natgillin/translations-raw huggingface dataset:
The Committee recommended that Sustiva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Sustiva odobri dovoljenje za promet.
Other information about Sustiva:
Druge informacije o zdravilu Sustiva:
The European Commission granted a marketing authorisation valid throughout the European Union for Sustiva on 28 May 1999.
Evropska komisija je dovoljenje za promet z zdravilom Sustiva, veljavno po vsej Evropski uniji, odobrila dne 28. maja 1999.
The marketing authorisation holder is Bristol-Myers Squibb Pharma EEIG.
Imetnik dovoljenja za promet je družba Bristol- Myers Squibb Pharma EEIG.
The full EPAR for Sustiva can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sustiva je na voljo tukaj.
Dark yellow and white, printed with "SUSTIVA" on the dark yellow cap and "50 mg" on the white body.
Trde kapsule so temno rumene in bele barve in imajo napis » SUSTIVA « na temno rumenem delu in "50 mg" na belem.
SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
SUSTIVA je indiciran za kombinirano protivirusno zdravljenje odraslih, mladostnikov in otrok, starih tri leta ali več, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1).
SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/ mm3, or after failure of protease inhibitor (PI) containing regimens.
Uporabe zdravila SUSTIVA še niso dovolj preučili pri bolnikih z napredovano boleznijo HIV, to je pri bolnikih z vrednostjo CD4 < 50 celic/ mm3, ali po neuspelem zdravljenju z režimom, ki je vključeval zaviralce proteaze (ZP).
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
Čeprav navzkrižna rezistenca efavirenza z ZP ni dokumentirana, trenutno nimamo dovolj podatkov o učinkovitosti uporabe kombiniranega zdravljenja, ki vključuje ZP, po neuspelem zdravljenju z režimom, ki je vključeval tudi SUSTIVA.
SUSTIVA must be given in combination with other antiretroviral medicines (see section 4.5).
SUSTIVA je treba dajati v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4. 5).
It is recommended that SUSTIVA be taken on an empty stomach.
Priporočamo, da se SUSTIVA jemlje na prazen želodec.
The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse reactions (see sections 4.4. and 5.2).
Povišana koncentracija efavirenza, ki so jo opazili po zaužitju zdravila SUSTIVA s hrano, lahko vodi do povečane pogostosti neželenih učinkov (glejte poglavji 4. 4 in 5. 2).
Adults: the recommended dosage of SUSTIVA in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
V kombinaciji z nukleozidnimi zaviralci revezne transkriptaze (NRTI- ji), z ali brez ZP, je priporočeni odmerek efavirenza 600 mg peroralno, enkrat dnevno (glejte poglavje 4. 5).
Paediatric patients (3 to 17 years): the recommended dose of SUSTIVA in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
V kombinaciji z ZP in/ ali NRTI- ji je priporočeni odmerek zdravila SUSTIVA za bolnike stare od 3 do 17 let naveden v Preglednici 1.
SUSTIVA hard capsules must only be administered to children who are able to reliably swallow hard capsules.
SUSTIVA trde kapsule smemo dati le otrokom, ki so trde kapsule zmožni pogoltniti.
2 SUSTIVA is not recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
2 Zdravila SUSTIVA za bolnike, stare manj kot 3 leta ali lažje od 13 kg, zaradi pomanjkanja podatkov o varnosti in učinkovitosti za to starostno skupino ne priporočamo (glejte poglavji 5. 1. in 5. 2.).
Alternative method of administration: for children at least 3 years old and weighing at least 13 kg and adults who cannot reliably swallow hard capsules, SUSTIVA oral solution is the preferred formulation.
Dodatna možnost uporabe: pri otrocih, ki so stari vsaj 3 leta in tehtajo vsaj 13 kg, ter odraslih, ki ne morejo pogoltniti trdih kapsul, je priporočljiva uporaba peroralne raztopine SUSTIVA.
Administration of the capsule contents with a small amount (1-2 teaspoons) of food may be considered for patients who cannot tolerate the oral solution.
Pri bolnikih, ki ne prenesejo okusa peroralne raztopine, je priporočljiva uporaba vsebine kapsule z majhno količino (2 kavni žlički) hrane.
In a palatability study in healthy adults of efavirenz mixed with applesauce, grape jelly, yogurt, or infant formula, grape jelly received the highest rating of good overall taste.
V študiji okusnosti efavirenza, zmešanega z jabolčno kašo, grozdnim želejem, jogurtom ali hrano za dojenčke, na zdravih odraslih osebah je grozdni žele prejel najvišjo oceno za vsesplošno dober okus.
Patients and caregivers must be instructed to open the capsule carefully to avoid spillage or dispersion of the capsule contents into the air.
Bolniki in negovalci naj kapsulo odprejo previdno ter se tako izognejo politju ali razpršitvi vsebine kapsule po zraku.
It is recommended to hold the capsule vertically with the cap facing up and to pull the cap away from the body of the capsule, and to mix the capsule contents with food in a small container.
Priporočljivo je, da kapsulo držite navpično, tako da je pokrovček kapsule obrnjen navzgor, nato galočiteod telesa kapsule, vsebino kapsule pa v majhni posodi zmešate s hrano.
The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Mešanico morate uporabiti takoj, ko je mogoče, vendar ne kasneje kot 30minut po pripravi.
After administration of the efavirenz-food mixture, an additional small amount (approximately 2 teaspoons) of food must be added to the empty mixing container, stirred to disperse any remaining residue of the medicinal product, and administered to the patient.
Po uporabi mešanice hrane in efavirenza v prazno posodo dodajte majhno količino hrane (približno 2 kavni žlički) in jo zmešajte ter tako poskrbite, da v njej ni ostankov zdravila, s hrano pa nahranite bolnika.
No additional food should be consumed for up to 2 hours after administration of efavirenz.
Po uporabi efavirenza hrane ne uživajte še nadaljnji 2 uri.
There are limited safety and tolerability data for administration of the capsule contents in paediatric patients.
Podatki o varnosti in prenosljivosti v zvezi z uporabo vsebine kapsule pri pediatričnih bolnikih so omejeni.
Table 1 Paediatric dose to be administered once daily*
Pediatrični odmerki za uporabo enkrat dnevno *
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
25 do < 32, 5 32, 5 do < 40 ≥ 40
*For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2.
* Za informacije o biorazpoložljivosti vsebine kapsule, zmešane s hrano, si oglejte poglavje 5. 2.
If SUSTIVA is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the SUSTIVA dose must be reduced by 50%, i. e., to 300 mg once daily.
Prilagoditev odmerjanja: če se SUSTIVA uporablja hkrati z vorikonazolom je trebavzdrževalni odmerek vorikonazola povečati na 400 mg na 12 ur, odmerek zdravila SUSTIVA pa zmanjšati za 50%, to je na 300 mg enkrat dnevno.
If SUSTIVA is coadministered with rifampicin, an increase in the dose of SUSTIVA to 800 mg/ day may be considered (see section 4.5).
Če se SUSTIVA uporablja skupaj z rifampicinom, je priporočljivo pretehtati možnost povečanja odmerka zdravila SUSTIVA na 800 mg dnevno (glejte poglavje 4. 5).
3 Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
3 Efavirenza se ne sme uporabljati hkrati s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin), ker bi kompeticija z efavirenzem za CYP3A4 lahko povzročila inhibicijo metabolizma in hude in/ ali življenjsko nevarne neželene učinke [na primer srčne aritmije, podaljšano sedacijo ali depresijo dihanja] (glejte poglavje 4. 5).
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate is not recommended.
Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in tenofovirdizoproksilfumarat, ne priporočamo.
When prescribing medicinal products concomitantly with SUSTIVA, physicians should refer to the corresponding Summary of Product Characteristics.
Pri predpisovanju zdravil, ki se jemljejo hkrati z zdravilom SUSTIVA, mora zdravnik upoštevati ustrezni Povzetek glavnih značilnosti zdravila.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Psihiatrični simptomi:
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Pri bolnikih, zdravljenih z efavirenzem, so poročali o psihiatričnih neželenih učinkih.
In particular, severe depression was more common in those with a history of depression.
Bolniki, ki so že v preteklosti imeli duševne motnje, so bolj nagnjeni k resnim psihiatričnim neželenim učinkom.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor
Bolnikom je treba svetovati, naj se v
4 immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
4 primeru pojava simptomov, kot so huda oblika depresije, psihoza ali misel na samomor, nemudoma posvetujejo s svojim zdravnikom, ki bo ocenil, ali so simptomi povezani z jemanjem efavirenza, in odločil, ali je tveganje nadaljevanja zdravljenja z efavirenzem večje od koristi (glejte poglavje 4. 8).
Effect of food: the administration of SUSTIVA with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Pri zaužitju zdravila SUSTIVA skupaj s hrano se lahko poveča izpostavitev efavirenzu (glejte poglavje 5. 2) in lahko pride do večje pogostosti neželenih učinkov (glejte poglavje 4. 8).
It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime.
Priporočamo, da se SUSTIVA jemlje na prazen želodec, po možnosti zvečer pred spanjem.
The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
5 Varnost in učinkovitost pri bolnikih z obstoječimi pomembnimi motnjami v delovanju jeter nista bili ugotovljeni.
Efavirenz is contraindicated in patients with severe hepatic impairment (see
Efavirenz je kontraindiciran pri bolnikih s hudo okvaro jeter (glejte poglavje 4. 3).
Patients with pre- existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pri bolnikih z obstoječimi motnjami v delovanju jeter, vključno z aktivnim kroničnim hepatitisom se med kombiniranim protiretrovirusnim zdravljenjem nepravilnosti v delovanju jeter pojavljajo bolj pogosto; bolnike je treba spremljati v skladu z utečeno prakso.
Therefore, efavirenz should not be given to children less than 3 years of age.
Zato se zdravila SUSTIVA ne sme dati otrokom, mlajšim od 3 let.
Lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Contraindications of concomitant use Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Kontraindikacije za sočasno uporabo Efavirenza se ne sme jemati hkrati s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin), ker zaviranje njihovega metabolizma lahko povzroči resne, življenje ogrožajoče dogodke (glejte poglavje 4. 3).
John’ s wort (Hypericum perforatum): co-administration of efavirenz and St.
Šentjanževka (Hypericum perforatum): sočasna uporaba efavirenza in šentjanževke ali zeliščnih pripravkov, ki vsebujejo šentjanževko, je kontraindicirana.
John’ s wort or herbal preparations containing St.
Sočasna uporaba šentjanževke lahko zmanjša koncentracije efavirenza v plazmi.
John’ s wort is contraindicated.
Do tega pride zato, ker šentjanževka inducira encime, ki presnavljajo zdravilo in/ ali transportne proteine.
Plasma levels of efavirenz can be reduced by concomitant use of St.
Če bolnik že jemlje šentjanževko, naj preneha, preveri naj se koncentracija virusa in, če je možno, koncentracija efavirenza.
John’ s wort due to induction of drug metabolising enzymes and/ or transport proteins by St.
Raven efavirenza se lahko po prenehanju jemanja šentjanževke poveča, zato je morda potrebno prilagoditi odmerek efavirenza.
If a patient is already taking St.
Induktivni učinek šentjanževke lahko traja vsaj še 2 tedna po prenehanju zdravljenja (glejte poglavje 4. 3).
John’ s wort, stop St.
6 oz. » q12h «).
John’ s wort, check viral levels and if possible efavirenz levels.
90- odstotni ali 95- odstotni intervali zaupanja so prikazani v oklepajih, če so na voljo.
Efavirenz levels may increase on stopping St.
Študije so izvajali na zdravih posameznikih, razen če ni drugače navedeno.
John’ s wort and the dose of efavirenz may need adjusting.
Študije interakcij so izvedli le pri odraslih bolnikih.
The inducing effect of St.
Preglednica 2:
John’ s wort may persist for at least 2 weeks after cessation of treatment.
Interakcije med efavirenzem in drugimi zdravili
Other interactions Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “ q8h” or “ q12h”).
Zdravilne učinkovine po terapevtskihUčinki na koncentracije učinkovin področjih Srednja sprememba AUC, Cmax, (odmerek) Cmin z intervali zaupanja, če so na voljoa (mehanizem) ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Protiretrovirusne učinkovine Zaviralci proteaze (ZP)
If available, 90% or 95% confidence intervals are shown in parentheses.
Priporočilo glede sočasne uporabe z efavirenzem
Interaction studies have only been performed in adults.
atazanavir/ ritonavir/ efavirenz (400 mg enkrat na dan/ 100 mg enkrat na dan/ 600 mg enkrat na dan, vse se vzame s hrano)
6 Table 2:
atazanavir (popoldne):
Interactions between efavirenz and other medicinal products
Če je v kombinaciji z efavirenzem potrebna sočasna uporaba atazanavira in NNRTI, lahko
Medicinal product by
atazanavir/ ritonavir/ efavirenz
Recommendation concerning
razmislite o povečanju
therapeutic areas (dose)
(400 mg enkrat na dan/ 200 mg enkrat
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
AUC: ↔ * / ** (↓ 10% do
co-administration with efavirenz
odmerka atazanavira na 400
ANTI-INFECTIVES Antiretrovirals Protease inhibitors (PI) Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 100 mg once daily/ 600 mg once daily, all administered with food)
na dan/ 600 mg enkrat na dan, vse se
Atazanavir (pm):
↑ 26%)
Co-administration of efavirenz with atazanavir/ ritonavir is not recommended.
mg in odmerka ritonavira na
Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 200 mg once daily/ 600 mg once daily, all administered with food)
vzame s hrano)
AUC: ↔ */ ** (↓ 10% to ↑ 26%) Cmax: ↔ */ ** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/ ** (↓ 16% to ↑ 49%) (CYP3A4 induction). * When compared to atazanavir 300 mg/ ritonavir 100 mg once daily in the evening without efavirenz.
Cmax: ↔ * / ** (↓ 5% do ↑ 26%) Cmin: ↑ 12% * / ** (↓ 16% do ↑ 49%) (indukcija CYP3A4) * v primerjavi z atazanavirom 300 mg/ ritonavir 100 mg enkrat na dan zvečer brez efavirenza.
atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
200 mg ob skrbem kliničnem spremljanju.
Darunavir/ ritonavir/ Efavirenz (300 mg twice daily*/ 100 mg twice daily/ 600 mg once daily)
darunavir/ ritonavir/ efavirenz (300 mg dvakrat na dan * / 100 mg
AUC: ↓ 13% Cmin: ↓ 31% (CYP3A4 induction)
AUC: ↓ 13%
The clinical significance of the changes has not been established.
Podobne
Similar findings are expected with the approved
ugotovitve pričakujemo za odobren odmerek
darunavir/ ritonavir 600/ 100 mg twice daily dose.
darunavir/ ritonavir 600/ 100 mg dvakrat na dan.
AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40% A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
AUC: ↓ 31% (↓ 8 do ↓ 47) Cmin: ↓ 40% Pri jemanju indinavira 1000 mg q8h z efavirenzem 600 mg na dan so opazili podobno zmanjšanje v izpostavljenosti indinaviru.
Medicinal product by
indinavir/ ritonavir/ efavirenz
Effects on drug levels
AUC: ↓ 25% (↓ 16 do ↓ 32) b
Recommendation concerning
Pri jemanju z indinavirom ali
therapeutic areas (dose)
(800 mg dvakrat na dan/ 100 mg
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Cmax: ↓ 17% (↓ 6 do ↓ 26) b
co-administration with efavirenz
indinavirom/ ritonavirom
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
dvakrat na dan/ 600 mg enkrat na dan)
AUC: ↓ 25% (↓ 16 to ↓ 32)b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b Efavirenz:
Cmin: ↓ 50% (↓ 40 do ↓ 59) b efavirenz:
No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/ l) when given with ritonavir
Geometrična srednja vrednost Cmin
No dosage adjustment is necessary for efavirenz when given with indinavir or indinavir/ ritonavir.
prilagoditev odmerka efavirenza ni potrebna.
and efavirenz was higher than the mean historical Cmin (0.15 mg/ l) when indinavir was given alone at 800 mg q8h.
za indinavir (0, 33 mg/ l) pri dajanju z ritonavirom in efavirenzem je bila večja kot srednja vrednost do takratnih Cmin (0, 15 mg/ l) za indinavir sam v odmerku 800 mg na vsakih 8 ur.
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses
Pri sočasni uporabi z efavirenzem je potrebno razmisliti o zvišanju odmerka lopinavir/ ritonavir mehkih
by 33% should be considered (4 capsules/ ~6.5 ml twice daily
kapsul ali peroralne raztopine za 33% (4 kapsule/ ~6, 5 ml dvakrat dnevno, namesto 3 kapsule/ 5 ml dvakrat dnevno).
instead of 3 capsules/ 5 ml twice daily).
je lahko tako prilagajanje odmerkov pri nekaterih bolnikih nezadostno.
Caution is warranted
Pri
The dosage of lopinavir/ ritonavir tablets should be increased to 500/ 125 mg twice daily when co-administered with efavirenz 600 mg once daily.
jemanju z efavirenzem 600 mg enkrat na dan je treba odmerek lopinavir/ ritonavir tablet povečati na 500/ 125 mg dvakrat na dan.
therapeutic areas (dose)
8 Zdravilne učinkovine po terapevtskih področjih (odmerek)
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Učinki na koncentracije učinkovin Srednja sprememba AUC, Cmax, Cmin z intervali zaupanja, če so na voljoa (mehanizem)
co-administration with efavirenz
Priporočilo glede sočasne uporabe z efavirenzem
Ritonavir/ Efavirenz (500 mg twice daily/ 600 mg once daily)
ritonavir/ efavirenz (500 mg dvakrat na dan/ 600 mg enkrat na dan)
Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔ Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔ Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b Efavirenz:
AUC zjutraj: ↑ 18% (↑ 6 do ↑ 33) AUC zvečer: ↔ Cmax zjutraj: ↑ 24% (↑ 12 do ↑ 38) Cmax zvečer: ↔ Cmin zjutraj: ↑ 42% (↑ 9 do ↑ 86) b Cmin zvečer: ↑ 24 (↑ 3 do ↑ 50) b efavirenz:
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46) b (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
AUC: ↑ 21% (↑ 10 do ↑ 34) Cmax: ↑ 14% (↑ 4 do ↑ 26) Cmin: ↑ 25% (↑ 7 do ↑ 46) b (zaviranje oksidativne presnove, pri kateri sodelujejo encimi CYP) Kadar so efavirenz dajali skupaj s 500 mg ali 600 mg ritonavira dvakrat na dan, bolniki te kombinacije niso dobro prenašali (pojavili so se na primer omotica, navzea, parestezija in zvišane vrednosti jetrnih encimov).
When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Pri uporabi efavirenza z majhnim odmerkom ritonavira, je treba upoštevati možnost povečanja pogostnosti neželenih učinkov, povezanih z efavirenzem, zaradi morebitnih farmakodinamičnih interakcij.
Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil fumarate.
Specifičnih študij interakcij z efavirenzem in zdravili NRTI, razen z lamivudinom, zidovudinom in tenofovirdizoproksilfumaratom, niso opravili.
Clinically significant interactions are not expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Klinično pomembnih interakcij ni pričakovati, saj se
Medicinal product by
Zdravilne učinkovine po terapevtskih področjih (odmerek)
Effects on drug levels
Učinki na koncentracije učinkovin Srednja sprememba AUC, Cmax, Cmin z intervali zaupanja, če so na voljoa (mehanizem) zdravila NRTI presnavljajo po drugi poti kot efavirenz in ni verjetno, da bi prišlo do kompeticije za iste presnovne encime in poti izločanja.
therapeutic areas (dose)
NNRTI- ji/ efavirenz Antibiotiki
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Interakcij niso preučevali.
co-administration with efavirenz
Ker uporaba dveh zdravil NNRTI ni pokazala koristi glede učinkovitosti in varnosti, sočasne uporabe efavirenza in drugega zdravila NNRTI ne priporočamo.
Antibiotics Azithromycin/ Efavirenz (600 mg single dose/ 400 mg once daily)
azitromicin/ efavirenz (enkratni odmerek 600 mg/ 400 mg enkrat na dan)
Other macrolide antibiotics (e. g. ,erythromycin)/ Efavirenz Antimycobacterials
Drugi makrolidni antibiotiki (npr. eritromicin) / efavirenz
Rifabutin/ Efavirenz (300 mg once daily/ 600 mg once daily)
Zdravila za zdravljenje okužb z mikobakterijami rifabutin/ efavirenz (300 mg enkrat na dan/ 600 mg enkrat na dan)
The daily dose of rifabutin should be increased by 50% when administered with efavirenz.
Pri sočasni uporabi z efavirenzem je treba dnevni odmerek rifabutina povečati za 50%.