natgillin/translations-raw huggingface dataset:
Der findes ingen farmakokinetiske data for emtricitabin og tenofoviralafenamid under graviditet.
No pharmacokinetic data are available for emtricitabine and tenofovir alafenamide during pregnancy.
Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Det anbefalede dosisregime til voksne og unge i alderen 12 år og derover, der vejer mindst 40 kg, er én tablet, der tages én gang dagligt sammen med mad.
The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
For tenofoviralafenamid var Cmax 1,82 gange højere i fastende tilstand, mens AUC var 20 % lavere til sammenligning i fastende og ikke-fastende tilstand.
For tenofovir alafenamide, the Cmax was 1.82-fold higher in fasted condition, while the AUC was 20% lower to comparable in a fasted compared to fed condition.
Klinisk monitorering anbefales ved co-administration af Symtuza med perphenazin, risperidon eller thioridazin.
Clinical monitoring is recommended when co-administering Symtuza with perphenazine, risperidone or thioridazine.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after “EXP”.
• cobicistat, der booster (forstærker) virkningen af darunavir
• cobicistat, a booster (enhancer) of darunavir
Co-administration sammen med den moderate CYP3A-inducer efavirenz påvirkede ikke eksponeringen af tenofoviralafenamid signifikant.
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Revers transkriptase
Reverse transcriptase
Den samlede sikkerhedsprofil for Symtuza er baseret på data fra et randomiseret, dobbeltblindet, sammenlignende fase 2-studie, GS-US-299-0102 (N = 103 på darunavir/cobicistat/emtricitabin/tenofoviralafenamid [D/C/F/TAF]), data fra to fase 3-studie TMC114FD2HTX3001 (AMBER, N = 362 på D/C/F/TAF) og TMC114IFD3013 (EMERALD, N = 763 på D/C/F/TAF), og på alle tilgængelige data fra kliniske studier og efter markedsføringen af de enkelte komponenter.
The overall safety profile of Symtuza is based on data from a randomised, double-blinded, comparative Phase 2 trial, GS-US-299-0102 (N = 103 on darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), data from 2 Phase 3 trials TMC114FD2HTX3001 (AMBER, N = 362 on D/C/F/TAF) and TMC114IFD3013 (EMERALD, N = 763 on D/C/F/TAF), and on all available clinical trial and post-marketing data of its components.
Sildenafil til behandling af hjerte- og lungesygdommen der kaldes pulmonal arteriel hypertension.
Sildenafil to treat a heart and lung disorder called pulmonary arterial hypertension.
ALFA-RECEPTORANTAGONISTER Alfusozin
ALPHA ADRENORECEPTOR ANTAGONISTS Alfusozin
I fase 3-studiet TMC114FD2HTX3001med behandlingsnaive patienter, var Symtuza associeret med ingen eller mindre reduktion i knoglemineraldensitet (BMD) sammenlignet med kontrolgruppen (DRV/COBI+F/TDF) målt med DXA-analyse af hofte (least square means-procentændring: 0,17 % vs -2,69 %, p < 0,001) og lændehvirvelsøjlen (least square means procentændring: -0,68 % vs -2,38 %, p =0,004) efter 48 ugers behandling.
In the Phase 3 study TMC114FD2HTX3001in treatment-naïve patients, Symtuza was associated with no or smaller reductions in bone mineral density (BMD) compared DRV/COBI+F/TDF as measured by DXA analysis of hip (LS means percent change: 0.17% vs -2.69%, p < 0.001) and lumbar spine (LS means percent change: -0.68% vs -2.38%, p =0.004) after 48 weeks of treatment.
Medianen for CD4+-celletallet ved baseline var 628 x 10
The median baseline CD4+ cell count was 628 x 10
Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at darunavirs farmakokinetik ikke var signifikant påvirket hos hiv-inficerede patienter med moderat nedsat nyrefunktion (eGFRCG mellem 30 og 60 ml/min, N=20) (se pkt.
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 (eGFRCG between 30-60 mL/min, N = 20) (see sections 4.2 and 4.4).
De virologiske resultater fra uge 48 og 96 i EMERALD-studiet er vist i tabel 6.
Week 48 and 96 virologic outcomes in the EMERALD trial are provided in Table 6.
Over 96 ugers behandling i fase 3-studierne TMC114FD2HTX3001 (AMBER) hos behandlingsnaive patienter og TMC114IFD3013 (EMERALD) hos virologisk supprimerede, behandlingserfarne patienter blev der udført resistenstestning på prøver fra patienter, som oplevede protokoldefineret virologisk svigt (PDVF), og som havde hiv-1 RNA ≥ 400 kopier/ml ved svigtet eller på senere tidspunkter.
Over 96 weeks of treatment in the Phase 3 studies TMC114FD2HTX3001 (AMBER) in treatmentnaïve patients and TMC114IFD3013 (EMERALD) in virologically suppressed treatment-experienced patients, resistance testing was performed on samples from patients experiencing protocol-defined virologic failure (PDVF) and who had HIV-1 RNA ≥400 copies/mL at failure or at later time points.
Symtuza er derfor kontraindiceret til patienter med svært nedsat leverfunktion.
Symtuza is, therefore, contraindicated in patients with severe hepatic impairment.
Hos hivinficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af CART kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Symtuza kan forhøje blodsukkerniveauet.
Symtuza might increase sugar levels in the blood.
Hiv-1-behandlingserfarne patienter
HIV-1 Treatment experienced Patients
Emtricitabins antivirale aktivitet mod laboratorie- og kliniske isolater af hiv-1 blev vurderet i lymfoblastoide cellelinjer, MAGI CCR5-cellelinjen og PBMC'er.
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
Sikkerheden af komponenterne i Symtuza blev imidlertid evalueret i det kliniske studie TMC114-C230 (N=12) for darunavir med ritonavir og GS-US-292-0106 (N=50) for en fastdosiskombination indeholdende elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid.
However,the safety of components of Symtuza was evaluated through the clinical study TMC114-C230 (N = 12) for darunavir with ritonavir and GS-US-292-0106 (N = 50) for a fixed dose combination containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Almene symptomer og reaktioner på administrationsstedet almindelig asteni, træthed
General disorders and administration site conditions common asthenia, fatigue
Der har været rapporter om hyppigere spontane blødninger hos patienter med hæmofili, der fik antiretrovirale proteasehæmmere (se pkt.
There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af hiv-1 og laboratoriestammer af hiv-2 i akut inficerede T-cellelinjer, humane PBMC'er og humane monocytter/makrofager med mediane EC50-værdier i intervallet fra 1,2 til 8,5 nM (0,7 til 5,0 ng/ml).
Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human PBMCs and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Når du er ved at løbe tør for Symtuza, skal du bede om mere fra lægen eller på apoteket.
When your supply of Symtuza starts to run low, get more from your doctor or pharmacist.
Udover disse opportunistiske infektioner kan autoimmune lidelser (en tilstand, der opstår, når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Derfor skal mærkningen af hvert lægemiddel, som administreres sammen med Symtuza, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration.
The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with Symtuza should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
I studie GS-US-292-0106 blev virkningen, sikkerheden og farmakokinetikken af emtricitabin og tenofoviralafenamid evalueret i et åbent studie, i hvilket 50 hiv-1-inficerede behandlingsnaive unge fik emtricitabin og tenofoviralafenamid (10 mg) med elvitegravir og cobicistat som en fastdosiskombinationstablet.
In the study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Hos nogle patienter med fremskreden hiv-infektion, som havde usædvanlige infektioner på grund af et svækket immunforsvar (opportunistiske infektioner), kan tegn og symptomer på betændelse fra tidligere infektioner vise sig kort efter, at du har påbegyndt hiv-behandling.
In some patients with advanced HIV infection and who had unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after you start HIV treatment.
Der findes imidlertid farmakokinetiske data for de forskellige komponenter i Symtuza, der indikerer, at doser på 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabin og 10 mg tenofoviralafenamid resulterer i tilsvarende eksponeringer hos voksne og unge fra alderen 12 år og op, som vejer mindst 40 kg.
However, there are pharmacokinetic data for the different components of Symtuza, indicating that doses of 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide result in similar exposures in adults and adolescents aged 12 years and older, weighing at least 40 kg.
Hiv-1-behandlingsnaive patienter
HIV-1 Treatment naïve Patients
Det er påvist in vitro og in vivo, at nukleosid- og nukleotidanaloger i forskellig grad forårsager skader på mitokondrierne.
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Samtidig brug af en HMG-CoAreduktasehæmmer og Symtuza kan øge plasmakoncentrationen af det lipidsænkende stof, hvilket kan medføre bivirkninger såsom myopati.
Concomitant use of a HMG CoA reductase inhibitor and Symtuza may increase plasma concentrations of the lipid lowering agent, which may lead to adverse reactions such as myopathy.
I fase 2/3-studierne af behandlingsnaive patienter oplevede 12,7 % (59/465) af de patienter, der fik Symtuza, udslæt (af hvilke de fleste var af grad 1), 1,5 % (7/465) af patienterne afbrød behandlingen på grund af udslæt, af hvilke én både havde udslæt og overfølsomhed.
In the Phase 2/3 trials in treatment-naïve patients, 12.7% (59/465) of patients receiving Symtuza experienced rash (most of which were grade 1), 1.5% (7/465) of patients discontinued treatment due to rash, of whom one for rash and hypersensitivity.
Aktive stoffer: darunavir, cobicistat, emtricitabin og tenofoviralafenamid.
The active substances are darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
Samtidig brug af everolimus og Symtuza frarådes.
Concomitant use of everolimus and Symtuza is not recommended.
Et forøsg med farmakokinetikken af cobicistat blev udført hos ikke-hiv-1-inficerede personer med svært nedsat nyrefunktion (eGFRCG under 30 ml/min).
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (eGFRCG below 30 mL/min).
Tenofovirdiphosphat hæmmer hiv-replikationen ved optagelsen i det virale DNA, der medieres af hiv-RT, hvilket resulterer i DNA-kædeafslutning.
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Co-administration of tadalafil til behandling af pulmonal arteriel hypertension med Symtuza frarådes.
Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with Symtuza is not recommended.
Co-administration af tenofoviralafenamid med andre lægemidler, som hæmmer P-gp (f.eks. cobicistat, ritonavir, ciclosporin), forventes at øge absorptionen og plasmakoncentrationen af tenofoviralafenamid.
Co-administration of tenofovir alafenamide with other medicinal products that inhibit P-gp (e.g., cobicistat, ritonavir, ciclosporin) are expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Kontakt altid lægen, når du får udslæt.
Please contact your doctor whenever you develop a rash.
Symtuza bør ikke anvendes til pædiatriske patienter under 3 år på grund af problemstillinger vedrørende sikkerhed (se pkt.
Symtuza should not be used in paediatric patients below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, har en øget risiko for alvorlige og potentielt dødelige leverbivirkninger.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
De selekterede vira kunne ikke vokse ved tilstedeværelse af darunavir-koncentrationer over 400 nM. Vira, der blev selekteret under disse betingelser, og som viste nedsat følsomhed over for darunavir (interval: 23-50 fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet.
Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Co-administration af Symtuza og disse antikoagulantia frarådes.
Co-administration of Symtuza and these anticoagulants is not recommended.
Vægtøgning og forhøjede lipider og glucose i blodet kan forekomme under antiretroviral behandling.
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Patienter med eksisterende leverdysfunktion, herunder kronisk hepatitis B eller C, har en øget risiko for leverfunktionsanomalier, herunder alvorlige og potentielt dødelige leverbivirkninger.
Patients with pre-existing liver dysfunction, including chronic hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Krydsresistens hos hiv-1-inficerede, behandlingsnaive og virologisk supprimerede patienter
Cross-resistance in HIV-1 infected, treatment-naïve and virologically suppressed patients
Hos hiv-inficerede patienter med svær immundefekt på tidspunktet for initiering af 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 CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for tenofoviralafenamid eller tenofovir hos raske personer og hos patienter med svært nedsat nyrefunktion (eGFRCG > 15 men < 30 ml/min) i studier af tenofoviralafenamid.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (eGFRCG > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
Alternativ eller yderligere prævention anbefales ved coadministration af østrogenbaseret prævention med Symtuza.
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are coadministered with Symtuza.
De hyppigst indrapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlactatæmi, hyperlipasæmi).
The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Symtuza kan co-administreres med protonpumpehæmmere uden dosisjustering.
Symtuza can be co-administered with proton pump inhibitors without dose adjustments.
FDA-snapshot-resultater Hiv-1 RNA <50 kopier/ml Virologisk svigt
FDA Snapshot Outcome HIV-1 RNA < 50 copies/mL Virologic Failure
Klinisk monitorering af terapeutisk virkning og bivirkninger anbefales, når disse lægemidler administreres samtidigt med Symtuza.
Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with Symtuza.
(CYP3A-hæmning) Co-administration af ciclosporin forventes at øge plasmakoncentrationen af tenofoviralafenamid.
(CYP3A inhibition) Co-administration of ciclosporin is expected to increase plasma concentrations of tenofovir alafenamide.
Hvis en dosis Symtuza glemmes i op til 12 timer efter det tidspunkt, hvor den sædvanligvis tages, skal patienterne informeres om snarest muligt at tage den ordinerede dosis Symtuza sammen med mad.
If a dose of Symtuza is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of Symtuza with food as soon as possible.
I det dobbeltblindede fase-3-studie TMC114FD2HTX3001 (AMBER) blev behandlingsnaive patienter randomiseret til at få enten Symtuza (N = 362) eller en kombination af en fastdosis-kombination af darunavir og cobicistat og en fastdosis-kombination af emtricitabin og tenofovirdisoproxilfumarat (F/TDF) (N = 363) en gang dagligt.
In double-blind Phase 3 Trial TMC114FD2HTX3001 (AMBER), treatment-naïve patients were randomised to receive either Symtuza (N = 362) or a combination of fixed-dose combination of darunavir and cobicistat and fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (F/TDF) (N = 363) once daily.
Virologiske resultater ved uge 48 og 96 i EMERALD-studiet Uge 48
Week 48 and 96 Virologic Outcomes in EMERALD Trial Week 48
Behandling med Symtuza bør derfor ikke påbegyndes under graviditet, og kvinder, som bliver gravide under behandling med Symtuza, bør skiftes til et alternativt regime (se pkt.
Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see sections 4.2 and 4.4).
Da Symtuza indeholder darunavir, cobicistat, emtricitabin og tenofoviralafenamid, kan der forventes de samme bivirkninger som dem, der er forbundet med de enkelte stoffer.
As Symtuza contains darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, the adverse reactions associated with each of the individual compounds may be expected.
Behandling med 800/150 mg darunavir/cobicistat en gang dagligt under graviditet fører til lav eksponering for darunavir (se tabel 8).
Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure (see Table 8).
6 celler/l).
6 cells/L),
Patienterne havde en medianalder på 46 år (interval 19-78), 82 % var mænd, 75,5 % hvide, 20,9 % sorte og 2,3 % asiater.
Patients had a median age of 46 years (range 19-78), 82% were male, 75.5% White, 20.9% Black, and 2.3% Asian.
Der er ikke udført interaktionsstudier med Symtuza.
No drug interaction trials have been performed using Symtuza.
De hyppigst rapporterede bivirkninger (> 5 %) hos supprimerede, behandlingserfarne patienter (EMERALD-studiet TMC114IFD3013, uge 96-analyse) var diarré (10,5 %), hovedpine (10,4 %), artralgi (7,7 %), abdominalsmerter (7,5 %), træthed (5,9 %) og udslæt (5,1 %).
The most frequent (> 5%) adverse reactions reported in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013, Week 96 analysis) were diarrhoea (10.5%), headache (10.4%), arthralgia (7.7%), abdominal pain (7.5%), fatigue (5.9%), and rash (5.1%).
Forsigtighed tilrådes, og monitorering af den terapeutiske koncentration anbefales om muligt, når disse antiarytmika administreres samtidig med Symtuza.
Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with Symtuza.
Symtuza 800 mg/150 mg/200 mg/10 mg filmovertrukne tabletter
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets
Metabolisme og ernæring almindelig diabetes mellitus, anoreksi, hyperkolesterolæmi, forhøjet LDL-kolesterol, hypertriglyceridæmi, hyperlipidæmi, dyslipidæmi ikke almindelig hyperglykæmi
Metabolism and nutrition disorders common diabetes mellitus, anorexia, hypercholesterolaemia, low density lipoprotein increased, hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia uncommon hyperglycaemia
I fase 3-studiet hos supprimerede, behandlingserfarne patienter (EMERALD-studiet TMC114IFD3013) oplevede 5,1 % (39/763) af de patienter, der fik Symtuza, udslæt (af hvilke de fleste var af grad 1), ingen afbrød behandlingen på grund af udslæt.
In the Phase 3 trial in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013), 5.1% (39/763) of patients receiving Symtuza experienced rash (most of which were grade 1), none discontinued treatment due to rash.
Gennemsnitligt baseline plasma hiv-1 RNA og medianen for CD4+-celletal ved baseline var henholdsvis 4,48 log10 kopier/ml (SD = 0,61) og 453 x 10
The mean baseline plasma HIV-1 RNA and the median baseline CD4+ cell count were 4.48 log10 copies/mL (SD = 0.61) and 453 x 10
I forbindelse med svangerskabsforebyggelse anbefales det, at du anvender prævention, der ikke indeholder hormoner.
When used for birth control, non-hormonal contraception methods are recommended.
Co-administration af Symtuza og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt.
Therefore, co-administration of Symtuza and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
• muskelsmerter, muskelkramper eller muskelsvaghed
• muscle pain, muscle cramps or weakness
HMG-CO-A-REDUKTASEHÆMMERE Atorvastatin
HMG CO-A REDUCTASE INHIBITORS Atorvastatin
Ny resistens hos hiv 1-inficerede, behandlingsnaive og virologisk supprimerede patienter
Emerging resistance in HIV-1 infected, treatment-naïve and virologically suppressed patients
(lægemiddel)overfølsomhed ikke almindelig immunrekonstitutionsinflammatorisk syndrom
(drug) hypersensitivity uncommon immune reconstitution inflammatory syndrome
Darunavir er en CYP3A-hæmmer, en svag CYP2D6-hæmmer og en P-gp-hæmmer.
Darunavir is an inhibitor of CYP3A, a weak inhibitor of CYP2D6 and an inhibitor of P-gp.
Gul til gullig-brun kapselformet, filmovertrukket tablet, hvor der står „8121“ på den ene side og „JG“ på den anden side.
What Symtuza looks like and contents of the pack Yellow to yellowish-brown capsule shaped film-coated tablet, mentioning “8121” on one side and “JG” on the other side.
Afbrydelse af behandlingen med Symtuza hos patienter med samtidig hiv- og HBV-infektion kan føre til alvorlig, akut forværring af hepatitis.
Discontinuation of Symtuza therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.