natgillin/translations-raw huggingface dataset:
72 (55, 0%) 18 (14, 5%)
72 (55.0%) 18 (14.5%) 40.4%
HIV RNA < 50 kopier/ mlc a
HIV RNA < 50 copies/mlc a
59 (45, 0%) 14 (11, 3%)
59 (45.0%)
Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter der afbrød behandlingen i utide medregnes med en ændring, der tillægges størrelsen 0. b Tilregning af LOCF (sidste udførte observation). c Tilregninger i henhold til TLOVR- algoritmen (time to loss of viral response). d 95% konfidensintervaller.
Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0 b Last Observation Carried Forward imputation c Imputations according to the TLOVR algorithm d 95% confidence intervals.
Dataanalyser gennem 96 ugers behandling i de tre POWER- forsøg påviste vedvarende antiretroviral effekt og immunologisk fordel.
Analyses of data through 96 weeks of treatment in the three POWER trials demonstrated sustained antiretroviral efficacy and immunological benefit.
Behandling med PREZISTA, co- administreret med ritonavir (600/ 100 mg x 2), resulterede i 56, 5% (POWER 1og 2) og 52, 2% (POWER 3) respondenter med et fald på mindst 1 log10 i HIV RNA fra baseline, 38, 9% (POWER 1 og 2) og 42, 1% (POWER 3) forsøgspersoner med et HIV RNA- niveau < 50 kopier/ ml og henholdsvis 49, 6% (POWER 1 og 2) og 50, 0% (POWER 3) forsøgspersoner med et HIV RNA- niveau på under 400 kopier/ ml.
Treatment with PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) resulted in 56.5% (POWER 1 and 2) and 52.2% (POWER 3) of responders with a decrease of at least 1 log10 in HIV RNA from baseline, 38.9% (POWER 1 and 2) and 42.1% (POWER 3) of subjects with an HIV RNA level < 50 copies/ml and 49.6% (POWER 1 and 2) and 50.0% (POWER 3) respectively of subjects with an HIV RNA level less than 400 copies/ml.
Det gennemsnitlige fald i HIV RNA- niveau sammenlignet med baseline var 1, 58 (POWER 1 og 2) og 1, 43 (POWER 3) log10 kopier/ ml og, der blev observeret en gennemsnitlig stigning i CD4+ celletal på 133 x 106 celler/ l (POWER 1 og 2) og 103 x 106 celler/ l (POWER 3).
The mean decrease in HIV RNA level compared to baseline was 1.58 (POWER 1 and 2) and 1.43 (POWER 3) log10 copies/ml and a mean increase in CD4+ cell count of 133 x 106 cells/l (POWER 1 and 2) and 103 x 106 cells/l (POWER 3) was observed.
Af de 206 forsøgspersoner, der responderede med komplet virologisk suppression (< 50 kopier/ ml) ved uge 48, var 177 forsøgspersoner (86% af de responderende i uge 48) fortsat responderende i uge 96.
Out of the 206 subjects who responded with complete viral suppression (< 50 copies/ml) at week 48, 177 subjects (86% of the responders at week 48) remained responders at week 96.
18 Genotype og fænotype ved baseline og virologisk udfald I en pooled analyse af grupperne, der modtog 600/ 100 mg x 2, fra POWER - og DUET- forsøgene var tilstedeværelsen ved baseline af mindst 3 af mutationerne V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V or L89V forbundet med et reduceret virologisk respons over for PREZISTA co- administreret med 100 mg ritonavir.
Baseline genotype or phenotype and virologic outcome In a pooled analysis of the 600/100 mg b.i.d. groups of the POWER and DUET trials, the presence at baseline of 3 or more of mutations V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V was associated with a decreased virologic response to PREZISTA co-administered with 100 mg ritonavir.
Tilstedeværelsen af disse individuelle mutationer var forbundet med en median på 13 til 15 PI- resistensforbundne mutationer på IAS- USA- listen over mutationer.
The presence of these individual mutations was associated with a median of 13 to 15 PI resistance associated mutations of the IAS-USA list of mutations.
Der blev fundet tre eller flere af disse mutationer hos kun 4% af patienterne ved baseline i forsøget med tidlig behandlingserfarne patienter (TITAN).
In early treatment-experienced patients (TITAN) three or more of these mutations were only found in 4% of the patients at baseline.
Respons( HIV- 1 RNA < 50 kopier/ ml ved uge 24) over for PREZISTA co- administreret med ritonavir (600/ 100 mg x 2) efter genotype ved baseline * og efter brug af enfuvirtid (ENF):
Response (HIV-1 RNA < 50 copies/ml at week 24) to PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) by baseline genotype* and by use of enfuvirtide (ENF):
POWER - og DUET - forsøgene analyseres som behandlet.
As treated analysis of the POWER and DUET trials.
Antal mutationer ved baseline *
Number of mutations at baseline*
Alle forsøgspersoner
All subjects% n/N
Forsøgspersoner, som ikke bruger eller, som er non- behandlingsnaive over for brug af ENF
Subjects with no/non-naïve use of ENF% n/N
Forsøgspersoner, som er behandlingsnaive over for brug af ENF
Subjects with naïve use of ENF% n/N
45% 455/ 1. 014
45% 455/1,014
* Antal mutationer fra listen af mutationer assicieret med et formindsket respons over for PREZISTA/ ritonavir (V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V eller L89V)
* Number of mutations from the list of mutations associated with a diminished response to PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V)
Darunavir- fænotype ved baseline (ændring i følsomhed i forhold til reference) blev vist at være en indikator for virologisk udfald.
Baseline darunavir phenotype (shift in susceptibility relative to reference) was shown to be a predictive factor of virologic outcome.
Respons over for PREZISTA co- administreret med ritonavir (600/ 100 mg x 2) efter darunavir - fænotype ved baseline *:
Response (HIV-1 RNA < 50 copies/ml at week 24) to PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) by baseline darunavir phenotype and by use of enfuvirtide:
POWER 1, 2, 3 analyseres som behandlet.
As treated analysis of the POWER and DUET trials.
Darunavir- fænotype ved baseline
18 Baseline darunavir phenotype
De farmakokinetiske egenskaber af darunavir co- administreret med ritonavir er blevet vurderet hos raske, voksne, frivillige forsøgspersoner og hos HIV- 1- inficerede patienter.
The pharmacokinetic properties of darunavir, co-administered with ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients.
Eksponeringen for
Exposure to darunavir was higher in HIV-1 infected patients than in healthy subjects.
Den øgede eksponering for darunavir hos HIV- 1- inficerede patienter sammenlignet med raske forsøgspersoner kan muligvis forklares ved de højere koncentrationer af α1- syre glycoprotein (AAG) hos HIV- 1 - inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma- AAG og derfor i højere plasmakoncentrationer.
The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of alpha-1-acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Absorption Darunavir blev hurtigt optaget efter peroral administration.
Absorption Darunavir was rapidly absorbed following oral administration.
Den maksimale plasmakoncentration for darunavir ved tilstedeværelse af lavdosis ritonavir opnås generelt inden for 2, 5- 4, 0 timer.
Maximum plasma concentration of darunavir in the presence of low dose ritonavir is generally achieved within 2.5-4.0 hours.
82% ved tilstedeværelse af 100 mg ritonavir x 2.
The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg b.i.d. ritonavir.
14- fold stigning i den systemiske eksponering for darunavir ved administration af en peroral enkeltdosis darunavir på 600 mg i kombination med ritonavir 100 mg x 2 (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 b.i.d.
95%.
Distribution Darunavir is approximately 95% bound to plasma protein.
Darunavir binder sig især til plasma α1- syre glycoprotein.
Darunavir binds primarily to plasma alpha-1-acid glycoprotein.
Efter intravenøs administration var distributionsvolumen for darunavir administreret alene 88, 1 ± 59, 0 l (gennemsnit ± SD) og steg til 131 ± 49, 9 l (gennemsnit ± SD) ved tilstedeværelse af 100 mg ritonavir to gange dagligt.
Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Metabolisme In vitro- forsøg med humane levermikrosomer (HLM’ er) tyder på, at darunavir primært gennemgår oxidativ metabolisme.
Metabolism In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Darunavir metaboliseres i udstrakt grad via det hepatiske CYP- system og næsten udelukkende via isozym- CYP3A4.
Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Et 14C- darunavir- forsøg med raske, frivillige forsøgspersoner viste, at størstedelen af radioaktiviteten i plasma efter en enkeltdosis darunavir med ritonavir på 400/ 100 mg skyldtes det aktive moderstof.
A 14C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
De viste alle aktivitet, der var mindst 10 gange mindre end aktiviteten af darunavir over for vildtype HIV.
At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Elimination Efter en 14C- darunavir med ritonavir- dosis på 400/ 100 mg kunne 79, 5% og 13, 9% af den administrerede dosis af 14C- darunavir genfindes i henholdsvis fæces og urin.
Elimination After a 400/100 mg 14C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of 14C-darunavir could be retrieved in faeces and urine, respectively.
41, 2% og 7, 7% af den administrerede dosis i henholdsvis fæces og urin.
Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine,
Den terminale halveringstid for darunavir var ca.
19 respectively.
15 timer, når det blev givet med ritonavir.
The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Den intravenøse clearance af darunavir alene (150 mg) og ved tilstedeværelse af lavdosis ritonavir var henholdsvis 32, 8 l/ t og 5, 9 l/ t.
The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Særlige populationer Pædiatriske patienter Der foreligger ingen farmakokinetiske data for børn og unge.
Special Populations Paediatrics There are no pharmacokinetic data available in children and adolescents.
Ældre patienter 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.
Elderly 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).
Køn En populationsfarmakokinetisk analyse viste en lidt højere eksponering for darunavir (16, 8%) hos HIV- inficerede kvinder i forhold til mænd.
Gender Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV infected females compared to males.
7, 7% af den administrerede dosis darunavir udskilles uomdannet i urinen.
Renal impairment Results from a mass balance study with 14C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
4. 2 og 4. 4).
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Nedsat leverfunktion Darunavir metaboliseres og elimineres især i leveren.
Hepatic impairment Darunavir is primarily metabolised and eliminated by the liver.
I et flerdosisforsøg med PREZISTA, co- administreret med ritonavir, 600/ 100 mg to gange dagligt, blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med mild (Child- Pugh klasse A, n=8) og moderat (Child- Pugh klasse B, n=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
In a multiple dose study with PREZISTA co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (Child-Pugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
55% (Child- Pugh klasse A) og 100% (Child- Pugh klasse B) højere.
However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
4. 2, 4. 3 og 4. 4).
The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4.2, 4.3 and 4.4).
Der er blevet udført toksikologiske dyreforsøg ved eksponeringer op til kliniske eksponeringsniveauer med darunavir administreret alene til mus, rotter og hunde og i kombination med ritonavir til rotter og hunde.
Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs.
I toksikologiforsøg med gentagne doser til mus, rotter og hunde var der kun begrænset virkning af behandling med darunavir.
In repe ated-dose toxicology studies in mice, rats and dogs, there were only limited effects of treatment with darunavir.
I forsøget med rotter faldt antallet af corpora lutea og implantationssteder ved tilstedeværelse af maternel toksicitet.
In a study conducted in rats, the number of corpora lutea and implantations were decreased in the presence of maternal toxicity.
Ellers var der ingen virkninger på parring eller fertilitet ved darunavirbehandling op til 1. 000 mg/ kg/ dag og eksponeringsniveauer under det humane niveau ved den klinisk anbefalede dosis (½ AUC).
Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Op til det samme dosisniveau var der ingen teratogenicitet med darunavir administreret alene hos rotter og kaniner og heller ikke hos mus, når de blev behandlet i kombination med ritonavir.
The
Eksponeringsniveauerne var lavere end ved den anbefalede kliniske dosis til mennesker.
20 exposure levels were lower than those with the recommended clinical dose in humans.
I en vurdering af præ - og postnatal udvikling hos rotter medførte darunavir med og uden ritonavir en forbigående reduktion i vægtstigning hos afkommet inden fravænning, og åbning af øjne og ører skete lidt senere end normalt.
In a pre- and postnatal development assessment in rats, darunavir with and without ritonavir, caused a transient reduction in body weight gain of the offspring pre-weaning and there was a slight delay in the opening of eyes and ears.
Disse virkninger kan være sekundære til hvalpenes eksponering for det aktive stof via mælken og/ eller maternel toksicitet.
These effects may be secondary to pup exposure to the active substance via the milk and/or maternal toxicity.
Hos unge rotter, der fik darunavir indtil dag 23- 26, blev der observeret øget mortalitet med krampeanfald hos nogle dyr.
In juvenile rats receiving darunavir up to days 23-26, increased mortality was observed with convulsions in some animals.
Eksponeringen i plasma, lever og hjerne var betydeligt højere end hos voksne rotter efter sammenlignelige doser i mg/ kg ved en alder på mellem 5 og 11 dage.
Exposure in plasma, liver and brain was considerably higher than in adult rats after comparable doses in mg/kg between days 5 and 11 of age.
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.
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.
21 Hos mennesker nærmer aktiviteten af de lægemiddelmetaboliserende enzymer sig værdierne for voksne omkring en alder på 1 til 3 år.
In humans, the activity of drug-metabolising enzymes approaches adult values by 1 to 3 years of age.
Darunavir er blevet vurderet for carcinogent potentiale ved peroral tvangsfodring af mus og rotter i op til 104 uger.
Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Daglige doser på 150, 450 og 1. 000 mg/ kg blev administreret til mus, og doser på 50, 150 og 500 mg/ kg blev administreret til rotter.
Daily doses of 150, 450 and 1,000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats.
Dosisrelaterede stigninger i incidencen af hepatocellulære adenomer og carcinomer blev observeret hos både hanner og hunner af begge arter.
Dose-related increases in the incidences of hepatocellular adenomas and carcinomas were observed in males and females of both species.
Administration af darunavir forårsagede ikke en statistisk signifikant stigning i incidencen af andre benigne eller maligne neoplasmer hos mus eller rotter.
Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Ved de højeste af de testede doser var den systemiske eksponering (baseret på AUC) for darunavir mellem 0, 4 - og 0, 7- fold (mus) og 0, 7 - og 1- fold (rotter), sammenlignet med den, der blev observeret hos mennesker ved de anbefalede terapeutiske doser.
At the highest tested doses, the systemic exposures (based on AUC) to darunavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Darunavir var ikke mutagent eller genotoksisk i et sæt in vitro - og in vivo- analyser, herunder bakteriel revers mutation (Ames), kromosomafvigelse i humane lymfocytter og in vivo mikronukleustest hos mus.
Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Tabletkerne Mikrokrystallinsk cellulose Kolloidal vandfrit silica Crospovidon Magnesium stearat
Tablet core Microcrystalline cellulose Colloidal anhydrous silica Crospovidone Magnesium stearate
Filmovertræk Poly( vinyl alkohol) – delvist hydrolyseret Macrogol 3350 Titanium dioxid (E171) Talkum Sunset yellow FCF (E110)
Tablet film-coat Poly(vinyl alcohol) – partially hydrolyzed Macrogol 3350 Titanium dioxide (E171) Talc Sunset yellow FCF (E110)
6. 3 Opbevaringstid
21 6.3 Shelf life
Plastikglas af polyetylen med høj densitet (HDPE), der indeholder 120 tabletter, og som har børnesikret lukkeanordning af polypropylen (PP).
High density polyethylene (HDPE) plastic bottle containing 120 tablets, fitted with polypropylene (PP) child resistant closure.
22 Et glas.
One bottle
12. februar 2007 Dato for seneste fornyelse:
12 February 2007 Date of latest renewal:
12. februar 2008
12 February 2008
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Hver tablet indeholder 0, 834 mg Sunset yellow FCF (E110).
Each tablet contains 0.834 mg sunset yellow FCF (E110).
Lys orange, oval tablet med "400MG" præget på den ene side og "TMC" præget på den anden side.
Light orange oval shaped tablet, debossed with “400MG” on one side and “TMC” on the other side.
PREZISTA 400 mg, administreret sammen med lavdosis ritonavir, er indiceret i kombination med andre antiretrovirale lægemidler til behandling af human immundefekt virus (HIV- 1) - infektion i antiretroviral behandling (ART) hos behandlingsnaive voksne.
PREZISTA 400 mg, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART) naïve adults.
Voksne ART- behandlingsnaive patienter Den anbefalede dosis af PREZISTA er 800 mg én gang dagligt (x 1) indtaget sammen med ritonavir 100 mg.
Adults ART-naïve patients The recommended dosage of PREZISTA is 800 mg once daily (q.d.) taken with ritonavir 100 mg q.d. and with food.
Patienterne skal gøres opmærksom på, at tage PREZISTA sammen med lavdosis ritonavir inden for 30 minutter efter, at et måltid er afsluttet.
Patients should be instructed to take PREZISTA with low dose ritonavir within 30 minutes after completion of a meal.
ART- behandlingserfarne patienter Se venligst doseringsanbefalingerne til ART- behandlingserfarne patienter i produktresuméerne for PREZISTA 300 mg og 600 mg tabletter.
ART-experienced patients For dosage recommendations in ART-experienced patients see the Summary of Product Characteristics for PREZISTA 300 mg and 600 mg tablets.
Patienter skal rådegives til ikke at ændre doseringen eller ophøre med behandlingen uden samråd med deres læge efter, at behandlingen med PREZISTA er påbegyndt.
After therapy with PREZISTA has been initiated, patients should be advised not to alter the dosage or discontinue therapy without instruction of their physician.
Børn og unge PREZISTA bør ikke anvendes til børn og unge, da der ikke foreligger tilstrækkelig data om sikkerhed, virkning og farmakokinetik.
Children and adolescents PREZISTA is not recommended for use in children and adolescents because due to insufficient data on safety, efficacy and pharmacokinetics.
4. 4 og 5. 2).
23 Limited information is available in this population and therefore PREZISTA should be used with caution in this age group (see sections 4.4 and 5.2).
Nedsat leverfunktion
Hepatic impairment Darunavir is metabolised by the hepatic system.
4. 4 og 5. 2).
Renal impairment No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Hvis en patient bliver opmærksom på, at en daglig dosis 800/ 100 mg PREZISTA / ritonavir er blevet glemt inden for 12 timer efter det tidspunkt, hvor den normalt tages, skal patienten instrueres i at tage den ordinerede dosis PREZISTA og ritonavir med mad så hurtigt som muligt.
If an 800/100 mg once daily dose of PREZISTA/ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible.
24 timer.
This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 24 hours.
4. 5).
The combination product lopinavir/ritonavir should not be used with PREZISTA because co-administration causes large decreases in darunavir concentrations, which may in turn significantly decrease the darunavir therapeutic effect (see section 4.5).
4. 5).
Herbal preparations containing St John’s wort (Hypericum perforatum) must not be used while taking PREZISTA due to the risk of decreased plasma concentrations and reduced clinical effects of darunavir (see section 4.5).