske sammensætning.
kidney or lung] - heart attack, slow heart beating, palpitations - visual disturbance - chills, feeling abnormal - a feeling of confusion or disorientation, altered mood, restlessness - fainting, epileptic fits, changes or loss of taste - mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue - running nose - skin lesions, dry skin - stiffness of muscles or joints, joint pain with or without inflammation - changes in some values of your blood cells or chemistry.
800 mg darunavir) sammen med 100 mg ritonavir en gang dagligt.
800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Koldformet PVC/Al/OPA-Al-blisterpakning, der indeholder 240 tabletter og 240 x 1 tabletter.
Cold form PVC/Al/OPA-Al blister pack containing 240 tablets and 240x1 tablets.
Darunavir anvendes til at behandle voksne og børn fra og med 3 år med en kropsvægt på mindst 15 kg, som er hiv-inficerede, og som allerede har anvendt andre antiretrovirale lægemidler.
Darunavir is used to treat adults and children of 3 years of age and above, and at least 15 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.
Koldformet PVC/Al/OPA-Al-blisterpakning, der indeholder 480 tabletter og 480 x 1 tabletter.
Cold form PVC/Al/OPA-Al blister pack containing 480 tablets and 480x1 tablets.
Co-administration af domperidon og boostet Darunavir Mylan er kontraindiceret.
Co-administration of domperidone with boosted darunavir is contraindicated.
Darunavir i kombination med ritonavir påvirker ikke eller kun i ubetydelig grad Trafik- og arbejdssikkerhed.
Darunavir in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Co-administration af darunavir/ritonavir med lægemidler, der især metaboliseres af CYP3A og/eller CYP2D6 eller transporteres af P-gp, kan forårsage øget systemisk eksponering for sådanne lægemidler, hvilket kan øge eller forlænge både den terapeutiske virkning og bivirkninger.
Co-administration of darunavir/ ritonavir with medicinal products primarily metabolised by CYP3A and/or CYP2D6 or transported by P-gp may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
I henhold til LOCF (last obervation carried forward)
Last Observation Carried Forward imputation
Sjælden letargi, paræstesi, hypæstesi, dysgeusi, opmærksomhedsforstyrrelser, hukommelsestab, somnolens synkope, krampe, ageusi, forstyrrelser i søvnfaserytmen
Rare headache, peripheral neuropathy, dizziness lethargy, paraesthesia, hypoaesthesia, dysgeusia, disturbance in attention, memory impairment, somnolence syncope, convulsion, ageusia, sleep phase rhythm disturbance
DIREKTE VIRKENDE ANTIVIRALE MIDLER MOD HEPATITIS C-VIRUS (HCV) NS3-4A-proteasehæmmere Elbasvir/grazoprevir Boostet darunavir kan medføre en stigning i eksponeringen for grazoprevir.
HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors
240 filmovertrukne tabletter 240 x 1 filmovertrukne tabletter
Blister carton 240 film-coated tablets 240 x 1 film-coated tablets
Boostet darunavir kan administreres sammen med disse NRTI'er uden dosisjusteringer.
Boosted darunavir can be used with these NRTIs without dose adjustment.
Saquinavir: sammenligning af saquinavir/ritonavir 1.000/100 mg x 2 vs saquinavir/darunavir/ritonavir 1.000/400/100 mg x 2.
Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily.
Derfor bør darunavir 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).
Darunavir Mylan 75 mg filmovertrukne tabletter PVC/PE/PVDC-Al-blisterpakning, der indeholder 480 tabletter og 480 x 1 tabletter.
Darunavir Mylan 75 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 480 tablets and 480x1 tablets.
Hiv-1-RNA < 50 kopier/ml c
HIV-1 RNA < 50 copies/ml c
Samtidig brug af everolimus eller irinotecan og boostet darunavir frarådes.
Concominant use of everolimus or Irinotecan and boosted darunavir is not recommended.
Darunavir skal tages i kombination med en lav dosis af ritonavir og andre anti-hiv-lægemidler.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-HIV medicines.
Æske til flaske 60 filmovertrukne tabletter 240 filmovertrukne tabletter
Bottle carton 60 film-coated tablets 240 film-coated tablets
HDPE-flaskepakke med polypropylenskruelåg indeholdende 30 og 120 tabletter.
HDPE bottle pack with a PP screw cap containing 30 and 120 tablets.
Der skal udvises forsigtighed ved samtidig brug af andre PDE-5-hæmmere til behandling af erektil dysfunktion og darunavir administreret sammen med lavdosis ritonavir.
Concomitant use of other PDE-5 inhibitors for the treatment of erectile dysfunction with darunavir co-administered with low dose ritonavir should be done with caution.
Darunavir Mylan findes i andre styrker.
Other strengths of Darunavir Mylan are available.
Co-administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom methadon) 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.
Ændring i følsomhed i forhold til reference c
Last Observation Carried Forward imputation c
Darunavir, administreret sammen med lavdosis ritonavir, er i kombination med andre antiretrovirale lægemidler indiceret til behandling af patienter med human immundefektvirus (hiv-1)-infektion (se pkt.
Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Vedrørende dosisanbefalinger for børn henvises til produktresuméet for darunavir 75 mg, 150 mg, 300 mg og 600 mg tabletter.
For dosage recommendations in children, see the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg, 600 mg tablets.
Co-administration af darunavir, lavdosis ritonavir og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt.
Therefore, coadministration of darunavir with low dose ritonavir and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
etravirin AUC ↓ 37% etravirin Cmin ↓ 49% etravirin Cmax ↓ 32% darunavir AUC  15% darunavir Cmin ↔ darunavir Cmax ↔
Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Co-administration af darunavir og ritonavir med lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom methadon) 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.
Darunavir kan administreres sammen med lavdosis ritonavir og etravirin 200 mg x 2 uden dosisjusteringer.
Darunavir co-administered with low dose ritonavir and etravirine 200 mg twice daily can be used without dose adjustments.
Darunavir Mylan 150 mg filmovertrukne tabletter PVC/PE/PVDC-Al-blisterpakning, der indeholder 240 tabletter og 240 x 1 tabletter.
Darunavir Mylan 150 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 240 tablets and 240x1 tablets.
meget kraftig svedafsondring, nattesved, hårtab, akne, skællet hud, misfarvning af negle - muskelsmerter, muskelkramper eller -svaghed, smerter i lemmerne, knogleskørhed - nedsættelse af skjoldbruskkirtlens funktion.
excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails - muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis - slowing down of the thyroid gland function.
- Buspiron, clorazepat, diazepam, estazolam, flurazepam, midazolam, når det tages som injektion, zoldipem (beroligende midler) - Perphenazin, risperidon, thioridazin (til behandling af psykiske lidelser).
- Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection,
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
30 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 120 x 1 filmovertrukne tabletter
Blister carton 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 120 x 1 film-coated tablets
Denne dosis må ikke overstige den anbefalede dosis til voksne, som er 800 mg darunavir sammen med 100 mg ritonavir én gang dagligt.
This dose must not exceed the recommended adult dose, which is 800 milligram darunavir together with 100 milligram ritonavir once a day.
- Hvis du oplever bivirkninger, skal du tale med din læge, apotekspersonalet eller din sygeplejerske.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
(CYP3A-, CYP2D6- og/eller P-gphæmning)
(CYP3A, CYP2D6 and/or P-gp inhibition)
4.1) kan der anvendes et regime på 800 mg en gang dagligt sammen med ritonavir 100 mg en gang dagligt i forbindelse med et måltid.
6/l, a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
Hver tablet indeholder 75 mg darunavir.
Each tablet contains 75 milligrams of darunavir.
Klinisk monitorering anbefales, når boostet darunavir administreres sammen med clonazepam.
Clinical monitoring is recommended when co administering boosted darunavir and clonazepam.
Indinavir: sammenligning af indinavir/ritonavir 800/100 mg x 2 vs indinavir/darunavir/ritonavir 800/400/100 mg x 2.
Indinavir: comparison of indinavir/ritonavir 800/100 mg twice daily vs. indinavir/darunavir/ritonavir 800/400/100 mg twice daily.
nevirapin AUC ↑ 27% nevirapin Cmin ↑ 47% nevirapin Cmax ↑ 18% darunavir: koncentrationerne var i overensstemmelse med historiske data.
Nevirapine 200 mg twice daily nevirapine AUC ↑ 27% nevirapine Cmin ↑ 47% nevirapine Cmax ↑ 18% darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition)
Vedrørende kliniske studieresultater hos ART-naive voksne patienter henvises til produktresuméet for darunavir 400 mg og 800 mg tabletter.
For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for darunavir 400 mg and 800 mg tablets.
Hvis efavirenz skal anvendes i kombination med darunavir/ritonavir, bør der anvendes et regime med darunavir/ritonavir 600/100 mg x 2 (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).
Det frarådes at co-administrere darunavir med lavdosis ritonavir og simeprevir.
It is not recommended to coadminister darunavir with low dose ritonavir and simeprevir.
Virkning af darunavir 600 mg to gange dagligt co-administreret med 100 mg ritonavir to gange dagligt hos ART-erfarne patienter
Efficacy of darunavir 600 mg twice daily co-administered with 100 mg ritonavir twice daily in ARTexperienced patients
Boostet darunavir kan forventes at øge plasmakoncentrationen af calciumantagonisterne.
Boosted darunavir can be expected to increase the plasma concentrations of calcium channel blockers.
Børn og unge Darunavir 800 mg må ikke anvendes til børn under 3 år, eller som vejer mindre end 40 kg.
Darunavir Mylan 800 mg tablets is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Darunavir skal altid gives oralt sammen med lavdosis ritonavir som 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).
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
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
Alle forsøgspersoner darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=313
All subjects darunavir/cobicistat 800/150 mg once daily + OBR N=313
Co-administration af boostet Darunavir Mylan og dapoxetin er kontraindiceret.
Co-administration of boosted darunavir with dapoxetine is contraindicated.
Samtidig anvendelse af bosentan og darunavir administreret sammen med lavdosis ritonavir kan øge plasmakoncentrationen af bosentan.
Concomitant use of bosentan and darunavir coadministered with low dose ritonavir may increase plasma concentrations of bosentan.
Samtidig anvendelse af salmeterol og darunavir administreret sammen med lavdosis ritonavir kan øge plasmakoncentrationen af salmeterol.
Concomitant use of salmeterol and darunavir coadministered with low dose ritonavir may increase plasma concentrations of salmeterol.
Kombination 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).
(CYP2D6- og/eller CYP3A-hæmning)
(CYP2D6 and/or CYP3A inhibition)
Æske til flaske 60 filmovertrukne tabletter 100 filmovertrukne tabletter
Bottle carton 60 film-coated tablets 100 film-coated tablets
Hos kvinder, der fik 600/100 mg darunavir/ritonavir to gange dagligt i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC12t og Cmin for total-darunavir hhv. 28%, 26% og 26% lavere i forhold til post partum.
In women receiving darunavir/ritonavir 600/100 mg twice daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC12h and Cmin were 28%, 26% and 26% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC12h and Cmin values were 18%, 16% lower and 2% higher, respectively, as compared with postpartum.
Samtidig brug af lovastatin eller simvastatin og boostet darunavir er derfor kontraindiceret (se pkt.
Concomitant use of boosted darunavir with lovastatin and simvastatin is therefore contraindicated (see section
ART-erfarne pædiatriske patienter i alderen 6 til < 18 år med legemsvægt mindst 20 kg 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.
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.
Darunavir/ritonavir 600/100 mg x 2 + OBR
Darunavir/ritonavir 600/100 mg twice daily + OBR
Darunavir Mylan 400 mg filmovertrukne tabletter 3 år
Darunavir Mylan 400 mg film-coated tablets 3 years
celler/l.I forbindelse med beslutningen om at påbegynde behandling med darunavir hos sådanne ART-erfarne patienter bør brugen af darunavir vejledes af genotypebestemmelse (se pkt.
In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
Koldformet PVC/Al/OPA-Al-blisterpakning, der indeholder 30, 60 og 120 tabletter og 120 x 1 tabletter.
Cold form PVC/Al/OPA-Al blister pack containing 30, 60 and 120 tablets and 120x1 tablets.
Kombination af rifampicin og darunavir med lavdosis ritonavir (se pkt.
Combination of rifampicin with darunavir with concomitant low dose ritonavir (see section 4.5).
celler /l.
6/l.
Darunavir med lavdosis ritonavir med triazolam eller oral midazolam er kontraindiceret (se pkt.
Darunavir co-administered with low dose ritonavir is contraindicated with triazolam or oral midazolam (see section 4.3).
Sjælden dyspnø, hoste, næseblødning, halsirritation næseflåd
Rare dyspnoea, cough, epistaxis, throat irritation rhinorrhoea
Æske til flaske 30 filmovertrukne tabletter 120 filmovertrukne tabletter
Bottle carton 30 film-coated tablets 120 film-coated tablets
clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC  13% #darunavir Cmin  1% darunavir Cmax  17% 14-OH-clathromycinkoncentrationenerne var ikke målbare ved kombination med darunavir/ritonavir.
ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% #darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% 14-OH-clarithromycin concentrations were not detectable when combined with darunavir/ritonavir.
ELLER - 600 mg darunavir (2 tabletter der indeholder 300 mg darunavir eller 1 tablet der indeholder 600 mg darunavir) sammen med 100 mg ritonavir to gange dagligt.
OR - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) together with 100 milligram ritonavir twice daily.
Hver filmovertrukken tablet indeholder 75 mg darunavir.
Each film-coated tablet contains 75 mg of darunavir.
Darunavir Mylan 800 mg filmovertrukne tabletter 3 år
Darunavir Mylan 800 mg film-coated tablets 3 years
Atazanavir: sammenligning af atazanavir/ritonavir 300/100 mg x 1 vs atazanavir 300 mg x 1 i kombination med darunavir/ritonavir 400/100 mg x 2.
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 Mylan 300 mg filmovertrukne tabletter fås i blisterkort med 30, 60 og 120 tabletter og i plastbeholdere med 30 og 120 tabletter.
Darunavir Mylan 300 mg film-coated tablets are available in blister packs containing 30, 60 and 120 tablets and in plastic bottles containing 30 and 120 tablets.
Interaktionsstudiet viste en sammenlignelig daglig systemisk eksponering af rifabutin imellem behandling med 300 mg x 1 og 150 mg hver anden dag i kombination med darunavir /ritonavir (600/100 mg x 2).
The interaction trial showed a comparable daily systemic exposure for rifabutin between treatment at 300 mg once daily alone and 150 mg once every other day in combination with darunavir/ritonavir (600/100 mg twice daily) with an about 10-fold increase in the daily exposure to the active metabolite
Nedsat nyrefunktion Der er ikke behov for dosisjustering hos patienter med nedsat nyrefunktion (se pkt.
Renal impairment No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).