natgillin/translations-raw huggingface dataset:
Immunsystemet almindelig lægemiddeloverfølsomhed ikke almindelig immunreaktiveringssyndrom
Immune system disorders common drug hypersensitivity uncommon immune reconstitution syndrome
400 mg en gang dagligt didanosin
Didanosine 400 mg once daily didanosine
Tabel 9: Farmakokinetiske resultater for total-etravirin efter administration af 200 mg etravirin to gange dagligt som del af et antiretroviralt regime i andet og tredje trimester af graviditeten og post partum.
Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
I fase III-forsøgene DUET-1 og DUET-2 var de mutationer, som oftest blev udviklet hos patienter med virologisk svigt over for etravirin-regimet V108I, V179F, V179I, Y181C og Y181I, som normalt opstod sammen med flere andre NNRTI-resistensassocierede mutationer (RAM).
In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the etravirine containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
INTELENCE indeholder lactose
INTELENCE contains lactose
Median hiv-1 RNA i plasma ved baseline var 3,9 log10 kopier/ml, og mediant CD4-celletal var 385 x 10
The median baseline plasma HIV-1 RNA was 3.9 log10 copies/ml, and the median baseline CD4 cell count was 385 x 10
40 mg en gang dagligt atorvastatin
40 mg once daily atorvastatin
HMG-COA-REDUKTASEHÆMMERE Atorvastatin
HMG CO-A REDUCTASE INHIBITORS Atorvastatin
Dolutegravir + darunavir/ritonavir 50 mg en gang dagligt + 600/100 mg to gange dagligt
Dolutegravir + darunavir/ritonavir 50 mg once daily + 600/100 mg twice daily
Opbevar INTELENCE-tabletterne i den originale beholder og hold beholderen tæt tillukket for at beskytte mod fugt.
INTELENCE tablets should be stored in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Luftveje, thorax og mediastinum almindelig anstrengelsesdyspnø ikke almindelig bronkospasme
Respiratory, thoracic and mediastinal disorders common exertional dyspnoea uncommon bronchospasm
I et forsøg med rotter var der ingen effekt på parring eller fertilitet ved eksponeringsniveauer svarende til eksponeringsniveauer hos mennesker ved den klinisk anbefalede dosis.
In a study conducted in rats, there were no effects on mating or fertility at exposure levels equivalent to those in humans at the clinically recommended dose.
INTELENCE 25 mg tabletter INTELENCE 100 mg tabletter INTELENCE 200 mg tabletter
INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets
Østrogen- og/eller progesteronbaserede antikonceptiva og INTELENCE kan gives i kombination uden dosisjustering.
The combination of oestrogen- and/or progesterone-based contraceptives and INTELENCE can be used without dose adjustment.
I et forsøg blev otte patienter med let nedsat leverfunktion (Child-Pugh-klasse A) sammenlignet med otte matchede kontrolforsøgspersoner, og otte patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) blev sammenlignet med otte matchede kontrolforsøgspersoner ved gentagne doseringer.
In a study comparing 8 patients with mild (Child-Pugh Class A) hepatic impairment to 8 matched controls and 8 patients with moderate (Child-Pugh Class B) hepatic impairment to 8 matched controls, the multiple dose pharmacokinetic disposition of etravirine was not altered in patients with mild to moderate hepatic impairment.
For at definere sikkerheden for fostret skal såvel dyredata som kliniske erfaringer hos gravide kvinder som hovedregel tages i betragtning, når det besluttes at anvende antiretrovirale lægemidler til behandling af hiv-infektion hos gravide og dermed reducere risikoen for vertikal transmission af hiv til den nyfødte.
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women, and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Almene symptomer og reaktioner på administrationsstedet almindelig træthed ikke almindelig sløvhed
General disorders and administration site conditions common fatigue uncommon sluggishness
Samtidig administration med elbasvir/grazoprevir (se pkt.
Co-administration with elbasvir/grazoprevir (see section 4.5).
≥ 25 til < 30 kg
≥ 25 to < 30 kg
TMC125-C213 6 til < 12 år ETR N = 41
TMC125-C213 6 to < 12 years ETR N = 41
Opbevar i den originale beholder og hold beholderen tæt tillukket for at beskytte mod fugt.
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.
81,2-86,4 % af den indgivne dosis fandtes uforandret i fæces.
Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
≥ 20 til < 25 kg
≥ 20 to < 25 kg
Yderligere oplysninger om interaktioner med lægemidler findes i pkt.
For further information on interactions with medicinal products see section 4.5.
Placebogrupper N = 569
Placebo arms N = 569
Clarithromycineksponeringen blev reduceret af etravirin, men koncentrationen af den aktive metabolit,
Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Nedsat nyrefunktion Der kræves ingen dosisjustering til patienter med nedsat nyrefunktion (se pkt.
Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
EXP Må ikke anvendes senere end 6 uger efter første åbning af beholderen.
EXP Do not use after 6 weeks of first opening the bottle.
EXP Må ikke anvendes senere end 8 uger efter første åbning af beholderen.
EXP Do not use after 8 weeks of first opening the bottle.
20 mg en gang dagligt paroxetin
20 mg once daily paroxetine
Udslæt var for det meste selvbegrænsende og forsvandt generelt inden for 1 til 2 uger med fortsat behandling (se pkt.
Rash was mostly self-limiting, and generally resolved within 1-2 weeks on continued therapy (see section 4.4).
ØSTROGENBASEREDE ANTIKONCEPTIVA Ethinyløstradiol
OESTROGEN-BASED CONTRACEPTIVES Ethinylestradiol
Lægemidler, som påvirkes af etravirin
Medicinal products that are affected by the use of etravirine
- Fortæl det til lægen, hvis du har eller har haft leverproblemer, herunder hepatitis B og/eller C (leverbetændelse).
- Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take INTELENCE.
Hvis en patient glemmer at tage INTELENCE og kommer i tanke om dette inden for 6 timer efter det tidspunkt, hvor patienten skulle have taget lægemidlet, skal patienten tage den pågældende dosis efter et måltid så hurtigt som muligt og dernæst tage den følgende dosis på det sædvanlige tidspunkt.
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time.
Lidocain (systemisk) Mexiletin
Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Samtidig indgift af etravirin og efavirenz eller nevirapin kan forårsage signifikant reduktion i plasmakoncentrationen af etravirin og tab af terapeutisk virkning af etravirin.
Concomitant use of etravirine with efavirenz or nevirapine may cause a significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of etravirine.
Samtidig indgift af etravirin og indinavir kan forårsage signifikant reduktion i plasmakoncentrationen af indinavir og tab af den terapeutiske virkning af indinavir.
Concomitant use of etravirine with indinavir may cause a significant decrease in the plasma concentration of indinavir and loss of therapeutic effect of indinavir.
Analyse af genotype eller fænotype og virologisk resultat ved baseline I DUET-1 og DUET-2 var forekomsten ved baseline af tre eller flere af følgende mutationer: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A og G190S (etravirin-resistensassocierede mutationer) forbundet med nedsat virologisk respons på etravirin (se tabel 5).
Baseline genotype or phenotype and virologic outcome analyses In DUET-1 and DUET-2, the presence at baseline of 3 or more of the following mutations: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A and G190S, (etravirine RAMs) was associated with a decreased virologic response to etravirine (see table 5).
40 mg en gang dagligt etravirin
40 mg once daily etravirine
Hvis du kaster op mere end 4 timer efter, at du har taget INTELENCE, behøver du ikke at tage en ny dosis, før det er tid til at tage den næste planlagte dosis.
If you vomit more than 4 hours after taking INTELENCE, then you do not need to take another dose until your regularly scheduled dose.
Øjne almindelig sløret syn
Eye disorders common blurred vision
Der kræves yderligere data for at vurdere indflydelsen fra K103N i forbindelse med mutationer ved andre NNRTI'er.
Furthermore, the presence of this mutation alone did not affect the response in the etravirine arm. Additional data is required to conclude on the influence of K103N when associated with other NNRTIs mutations.
Anbefalinger vedrørende samtidig indgift
Recommendations concerning co-administration
Behandlingserfarne pædiatriske patienter (i alderen 6 år til yngre end 18 år) PIANO er et fase II-forsøg med en enkelt gruppe til evaluering af farmakokinetik, sikkerhed, tolerabilitet og virkning af etravirin hos 101 antiretroviralt behandlingserfarne pædiatriske patienter med hiv-1-infektion i alderen 6 år til yngre end 18 år og med en legemsvægt på mindst 16 kg. I studiet indgik patienter, der var i stabil antiretroviral behandling, men med virologisk svigt, og som havde en bekræftet viral load i plasma på ≥ 500 hiv-1 RNA kopier/ml.
Treatment-experienced paediatric patients (6 years to less than 18 years of age) PIANO is a single-arm, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of etravirine in 101 antiretroviral treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age and weighing at least 16 kg.
- Øvrige indholdsstoffer: hypromellose, silificeret mikrokrystallinsk cellulose, mikrokrystallinsk cellulose, kolloid vandfri silica, croscarmellosenatrium og magnesiumstearat.
- The other ingredients are hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.
TMC125-C213 12 til < 18 år ETR N = 60
TMC125-C213 12 to < 18 years ETR N = 60
Det frarådes at indgive tipranavir/ritonavir samtidig med INTELENCE (se pkt.
It is not recommended to co-administer tipranavir/ritonavir and INTELENCE (see section 4.4).
Cmax ↔ 0,91 (0,58-1,42) etravirin
Cmax ↔ 0.91 (0.58-1.42) etravirine
150 mg to gange dagligt etravirin
150 mg twice daily etravirine
200 mg etravirin to gange dagligt post partum N = 10
Etravirine 200 mg twice daily postpartum N = 10
Der rapporteredes hyppigere udslæt hos kvindelige forsøgspersoner end hos mandlige (udslæt ≥ grad 2 forekom hos 13/64 [20,3 %] kvinder versus 2/37 [5,4 %] mænd.
Rash was reported more frequently in female subjects than in male subjects (rash ≥ grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males) (see section 4.4).
Lovastatin, rosuvastatin og simvastatin er CYP3A4-substrater, og samtidig indgift med etravirin kan reducere plasmakoncentrationen af HMG-CoA-reduktasehæmmeren.
Lovastatin, rosuvastatin and simvastatin are CYP3A4 substrates and co-administration with etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor.
INTELENCE kan anvendes sammen med disse NRTImidler uden dosisjustering.
INTELENCE can be used with these NRTIs without dose adjustment.
P-værdi = 0,0006 for gennemsnitlig ændring i CD4-celletal.
P-value < 0.0001 for mean decrease in HIV-1 RNA; P-value = 0.0006 for mean change in CD4 cell count.
Et studie, der evaluerede etravirin (200 mg to gange dagligt) i kombination med andre antiretrovirale lægemidler hos 15 gravide kvinder i andet og tredje trimester af graviditeten samt post partum, viste, at eksponering for total-etravirin generelt var højere under graviditet i forhold til post partum.
Etravirine (200 mg twice daily), evaluated in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, demonstrated that exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure (see section 5.2).
Etravirin forventes at øge plasmakoncentrationen af diazepam.
Etravirine is expected to increase plasma concentrations of diazepam.
Hos nogle patienter med fremskreden hiv-infektion, som tidligere har haft opportunistiske infektioner (dvs. infektioner, som raske mennesker er modstandsdygtige over for, og som kun angriber mennesker med nedsat immunforsvar), kan tegn og symptomer på betændelse fra tidligere infektioner vise sig straks efter påbegyndelse af hiv-behandling.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Tipranavir/ritonavir 500/200 mg to gange dagligt tipranavir
Tipranavir/ritonavir 500/200 mg twice daily tipranavir
Nedsat virologisk respons over for etravirin blev observeret hos patienter med virusstammer med tre eller flere af følgende mutationer: V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V og G190A/S (se pkt.
A decreased virologic response to etravirine was observed in patients with viral strains harbouring 3 or more among the following mutations V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, and G190A/S (see section 5.1).
Alle områder
All ranges
Cmax ↓ 0,55 (0,40-0,75) N-desmetylsildenafil AUC ↓ 0,59 (0,52-0,68) Cmin ND
Cmax ↓ 0.55 (0.40-0.75) N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) Cmin ND
Der anbefales ingen dosisjustering til patienter med let eller moderat nedsat leverfunktion (Child-Pugh-klasse A eller B).
No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic impairment.
Kombinationen af INTELENCE og ribavirin kan anvendes uden dosisjusteringer.
The combination of INTELENCE and ribavirin can be used without dose adjustments.
I alt de novo ENF
Overall de novo ENF
INTELENCE anbefales derfor ikke til patienter med svært nedsat leverfunktion (se pkt.
Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Dexamethason forventes at reducere plasmakoncentrationen af etravirin.
Dexamethasone is expected to decrease plasma concentrations of etravirine
INTELENCE og darunavir/ritonavir kan anvendes uden dosisjustering (se også pkt.
INTELENCE and darunavir/ritonavir can be used without dose adjustments (see also section 5.1).
I de fleste tilfælde var udslættet let til moderat, makulopapulært og optrådte i den anden uge af behandlingen.
Most often, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy.
- Fortæl det til lægen, hvis du får udslæt.
- Tell your doctor if you develop a rash.
TMC125-C213 6 til < 18 år ETR N = 101
TMC125-C213 6 to < 18 years ETR N = 101
Rifampicin og rifapentin forventes at reducere plasmakoncentration af etravirin.
Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.
2 år
During the 2
Dolutegravir + Lopinavir/ritonavir 50 mg en gang dagligt + 400/100 mg to gange dagligt dolutegravir AUC ↓ 0,29 (0,26-0,34) Cmin ↓ 0,12 (0,09-0,16) Cmax ↓ 0,48 (0,43-0,54) etravirin
Dolutegravir + Lopinavir/ritonavir 50 mg once daily + 400/100 mg twice daily dolutegravir AUC ↓ 0.29 (0.26-0.34) Cmin ↓ 0.12 (0.09-0.16) Cmax ↓ 0.48 (0.43-0.54) etravirine
INTELENCE og disse antimykotika kan anvendes uden dosisjustering.
INTELENCE and these antifungals can be used without dose adjustments.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder mindre end 1 mmol (23 mg) natrium og er i det væsentlige natriumfri.
Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Der er rapporteret udslæt ved brug af etravirin.
Rash has been reported with etravirine.
Darunavir/ritonavir 600/100 mg to gange dagligt darunavir
Darunavir/ritonavir 600/100 mg twice daily darunavir
INTELENCE kan anvendes sammen med protonpumpehæmmere uden dosisjustering.
INTELENCE can be co-administered with proton pump inhibitors without dose adjustments.
Hypromellose Mikrokrystallinsk cellulose Kolloid vandfri silica Croscarmellosenatrium Magnesiumstearat Lactosemonohydrat
Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate
Clarithromycin 500 mg to gange dagligt clarithromycin AUC ↓ 0,61 (0,53-0,69) Cmin ↓ 0,47 (0,38-0,57) Cmax ↓ 0,66 (0,57-0,77) 14-OH-clarithromycin AUC ↑ 1,21 (1,05-1,39) Cmin ↔ 1,05 (0,90-1,22) Cmax ↑ 1,33 (1,13-1,56) etravirin
Clarithromycin 500 mg twice daily clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
Hvis patienten kaster op mere end 4 timer efter at have indtaget lægemidlet, skal vedkommende ikke tage en ny dosis, før det er tid til at tage den næste planlagte dosis.
If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
Udslættet var for det meste selvbegrænsende og forsvandt generelt i løbet af 1 uge, hvis behandlingen fortsattes.
Rash was mostly self-limiting and generally resolved within 1 week on continued therapy.
Samtidig indgift af etravirin og lægemidler, der hæmmer CYP3A4, CYP2C9 eller CYP2C19, kan reducere clearance af etravirin og øge plasmakoncentrationen af etravirin.
Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Det reproduktive system og mammae ikke almindelig gynækomasti
Reproductive system and breast disorders uncommon gynaecomastia
INTELENCE og tenofovir kan anvendes uden dosisjustering.
INTELENCE and tenofovir can be used without dose adjustments.
Der er rapporteret svære kutane bivirkninger ved etravirin.
Severe cutaneous adverse reactions have been reported with etravirine.
INTELENCE kan anvendes sammen med paroxetin uden dosisjustering.
INTELENCE can be co-administered with paroxetine without dose adjustments.
Må ikke anvendes senere end 8 uger efter første åbning af beholderen.
Do not use after 8 weeks of first opening the bottle.
- Øvrige indholdsstoffer: hypromellose, mikrokrystallinsk cellulose, kolloid vandfri silica,
- The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
INTELENCE er ikke undersøgt til patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) og bør derfor ikke anvendes (se pkt.
INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and is therefore not recommended (see sections 4.2 and 4.4).
Det kan være nødvendigt at reducere dosis af amprenavir/ritonavir og fosamprenavir/ritonavir ved indgift samtidig med INTELENCE.
Amprenavir/ritonavir and fosamprenavir/ritonavir may require dose reduction when co-administered with INTELENCE.
Tabletter Ovale, hvide eller offwhite tabletter præget med "T125" på den ene side og "100" på den anden side.
Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side.
INTELENCE og azithromycin kan anvendes uden dosisjustering.
INTELENCE and azithromycin can be used without dose adjustments.
Må ikke anvendes senere end 6 uger efter første åbning af beholderen.
Do not use after 6 weeks of first opening the bottle.
R(-) metadon AUC ↔ 1,06 (0,99-1,13) Cmin ↔ 1,10 (1,02-1,19) Cmax ↔ 1,02 (0,96-1,09) S(+) metadon AUC ↔ 0,89 (0,82-0,96) Cmin ↔ 0,89 (0,81-0,98) Cmax ↔ 0,89 (0,83-0,97) etravirin
R(-) methadone AUC ↔ 1.06 (0.99-1.13) Cmin ↔ 1.10 (1.02-1.19) Cmax ↔ 1.02 (0.96-1.09) S(+) methadone AUC ↔ 0.89 (0.82-0.96) Cmin ↔ 0.89 (0.81-0.98) Cmax ↔ 0.89 (0.83-0.97) etravirine
Mave-tarm-kanalen meget almindelig diaré, kvalme almindelig gastroøsofageal refluks, opkastning, abdominalsmerter, abdominal distension, flatulens, gastritis, obstipation, mundtørhed, stomatitis, forhøjet lipase, forhøjet amylase i blodet ikke almindelig pankreatitis, hæmatemese, kløgning
Gastrointestinal very common diarrhoea, nausea disorders common gastrooesophageal reflux disease, vomiting, abdominal pain, abdominal distension, flatulence, gastritis, constipation, dry mouth, stomatitis, lipase increased, blood amylase increased uncommon pancreatitis, haematemesis, retching Hepatobiliary disorders common increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST) uncommon hepatitis, hepatic steatosis, cytolytic hepatitis, hepatomegaly
Boostede hiv-proteasehæmmere med cobicistat Atazanavir/cobicistat
HIV PIs - Boosted with cobicistat Atazanavir/cobicistat Darunavir/cobicistat
INTELENCE 25 mg tabletter
INTELENCE 25 mg tablets
Lægen vil kontrollere dit blod - fluconazol, itraconazol, ketoconazol, posaconazol, voriconazol (til behandling af svampeinfektioner) - clarithromycin, rifabutin (antibiotika) - artemether/lumefantrin (malariamiddel) - diazepam (til behandling af søvnforstyrrelser og/eller angst) - dexamethason (et steroid, som bruges til behandling af mange forskellige tilstande, f.eks.
Your doctor will have to check your blood - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections) - clarithromycin, rifabutin (antibiotics) - artemether/lumefantrine (a medicine to treat malaria) - diazepam (medicines to treat trouble with sleeping and/or anxiety) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) - boceprevir (a medicine to treat hepatitis C infection) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines) - cyclosporine, sirolimus, tacrolimus (immunosuppressants - medicines used to dampen down your immune system) - sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension) - clopidogrel (a medicine to prevent blood clots).
Derimod kan der forventes en øget rifabutineksponering, især for 25-O-desacetylrifabutin.
Based on historical data, a decrease in etravirine exposure may be expected whereas an increase in rifabutin exposure and especially in 25-O-desacetyl-rifabutin may be expected.
INTELENCE og raltegravir kan anvendes uden dosisjustering.
INTELENCE and raltegravir can be used without dose adjustments.
Samtidig indgift af etravirin og rilpivirin kan forårsage nedsat rilpivirin-plasmakoncentration og manglende terapeutisk virkning af rilpivirin.
Concomitant use of etravirine with rilpivirine may cause a decrease in the plasma concentration of rilpivirine and loss of therapeutic effect of rilpivirine.
Udslættet var for det meste selvbegrænsende og forsvandt generelt i løbet af 1-2 uger, hvis behandlingen fortsattes.
Rash was mostly self-limiting and generally resolved within 1 to 2 weeks on continued therapy.
1 mg en gang dagligt ethinyløstradiol AUC ↑ 1,22 (1,13-1,31) Cmin ↔ 1,09 (1,01-1,18) Cmax ↑ 1,33 (1,21-1,46) norethindron AUC ↔ 0,95 (0,90-0,99) Cmin ↓ 0,78 (0,68-0,90) Cmax ↔ 1,05 (0,98-1,12) etravirin
1 mg once daily ethinylestradiol AUC ↑ 1.22 (1.13-1.31) Cmin ↔ 1.09 (1.01-1.18) Cmax ↑ 1.33 (1.21-1.46) norethindrone AUC ↔ 0.95 (0.90-0.99) Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine