natgillin/translations-raw huggingface dataset:
Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af køn for hverken atazanavir eller cobicistat.
No clinically relevant pharmacokinetic differences due to gender have been identified for atazanavir or cobicistat.
Tag ikke EVOTAZ: hvis du er allergisk over for atazanavir, cobicistat eller et af de øvrige indholdsstoffer i EVOTAZ (angivet i afsnit 6)
Do not take EVOTAZ: if you are allergic to atazanavir, cobicistat or any of the other ingredients of this medicine (listed in section 6) if you have moderate to severe liver problems if you are taking any of these medicines: see also Other medicines and EVOTAZ
Der er anden medicin, som du ikke må tage samtidig med EVOTAZ eller som skal indgives på anden vis, når de tages samtidigt med EVOTAZ.
There are other medicines that may not be taken together or may require a change in their mode of administration when taken with EVOTAZ.
Eftersom atazanavir er et af indholdsstofferne i EVOTAZ, frarådes samtidig administration af EVOTAZ og nevirapin eller efavirenz (se pkt.
Because atazanavir is a component of EVOTAZ, co-administration of EVOTAZ with nevirapine or efavirenz is not recommended (see section 4.5).
EVOTAZ forventes at øge simeprevir plasmakoncentrationerne.
EVOTAZ is expected to increase simeprevir plasma concentrations.
EVOTAZ må ikke anvendes til patienter med moderat til svært nedsat leverfunktion (se pkt.
EVOTAZ must not be used in patients with moderate to severe hepatic impairment (see section 4.3).
EVOTAZ frarådes til samtidig administration med etravirin, da det kan medføre tab af terapeutisk effekt og udvikling af resistens over for atazanavir.
EVOTAZ is not recommended for co-administration with etravirine because it may result in the loss of therapeutic effect and development of resistance to atazanavir.
Cobicistat er en svag CYP2D6-hæmmer og metaboliseres i mindre grad af CYP2D6.
Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Samtidig administration af EVOTAZ og lægemidler, som er moderat til svage CYP3A-induktorer kan resultere i nedsat plasmakoncentration af atazanavir og/eller cobicistat, hvilket medfører tab af terapeutisk effekt og mulig udvikling af resistens over for atazanavir.
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Samtidig administration med EVOTAZ kan medføre øget koncentration af PDE5-hæmmeren og øget antal bivirkninger relateret til PDE5-hæmmeren.
Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5 inhibitor-associated adverse events.
Disse lægemidler omfatter alfuzosin, amiodaron, astemizol, bepridil, cisaprid, colchicin, dronedaron, ergotaminderivater (f.eks. dihydroergotamin, ergometrin, ergotamin, methylergonovin), lovastatin, oralt administreret midazolam, pimozid, quetiapin, quinidin, lurasidon, simvastatin, sildenafil (når det anvendes til behandling af pulmonal arteriel hypertension), avanafil, systemisk lidocain, ticagrelor, terfenadin og triazolam.
These medicinal products include alfuzosin, amiodarone, astemizole, bepridil, cisapride, colchicine, dronedarone, ergot deriviatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine), lovastatin, orally administered midazolam, pimozide, quetiapine, quinidine, lurasidone, simvastatin, sildenafil (when used to treat pulmonary arterial hypertension), avanafil, systemic lidocaine, ticagrelor, terfenadine and triazolam.
Midazolam og triazolam metaboliseres i udstrakt grad af CYP3A4.
Midazolam and triazolam are extensively metabolized by CYP3A4.
Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg enkeltdosis* (atazanavir 300 mg med ritonavir 100 mg 1 gang dagligt)
Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg single dose* (atazanavir 300 mg with ritonavir 100 mg once daily)
Samtidig administration af atorvastatin og EVOTAZ frarådes.
Co-administration of atorvastatin with EVOTAZ is not recommended.
Samtidig administration af EVOTAZ og en protonpumpehæmmer frarådes.
Co-administration of EVOTAZ with proton pump inhibitors is not recommended.
Samtidig administration af EVOTAZ med produkter indeholdende grazoprevir inklusive elbasvir/grazoprevir i fastdosiskombination (bruges til behandling af kronisk hepatitis C infektion) er kontraindiceret på grund af stigning i plasmakoncentrationerne af grazoprevir og elbasvir og den mulige forøgelse i risiko for ALAT-stigninger som er associeret med stigning i grazoprevirkoncentrationer (se pkt.
Co-administration of EVOTAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with the increase in grazoprevir concentrations (see section 4.3 and Table 1).
Der er ikke udført interaktionsstudier med EVOTAZ.
Drug interaction trials were not conducted for EVOTAZ.
Samtidig behandling med EVOTAZ og regimer indeholdende voxilaprevir frarådes.
Coadministration of EVOTAZ with voxilaprevir-containing regimens is not recommended.
Koncentrationen af dabigatran kan være påvirket ved samtidig administration af EVOTAZ.
Concentrations of dabigatran may be affected upon co-administration with EVOTAZ.
Atazanavir, som er et stof i EVOTAZ, udskilles i modermælken hos mennesker.
Atazanavir, a component of EVOTAZ is excreted in human milk.
Filmovertræk hypromellose (hydroxypropylmethylcellulose, E464) titandioxid (E171) talcum (E553b) triacetin (E1518) rød jernoxid (E172)
Film-coating hypromellose (hydroxypropyl methyl cellulose, E464) titanium dioxide (E171) talc (E553b) triacetin (E1518) red iron oxide (E172)
Behandling med EVOTAZ bør ikke påbegyndes hos patienter med kreatininclearance under 70 ml/min, hvis et eventuelt samtidigt administreret præparat (f.eks. emtricitabin, lamivudin, tenofovirdisoproxil eller adefovir) kræver dosisjustering baseret på kreatininclearance (se pkt.
EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if any co-administered agent (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Interaktionsmekanismen er nedsat opløselighed af atazanavir pga. intragastrisk pH-stigning med H2-blokkere.
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers.
Samtidig administration af EVOTAZ har potentiale til at øge plasmakoncentrationerne af warfarin.
Co-administration with EVOTAZ has the potential to increase warfarin plasma concentrations.
Maksimumkoncentration af digoxin øges ved samtidig administration af cobicistat.
The peak concentration of digoxin is increased when co-administered with cobicistat.
Famotidin 20 mg to gange dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt) hos hiv-inficerede patienter
Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) in HIV-infected patients
Betydningen af nedsat leverfunktion for farmakokinetikken for atazanavir sammen med cobicistat er ikke undersøgt.
The effects of hepatic impairment on the pharmacokinetics of atazanavir given with cobicistat have not been studied.
Interaktionsmekanismen er cobicistats CYP2D6-hæmning.
The mechanism of interaction is inhibition of CYP2D6 by cobicistat.
Samtidig administration af EVOTAZ og nevirapin frarådes og kan medføre tab af EVOTAZ's terapeutiske effekt og udvikling af resistens over for atazanavir.
Co-administration of EVOTAZ and nevirapine is not recommended and may result in a loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir.
Rifabutin 150 mg hver anden dag/elvitegravir 150 mg 1 gang dagligt/cobicistat 150 mg 1 gang dagligt
Rifabutin 150 mg every other day/elvitegravir 150 mg once daily/cobicistat 150 mg once daily
Der foreligger ingen data for atazanavirs og cobicistats kombinerede farmakokinetik hos pædiatriske patienter.
No data are available on the pharmacokinetics of atazanavir and cobicistat in combination in paediatric patients.
Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af etnisk oprindelse for hverken atazanavir eller cobicistat.
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for atazanavir or cobicistat.
Cobicistat er et CYP3A-substrat og metaboliseres i mindre grad af CYP2D6.
Cobicistat is a CYP3A substrate and is metabolised to a minor extent by CYP2D6.
Klinisk signifikante interaktioner mellem EVOTAZ og CYP1A2-, CYP2B6-, CYP2C9- eller CYP2C19-substrater forventes ikke.
Clinically significant interactions between EVOTAZ and substrates of CYP1A2, CYP2B6, CYP2C9 or CYP2C19 are not expected.
Du må ikke tage sildenafil sammen med EVOTAZ, hvis sildenafil anvendes til behandling af pulmonal arteriel hypertension (for højt blodtryk i lungernes blodkar).
Do not take sildenafil with EVOTAZ when sildenafil is used for the treatment of pulmonary arterial hypertension.
Kombinationen af rifampicin og EVOTAZ er kontraindiceret (se pkt.
The combination of rifampicin and EVOTAZ is contraindicated (see section 4.3).
Samtidig brug af EVOTAZ og lægemidler, der er kraftige CYP3A-induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin og prikbladet perikon [Hypericum perforatum]) kan resultere i nedsatte plasmakoncentrationer af atazanavir og/eller cobicistat, hvilket medfører tab af terapeutisk effekt og mulig udvikling af resistens over for atazanavir (se pkt.
Co-administration of EVOTAZ with medicinal products that are strong inducers of CYP3A (such as carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort [Hypericum perforatum]) may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir (see section 4.3 and Table 1).
Patienter med blødersygdom (hæmofili A eller B) kan få øget blødning.
People who already have type A or B haemophilia may notice increased bleeding.
Samtidig administration af EVOTAZ og elbasvir/grazoprevir er kontraindiceret på grund af en forventet stigning i plasmakoncentrationerne for grazoprevir og den associerede potentielle forøgelse i risiko for ALAT-stigninger (se pkt.
Co-administration of EVOTAZ and elbasvir/grazoprevir is contraindicated because of the expected increase in grazoprevir plasma concentrations and the associated potential increase in the risk of ALT elevations (see section 4.3).
EVOTAZ forventes at øge rilpivirin plasmakoncentrationerne.
EVOTAZ is expected to increase rilpivirine plasma concentrations.
Almindelige (kan forekomme hos op til 1 ud af 10 personer) øget appetit, smagsforstyrrelse, tør mund hovedpine, svimmelhed søvnbesvær, unormale drømme, døsighed (træthed) opkastning, diarre, mavesmerter, fordøjelsesbesvær, oppustethed, afgang af tarmluft (flatulens) forhøjede niveauer af bilirubin i blodet (hyperbilirubinæmi) udslæt voldsom træthed
Common (may affect up to 1 in 10 people) increased appetite, dysgeusia (impairment of the sense of taste), dry mouth headache, dizziness insomnia (difficulty sleeping), abnormal dreams, somnolence (sleepiness) vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), dyspepsia (indigestion), bloated or distended tummy (abdomen), flatulence (wind) hyperbilirubinaemia (increased levels of bilirubin in the blood) rash fatigue (extreme tiredness)
Samtidig administration af tenofovir DF og cobicistat forventes at øge plasmakoncentrationerne af tenofovir.
Co-administration of tenofovir DF with cobicistat is expected to increase tenofovir plasma concentrations.
Amiodaron Dronedaron Quinidin
Amiodarone Dronedarone Quinidine Systemic lidocaine
Samtidig administration af EVOTAZ og disse antiepileptika er kontraindiceret (se pkt.
Co-administration of EVOTAZ and these antiepileptics is contraindicated (see section 4.3).
4.3 og 4.5), da plasmakoncentrationer af atazanavir reduceres på grund af induktion af CYP3A4, og derudover kan reducerede plasmakoncentrationer af cobicistat medføre plasmaniveauer af cobicistat, som er utilstrækkelige til at opnå fornøden farmakoforstærkning af atazanavir.
Co-administration of EVOTAZ and medicinal products that induce CYP3A4 is contraindicated or not recommended (see sections 4.3 and 4.5) because, in addition to decreased plasma concentrations of atazanavir due to induction of CYP3A4, decreased plasma concentrations of cobicistat could result in cobicistat plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir.
Se produktresuméet for cobicistat for yderligere oplysninger.
For more information consult the cobicistat Summary of Product Characteristics.
(atazanavir 300 mg 1 gang dagligt og cobicistat 150 mg 1 gang dagligt)
(atazanavir 300 mg once daily with cobicistat 150 mg once daily)
4.5) sildenafil - når det anvendes til behandling af pulmonal arteriel hypertension (se pkt.
Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE
Specific dosing recommendations are not
Cobicistat, som er et af indholdsstofferne i EVOTAZ, reducerer den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin.
Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Cobicistat er en kraftig mekanisme-baseret CYP3A-hæmmer og et CYP3A-substrat.
Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
I modsætning til ritonavir er cobicistat ikke en CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19eller UGT1A1-induktor.
Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
KARDIOVASKULÆRE MIDLER
CARDIOVASCULAR AGENTS
Sådan skal du tage EVOTAZ
How to take EVOTAZ
Efavirenz 600 mg som enkeltdosis (cobicistat 150 mg 1 gang dagligt)
Efavirenz 600 mg single dose (cobicistat 150 mg once daily)
På grund af risiko for både overførsel af hiv samt risiko for alvorlige bivirkninger hos ammede spædbørn, bør mødre informeres om ikke at amme, hvis de får EVOTAZ.
Studies in animals have been shown excretion of cobicistat/metabolites in milk Because of both the potential for HIV transmission and the potential for serious adverse reactions in breast-feeding infants, women should be instructed not to breast-feed if they are receiving EVOTAZ.
Drospirenon/ethinylestradiol 3 mg/0,02 mg enkeltdosis (atazanavir 300 mg 1 gang dagligt med cobicistat 150 mg 1 gang dagligt)
Drospirenone/ethinyloestradiol 3 mg/0.02 mg single dose (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Dosisjustering er ikke nødvendig ved samtidig administration af methadon og EVOTAZ.
No dosage adjustment is necessary if methadone is co-administered with EVOTAZ.
Da atazanavir er et af indholdsstofferne i EVOTAZ, frarådes kombinationen af EVOTAZ og atorvastatin (se pkt.
Because atazanavir is a component of EVOTAZ, the combination of EVOTAZ with atorvastatin is not recommended (see section 4.5).
Samtidig administration af EVOTAZ og lægemidler, der hæmmer CYP3A kan resultere i øget plasmakoncentration af atazanavir og/eller cobicistat.
Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may result in increased plasma concentration of atazanavir and/or cobicistat.
Samtidig administration af EVOTAZ med glecaprevir/pibrentasvir i fastdosiskombination er kontraindiceret på grund af den potentielle forøgelse i risiko for ALAT-stigninger grundet en signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir (se pkt.
Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 300 mg atazanavir (som sulfat) og 150 mg cobicistat.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg of atazanavir (as sulphate) and 150 mg of cobicistat.
Samtidig administration af EVOTAZ og protonpumpehæmmere (PPI'er) frarådes på grund af nedsat opløselighed af atazanavir, da den intragastriske pH stiger med protonpumpehæmmere (se pkt.
Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs (see section 4.5).
Cobicistat har vist sig at nedsætte estimeret kreatininclearance på grund af hæmningen af tubulær kreatininudskillelse.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Der er ikke set signifikant påvirkning af methadon-koncentrationen ved samtidig administration af atazanavir.
No significant effect on methadone concentrations was observed when co-administered with atazanavir.
Samtidig behandling med EVOTAZ og andre proteasehæmmere frarådes.
Co-administration of EVOTAZ with other protease inhibitors is not recommended.
CYP3A4-substrater eller UGT1A1-isoformen af UDP-glucuronyltransferase og som har et smalt terapeutisk vindue: alfuzosin (alpha-1-adrenoreceptor antagonist) amiodaron, bepridil, dronedaron, quinidin, systemisk lidocain (antiarytmika/midler mod angina pectoris) astemizol, terfenadin (antihistaminer) cisaprid (gastrointestinalt motilitetsfremmende middel) ergotaminderivater (f.eks. dihydroergotamin, ergometrin, ergotamin, methylergonovin) pimozid, quetiapin, lurasidon (antipsykotika/neuroleptika) (se pkt.
substrates of CYP3A4 or the UGT1A1 isoform of UDP-glucuronyltransferase and have narrow therapeutic windows: alfuzosin (alpha-1-adrenoreceptor antagonist) amiodarone, bepridil, dronedarone, quinidine, systemic lidocaine (antiarrhythmics/antianginals) astemizole, terfenadine (antihistamines) cisapride (gastrointestinal motility agent) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) pimozide, quetiapine, lurasidone (antipsychotics/neuroleptics) (see section 4.5) ticagrelor (platelet aggregation inhibitor) triazolam, midazolam administered orally (sedatives/hypnotics) (for caution on parenterally administered midazolam, see section 4.5).
Manglende data i tidsvinduet men får studielægemiddel aUge 48-vindue er fra dag 309 til 378 (inklusive) b Uge 144-vindue er fra dag 967 til 1.050 (inklusive) c Omfatter forsøgspersoner, som havde ≥50 kopier/ml i uge 48- eller 144-vinduet, forsøgspersoner, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, forsøgspersoner, som afbrød behandlingen af andre årsager end en bivirkning, død eller manglende eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥50 kopier/ml.
c Includes subjects who had ≥50 copies/ml in the week 48 or 144 windows, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/ml.
Tenofovirdisoproxilfumarat (tenofovir DF) 300 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt)
Tenofovir disoproxil fumarate (tenofovir DF) 300 mg once daily (atazanavir 400 mg once daily)
Raltegravir 400 mg to gange dagligt (atazanavir 400 mg)
Raltegravir 400 mg twice daily (atazanavir 400 mg)
Samtidig administration af EVOTAZ og cisaprid er kontraindiceret (se pkt.
Co-administration of EVOTAZ and cisapride is contraindicated (see section 4.3).
Dosisjustering er ikke nødvendig for telaprevir ved samtidig administration af EVOTAZ.
No dose adjustment is required for telaprevir if co-administered with EVOTAZ.
Samtidig administration af EVOTAZ og CYP3A-hæmmende lægemidler kan nedsætte clearance af atazanavir og cobicistat, hvilket medfører øgede plasmakoncentrationer af atazanavir og cobicistat (se pkt.
Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may decrease the clearance of atazanavir and cobicistat, resulting in increased atazanavir and cobicistat plasma concentrations (see section 4.5).
Samtidig administration af EVOTAZ og astemizol og terfenadin er kontraindiceret (se pkt.
Co-administration of EVOTAZ with astemizole and terfenadine is contraindicated (see section 4.3).
hverken ketoconazol eller itraconazol.
available for co-administration of EVOTAZ with either ketoconazole or itraconazole.
EVOTAZ bør ikke administreres sammen med triazolam eller oralt administreret midazolam (se pkt.
EVOTAZ should not be co-administered with triazolam or orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of EVOTAZ and parenteral midazolam.
ANTIMYKOBAKTERIELLE MIDLER
ANTIMYCOBACTERIALS
Gruppen med atazanavir og cobicistat var sammenlignelig med gruppen med atazanavir og ritonavir med hensyn til demografiske karakteristika og karakteristika ved baseline.
The demographic and baseline characteristics were similar between the atazanavir with cobicistat and atazanavir with ritonavir groups.
Kombinationen af avanafil og EVOTAZ er kontraindiceret (se pkt.
The combination of avanafil and EVOTAZ is contraindicated (see section 4.3).
Samtidig administration af EVOTAZ og rivaroxaban bør undgås.
Avoid concomitant use of EVOTAZ and rivaroxaban.
Samtidig administration af salmeterol og EVOTAZ frarådes (se pkt.
Co-administration of salmeterol with EVOTAZ is not recommended (see section 4.4).
Cobicistat er en kraftig mekanisme-baseret CYP3A-hæmmer og en svag CYP2D6-hæmmer.
Cobicistat is a strong mechanism-based CYP3A inhibitor and a weak CYP2D6 inhibitor.
Omeprazol 40 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt, 2 timer efter omeprazol)
Omeprazole 40 mg once daily (atazanavir 400 mg once daily, 2 hours after omeprazole)
Der er ikke set signifikant effekt på koncentrationen af lamivudin eller zidovudin ved samtidig administration med atazanavir.
No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Koncentrationen af disse immunsuppressiva kan øges ved samtidig administration af EVOTAZ.
Concentrations of these immunosuppressants may be increased when co-administered with EVOTAZ.
Der er rapporteret nephrolithiasis hos patienter behandlet med atazanavir (se pkt.
Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
Hvis du har taget for meget EVOTAZ
If you take more EVOTAZ than you should