natgillin/translations-raw huggingface dataset:
I disse farmakokinetiske studier var eksponeringen for darunavir 800 mg forstærket med cobicistat 150 mg konsistent med den, der blev observeret ved forstærkning med ritonavir 100 mg. Som komponent i REZOLSTA er darunavir bioækvivalent med darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt som individuelle lægemidler (se pkt.
In these pharmacokinetic trials, the exposure of darunavir 800 mg boosted with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. Darunavir as a component of REZOLSTA is bioequivalent to darunavir 800 mg once daily in combination with cobicistat 150 mg once daily co-administered as single medicinal products (see section 5.2).
Samtidig administration af REZOLSTA og dabigatran eller ticagrelor er kontraindiceret.
Concomitant administration of REZOLSTA with dabigatran or ticagrelor is contraindicated.
Pakningsstørrelser med én beholder.
Pack size of one bottle.
Hiv-1-inficerede patienter, der var egnede til at indgå i dette studie, havde en screening-genotype, der ikke viste darunavir-RAM, og plasma hiv-1 RNA ≥ 1.000 kopier/ml.
HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/mL.
Patienter, der tager REZOLSTA, kan udvikle hududslæt.
People taking REZOLSTA may develop a skin rash.
Stevens-Johnsons syndrom #, angioødem,
Stevens-Johnson syndrome
REZOLSTA 800 mg/150 mg filmovertrukne tabletter
REZOLSTA 800 mg/150 mg film-coated tablets
Hos raske frivillige blev den maksimale plasmakoncentration af cobicistat observeret 2-5 timer efter oral administration af REZOLSTA.
Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
De hyppigste alvorlige bivirkninger er akut nyresvigt, myokardieinfarkt, immunrekonstitutionsinflammatorisk syndrom (IRIS), trombocytopeni, osteonekrose, diarré, hepatitis og pyreksi.
The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Samtidig brug af everolimus og REZOLSTA frarådes.
Concomitant use of everolimus and REZOLSTA is not recommended.
Samtidig brug af en HMG-CoAreduktasehæmmer og REZOLSTA øger muligvis plasmakoncentrationen af det lipidsænkende stof, hvilket kan medføre bivirkninger så som myopati.
Concomitant use of a HMG CoA reductase inhibitor and REZOLSTA may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy.
Lægemidler, der inducerer CYP3A-aktivitet, må forventes at øge clearance af darunavir og cobicistat, hvilket kan medføre en lavere plasmakoncentration af darunavir og cobicistat (f.eks. efavirenz, carbamazepin, phenytoin, phenobarbital, rifampicin, rifapentin, rifabutin, perikon) (se pkt.
Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat (e.g. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St John's wort) (see section 4.3 and interaction table below).
Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, antivirale stoffer til behandling af hiv-infektion, kombinationer.
Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR14
Det reproduktive system og mammae ikke almindelig gynækomasti*
Reproductive system and breast disorders Uncommon gynaecomastia*
Der har været rapporter om forhøjet CPK (kreatinkinase), myalgi, myositis og, i sjældne tilfælde, rabdomyolyse i forbindelse med hiv-proteasehæmmere, især i kombination med NRTI'er.
Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for glecaprevir og pibrentasvir.
Based on theoretical considerations REZOLSTA may increase the exposure to glecaprevir and pibrentasvir.
(P-glykoproteinhæmning)
(P-glycoprotein inhibition)
Non-nukleos(t)id-revers-transkriptase-hæmmere (NNRTI'er) mod hiv Efavirenz
HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
En REZOLSTA filmovertrukken tablet, en gang dagligt, i forbindelse med et måltid, kan anvendes til patienter, der tidligere har været eksponeret for antiretrovirale lægemidler, men ikke har mutationer associeret med darunavirresistens (DRV-RAM)*, og som har plasma-hiv-1 RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products, but 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 10
REZOLSTA bør ikke anvendes sammen med præparater eller regimer, der indeholder ritonavir eller cobicistat.
REZOLSTA should not be used concurrently with products or regimens containing ritonavir or cobicistat.
Darunavir indeholder en sulfonamid-del. REZOLSTA skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi.
REZOLSTA should be used with caution in patients with a known sulphonamide allergy.
I modsætning til ritonavir inducerer cobicistat ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller UGT1A1.
Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
REZOLSTA kan coadministreres med protonpumpehæmmere uden dosisjustering.
REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
Da darunavir og cobicistat i høj grad bindes til plasmaproteiner, er det usandsynligt, at disse lægemidler vil blive fjernet i signifikant grad ved hæmodialyse eller peritonealdialyse (se pkt.
As darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Baseret på teoretiske overvejelser forventes REZOLSTA at øge eksponeringen for lomitapid ved co-administration.
Based on theoretical considerations, REZOLSTA is expected to increase the exposure of lomitapide when coadministered.
Primære (major) PImutationer
Primary (major) PI mutations PI RAMs
Hududslæt, eventuelt med kløe, er en almindelig bivirkning i forbindelse med REZOLSTA (ses oftere ved anvendelse sammen med raltegravir).
A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Op til det samme dosisniveau udviste darunavir ingen teratogenicitet administreret alene hos rotter og kaniner eller i kombination med ritonavir hos mus.
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.
Co-administration af REZOLSTA og disse antikoagulantia frarådes.
Co-administration of REZOLSTA and these anticoagulants is not recommended.
Samtidig brug af REZOLSTA og elbasvir/grazoprevir er kontraindiceret (se pkt.
Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Der er kun begrænset erfaring med akut overdosering af REZOLSTA eller darunavir administreret i kombination med cobicistat hos mennesker.
Human experience of acute overdose with REZOLSTA or darunavir in combination with cobicistat is limited.
(CYP3A-hæmning, UGT/SULT-induktion)
(CYP3A inhibition, UGT/SULT induction)
Immunrekonstitutionsinflammatorisk syndrom (IRIS) Hos hiv-patienter med alvorlig immundefekt på tidspunktet for initiering af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske infektioner.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
REZOLSTA kan øge risikoen for, at drospirenon øger kaliumniveauet.
REZOLSTA might increase the risk for elevated potassium levels by drospirenone.
I forbindelse med svangerskabsforebyggelse anbefales det, at du i stedet anvender prævention, der ikke indeholder hormoner.
When used for birth control, alternative methods of non-hormonal contraception are recommended.
Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for grazoprevir.
Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Det er vist, at cobicistat nedsætter den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Darunavir og cobicistat metaboliseres i leveren.
Darunavir and cobicistat are metabolised by the hepatic system.
Baseret på teoretiske overvejelser kan REZOLSTA muligvis øge plasmakoncentrationen af buprenorphin og/eller norbuprenorphin.
Based on theoretical considerations REZOLSTA may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Der blev observeret lav udvikling af resistent hiv-1-virus hos ART-naive patienter, som behandles for første gang med REZOLSTA eller darunavir/ritonavir 800/100 mg en gang dagligt i kombination med et andet antiretroviralt middel, og hos ART-erfarne patienter uden darunavir-RAM, som fik REZOLSTA eller darunavir/ritonavir 800/100 mg en gang dagligt i kombination med et andet antiretroviralt middel.
Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART, and in ART-experienced patients with no darunavir RAMs receiving REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART.
REZOLSTA indeholder: - Aktive stoffer: darunavir og cobicistat.
What REZOLSTA contains - The active substances are darunavir and cobicistat.
Klinisk monitorering anbefales ved co-administration af REZOLSTA og clonazepam.
Clinical monitoring is recommended when co-administering REZOLSTA with clonazepam.
Der foreligger begrænsede data for patienter med andre hiv-1-subtyper end subtype B (se pkt.
Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Kombination af lurasidon, pimozid, quetiapin eller sertindol og REZOLSTA er kontraindiceret (se pkt.
The combination of lurasidone, pimozide, quetiapine or sertindole and REZOLSTA is contraindicated (see section 4.3).
I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation til forskellen i % respons Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter, der afbrød behandlingen i utide, medregnes med en ændring, der tillægges værdien 0
Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Patienter skal informeres om, at hvis en dosis REZOLSTA glemmes i op til 12 timer efter det tidspunkt, hvor den sædvanligvis tages, skal den glemte dosis tages tages sammen med mad hurtigst muligt.
If REZOLSTA is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of REZOLSTA with food as soon as possible.
Der blev vist bioækvivalens mellem REZOLSTA og darunavir/cobicistat 800/150 mg co-administreret som enkelte lægemidler hos ikke-fastende og fastende raske forsøgspersoner.
The bioequivalence between REZOLSTA and darunavir/cobicistat 800/150 mg co-administered as single agents was established under fed and fasted conditions in healthy subjects.
- Fortæl din læge, hvis du har haft nyreproblemer.
- Tell your doctor if you have had problems with your kidneys.
(CYP3A-hæmning og/eller transport)
(CYP3A inhibition and/or transport)
Patienter, der tager REZOLSTA sammen med raltegravir (mod hiv-infektion), kan hyppigere få udslæt end patienter, der kun får det ene af disse lægemidler.
In patients taking REZOLSTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Der foreligger ingen data vedrørende anvendelse af darunavir eller cobicistat til patienter med svært nedsat leverfunktion.
There are no data regarding the use of darunavir or cobicistat in patients with severe hepatic impairment.
Lurasidon Pimozid Sertindol Quetiapin
Lurasidone Pimozide Sertindole Quetiapine
Silicificeret mikrokrystallinsk cellulose Crospovidon
Colloidal silicon dioxide Silicified microcrystalline cellulose Crospovidone
Darunavir binder især til surt α1-glykoprotein i plasma.
Darunavir binds primarily to plasma α1-acid glycoprotein.
Hud og subkutane væv meget almindelig udslæt (herunder makuløst, makulopapuløst, papuløst, erytematøst, kløende udslæt, generaliseret udslæt og allergisk dermatitis)
Skin and subcutaneous tissue disorders Very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Co-administration af REZOLSTA og naloxegol er kontraindiceret.
Co-administration of REZOLSTA and naloxegol is contraindicated.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - allergiske reaktioner såsom kløe - nedsat appetit - unormale drømme - opkastning, mavesmerter eller -udspiling, fordøjelsesbesvær, luft i tarmene - muskelsmerter - træthed - unormale resultater af blodprøver som for eksempel visse undersøgelser af lever eller nyrer; din læge vil forklare dig om dette - svaghed.
Common side effects (may affect up to 1 in 10 people) - allergic reactions such as itching - decreased appetite - abnormal dreams - vomiting, pain or swelling of the belly, indigestion, flatulence - muscle pain - tiredness - abnormal blood test results such as some tests for your liver or kidney.
Dokumentationen for virkningen af REZOLSTA en gang dagligt er baseret på analysen af 48-ugers data fra studiet GS-US-216-130 med ART-naive og ART-erfarne patienter, studiet TMC114FD2HTX3001 med ART-naive patienter og to fase III-studier, ARTEMIS og ODIN, udført med darunavir/ritonavir 800/100 mg dagligt hos henholdsvis ART-naive og ART-erfarne patienter.
The evidence of efficacy of REZOLSTA once daily is based on the analysis of 48 week data from trial GS-US-216-130 in ART-naïve and ART-experienced patients, trial TMC114FD2HTX3001 in ART-naïve patients, and two Phase III trials ARTEMIS and ODIN conducted with darunavir/ritonavir 800/100 mg q.d.
Kombination af colchicin og REZOLSTA er kontraindiceret hos patienter med nedsat nyreeller leverfunktion (se pkt.
The combination of colchicine and REZOLSTA is contraindicated in patients with renal or hepatic impairment (see section 4.3).
I 96-ugers-analysen svarede sikkerhedsprofilen for darunavir/ritonavir 800/100 mg en gang dagligt hos behandlingsnaive patienter til profilen for darunavir/ritonavir 600/100 mg to gange dagligt hos behandlingserfarne patienter med undtagelse af kvalme, der sås hyppigere hos behandlingsnaive patienter.
In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatment-naïve subjects was similar to that seen with darunavir/ritonavir 600/100 mg twice daily in treatment-experienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
I henhold til TLOVR-algoritmen (time to loss of viral response) I henhold til LOCF (last observation carried forward)
Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation
Separate studier med darunavir/ritonavir og cobicistat tyder på, at dosisjustering ikke er nødvendig hos patienter med let (Child-Pugh klasse A) eller moderat (Child-Pugh klasse B) nedsat leverfunktion.
Separate trials of darunavir/ritonavir and cobicistat suggest no dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, REZOLSTA should be used with caution in these patients.
Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Tabletten skal synkes hel for at sikre administration af hele dosen af både darunavir og cobicistat.
To ensure administration of the entire dose of both darunavir and cobicistat, the tablet should be swallowed whole.
Hver tablet indeholder 800 mg darunavir (som ethanolat) og 150 mg cobicistat.
Each tablet contains 800 mg of darunavir (as ethanolate) and 150 mg cobicistat.
(OATP1B- og CYP3A-hæmning)
(OATP1B and CYP3A inhibition)
Bivirkninger med darunavir/cobicistat hos voksne patienter
Adverse reactions with darunavir/cobicistat in adult patients
Emtricitabin/tenofoviralafenamid Tenofoviralafenamid ↔ Tenofovir ↑
Tenofovir alafenamide ↔ Tenofovir ↑
REZOLSTA bør ikke anvendes til behandlingserfarne patienter med en eller flere DRV-RAM hiv-1 RNA ≥ 100.000 kopier/ml eller CD4+-celletal < 100 x 10
REZOLSTA should not be used in treatment-experienced patients with one or more DRV-RAMs or HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
REZOLSTA og antacida kan anvendes samtidig uden dosisjustering.
REZOLSTA and antacids can be used concomitantly without dose adjustment.
REZOLSTA må derfor ikke anvendes til patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
Therefore, REZOLSTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Ved 48-ugers-analysen blev non-inferioritet i virologisk respons over for darunavir/ritonavirbehandlingen, defineret som procentdelen af patienter med plasma-hiv-1 RNA < 50 kopier/ml, påvist (ved den forud definerede 12 % non-inferioritetsgrænse) 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.
Nukleos(t)id-revers-transkriptase-hæmmere (NRTI'er) mod hiv Didanosin
HIV Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine
Co-administration af REZOLSTA og rifabutin og rifapentin frarådes.
Co-administration of REZOLSTA with rifabutin and rifapentine is not recommended.
Hver filmovertrukken tablet indeholder 800 mg darunavir (som ethanolat) og 150 mg cobicistat.
Each film-coated tablet contains 800 mg darunavir (as ethanolate) and 150 mg cobicistat.
Med CD4+celletal < 200 ved baseline Med CD4+celletal ≥ 200 ved baseline Median ændring i CD4+-celletal fra baseline (x 10
With baseline CD4+ cell count ≥ 200 median CD4+ cell count change from baseline (x 10
Co-administration af REZOLSTA og tadalafil til behandling af pulmonal arteriel hypertension frarådes.
Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with REZOLSTA is not recommended.
Der er rapporteret om svimmelhed under behandling med regimer, der indeholder darunavir administreret samtidig med cobicistat, hos nogle patienter.
Dizziness has been reported in some patients during treatment with regimens containing darunavir administered with cobicistat and should be borne in mind when considering a patient's ability to drive or operate machinery.
Lægemidler, der påvirker eksponeringen for darunavir/cobicistat
Medicinal products that affect darunavir/cobicistat exposure
Behandling med REZOLSTA under graviditet fører til lav eksponering for darunavir (se pkt.
Treatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Det forventes ikke, at cobicistat hæmmer CYP1A2, CYP2B6, CYP2C8, CYP2C9 eller CYP2C19, eller at det inducerer CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1 eller P-gp (MDR1).
Cobicistat is not expected to induce CYP1A2, CYP3A4, CYP2C9, CYP2C19, UGT1A1, or P-gp (MDR1).
Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter, der afbrød behandlingen i utide, medregnes med en ændring, der tillægges størrelsen 0.
Non completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Hiv-1 RNA < 50 kopier/ml Med hiv-1 RNA (kopier/ml) ved baseline
HIV-1 RNA < 50 copies/mL With Baseline
Samtidig infektion med hepatitis B og/eller hepatitis C Der var utilstrækkelige farmakokinetiske data i de kliniske studier til at bestemme virkningen af hepatitis B- og/eller C-virusinfektion på darunavirs og cobicistats farmakokinetik (se pkt.
There were insufficient pharmacokinetic data in the clinical trials to determine the effect of hepatitis B and/or C virus infection on the pharmacokinetics of darunavir and cobicistat (refer to sections 4.4 and
Co-administration af domperidon og REZOLSTA er kontraindiceret.
Co-administration of domperidone with REZOLSTA is contraindicated.
Der skal udvises forsigtighed ved samtidig brug af REZOLSTA og PDE-5hæmmere til behandling af erektil dysfunktion.
Concomitant use of PDE-5 inhibitors for the treatment of erectile dysfunction with REZOLSTA should be done with caution.
I henhold til LOCF (last observation carried forward)
Last Observation Carried Forward imputation
Det virologiske respons, defineret som procentdelen af patienter med plasma-hiv-1 RNA < 50 kopier/ml, ved behandling med darunavir/ritonavir 800/100 mg en gang dagligt, viste sig efter 48 uger at være non-inferiørt (ved den forud definerede 12 % grænse for non-inferioritet) 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.
TMC114FD2HTX3001 er et randomiseret, aktivt kontrolleret, dobbeltblindt fase III-studie til vurdering af virkningen og sikkerheden af darunavir/cobicistat/emtricitabin/tenofoviralafenamid kontra fastdosis-kombination af darunavir/cobicistat + emtricitabin/tenofovirdisoproxilfumarat.
Efficacy of darunavir/cobicistat fixed-dose combination 800/150 mg once daily in ART-naïve patients TMC114FD2HTX3001 is a randomized, active-controlled, double blind, Phase III trial to evalate the efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus darunavir/cobicistat fixed-dose combination + emtricitabine/tenofovir disoproxil fumarate.
REZOLSTA og raltegravir kan anvendes uden dosisjusteringer.
REZOLSTA and raltegravir can be used without dose adjustments.
fra baseline ved uge 2 og -9,6 ml/min.
The mean eGFRCG change from baseline was -9.6 mL/min at week 2, and -9.6 mL/min at week 48.
REZOLSTA kan anvendes sammen med disse NRTI-midler uden dosisjustering.
REZOLSTA can be used with these NRTIs without dose adjustment.
REZOLSTA bør ikke anvendes til patienter med en eller flere mutationer associeret med darunavirresistens (DRV-RAM), hiv-1 RNA ≥ 100.000 kopier/ml eller CD4+-celletal < 100 x 10 celler/l (se pkt.
REZOLSTA 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
REZOLSTA 800 mg/150 mg tabletter darunavir/cobicistat
REZOLSTA 800 mg/150 mg tablets darunavir/cobicistat