natgillin/translations-raw huggingface dataset:
K103N was the most frequently observed RT substitution in viral isolates from patients who experienced a significant rebound in viral load during clinical studies of efavirenz in combination with indinavir or zidovudine + lamivudine.
V virusnih izolatih bolnikov, ki so v kliničnih raziskavah z efavirenzem v kombinaciji z indinavirjem ali zidovudinom + lamivudinom doživeli znaten povratek virusnega bremena, je bila najpogostejša RT substitucija substitucija K103N.
This mutation was observed in 90% of patients receiving efavirenz with virological failure.
To mutacijo so opazili pri 90% bolnikov, ki so prejemali efavirenz, vendar se količina virusne RNA ni znižala pod mejo določitve.
The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medications used in combination with efavirenz.
Struktura aminokislinskih substitucij na RT, ki so bile povezane z rezistenco na efavirenz, ni bila odvisna od uporabe drugih protivirusnih zdravil v kombinaciji z efavirenzem.
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Dva od
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
21 treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Pri virusnih izolatih, ki so jih dobili od PBMC- jev bolnikov, ki so sodelovali v kliničnih raziskavah efavirenza in pri katerih je bilo zdravljenje neuspešno (povratek virusnega bremena), so določili občutljivost na NNRTI- je.
Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT.
Pri petih od teh na NNRTI- je rezistentnih izolatov so našli substitucijo K103N ali substitucijo valin- v- izolevcin na položaju 108 (V108I) na RT.
The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Možnost za navzkrižno rezistenco med efavirenzem in NRTI- ji je majhna zaradi različnih vezavnih mest in različnega mehanizma delovanja.
Pharmacodynamic effects:
Farmakodinamski učinki:
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/ mm3, or in PI or NNRTI experienced patients.
Efavirenza niso preučevali v kontroliranih raziskavah bolnikov z napredovano boleznijo HIV, to je pri bolnikih s CD4 < 50 celic/ mm3, ali bolnikih, ki so se zdravili z zaviralcem proteaze ali NNRTI- ji.
Clinical experience in controlled studies with combinations including didanosine or zalcitabine is limited.
Klinične izkušnje iz kontroliranih raziskav s kombinacijami zdravil, ki so vključevale didanozin ali zalcitabin, so omejene.
Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/ or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV-infected patients.
Dve kontrolirani raziskavi (006 in ACTG 364) z efavirenzem v kombinaciji z NRTI- ji in/ ali zaviralci proteaze, ki sta trajali približno eno leto, sta pokazali zmanjšanje virusnega bremena pod mejo določitve testa in povečanje števila CD4 limfocitov pri s HIV okuženimi bolniki, ki še niso dobivali protiretrovirusnih zdravil in tistih, ki so bili že zdravljeni z NRTI- ji.
Study 020 showed similar activity in NRTI-experienced patients over 24 weeks.
Raziskava 020 je pri bolnikih, ki so se že zdravili z NRTI- ji, po 24 tednih pokazala podobno aktivnost.
In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Odmerek indinavira pri uporabi z efavirenzem je bil 1. 000 mg na vsakih 8 ur, brez uporabe efavirenza pa 800 mg na vsakih 8 ur.
The dose of nelfinavir was 750 mg given three times a day.
Odmerek nelfinavira je bil 750 mg trikrat dnevno.
The standard doses of NRTIs given every 12 hours were used in each of these studies.
V vsaki od teh raziskav so uporabili standardne odmerke NRTI- jev na vsakih 12 ur.
Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
Raziskava 006, randomizirana, odprta raziskava, je primerjala efavirenz + zidovudin + lamivudin ali efavirenz + indinavir z indinavirjem + zidovudinom + lamivudinom pri 1. 266 bolnikih, ki se pred vstopom v raziskavo še niso smeli zdraviti z efavirenzem, lamivudinom, NNRTI ali PI.
The mean baseline CD4 cell count was 341 cells/ mm3 and the mean baseline HIV-RNA level was 60,250 copies/ ml.
Povprečno izhodiščno število CD4 ob vstopu je bilo 341 celic/ mm3, povprečna izhodiščna raven HIV- RNA je bila 60. 250 kopij/ ml.
Efficacy results for study 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 3.
Rezultate učinkovitosti raziskave 006 pri podskupini 614 bolnikov, vključenih vsaj 48 tednov, prikazuje preglednica 3.
In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ ml at the missing time points.
Pri analizi deležev bolnikov, ki so se odzvali na zdravljenje (bolnik, ki raziskave ni končal, pomeni napako analize; NK = NA), so privzeli, da imajo bolniki, ki so raziskavo iz kakršnegakoli razloga predčasno prekinili ali so izpustili eno merjenje HIV- RNA vrednosti (vrednost pred ali za njo pa je bila nad mejo določitve testa), v manjkajočih časovnih točkah HIV- RNA vrednost izpuščene meritve nad 50 ali nad 400 kopij/ ml.
Table 3:
22 Preglednica 3:
Efficacy results for study 006
Rezultati učinkovitosti za raziskavo 006
Responder rates (NC = Fa) Plasma HIV-RNA
Delež bolnikov, ki so se odzvali na zdravljenje (NK = NAa) plazemska HIV - RNA
Mean change from baseline-CD4 cell count
Povprečna sprememba od začetne vrednosti CD4 celic/ mm3
400 copies/ ml (95% C. I. b)
400 kopij/ ml * (95% C. I. b)
< 50 copies/ ml (95% C. I. b)
< 50 kopij/ ml
Treatme
Režimi zdravlje
nt n
njad n
Regimend EFV +
EFV + ZDV + 3TC
ZDV + 3TC EFV + IDV
EFV + IDV IDV + ZDV + 3TC a
(60
(60 (47 (38
(47%, 61%)
%, 73%) 54%%, 61%) 45%%, 52%)
(41%, 55%)
(55 (41 (34
400 copies/ ml (95% C. I. b)
%, 69%) 48%%, 55%) 40%%, 47%)
153
(11, 8) 177 (11, 3) 153 (12, 3)
S. E. M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
NK = NA, ni končal = napaka analize b C. I., interval zaupanja c S. E. M., standardna napaka povprečja d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ ml, HIV RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Dolgoročni rezultati po 168 tednih raziskave 006 (raziskavo je zaključilo 160 bolnikov, zdravljenih z EFV + IDV, 196 bolnikov z EFV + ZDV + 3TC in 127 bolnikov z IDV + ZDV + 3TC) kažejo na dolgotrajnost odziva glede na deleže bolnikov s HIV RNA < 400 kopij/ ml, HIV RNA < 50 kopij/ ml in glede na povprečno spremembo od izhodiščnega števila celic CD4.
Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Rezultate učinkovitosti v raziskavah ACTG 364 in 020 prikazuje preglednica 4.
Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Raziskava ACTG 364 je vključevala 196 bolnikov, ki so bili zdravljeni z NRTI, ne pa s PI ali NNRTI.
Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
V raziskavi ACTG 020 je sodelovalo 327 bolnikov, ki so bili zdravljeni z NRTI, ne pa s PI ali NNRTI.
Physicians were allowed to change their patient ’ s NRTI regimen upon entry into the study.
Zdravniki so ob vključitvi bolnika v raziskavo smeli zamenjati NRTI- režim.
Efficacy results for studies ACTG 364 and 020
Rezultati učinkovitosti za raziskave ACTG 364 in 020
Responder rates (NC = Fa)
Delež bolnikov, ki so se odzvali na zdravljenje (NK = NAa) plazemska HIV- RNA (95% C. I. c)
baseline-CD4 cell count
Povprečna sprememba od začetne vrednosti CD4 3 (S. E. M. d)
Study Number/ Treatment Regimensb
Številka raziskave / režimi zdravljenjab
% C. I. c)%
celic/ mm
Study ACTG 364 48 weeks
Raziskava ACTG 364 48 tednov
< 500 copies/ ml
< 500 kopij/ ml
< 50 copies/ ml
< 50 kopij/ ml
EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
EFV + NFV + NRTI EFV + NRTI NFV + NRTI
--- --- --- --- --- ---
- - - - - -
Study 020 24 weeks
Raziskava 020 24 tednov
< 400 copies/ ml
< 400 kopij/ ml
EFV + IDV + NRTIs IDV + NRTIs a
EFV + IDV + NRTI IDV + NRTI a
NC = F, noncompleter = failure. b EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir. c C. I., confidence interval for proportion of patients in response. d S. E. M., standard error of the mean. ---, not performed.
NK = NA, ni končal = napaka analize b EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, zaviralec nukleozidne reverzne transkriptaze; NFV, nelfinavir. c C. I., interval zaupanja d S. E. M., standardna napaka povprečja. – -, ni izvedeno.
Paediatric trial:
Pediatrična raziskava:
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
ACTG 382 je nekontrolirana raziskava, ki še poteka pri 57- ih pediatričnih bolnikih v starosti 3 do 16 let, ki so zdravljeni z NRTI- ji, in analizira farmakokinetiko, protivirusno aktivnost in varnost efavirenza v kombinaciji z nelfinavirom (20- 30 mg/ kg trikrat dnevno) in enim ali
The starting dose of efavirenz was the equivalent of a 600 mg dose (adjusted from calculated body size based on weight).
Začetni odmerek efavirenza je bil ekvivalenten 600 mg (prilagojen glede na izračunano velikost telesa na podlagi telesne teže).
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ ml at 48 weeks was 60% (95%, C. I.
Delež bolnikov, ki so se odzvali na zdravljenje, je bil glede na NK = NA analizo odstotkov bolnikov s plazemsko HIV- RNA < 400 kopij/ ml po 48 tednih 60% (95%, C. I.
47, 72), and 53% (C. I.
47, 72) ter 53% (C. I.
40, 66) based on percentage of patients with plasma HIV-RNA < 50 copies/ ml.
40, 66) glede na delež bolnikov s plazemsko HIV- RNA < 50 kopij/ ml.
The mean CD4 cell counts were increased by 63 ± 34.5 cells/ mm3 from baseline.
Povprečno število CD4 celic pa se je od osnovne vrednosti povečalo za 63 ± 34, 5 celic/ mm3.
Absorption: peak efavirenz plasma concentrations of 1.6 - 9.1 μ M were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Absorpcija: maksimalne plazemske koncentracije efavirenza, 1, 6 - 9, 1 μM, so bile pri neokuženih prostovoljcih dosežene 5 ur po dajanju enkratnih peroralnih odmerkov 100 mg do 1. 600 mg.
Time to peak plasma concentrations (3 - 5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 - 7 days.
Ravnotežne plazemske koncentracije so bile dosežene v 6- 7 dneh.
In HIV infected patients at steady state, mean Cmax, mean Cmin, and mean AUC were linear with 200 mg, 400 mg, and 600 mg daily doses.
Pri bolnikih, okuženih s HIV, so bile povprečna Cmax, povprečna Cmin in povprečna AUC v stanju ravnotežja linearno odvisne od dnevnega 200 mg, 400 mg in 600 mg odmerka.
In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μ M (29%) [mean ± S. D.
Pri 35 bolnikih, ki so dobivali 600 mg efavirenza enkrat dnevno, so bile v stanju dinamičnega ravnovesja Cmax 12, 9 ± 3, 7 μM (29%) [povprečje ± S. D.
(% C. V.)], steady state Cmin was 5.6 ± 3.2 μ M (57%), and AUC was 184 ± 73 μ M·h (40%).
(% C. V.)], Cmin 5, 6 ± 3, 2 μM (57%) in AUC 184 ± 73 μM· h (40%).
Effect of food: the bioavailability of a single 600 mg dose of efavirenz hard capsules in uninfected volunteers was increased 22% and 17%, respectively, when given with a meal of high fat or normal composition, relative to the bioavailability of a 600 mg dose given under fasted conditions (see section 4.4).
Vpliv hrane: pri neokuženih prostovoljcih je bila biološka uporabnost enkratnega odmerka trdih kapsul efavirenza 600 mg ob obroku z veliko maščobami in normalno sestavo povečana za 22% in 17% v primerjavi z biološko uporabnostjo odmerka 600 mg na tešče (glejte poglavje 4. 4).
Distribution: efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
Porazdelitev: efavirenz se močno veže (približno 99, 5 - 99, 75%) na človeške plazemske beljakovine, predvsem na albumin.
In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19% (mean 0.69%) of the corresponding plasma concentration.
Pri bolnikih, okuženih s HIV- 1 (n = 9), ki so vsaj en mesec dobivali 200 do 600 mg efavirenza enkrat dnevno, je bila njegova koncentracija v cerebrospinalni tekočini v območju 0, 26 do 1, 19% (povprečno 0, 69%) ustrezne plazemske koncentracije.
This proportion is approximately 3-fold higher than the non-protein-bound (free) fraction of efavirenz in plasma.
Ta delež je približno 3- krat višji od frakcije efavirenza v plazmi, ki ni vezana na beljakovine (prosta frakcija).
Biotransformation: studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Biotransformacija: raziskave na ljudeh in in vitro raziskave z uporabo človeških jetrnih mikrosomov so pokazale, da se efavirenz metabolizira predvsem s sistemom citokroma P450, in sicer v hidroksilirane metabolite, ki se potem vežejo na glukuronsko kislino.
These metabolites are essentially inactive against HIV-1.
Ti metaboliti so v glavnem neaktivni proti HIV- 1.
The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Raziskave in vitro kažejo, da sta CYP3A4 in CYP2B6 glavna izoencima, odgovorna za metabolizem efavirenza, in da inhibirata P450 izoencime 2C9, 2C19 in 3A4.
In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
V raziskavah in vitro efavirenz ni inhibiral CYP2E1; CYP2D6 in CYP1A2 pa je inhibiral šele pri koncentracijah, ki so bile precej višje od tistih, ki jih dosežemo pri klinični uporabi zdravila.
The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Ni znano, da bi taka povezava imela klinične posledice, vendar pa možnost za povečanje pogostosti in resnosti z efavirenzom povezanih neželenih učinkov ne more biti izključena.
Efavirenz has been shown to induce P450 enzymes, resulting in the induction of its own metabolism.
Pokazalo se je, da efavirenz inducira encime P450, s čimer povzroči indukcijo svojega lastnega metabolizma.
In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Pri neokuženih prostovoljcih so 10- dnevni večkratni odmerki 200 - 400 mg dnevno povzročili manjšo akumulacijo zdravila od pričakovane (22 – 42% manjšo) in krajši terminalni razpolovni čas v primerjavi z enkratnim odmerkom (glejte spodaj).
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 – 55 hours after multiple doses.
Izločanje: efavirenz ima relativno dolg terminalni razpolovni čas: vsaj 52 ur po enkratnem odmerku in 40 do 55 ur po večkratnih odmerkih.
Approximately 14 - 34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Manj kot 1% odmerka se je z urinom izločilo v obliki nespremenjenega efavirenza.
In the single patient studied with severe hepatic impairment (Child Pugh Grade C), half life was doubled indicating a potential for a much greater degree of accumulation.
Pri edinem bolniku s hudo jetrno okvaro (stopnja C po Child Pugh- u) je bil razpolovni čas dvakrat daljši, kar kaže na možnost veliko večje akumulacije.
Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
24 Pediatrična farmakokinetika: pri 49 pediatričnih bolnikih, ki so dobivali odmerek, ekvivalenten 600 mg odmerku efavirenza (odmerek je bil prilagojen velikosti telesa, izračunan glede na telesno težo), je bila Cmax v stanju ravnotežja 14, 1 μM, Cmin v stanju ravnotežja 5, 6 μM in AUC 216 μM· h.
Although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Spol, rasa, starejši bolniki: čeprav omejeni podatki, ki so za sedaj na voljo, kažejo, da je lahko tako pri ženskah kot pri bolnikih iz Azije ali s Pacifiških otokov izpostavitev efavirenzu večja, ti nimajo nižje tolerance za zdravilo.
Pharmacokinetic studies have not been performed in the elderly.
Farmakokinetičnih raziskav pri starejših bolnikih še niso opravili.
Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
V običajnih raziskavah genotoksičnosti se evafirenz ni izkazal za mutagenega ali klastogenega.
Malformations were observed in 3 of 20 foetuses/ newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Malformacije so opazili pri 3 od 20 opičjih zarodkov/ novorojencev vrste Cynomolgus, ki so bili zdravljeni z efavirenzem v odmerkih, s katerimi so dosegli plazemske koncentracije efavirenza, ki so podobne tistim pri človeku.
No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Pri podganjih in kunčjih zarodkih, ki so bili zdravljeni z efavirenzem, niso opazili malformacij.
Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
Pri opicah Cynomolgus, ki so jim ≥ 1 leto dajali efavirenz v odmerkih, s katerimi so dosegli približno 2- krat večjo povprečno AUC vrednost kakor pri ljudeh, ki so dobivali zanje priporočeni odmerek, so opazili biliarno hiperplazijo.
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Pri nekaterih opicah, ki so prejemale efavirenz ≥ 1 leto, so opazili prehodne krče pri uporabi odmerkov, s katerimi so dosegli od 4 - do 13- krat višje vrednosti AUC kot pri ljudeh, ki so prejemali priporočene odmerke (glejte poglavji 4. 4 in 4. 8).
Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Raziskave karcinogenosti so pokazale porast pojava jetrnih in pljučnih tumorjev pri mišjih samicah, ne pa pri mišjih samcih.
The mechanism of tumour formation and the potential relevance for humans are not known.
Mehanizem nastanka tumorjev in možna pomembnost za ljudi nista znana.
Carcinogenicity studies in male mice, male and female rats were negative.
Raziskave karcinogenosti pri mišjih samcih ter samcih in samicah podgan so bile negativne.
Capsule core Sodium laurilsulfate Lactose monohydrate Magnesium stearate Sodium starch glycolate
Jedro kapsule natrijev lavrilsulfat laktoza monohidrat magnezijev stearat natrijev karboksimetilškrob
Capsule shell Gelatine Sodium laurilsulfate Yellow iron oxide (E172) Titanium dioxide (E171) Silicon dioxide (E551)
Ovojnica kapsule želatina natrijev lavrilsulfat rumeni železov oksid (E172) titanov dioksid (E171) silicijev dioksid (E551)
Printing ink Cochineal carminic acid (E120) Indigo carmine (E132) Titanium dioxide (E171)
Črnila za potisk škrlatna karminska kislina (E120) indigotin (E132) titanov dioksid (E171)
24 6.3 Shelf life
6. 3 Rok uporabnosti
EU/ 1/ 99/ 111/ 001 - bottle
EU/ 1/ 99/ 111/ 001 - plastenka
Date of latest renewal:
28. maj 1999 Datum zadnjega podaljšanja dovoljenja:
28 May 2004.
28. maj 2004
Excipient: each hard capsule contains 57.0 mg of lactose monohydrate.
Pomožne snovi: ena trda kapsula vsebuje 57, 0 mg laktoze monohidrata.
White, printed with “ 3807”.
Trde kapsule so bele barve in imajo napis » 3807 «.
Adults: the recommended dosage of STOCRIN 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 reverzne 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 STOCRIN 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 efavirenza za bolnike stare od 3 do 17 let naveden v Preglednici 1.
26 STOCRIN 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).
27 Zdravila STOCRIN za otroke, 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.).
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali za katerokoli od pomožnih snovi v njem.
4.4 Special warnings and precautions for use
28 4. 4 Posebna opozorila in previdnostni ukrepi
27 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.
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
28 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).