natgillin/translations-raw huggingface dataset:
Appropriate antihistamines and/ or corticosteroids may improve the tolerability and hasten the resolution of rash.
Uporaba ustreznih antihistaminikov in/ ali kortikosteroidov lahko izboljša bolnikovo prenašanje zdravila in pospeši zdravljenje izpuščaja.
Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
O hudem izpuščaju, ki ga spremljajo mehurji, vlažno luščenje kože ali ulceracije, so poročali pri manj kot 1% bolnikov, zdravljenih z efavirenzem.
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Pojavnost eritema multiforme ali Stevens- Johnsonovega sindroma je bila približno 0, 1%.
Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Jemanje efavirenza je treba prekiniti pri bolnikih, pri katerih se razvije hud izpuščaj, ki ga spremljajo mehurji, vlažno luščenje kože, težave s sluznico ali vročina.
If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Če zdravljenje z efavirenzem prekinemo, je treba razmisliti tudi o prenehanju zdravljenja z drugimi protiretrovirusnimi zdravili, da se izognemo razvoju rezistentnega virusa (glejte poglavje 4. 8).
Rash was reported in 26 of 57 children (46%) treated with efavirenz during a 48-week period and was severe in three patients.
Pri 3 bolnikih je prišlo do hude oblike izpuščaja.
Prophylaxis with appropriate antihistamines prior to initiating therapy with efavirenz in children may be considered.
Pred začetkom zdravljenja z efavirenzem pri otrocih lahko razmislimo o preventivi z ustreznim antihistaminikom.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Pri bolnikih, ki so jim zaradi izpuščaja ukinili zdravljenje z drugimi NNRTI- ji, je možno večje tveganje za pojav izpuščaja pri zdravljenju z efavirenzem.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Pri bolnikih, zdravljenih z efavirenzem, so poročali o psihiatričnih neželenih učinkih.
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Bolniki, ki so že v preteklosti imeli duševne motnje, so bolj nagnjeni k resnim psihiatričnim neželenim učinkom.
In particular, severe depression was more common in those with a history of depression.
Huda oblika depresije se je pojavljala bolj pogosto zlasti pri bolnikih z depresijo v anamnezi.
There have also been post-marketing reports of severe depression, death by suicide, delusions and psychosis-like behaviour.
V obdobju trženja zdravila so poročali tudi o hudi obliki depresije, smrti zaradi samomora, blodnjavih motnjah in reakcijah podobnih psihozi.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor 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).
Bolnikom je treba svetovati, naj se v 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).
Nervous system symptoms: symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
V kliničnih raziskavah z bolniki, ki so jemali 600 mg efavirenza dnevno, so pogosto poročali o neželenih učinkih, ki so vključevali tudi simptome omotice, nespečnosti, somnolence, slabe koncentracije in nočne more (glejte poglavje 4. 8).
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
Simptomi živčnega sistema se ponavadi pojavijo prvi dan ali v prvih dveh dnevih terapije in v glavnem minejo po prvih 2 – 4 tednih.
Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Bolnikom je treba povedati, da se bodo ti običajni simptomi, če se pojavijo, najbolj verjetno z nadaljevanjem terapije izboljšali in ne napovedujejo kasnejšega pojava manj pogostih psihiatričnih simptomov.
Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Pri bolnikih, ki se zdravijo z efavirenzem, so opazili krče, običajno pri tistih z napadi krčev v anamnezi.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Pri bolnikih, ki sočasno prejemajo antikonvulzive, ki se primarno metabolizirajo v jetrih, kot so fenitoin, karbamazepin in fenobarbital, je potrebno periodično spremljanje plazemskih koncentracij.
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
V raziskavi interakcij med zdravili so se plazemske koncentracije karbamazepina zmanjšale pri sočasni uporabi karbamazepina z efavirenzem (glejte poglavje 4. 5).
Caution must be taken in any patient with a history of seizures.
Pri vseh bolnikih z napadi krčev v anamnezi je potrebna posebna previdnost.
4 Effect of food: the administration of STOCRIN 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 STOCRIN 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 STOCRIN be taken on an empty stomach, preferably at bedtime.
Priporočamo, da se STOCRIN jemlje na prazen želodec, po možnosti zvečer pred spanjem.
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - “ combination antiretroviral therapy ”) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ ali žariščne okužbe z mikobakterijami in pljučnica, povzročena s Pneumocystis jiroveci (nekoč znana kot Pneumocystis carinii).
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Prerazporeditev telesnega maščevja (lipodistrofijo) so pri bolnikih s HIV povezali s kombiniranim protiretrovirusnim zdravljenjem.
The long-term consequences of these events are currently unknown.
Dolgoročne posledice teh dogodkov so trenutno nepoznane.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Domneva se povezava med visceralno lipomatozo in ZP in lipoatrofijo in NRTI- ji.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Pojavnost lipodistrofije je bolj verjetna v kombinaciji z individualnimi dejavniki, kot je višja starost, in z dejavniki povezanimi z zdravili, kot je dolgotrajno protiretrovirusno zdravljenje ter s tem povezanimi metabolnimi motnjami.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Pozornost je potrebno nameniti vrednostim serumskih lipidov na tešče in krvnega sladkorja.
Lipid disorders should be managed as clinically appropriate (see section 4.8)..
Neustrezne vrednosti lipidov je potrebno ustrezno klinično obravnavati (glejte poglavje 4. 8).
Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART – combination antiretroviral therapy) ali obojim.
Liver disease: because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild-to-moderate liver disease.
Zaradi obsežnega metabolizma efavirenza, vezanega na citokrom P450, in omejenih kliničnih izkušenj pri bolnikih s kroničnimi jetrnimi boleznimi moramo biti previdni pri predpisovanju efavirenza bolnikom z blagimi do zmernimi jetrnimi boleznimi.
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms.
Bolnika je treba natančno opazovati zaradi možnih od odmerka odvisnih neželenih učinkov, še posebej simptomov živčnega sistema.
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Za oceno stopnje jetrne bolezni je treba periodično opravljati laboratorijske teste (glejte poglavje 4. 2).
The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
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 section 4.3).
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.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Če pride do poslabšanja bolezni jeter ali če vrednosti serumskih transaminaz vztrajajo na več kot petkratni zgornji meji normalnega območja, je treba pretehtati koristi nadaljevanja zdravljenja z efavirenzem z možnim tveganjem pomembne toksičnosti tega zdravila za jetra.
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Pri teh bolnikih je potrebno razmisliti o prekinitvi oziroma prenehanju zdravljenja (glejte poglavje 4. 8).
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
V primeru sočasnega protivirusnega zdravljenja z zdravili proti hepatitisu B ali C, si, prosimo, preberite tudi povzetke glavnih značilnosti teh zdravil.
Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Vpliv
There is no experience in patients with severe renal failure and close safety monitoring is recommended in this population.
Pri njih zaradi varnosti priporočamo skrbno spremljanje.
5 Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
V kliničnih raziskavah niso preučili zadostnega števila starejših bolnikov, da bi lahko ugotovili, ali se ti odzivajo drugače od mlajših bolnikov.
Paediatric patients: efavirenz has not been evaluated in children below 3 years of age or who weigh less than 13 kg.
Pri otrocih, mlajših od 3 let ali lažjih od 13 kg, uporabe efavirenza niso preučili.
Therefore, efavirenz should not be given to children less than 3 years of age.
Zato se zdravila STOCRIN ne sme dati otrokom, mlajšim od 3 let.
Individuals with these conditions may take efavirenz oral solution, which is free from lactose.
Posamezniki s temi stanji lahko uporabljajo peroralno raztopino z efavirenzem, ki ne vsebuje laktoze.
Efavirenz is an inducer of CYP3A4 and an inhibitor of some CYP450 isoenzymes including CYP3A4 (see section 5.2).
Efavirenz je induktor CYP3A4 in inhibitor nekaterih izoencimov CYP450, vključno s CYP3A4 (glejte poglavje 5. 2).
Other compounds that are substrates of CYP3A4 may have decreased plasma concentrations when co-administered with efavirenz.
Plazemske koncentracije drugih snovi, ki so substrati za CYP3A4, se pri sočasnem jemanju z efavirenzem lahko zmanjšajo.
Efavirenz exposure may also be altered when given with medicinal products or food (for example, grapefruit juice) which affect CYP3A4 activity.
Izpostavitev efavirenzu se lahko spremeni tudi pri uporabi skupaj z drugimi zdravili ali s hrano (na primer sokom grenivke), ki vplivajo na aktivnost CYP3A4.
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 is contraindicated.
Šentjanževka (Hypericum perforatum): sočasna uporaba efavirenza in šentjanževke ali zeliščnih pripravkov, ki vsebujejo šentjanževko, je kontraindicirana.
Plasma levels of efavirenz can be reduced by concomitant use of St.
Sočasna uporaba šentjanževke lahko zmanjša koncentracije efavirenza v plazmi.
If a patient is already taking St.
Do tega pride zato, ker šentjanževka inducira encime, ki presnavljajo zdravilo in/ ali transportne proteine.
John’ s wort, check viral levels and if possible efavirenz levels.
Če bolnik že jemlje šentjanževko, naj preneha, preveri naj se koncentracija virusa in, če je možno, koncentracija efavirenza.
The inducing effect of St.
Raven efavirenza se lahko po prenehanju jemanja šentjanževke poveča, zato je morda potrebno prilagoditi odmerek efavirenza.
John’ s wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Induktivni učinek šentjanževke lahko traja vsaj še 2 tedna po prenehanju zdravljenja (glejte poglavje 4. 3).
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”).
12 ur s » q8h « oz. » q12h «).
If available, 90% or 95% confidence intervals are shown in parentheses.
90- odstotni ali 95- odstotni intervali zaupanja so prikazani v oklepajih, če so na voljo.
Studies were conducted in healthy subjects unless otherwise noted.
Študije so izvajali na zdravih posameznikih, razen če ni drugače navedeno.
Interaction studies have only been performed in adults.
Študije interakcij so izvedli le pri odraslih bolnikih.
Table 2:
6 Preglednica 2:
Interactions between efavirenz and other medicinal products
Interakcije med efavirenzem in drugimi zdravili
Medicinal product by therapeutic
Zdravilne učinkovine po terapevtskih področjih
Effects on drug levels
na koncentracije učinkovin
Recommendation concerning
Priporočilo glede sočasne uporabe z efavirenzem
areas (dose)
(odmerek)
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)
ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Protiretrovirusne učinkovine Zaviralci proteaze (ZP) atazanavir/ ritonavir/ efavirenz (400 mg enkrat na dan/ 100 mg enkrat na dan/ 600 mg enkrat na dan, vse se vzame s hrano)
AUC: ↔ * (↓ 9% to ↑ 10%) Cmax: ↑ 17%* (↑ 8% to ↑ 27%) Cmin: ↓ 42%* (↓ 31% to ↓ 51%)
AUC: ↔ * (↓ 9% do ↑ 10%) Cmax: ↑ 17% * (↑ 8% do ↑ 27%) Cmin: ↓ 42% * (↓ 31% do ↓ 51%)
Co-administration of efavirenz with atazanavir/ ritonavir is not recommended.
Sočasne uporabe efavirenza in atazanavira/ ritonavira ne priporočamo.
If the co-administration of atazanavir with an NNRTI is required, an
Če je v kombinaciji z efavirenzem potrebna sočasna uporaba atazanavira in NNRTI, lahko razmislite o povečanju odmerka atazanavira na 400 mg in
6 Medicinal product by therapeutic
atazanavir/ ritonavir/ efavirenz
Effects on drug levels
atazanavir (popoldne):
Recommendation concerning
odmerka ritonavira na 200 mg ob
co-administration with
(400 mg enkrat na dan/ 200 mg enkrat
(dose)
AUC: ↔ * / ** (↓ 10% do
Cmax, Cmin with confidence intervals if availablea (mechanism)
skrbem kliničnem spremljanju.
efavirenz
na dan/ 600 mg enkrat na dan, vse se 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.
↑ 26%) 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.
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir. ** based on historical comparison
To zmanjšanje v Cmin atazanavira lahko negativno vpliva na učinkovitost atazanavira. ** temelji na pretekli primerjavi
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 dvakrat na dan/ 600 mg enkrat na dan)
AUC: ↓ 13% Cmin: ↓ 31% (CYP3A4 induction)
AUC: ↓ 13% Cmin: ↓ 31% (indukcija CYP3A4)
The clinical significance of the changes has not been established.
Kliničnega pomena sprememb niso ugotovili.
Similar findings are expected with the approved
Podobne ugotovitve pričakujemo za odobren odmerek darunavir/ ritonavir 600/ 100 mg
*lower than recommended dose
* nižji od priporočenega odmerka
AUC: ↑ 21% Cmin: ↑ 17% (CYP3A4 inhibition)
AUC: ↑21% Cmin: ↑17% (inhibicija CYP3A4)
darunavir/ ritonavir 600/ 100 mg twice daily dose.
dvakrat na dan.
See ritonavir row below.
Glejte informacije za ritonavir v nadaljevanju.
Fosamprenavir/ ritonavir/ Efavirenz (700 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
fosamprenavir/ ritonavir/ efavirenz (700 mg dvakrat na dan/ 100 mg dvakrat na dan/ 600 mg enkrat na dan)
No dosage adjustment is necessary for any of these medicinal products.
Prilagoditev odmerka ni potrebna za nobeno od teh zdravil.
Fosamprenavir/ Nelfinavir/ Efavirenz
Fosamprenavir/ nelfinavir/ efavirenz
Fosamprenavir/ Saquinavir/ Efavirenz
Fosamprenavir/ sakvinavir/ efavirenz
Indinavir/ Efavirenz (800 mg q8h/ 200 mg once daily)
indinavir/ efavirenz
AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40% A similar reduction in indinavir exposures was observed when indinavir 1.000 mg q8h was given with efavirenz 600 mg daily.
(800 mg q8h/ 200 mg enkrat na dan)
(CYP3A4 induction) Efavirenz:
AUC: ↓ 31% (↓ 8 do ↓ 47)
No clinically significant
koncentracij indinavira niso
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.
Cmin: ↓ 40% Pri jemanju indinavira 1000 mg q8h z efavirenzem 600 mg na dan so opazili podobno zmanjšanje v izpostavljenosti indinaviru.
pharmacokinetic interaction
(indukcija CYP3A4)
No dosage adjustment is necessary for efavirenz when
ugotovili, vendar je treba stopnjo opažene farmakokinetične interakcije upoštevati pri izbiri režima zdravljenja, pri katerem se uporabljata oba – efavirenz in indinavir.
Effects on drug levels
Zdravilne učinkovine po terapevtskih področjih
Recommendation concerning
Učinki
percent change in AUC,
na koncentracije učinkovin
co-administration with
Priporočilo glede sočasne uporabe z efavirenzem
(dose)
(odmerek)
efavirenz
efavirenz:
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
indinavir/ ritonavir/ efavirenz (800 mg dvakrat na dan/ 100 mg
AUC: ↓ 25% (↓ 16 to ↓ 32) b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b
AUC: ↓ 25% (↓ 16 do ↓ 32) b
given with indinavir or indinavir/ ritonavir.
prilagoditev odmerka efavirenza ni
Efavirenz:
dvakrat na dan/ 600 mg enkrat na dan)
No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/ l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/ l) when indinavir was given alone at 800 mg q8h.
Geometrična srednja vrednost Cmin 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.
In HIV-1 infected patients (n = 6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
Pri bolnikih, okuženih s HIV- 1 (n = 6), sta bili farmakokinetiki indinavira in efavirenza primerljivi s podatki za neokužene prostovoljce.
Lopinavir/ ritonavir soft capsules or oral solution/ Efavirenz
lopinavir/ ritonavir mehke kapsule ali peroralna raztopina/ efavirenz
Substantial decrease in lopinavir exposure.
Bistveno zmanjšanje izpostavljenosti lopinaviru.
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses by 33% should be considered
Pri sočasni uporabi z efavirenzem je potrebno razmisliti o zvišanju odmerka lopinavir/ ritonavir mehkih kapsul ali peroralne
Lopinavir/ ritonavir tablets/ Efavirenz
lopinavir/ ritonavir tablete/ efavirenz
(4 capsules/ ~6.5 ml twice daily instead of 3 capsules/ 5 ml twice daily).
raztopine za 33% (4 kapsule/ ~6, 5 ml dvakrat dnevno, namesto 3 kapsule/ 5 ml dvakrat dnevno).
Caution is warranted
Previdnost je utemeljena, saj je lahko tako prilagajanje
(400/ 100 mg twice daily/ 600 mg once daily)
(400/ 100 mg dvakrat na dan/ 600 mg enkrat na dan)
Lopinavir concentrations: ↓ 30-40%
Koncentracije lopinavira: ↓ 30- 40%
since this dosage adjustment might be insufficient in some patients.
odmerkov pri nekaterih bolnikih nezadostno.
The dosage of
Pri jemanju z efavirenzem 600 mg enkrat na dan