natgillin/translations-raw huggingface dataset:
Patienterne havde en gennemsnitsalder på 15 år (interval 12 til 17 år), 56 % var kvinder, 12 % var asiater og 88 % var sorte.
Patients had a median age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
En populationsfarmakokinetisk analyse af hiv-inficerede patienter viste, at darunavirs farmakokinetik ikke er væsentligt forskellig i aldersgruppen (18-75 år) vurderet hos hiv-inficerede patienter (N=12, alder ≥ 65 år) (se pkt.
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 years) (see section 4.4).
2 på hinanden følgende hiv-1 RNA ≥ 50 kopier/ml, eller i tilfælde af afbrydelse eller ved uge 48/96 af enhver årsag, (enkelt) hiv-1 RNA ≥ 50 kopier/ml ved baseline (inkluderet)
2 consecutive HIV-1 RNA ≥ 50 copies/mL, or in case of discontinuation or at Week 48/96 for any reason, (single) HIV-1 RNA ≥ 50 copies/mL as of baseline (included)
Virologiske resultater i AMBER ved uge 48 og 96 (FDA-snapshot)
Virologic Outcomes in AMBER at Week 48 and 96 (FDA Snapshot) Week 48
Én filmovertrukket Symtuza-tablet taget én gang dagligt sammen med mad kan anvendes til patienter med tidligere eksponering for antiretrovirale lægemidler, men uden mutationer forbundet med darunavir-resistens (DRV-RAM'er)*, og som har hiv-1 RNA < 100.000 kopier/ml i plasma og CD4+celletal ≥ 100 x 10
One film-coated tablet of Symtuza 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
Tenofoviralafenamid var ikke mutagent eller klastogent i konventionelle genotoksicitetsanalyser.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Blod og lymfesystem almindelig anæmi
Blood and lymphatic system disorders common anaemia
Symtuza og sofosbuvir, sofosbuvir/ledipasvir eller daclatasvir kan anvendes samtidig uden dosisjustering
Symtuza and sofosbuvir, sofosbuvir/ledipasvir, or daclatasvir can be used concomitantly without dose adjustment
• unormale resultater af blodprøver såsom nogle test af dine nyrer.
• abnormal blood test results such as some tests for your kidney.
DRESS (lægemiddelrelateret udslæt med eosinofili og systemiske symptomer) og Stevens-Johnsons syndrom er rapporteret i sjældne tilfælde (< 0,1 %), og efter markedsføringen er toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose blevet rapporteret.
DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Cobicistat er en mekanismebaseret hæmmer af cytochrom P450 i CYP3A-underfamilien.
Cobicistat is a mechanism-based inhibitor of cytochrome P450 of the CYP3A subfamily.
Disse kan omfatte, men er ikke begrænset til, alvorligt udslæt eller udslæt ledsaget af feber, almen utilpashed, træthed, muskel- eller ledsmerter, blæredannelse, mundsår, konjunktivitis, hepatitis og/eller eosinofili.
These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Blandt 1.968 behandlingserfarne patienter, der fik darunavir co-administreret med ritonavir, 600/100 mg to gange dagligt, havde 236 patienter også hepatitis B eller C. Co-inficerede patienter var mere tilbøjelige til at have forhøjede levertransaminaser ved baseline og efter behandlingsstart end patienter uden kronisk viral hepatitis.
Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis.
Baseline-virusbelastning ≤100.000 kopier/ml >100.000 kopier/ml
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
Symtuza bør ikke administreres samtidig med antiretrovirale lægemidler, der kræver farmakokinetisk forstærkning med ritonavir eller cobicistat.
Symtuza should not be administered concomitantly with medicinal products requiring pharmacokinetic enhancement with ritonavir or cobicistat.
• Hvis du har problemer med muskler eller knogler.
• if you notice any muscle or bone problems.
Sikkerheden af emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet blev evalueret hos cirka 70 hiv/HBV co-inficerede patienter, der aktuelt var i behandling for hiv i et åbent klinisk studie (GS-US-292-1249).
The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Darunavir-resistensassocierede mutationer in vivo (V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V og L89V) i hiv-1-protease blev udledt fra data fra kliniske studier af ART-erfarne patienter, som alle var proteasehæmmererfarne.
In vivo, darunavir resistance-associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) in HIV-1 protease were derived from clinical trial data of ART-experienced patients, all of whom were protease inhibitor experienced.
Samtidig brug af everolimus eller irinotecan og Symtuza frarådes.
Concomitant use of everolimus or irinotecan and Symtuza is not recommended.
almindelig pruritus, urticaria ikke almindelig angioødem sjælden eosinofili og systemiske symptomer som reaktion på lægemidlet a, Stevens-Johnsons syndrom ikke kendt toksisk epidermal nekrolyse a, akut generaliseret eksantematøs pustulose
common pruritus, urticaria uncommon angioedema rare drug reaction with eosinophilia and systemic symptoms a, Stevens-Johnson syndrome not known toxic epidermal necrolysis a, acute generalised exanthematous pustulosis
De kan omfatte gulfarvning af huden og det hvide i øjnene, mørk (tefarvet) urin, bleg afføring (tarmbevægelser), kvalme, opkastning, appetitløshed eller smerter, jag eller smerter og ubehag i højre side af kroppen under ribbenene.
These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale-coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Symtuza må ikke tages sammen med et andet antiviralt lægemiddel, der indeholder en forstærker, eller et andet antiviralt lægemiddel, der kræver forstærkning.
Symtuza must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting.
Dabigatran, ticagrelor som hjælp til at standse sammenklumpning af blodplader hos patienter, der tidligere har haft et hjerteanfald
Dabigatran, ticagrelor to help stop the clumping of platelets in the treatment of patients with a history of a heart attack
Lægemiddelinduceret hepatitis (f.eks. akut hepatitis, cytolytisk hepatitis) er blevet rapporteret efter anvendelse af darunavir/ritonavir.
Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Tenofoviralafenamids mediane eliminationshalveringstid var 0,3 timer, når det blev administreret som Symtuza.
The median terminal elimination half-life of tenofovir alafenamide was 0.3 hours when administered as Symtuza.
Klinisk monitorering anbefales ved co-administration af Symtuza og disse sedativa/hypnotika, og det bør overvejes at give en lavere dosis af disse sedativa/hypnotika.
Clinical monitoring is recommended when co-administering Symtuza with these sedatives/hypnotics and a lower dose of the sedative/hypnotic should be considered.
Symtuza kan nedsætte plasmakoncentrationen af boceprevir.
Symtuza may decrease boceprevir plasma concentrations.
• unormale resultater af blodprøver såsom nogle test af din bugspytkirtel.
• abnormal blood test results such as some tests for your pancreas.
Hvis disse antidepressiva skal anvendes sammen med Symtuza, anbefales klinisk monitorering, og det kan være nødvendigt at justere dosis af det pågældende antidepressivum.
If these anti-depressants are to be used with Symtuza clinical monitoring is recommended and a dose adjustment of the anti-depressant may be needed.
Omhyggelig monitorering af patienten og justering af metformindosis anbefales, hvis patienten får Symtuza.
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Symtuza.
Hvid beholder af polyethylen med høj densitet (HDPE) med et silicagel-tørremiddel (i et separat pose eller en separat beholder), med et børnesikret låg af polypropylen (PP) med induktionsforsegling.
White, high density polyethylene (HDPE) bottle with a silica gel desiccant (contained in a separate sachet or canister) fitted with polypropylene (PP) child resistant closure with induction seal.
Det vides ikke, om co-administration af tenofoviralafenamid og xanthinoxidasehæmmere (f.eks. febuxostat) vil øge den systemiske eksponering for tenofovir.
It is not known whether the co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g. febuxostat) would increase systemic exposure to tenofovir.
• darunavir, et hiv-lægemiddel, der kaldes en proteasehæmmer
• darunavir, an anti-HIV medicine known as a protease inhibitor
Der foreligger kun begrænsede oplysninger om denne population, og Symtuza skal derfor anvendes med forsigtighed hos patienter over 65 år (se pkt.
Limited information is available in this population, and, therefore, Symtuza should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Koncentrationen af voriconazol kan øges eller nedsættes ved co-administration med DRV/COBI.
Concentrations of voriconazole may increase or decrease when co-administered with DRV/COBI.
Tenofoviralafenamid er permeabelt i cellerne, og som følge af en øget plasmastabilitet og intracellulær aktivering via hydrolyse af cathepsin A er tenofoviralafenamid mere effektivt end tenofovirdisoproxil til at koncentrere tenofovir i perifere mononukleære blodceller (PBMC'er) (herunder lymfocytter og andre hiv-målceller) og makrofager.
Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil in concentrating tenofovir in peripheral blood mononuclear cells (PBMC) (including lymphocytes and other HIV target cells) and macrophages.
Der er ikke udført tilstrækkelige og velkontrollerede studier med darunavir, cobicistat, emtricitabin, eller tenofoviralafenamid alene eller i kombination hos gravide kvinder.
There are no adequate and well controlled trials with darunavir, cobicistat, emtricitabine, or tenofovir alafenamide, alone or in combination, in pregnant women.
Cobicistat metaboliseres og elimineres primært i leveren.
Cobicistat is primarily metabolised and eliminated by the liver.
Patienten skal informeres om, at der kan forekomme svimmelhed under behandling med Symtuza (se pkt.
Patients should be informed that dizziness may occur when treated with Symtuza (see section 4.8).
En minimal infiltration af histiocytter var til stede i øjet hos hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 15 og 40 gange større, end hvad der forventes efter administration af Symtuza.
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 15 and 40 times greater, respectively, than those expected after administration of Symtuza.
Patienter med hæmofili skal derfor gøres opmærksomme på risikoen for øget blødningstendens.
Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Interaktioner
Interaction
Personer, der tager Symtuza, kan udvikle hududslæt.
People taking Symtuza may develop a skin rash.
Der sås ingen virkninger på parring eller fertilitet hos dyr (se pkt.
There was no effect on mating or fertility in animals (see section 5.3).
Latina Italien
Latina Italy
Der blev udført et åbent fase 2-studie (TMC114-C230) for at evaluere darunavirs farmakokinetik, sikkerhed, tolerabilitet og virkning sammen med lavdosis ritonavir hos 12 ART-naive hiv-1-inficerede pædiatriske patienter i alderen 12 år til under 18 år, og med en vægt på mindst 40 kg.
An open-label, Phase 2 trial (TMC114-C230) was conducted for evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Samtidig brug af Symtuza kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyrebarksuppression.
Concomitant use of Symtuza may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Ved maksimale plasmakoncentrationer var forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blod ca. 1,0, og forholdet mellem gennemsnitlig lægemiddelkoncentration i sæd og plasma var ca. 4,0.
At peak plasma concentration, the mean plasma to blood drug concentration ratio was approximately 1.0 and the mean semen to plasma drug concentration ratio was approximately 4.0.
Ændringer i målinger af nyrefunktion
Changes in measures of renal function
C]-emtricitabin blev hele emtricitabin-dosis genfundet i urin (ca. 86 %) og i fæces (ca. 14 %).
C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (approximately 86%) and faeces (approximately 14%).
Virologisk respons, % Hiv-1 RNA <50 kopier/ml
Virologic Response, % HIV-1 RNA < 50 copies/mL
Cobicistats mediane terminale plasmahalveringstid efter administration af Symtuza er 3,6 timer.
The median terminal plasma half-life of cobicistat following administration of Symtuza is 3.6 hours.
Hiv-1 RNA < 50 kopier/ml CD4+ procentvis middelændring fra baseline CD4+-celletal, gennemsnitlig ændring fra baseline ≥ 1,0 log10 fald fra baseline i plasmavirusbelastning
HIV-1 RNA < 50 copies/mL CD4+ percent median change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Tabel 8 Farmakokinetiske resultater for total-darunavir efter administration af 800/150 mg darunavir/cobicistat en gang dagligt som del af et antiretroviralt regime i andet trimester af graviditeten, tredje trimester af graviditeten og post partum Farmakokinetik for total-darunavir (Gennemsnit ± SD)
Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Der har været rapporter om øget blødningstendens, herunder spontane hudhæmatomer og hæmartrose hos patienter med type A- og B-hæmofili, der blev behandlet med hiv-PI (proteasehæmmere).
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with HIV PIs.
Lipidforstyrrelser skal behandles som klinisk indiceret.
Lipid disorders should be managed as clinically appropriate.
- Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
- Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Der har været rapporter om forhøjet kreatinkinase (CPK), myalgi, myositis og i sjældne tilfælde rabdomyolyse i forbindelse med hiv-proteasehæmmere, især i kombination med NRTI'er.
Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
I tilfælde af samtidig antiretroviral behandling af hepatitis C henvises der desuden til det relevante produktresumé for disse lægemidler.
In case of concomitant antiviral therapy for hepatitis C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Tenofovirs binding in vitro til humane plasmaproteiner er < 0,7 % og uafhængig af koncentrationen i intervallet 0,01-25 μg/ml.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 mcg/mL.
Hvis der er tegn på nyopstået eller forværret leverdysfunktion (herunder klinisk signifikant forhøjede leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørk urin, ømhed ved leveren, hepatomegali) hos patienter, der tager Symtuza, skal det omgående overvejes om behandlingen skal afbrydes midlertidigt eller helt seponeres (se pkt.
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using Symtuza, interruption or discontinuation of treatment should be considered promptly (see section 5.3).
Emtricitabintriphosphat hæmmer hiv-replikationen ved optagelsen i det virale DNA, der medieres af hiv revers-transkriptase (RT), hvilket resulterer i DNA-kædeafslutning.
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Filmovertrækket indeholder polyethylenglycol (macrogol), polyvinylalkohol (delvist hydrolyseret), talcum, titandioxid og jernoxid, gul.
The film-coating contains polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide and yellow ferric oxide.
Cobicistat metaboliseres via CYP3A- (primært) og CYP2D6- (i mindre grad) medieret oxidation og gennemgår ikke glukuronidering.
Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
I det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) blev der rapporteret alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4 % af patienterne.
During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Baseret på teoretiske overvejelser forventes Symtuza at øge eksponeringen for lomitapid ved co-administration.
Based on theoretical considerations, Symtuza is expected to increase the exposure of lomitapide when coadministered.
Det er påvist, at behandling med 800/150 mg darunavir/cobicistat i det andet og tredje trimester fører til lav eksponering for darunavir med en reduktion i værdierne for Cmin på ca. 90 % (se pkt.
Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Baseret på teoretiske overvejelser forventes Symtuza at øge koncentrationen af clonazepam (Hæmning af CYP3A).
Based on theoretical considerations Symtuza is expected to increase concentrations of clonazepam (inhibition of CYP3A)
Dosisjustering af Symtuza er ikke er nødvendig hos patienter med en estimeret glomerulær filtrationshastighed i henhold til Cockcroft-Gault-formlen (eGFRCG) ≥ 30 ml/min.
No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tenofovir, der var mindst fire gange større, end hvad der forventes efter administration af Symtuza.
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Symtuza.
Der foreligger ingen farmakokinetiske data for tenofoviralafenamid hos patienter med eGFRCG <15 ml/min.
There are no pharmacokinetic data on tenofovir alafenamide in patients with eGFRCG < 15 mL/min.
Koncentrationen af disse lægemidler øges muligvis ved co-administration med Symtuza og kan således muligvis resultere i en øget forekomst af de bivirkninger, som normalt er forbundet med disse lægemidler.
Concentrations of these medicinal products may be increased when co-administered with Symtuza resulting in the potential for increased adverse events usually associated with these medicinal products.
Co-administration af Symtuza og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og cobicistat og medføre øgede plasmakoncentrationer af darunavir og cobicistat (f.eks. antimykotiske azoler som clotrimazol).
Co-administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals like clotrimazole).
Darunavir binder primært til α1-glykoproteinsyre i plasma.
Darunavir binds primarily to plasma α1-acid glycoprotein.
Symtuza og antacida kan anvendes samtidig uden dosisjustering.
Symtuza and antacids can be used concomitantly without dose adjustment.
Baseret på stratumjusteret MH-test, hvor stratificeringsfaktorerne er hiv-1 RNA-niveau (≤100.000 eller > 100.000 kopier/ml) og CD4+-celletal (< 200 eller ≥200 celler/µl).
Based on stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and CD4+ cell count (< 200 or ≥ 200 cells/µL).
De i alt 725 patienter havde en gennemsnitsalder på 34 år (interval 18-71), 88,3 % var mænd, 83,2 % hvide, 11,1 % sorte, 1,5 % asiater.
The 725 patients in total had a median age of 34 years (range 18-71), 88.3% were male, 83.2% White, 11.1% Black, 1.5% Asian.
Lægemidler, der inducerer P-gp-aktivitet (f.eks. rifampicin, rifabutin, carbamazepin, phenobarbital) forventes at nedsætte absorptionen af tenofoviralafenamid, hvilket fører til en nedsat plasmakoncentration af tenofoviralafenamid, hvilket kan føre til tab af terapeutisk effekt af tenofoviralafenamid og udvikling af resistens.
Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of tenofovir alafenamide and development of resistance.
Tenofoviralafenamid er et substrat for OATP1B1 og OATP1B3 in vitro.
Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Fase 3-studiet TMC114IFD3013 (EMERALD) evaluerede virkningen af Symtuza hos virologisk supprimerede (hiv-1 RNA under 50 kopier/ml) hiv-1-inficerede patienter.
Phase 3 trial TMC114IFD3013 (EMERALD) evaluated the efficacy of Symtuza in virologicallysuppressed (HIV-1 RNA less than 50 copies/mL) HIV-1 infected patients.
Se produktresuméet for darunavir for yderligere oplysninger.
Consult the Summary of Product Characteristics for darunavir for further details.
Ud over de opportunistiske infektioner kan autoimmune lidelser (når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion på grund af en forbedring af kroppens immunforsvar.
In addition to the opportunistic infections, autoimmune disorders (when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection, due to an improvement in the body's immune response.
(CYP3A-hæmning) Koncentrationen af clarithromycin kan øges efter co-administration med DRV/COBI.
(CYP3A inhibition) Concentrations of clarithromycin may be increased upon co-administration with DRV/COBI.