natgillin/translations-raw huggingface dataset:
Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment. 
Pogledajte nastavak teksta i dio 5.3. Efavirenz se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje bolesnice ne zahtijeva takvo liječenje.
< 400 copies/ml 
< 400 kopija/ml
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). 
Bioraspoloživost jednokratne doze od 600 mg efavirenz tvrdih kapsula u nezaraženih dobrovoljaca porasla je 22% kada je lijek primjenjen s punomasnim obrokom, a 17% kada je primijenjen s normalnim obrokom u usporedbi s bioraspoloživošću doze od 600 mg primijenjene natašte (vidjeti dio 4.4).
Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus. 
U jednog ploda opažene su anencefalija i unilateralna anoftalmija sa sekundarnim povećanjem jezika, u drugog je zabilježena mikrooftalmija, a u trećega rascjep nepca.
if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin. 
ako ste nekada imali konvulzije (napadaje) ili se liječite antikonvulzivnim lijekovima kao što su karbamazepin, fenobarbital i fenitoin.
ANTICOAGULANTS Warfarin/Efavirenz Acenocoumarol/Efavirenz 
ANTIKOAGULANSI varfarin/efavirenz acenokumarol/efavirenz
Reproductive system and breast disorders uncommon gynaecomastia 
Poremećaji reproduktivnog sustava i dojki manje često ginekomastija
Other special populations 
Ostale posebne populacije bolesnika
SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. 
SUSTIVA je indicirana u kombiniranom antivirusnom liječenju odraslih, adolescenata i djece u dobi od 3 mjeseca i starijih te tjelesne težine od najmanje 3,5 kg, zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1).
PHARMACEUTICAL FORM Film-coated tablet 
Filmom obložena tableta
SUSTIVA is not recommeded for children under the age of 3 months or weighing less than 3.5 kg because it has not been adequately studied in these patients 
SUSTIVA se ne preporučuje za djecu mlađu od 3 mjeseca ili djecu tjelesne težine manje od 3,5 kg jer u tih bolesnika nije ispitan na odgovarajući način
No dose adjustment is necessary for any of these medicinal products. 
Nije potrebno prilagođavati dozu ni jednog od ovih lijekova.
Concomitant use of St. John's wort is contraindicated (see section 4.3). 
Istodobna primjena s gospinom travom je kontraindicirana (vidjeti dio 4.3).
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. 
Kako bi se olakšalo uklanjanje neapsorbiranog efavirenza može se primijeniti aktivni ugljen.
Table 5: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients 
Tablica 5: Predviđena farmakokinetika u stanju dinamičke ravnoteže efavirenza (kapsule/posipanje sadržaja kapsule) u pedijatrijskih bolesnika zaraženih HIV-om
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks. 
Simptomi živčanog sustava obično se pojavljuju na početku liječenja i u pravilu se smanjuju u prvih nekoliko tjedana.
MSD Α.Φ.Β.Ε.Ε Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com 
MSD Α.Φ.Β.Ε.Ε Τηλ: + 30 210 98 97 300 cora.greece.gragcm@merck.com
3.5 to < 5 
3,5 do < 5
Liver enzymes: elevations of AST and ALT to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5-8% after longterm treatment in study 006). 
Jetreni enzimi: povišene vrijednosti AST-a i ALT-a više od pet puta iznad gornje granice normale (GGN) opažene su u 3% od 1008 bolesnika liječenih efavirenzom u dozi od 600 mg (5-8% nakon dugotrajnog liječenja u ispitivanju 006).
The potential for cross resistance between efavirenz and PIs is low because of the different enzyme targets involved. 
Vrlo je mala vjerojatnost za križnu rezistenciju između efavirenza i inhibitora proteaze jer se vežu na različite ciljne enzime.
SUSTIVA contains lactose in each 600-mg daily dose. 
SUSTIVA sadrži laktozu u jednoj dnevnoj dozi od 600 mg.
AUC: ↓71% (↓67 to ↓74) Cmax: ↓51% (↓46 to ↓56) Cmin: ↓91% (↓88 to ↓92) Efavirenz: 
AUC: ↓ 71% (↓ 67 do ↓ 74) Cmax: ↓ 51% (↓ 46 do ↓ 56) Cmin: ↓ 91% (↓ 88 do ↓ 92) efavirenz:
cells/mm3 (S.E.M.d) 
stanica/mm3 (S.E.M.
Prophylaxis with appropriate antihistamines prior to initiating therapy with efavirenz in children may be considered. 
Može se razmotriti profilaksa odgovarajućim antihistaminicima prije početka liječenja djece efavirenzom.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
14. NAČIN PROPISIVANJA LIJEKA Lijek se izdaje na recept.
The median time on study therapy was 118 weeks; 25% of patients discontinued before Week 48. 
Medijan vremena provedenog u ispitivanom liječenju bio je 118 tjedana; 25% bolesnika prekinulo je liječenje prije 48. tjedna.
< 50 copies/ml 
< 50 kopija/ml
When efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily. 
Kad se efavirenz primjenjuje istodobno s vorikonazolom, doza održavanja vorikonazola mora se povisiti na 400 mg dvaput na dan, dok se doza efavirenza mora sniziti za 50%, tj. na 300 mg jedanput na dan.
20 to < 25 
20 do <25
Caution must be taken in any patient with a history of seizures. 
Nužan je oprez u svih bolesnika s napadajima u anamnezi.
Co-administraion 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 adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5). 
Istodobna primjena s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom niti ergot alkaloidima (npr. ergotaminom, dihidroergotaminom, ergonovinom i metilergonovinom) jer kompeticija efavirenza za CYP3A4 može uzrokovati inhibiciju metabolizma i stvoriti mogućnost pojave ozbiljnih i/ili po život opasnih nuspojava [npr. srčanih aritmija, produljene sedacije ili respiratorne depresije] (vidjeti dio 4.5).
Hepatic events 
Jetreni događaji
SUSTIVA film-coated tablets are not suitable for children weighing less than 40 kg. 
SUSTIVA filmom obložene tablete se ne preporučuju za djecu tjelesne težine manje od 40 kg.
No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of 
Nema utjecaja (↔) jednako smanjenje procjene srednje vrijednosti omjera od ≤20% ili povećanje procjene srednje vrijednosti omjera od
Efavirenz has been shown to be excreted in human milk. 
Efavirenz se izlučuje u majčino mlijeko u ljudi.
Cmax: ↔ 11% (CYP3A induction - effect on boceprevir) *0-8 hours 
AUC: ↔ 20% Cmax: ↔ 11% (indukcija CYP3A - utjecaj na boceprevir) *0-8 sati
Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3). 
Malformacije ploda opažene su i kod ženki majmuna koje su primale efavirenz (vidjeti dio 5.3).
Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures. 
U odraslih i pedijatrijskih bolesnika koji su uzimali efavirenz zabilježene su konvulzije, uglavnom u onih s poznatom anamnezom napadaja.
Your doctor may need to consider giving you a different anticonvulsant. 
Liječnik može razmotriti mogućnost primjene nekog drugog antikonvulziva.
Methadone (a medicine used to treat opiate addiction): your doctor may recommend an alternative treatment. 
metadon (lijek koji se koristi za liječenje ovisnosti o opijatima): liječnik će Vam možda preporučiti zamjensko liječenje.
7.5 to < 15 
7,5 do < 15
(CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin. 
Cmax: ↑ 11% (↑ 3 do ↑ 19) (indukcija CYP3A4) Osip se pojavio u 46% nezaraženih dobrovoljaca koji su primali efavirenz i klaritromicin.
Peak efavirenz plasma concentrations of 1.6 - 9.1 μM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers. 
Vršne koncentracije efavirenza u plazmi od 1,6-9,1 µM dostignute su u zdravih dobrovoljaca do 5 sati nakon jednokratne primjene oralnih doza lijeka od 100 do 1600 mg.
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. 
U randomiziranom, otvorenom ispitivanju 006 uspoređivao se učinak kombinacija efavirenz + zidovudin + lamivudin ili efavirenz + indinavir s kombinacijom indinavir + zidovudin + lamivudin u 1266 bolesnika koji prije ulaska u ispitivanje nisu primali efavirenz, lamivudin, NNRTI-je niti inhibitore proteaze.
The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI: 22-33%) and 79% (90% CI: 58-102%), respectively, when given with a high fat meal, relative to when given under fasted conditions (see section 4.4). 
Nakon primjene jednokratne doze od 600 mg efavirenz filmom obloženih tableta s punomasnim obrokom u nezaraženih dobrovoljaca AUC je porastao 28% (90% Cl: 22-33%), a Cmax 79% (90% Cl: 58-102%) u usporedbi s primjenom lijeka natašte (vidjeti dio 4.4).
PHARMACEUTICAL FORM AND CONTENTS 90 hard capsules: bottle 
4. FARMACEUTSKI OBLIK I SADRŽAJ 90 tvrdih kapsula: bočica 42 x 1 tvrda kapsula: blister
Information regarding post-marketing surveillance 
Podaci nakon stavljanja lijeka u promet
bone problems. 
tegobe s kostima.
Ear and labyrinth disorders uncommon tinnitus†, vertigo 
Poremećaji uha i labirinta manje često tinitus†, vrtoglavica
Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (see section 4.5). 
Istodobna primjena s elbasvirom (EBR) i grazoprevirom (GZR) zbog mogućeg značajnog smanjenja koncentracija elbasvira i grazoprevira u plazmi (vidjeti dio 4.5).
Indinavir: AUC: ↓ 25% (↓ 16 to ↓ 32) 
indinavir: AUC: ↓ 25% (↓ 16 do ↓ 32)
In a taste preference study in adults, SUSTIVA mixed with grape jelly received the best rating. 
pomiješana sa želeom od grožđa dobila je najviše ocjene.
15 to < 20 
15 do < 20
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. 
U ženki makaki majmuna koje su primale efavirenz zabilježene su malformacije u 3 od 20 plodova/novookoćenih majmuna pri koncentraciji efavirenza u plazmi sličnoj onoj u ljudi.
Concomitant administration of simeprevir with efavirenz resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir. 
Istodobna primjena simeprevira s efavirenzom rezultirala je značajnim smanjenjem koncentracija simeprevira u plazmi zbog indukcije CYP3A efavirenzom, što može rezultirati gubitkom terapijskog učinka simeprevira.
A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily. 
Slično smanjenje izloženosti indinaviru opaženo je kad se indinavir 1000 mg svakih 8h primjenjivao s efavirenzom 600 mg na dan. (indukcija CYP3A4) efavirenz:
Mean change from baseline-CD4 cell count 
Srednja vrijednost promjene od početnog broja CD4 stanica
If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily. 
Ako se efavirenz primjenjuje istodobno s vorikonazolom doza održavanja vorikonazola mora se povisiti na 400 mg svakih 12 sati, a doza lijeka efavirenz sniziti za 50%, tj. na dozu od 300 mg jedanput na dan.
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. 
SUSTIVA nije adekvatno ispitana u bolesnika s uznapredovalom HIV bolešću, odnosno u bolesnika s brojem CD4 <50 stanica/mm3 ili u onih u kojih nije uspjelo liječenje protokolima s inhibitorom proteaze (IP).
Cmax: ↓ 17% (↓ 6 to ↓ 26)b 
Cmax: ↓ 17% (↓ 6 do ↓ 26) b
Medicines used to treat malaria: artemether/lumefantrine: SUSTIVA may reduce the amount of artemether/lumefantrine in your blood. 
lijekove koji se koriste za liječenje malarije: artemeter/lumefantrin: SUSTIVA može smanjiti koncentraciju artemetera/lumefantrina u krvi atovakvon/progvanil: SUSTIVA može smanjiti koncentraciju atovakvona/progvanila u krvi.
No dose adjustment is necessary for efavirenz. 
Nije potrebno prilagođavati dozu efavirenza.
AUC: ↓ 17% Cmax: ↔ (CYP3A4 induction) 
AUC: ↓ 17% Cmax: ↔ (indukcija CYP3A4)
The administration of efavirenz 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). 
Primjena lijeka efavirenz s hranom može povećati izloženost efavirenzu (vidjeti dio 5.2) i može povećati učestalost nuspojava (vidjeti dio 4.8).
Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients Body Weight 
Tablica 4: Predviđena farmakokinetika u stanju dinamičke ravnoteže efavirenza (kapsule/posipanje sadržaja kapsule) u pedijatrijskih bolesnika zaraženih HIV-om
No clinically significant pharmacokinetic change. 
Nema klinički značajne farmakokinetičke promjene.
The net effect of coadministration is not clear. 
Neto učinak istodobne primjene nije razjašnjen.
Table 1: Interactions between efavirenz and other medicinal products in adults 
Tablica 1: Interakcije između efavirenza i drugih lijekova u odraslih Lijekovi po terapijskim područjima (doza)
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5). 
U ispitivanju interakcije lijekova istodobna primjena karbamazepina s efavirenzom snizila je koncentraciju karbamazepina u plazmi (vidjeti dio 4.5).
Rifabutin: AUC: ↓ 38% (↓ 28 to ↓ 47) 
rifabutin: AUC: ↓ 38% (↓ 28 do
Use in the paediatric population 
Primjena kod pedijatrijskih bolesnika
Efavirenz can be reinitiated in patients interrupting therapy because of rash. 
Moguće je ponovno započeti liječenje efavirenzom u bolesnika koji su ga zbog osipa prekinuli.
If you take too much SUSTIVA contact your doctor or nearest emergency department for advice. 
Ako uzmete više lijeka SUSTIVA nego što ste trebali Uzmete li previše lijeka SUSTIVA, javite se liječniku ili u najbližu hitnu službu radi savjeta.
In both studies, plasma progesterone levels for subjects receiving efavirenz and DMPA remained low consistent with suppression of ovulation. 
U oba su ispitivanja razine progesterona u plazmi za ispitanike koji su primali efavirenz i DMPA ostale niske, sukladno supresiji ovulacije.
Laboratory test abnormalities 
Promijenjeni laboratorijski nalazi
Efavirenz induced foetal resorptions in rats. 
U štakora je efavirenz inducirao resorpciju ploda.
Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (21/37) and 46% (17/37), respectively. 
Primjenom ITT analize, ukupan udio bolesnika s HIV RNK < 400 kopija/ml i < 50 kopija/ml u 48. tjednu bio je 57% (21/37), odnosno 46% (17/37).
Using an ITT analysis, the overall proportion of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (58/102) and 43% (44/102), respectively. 
Primjenom ITT analize, ukupan udio bolesnika s HIV RNK < 400 kopija/ml i < 50 kopija/ml u 48. tjednu bio je 57% (58/102), odnosno 43% (44/102).
Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz. 
Efiravenz može povisiti ili sniziti plazmatske koncentracije i učinke varfarina ili acenokumarola.
See also ritonavir row below. 
Vidjeti i navode za ritonavir, niže u tablici.
Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes) such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3). 
Kontraindicirana je istodobna primjena efavirenza s lijekovima (mogu uzrokovati produljenje QTc intervala i torsade de pointes) kao što su: antiaritmici skupina IA i III, neuroleptici i antidepresivi, pojedini antibiotici koji uključuju neke lijekove sljedećih skupina: makrolide, fluorokinolone; antimikotike koji sadrže imidazol i triazol, pojedine antihistaminike koji nemaju sedativno djelovanje (terfenadin, astemizol), cisaprid, flekainid, pojedine antimalarike i metadon (vidjeti dio 4.3).
Dark yellow, printed with "SUSTIVA" on the body and "200 mg" on the cap. 
Tamnožute, s otisnutom oznakom „SUSTIVA“ na tijelu i „200 mg“ na kapici.
Maraviroc: AUC12: ↓ 45% (↓ 38 to ↓ 51) 
maravirok: AUC12: ↓ 45% (↓ 38 do
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. 
Efavirenz filmom obložene tablete nisu prikladne za djecu čija je tjelesna težina manja od 40 kg.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172) and carnauba wax. 
Film ovojnica sadrži: hipromelozu (E464), titanijev dioksid (E171), makrogol 400, žuti željezov oksid (E172) i karnauba vosak.
What SUSTIVA looks like and contents of the pack SUSTIVA 200 mg hard capsules are supplied in bottles of 90 capsules and in packs containing 42 x 1 capsules in aluminium/PVC perforated unit dose blisters. 
SUSTIVA 200 mg tvrde kapsule dostupne su u bočici sa 90 kapsula te u pakiranju sa 42 x 1 kapsulom u aluminijskim/PVC perforiranim blisterima djeljivima na jedinične doze.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz. 
Osipi se obično javljaju u prva dva tjedna od početka liječenja efavirenzom u obliku blagih do umjerenih makulopapuloznih kožnih erupcija.
Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction) 
Cmin: ↓ 12% (↓ 24 do ↑ 1) (indukcija CYP3A4)
The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4. and 5.2). 
Povišene koncentracije efavirenza zapažene nakon primjene efavirenza uz hranu mogu povećati učestalost nuspojava (vidjeti dijelove 4.4 i 5.2).
Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2). 
Uzima li se efavirenz istodobno s hranom, mogući su učestaliji simptomi živčanog sustava, vjerojatno zbog povišene koncentracije lijeka u plazmi (vidjeti dio 5.2).
006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 2. 
U Tablici 2 prikazani su rezultati djelotvornosti lijekova u ispitivanju 006 za podskupinu od 614 bolesnika koji su bili uključeni u ispitivanje tijekom najmanje 48 tjedana.
Herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5). 
Biljni pripravci koji sadrže gospinu travu (Hypericum perforatum) jer njihova istodobna primjena može sniziti koncentraciju efavirenza u plazmi i smanjiti njegove kliničke učinke (vidjeti dio 4.5).
ANTI-INFECTIVES HIV antivirals 
Hepatitis C antivirusni lijekovi
SUSTIVA 600 mg film-coated tablets efavirenz 
SUSTIVA 600 mg filmom obložene tablete efavirenz
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, lifethreatening events (see section 4.3). 
Efavirenz se ne smije primjenjivati istodobno s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ni ergot alkaloidima (npr. ergotamin, dihidroergotamin, ergonovin i metilergonovin) jer inhibicija njihovog metabolizma može uzrokovati ozbiljne i po život opasne štetne događaje (vidjeti dio 4.3).
Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4). 
Ne preporučuje se istodobna primjena s ekstraktima Ginkga bilobe (vidjeti dio 4.4).
three 100 mg capsules 
tri kapsule od 100 mg
Co-administration of efavirenz and St. John's wort or herbal preparations containing St. John's wort is contraindicated. 
Istodobna primjena efavirenza i gospine trave ili biljnih pripravaka koji sadrže gospinu travu je kontraindicirana.
Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive. 
Ispitivanje PACTG 1021 bilo je otvoreno ispitivanje za procjenu farmakokinetike, sigurnosti, podnošljivosti i antivirusnog djelovanja lijeka SUSTIVA u kombinaciji s didanozinom i emtricitabinom u pedijatrijskih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima.
It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime. 
Preporučuje se uzimati lijek SUSTIVA na prazan želudac, po mogućnosti prije spavanja.
Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively. 
Primjenom ITT analize, ukupan udio bolesnika s HIV RNK < 400 kopija/ml i < 50 kopija/ml u 48. tjednu bio je 77% (33/43), odnosno 70% (30/43).
Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg once daily/600 mg once daily) 
Selektivni inhibitori ponovne pohrane serotonina (SSRI) sertralin/efavirenz (50 mg jedanput na dan/600 mg jedanput na dan)
Cmin: ↓ 86% (↓ 80 to ↓ 90) (induction of metabolism) Efavirenz: no clinically significant interaction. 
Cmax: ↓ 80% (↓ 77 do ↓ 83) Cmin: ↓ 86% (↓ 80 do ↓ 90) (indukcija metabolizma) efavirenz: nema klinički značajnih interakcija.
Elevations of GGT to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5-2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment). 
Porast vrijednosti GGT-a više od pet puta iznad GGN zabilježen je u 4% svih bolesnika koji su primali efavirenz u dozi od 600 mg i u 1,5-2% bolesnika liječenih kontrolnim protokolom (nakon dugotrajnog liječenja u 7% ispitanika koji su primali efavirenz i u 3% ispitanika u kontrolnom protokolu).
A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6). 
Uz hormonske kontraceptive mora se koristiti pouzdana mehanička metoda kontracepcije (vidjeti dio 4.6).
Efavirenz is a NNRTI of HIV-1. 
Efavirenz je nenukleozidni inhibitor reverzne transkriptaze (NNRTI) HIV-1 virusa.
Efavirenz: AUC: ↓ 26% (↓ 15 to ↓ 36) 
efavirenz: AUC: ↓ 26% (↓ 15 do