FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Študija 006, randomizirano, odprto preskušanje, je primerjala efavirenz + zidovudin + lamivudin ali efavirenz + indinavir z indinavirjem + zidovudinom + lamivudinom pri 1.266 bolnikih, ki se pred vstopom v študijo še niso smeli zdraviti z efavirenzem, lamivudinom, NNRTI ali ZP.
English: Medicinal product by therapeutic areas (dose)
Slovenian: Učinkovine po terapevtskih področjih (odmerek)
English: 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.
Slovenian: Pri virusnih izolatih, ki so jih dobili od PBMC-jev bolnikov, ki so sodelovali v kliničnih študijah efavirenza in pri katerih je bilo zdravljenje neuspešno (povratek virusnega bremena), so določili občutljivost na NNRTI-je.
English: Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy.
Slovenian: Pri zarodkih živali in pri otrocih žensk, ki so med nosečnostjo jemale efavirenz ali kombinirano zdravilo, ki vsebuje efavirenz, emtricitabin in tenofovir, so opazili resne prirojene okvare.
English: 10 Mix the capsule contents and food together (illustration e).
Slovenian: 10 Zmešajte vsebino kapsule s hrano (slika e).
English: Other special populations
Slovenian: Druge posebne populacije bolnikov
English: Each film-coated tablet contains 249.6 mg of lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 249,6 mg laktoze (v obliki monohidrata).
English: 32.5 to < 40
Slovenian: 32,5 do < 40
English: Efavirenz may cause dizziness, impaired concentration, and/or somnolence.
Slovenian: Efavirenz lahko povzroči omotico, motnje koncentracije in/ali zaspanost.
English: Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Slovenian: Pri prilagajanju odmerka je potrebno upoštevati posameznikovo prenašanje zdravila in virološki odziv (glejte poglavje 5.2).
English: ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, lifethreatening events (see section 4.3).
Slovenian: ergonovinom in metilergonovinom), ker zaviranje njihovega metabolizma lahko povzroči resne, življenje ogrožajoče neželene učinke (glejte poglavje 4.3).
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Slovenian: V študijah 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.
English: (CYP3A4 induction) Efavirenz:
Slovenian: (indukcija CYP3A4) efavirenz:
English: The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 months and 17 years of age is described in Table 1.
Slovenian: V kombinaciji z ZP in/ali NRTI-ji so priporočeni odmerki efavirenza za bolnike, stare od 3 mesecev do 17 let, navedeni v preglednici 1.
English: bone problems.
Slovenian: težave s kostmi.
English: Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container, stirring to make sure there is no drug residue remaining in the container, and have the child eat the full amount again.
Slovenian: V prazno posodo nato dodajte majhno količino hrane (približno 2 kavni žlički) in jo zmešajte ter tako poskrbite, da v posodi ni ostankov zdravila in da otrok poje vso hrano.
English: No data are available to make a dose recommendation.
Slovenian: Ker podatkov ni na voljo, ne moremo podati priporočila glede odmerjanja.
English: The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Slovenian: Dolgoročni profil varnosti zdravljenja s kombinacijami zdravil, ki so vključevale efavirenz, so ocenjevali v nadzorovanem preizkušanju (006), v katerem so bolniki prejemali efavirenz + zidovudin + lamivudin (n = 412, mediana vrednost časa trajanja 180 tednov), efavirenz + indinavir (n = 415, mediana vrednost časa trajanja 102 tedna) ali indinavir + zidovudin + lamivudin (n = 401, mediana vrednost časa trajanja 76 tednov).
English: Efavirenz has been shown to be excreted in human milk.
Slovenian: Pokazalo se je, da se efavirenz izloča v materino mleko pri človeku.
English: Pregnancies have occurred in women taking SUSTIVA while using a contraceptive implant, although it has not been established that the SUSTIVA therapy caused the contraceptive to fail.
Slovenian: Nekatere ženske, ki so med uporabo kontracepcijskega vsadka jemale zdravilo SUSTIVA, so zanosile, kljub temu da ni bilo dokazano, da zdravljenje z zdravilom SUSTIVA prepreči delovanje kontraceptiva.
English: Metabolic parameters
Slovenian: Presnovni parametri
English: 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.
Slovenian: Dolgoročni rezultati po 168 tednih študije 006 (študijo je zaključilo 160 bolnikov, zdravljenih z EFV + IDV, 196 bolnikov, zdravljenih z EFV + ZDV + 3TC, in 127 bolnikov, zdravljenih 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.
English: When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored (see section 4.5).
Slovenian: Ko je zdravljenje z vorikonazolom končano, je treba ponovno uvesti začetni odmerek efavirenza (glejte poglavje 4.5).
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Slovenian: Če se efavirenz uporablja v kombinaciji z darunavirjem/ritonavirjem, je treba uporabiti režim odmerjanja darunavir/ritonavir 600/100 mg dvakrat na dan.
English: Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited (see section 4.8).
Slovenian: Izkušenj z efavirenzem pri bolnikih, ki so prenehali z zdravljenjem z drugimi protiretrovirusnimi zdravili iz razreda NNRTI-jev, je malo (glejte poglavje 4.8).
English: They include some common medicines and a herbal remedy (St. John's wort) which can cause serious interactions.
Slovenian: Mednje je vključenih nekaj pogosto uporabljanih zdravil in rastlinski pripravek (šentjanževka), zaradi katerih lahko pride do resnih interakcij.
English: two 200 mg capsules one 600 mg tablet OR three 200 mg capsules
Slovenian: dve 200 mg kapsuli ena 600 mg tableta ALI tri 200 mg kapsule
English: Physicians were allowed to change their patient's NRTI regimen upon entry into the study.
Slovenian: Zdravniki so ob vključitvi bolnika v študijo smeli zamenjati NRTI-režim.
English: 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).
Slovenian: 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).
English: 20 to < 25
Slovenian: 20 do < 25
English: MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
Slovenian: Danmark MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Slovenian: Pri sočasni uporabi z efavirenzem je treba po potrebi zvišati odmerek lopinavir/ritonavir mehkih kapsul ali peroralne raztopine za 33 % (4 kapsule/~6,5 ml dvakrat na dan, namesto 3 kapsule/5 ml dvakrat na dan).
English: 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.
Slovenian: 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; te bolnike je treba spremljati v skladu z utečeno prakso.
English: If you notice any symptoms of infection, please tell your doctor immediately.
Slovenian: Če opazite kakršne koli znake okužbe, prosimo, da to takoj poveste svojemu zdravniku.
English: uncommon hepatitis acute rare hepatic failure‡,*
Slovenian: občasni akutni hepatitis redki odpoved jeter
English: Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
Slovenian: Zdravnik vam bo po potrebi lahko predpisal drugo zdravilo ali spremenil odmerek zaviralcev proteaze.
English: Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Slovenian: Ker se efavirenz močno veže na proteine, je malo verjetno, da bi z dializo iz krvi lahko odstranili znatnejšo količino efavirenza.
English: Glecaprevir/pibrentasvir
Slovenian: glekaprevir/pibrentasvir
English: UNIQUE IDENTIFIED - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: On the basis of the scientific conclusions for efavirenz the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing efavirenz is unchanged subject to the proposed changes to the product information
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za efavirenz odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) efavirenz nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: 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.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - “combination antiretroviral therapy”) lahko nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: A few of the postmarketing reports of hepatic failure occurred in patients with no pre-existing hepatic disease or other identifiable risk factors (see section 4.8).
Slovenian: O odpovedi jeter so v obdobju trženja zdravila nekajkrat poročali tudi pri bolnikih brez predhodne bolezni jeter ali drugih odkritih dejavnikov tveganja (glejte poglavje 4.8).
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Slovenian: Efavirenz v kombinaciji z darunavirjem/ritonavirjem 800/100 mg enkrat na dan lahko povzroči suboptimalno Cmin darunavirja.
English: 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).
Slovenian: Povišanja GGT na več kot petkratno ZMN so opazili pri 4 % vseh bolnikov, zdravljenih s 600 mg efavirenza, in pri 1,5-2 % bolnikov, na kontrolnem režimu (po dolgotrajnem zdravljenju pri 7 % bolnikov, zdravljenih z efavirenzem, in 3 % bolnikov, na kontrolnem režimu).
English: Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Slovenian: Amilaze: v kliničnem preizkušanju so v podskupini 1.008 bolnikov asimptomatska zvišanja vrednosti serumskih amilaz, večja kot 1,5-kratna zgornja meja normalne vrednosti, opazili pri 10 % bolnikov, zdravljenih z efavirenzem, in pri 6 % bolnikov na kontrolnem režimu.
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 x 1 filmsko obloženih tablet
English: 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 4.4).
Slovenian: Farmakokinetike efavirenza pri bolnikih z ledvično insuficienco niso preučevali, vendar se manj kot 1 % odmerka efavirenza izloči nespremenjenega z urinom, tako da naj bi bil učinek ledvične okvare na izločanje efavirenza minimalen (glejte poglavje 4.4).
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Slovenian: Pri uporabi efavirenza so opazili podaljšanje intervala QTc (glejte poglavji 4.5 in 5.1).
English: No dose adjustment is necessary for raltegravir.
Slovenian: Prilagoditev odmerka raltegravirja ni potrebna.
English: Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week in combination with efavirenz.
Slovenian: Pri režimih, kjer se rifabutin daje 2- ali 3-krat na teden v kombinaciji z efavirenzem, je treba po potrebi podvojiti odmerek rifabutina.
English: Close monitoring of immunosuppressant concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz.
Slovenian: Na začetku ali ob prenehanju zdravljenja z efavirenzem priporočamo skrbno spremljanje koncentracij imunosupresiva vsaj 2 tedna (dokler niso dosežene stabilne koncentracije).
English: Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Slovenian: Spodaj so našteti zmerni ali resnejši neželeni učinki, katerih vzročna povezava z zdravljenjem je bila (s strani raziskovalca) ocenjena vsaj kot mogoča in so o njih poročali v kliničnih preskušanjih efavirenza pri priporočenem odmerku v kombiniranem zdravljenju (n = 1.008).
English: 1 Avoid giving the daily SUSTIVA dose within 1 hour after a feeding or meal.
Slovenian: 1Dnevnega odmerka zdravila SUSTIVA ne dajajte v 1uri po obroku.
English: In both studies, plasma progesterone levels for subjects receiving efavirenz and DMPA remained low consistent with suppression of ovulation.
Slovenian: V obeh študijah so pri osebah, ki so prejemale efavirenz in DMPA, plazemske vrednosti progesterona ostale nizke, tako da je bila ovulacija preprečena.
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or
Slovenian: Opazili so tudi substitucije na RT na položajih 98, 100, 101, 108, 138, 188, 190 ali 225, vendar redkeje in pogosto le v kombinaciji s K103N.
English: The reproductive performance of offspring born to female rats given efavirenz was not affected.
Slovenian: Zmožnost razmnoževanja potomcev podganjih samic, ki so dobivale efavirenz, ni bila prizadeta.
English: 6 With your hands over the container, hold the capsule with the cap facing up (see illustration b).
Slovenian: 6 Kapsulo držite nad posodo s hrano tako, da je pokrovček kapsule obrnjen navzgor (glejte sliko b).
English: In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
Slovenian: V študiji interakcij med zdravili so se plazemske koncentracije karbamazepina zmanjšale pri sočasni uporabi karbamazepina z efavirenzem (glejte poglavje 4.5).
English: Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital.
Slovenian: Zdravila za zdravljenje konvulzij/napadov krčev (antikonvulzivi): karbamazepin, fenitoin, fenobarbital.
English: LIST OF EXCIPIENTS It contains: lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje laktozo monohidrat.
English: Indigo carmine (E132)
Slovenian: Indigotin (E132)
English: 15 to < 20
Slovenian: 15 do < 20
English: Packs of 42 x 1 hard capsules in aluminium/PVC perforated unit dose blisters.
Slovenian: Škatle z 42 x 1 trdimi kapsulami v aluminijevih/PVC perforiranih pretisnih omotih za enkratne odmerke.
English: Dose adjustment
Slovenian: Prilagoditev odmerka
English: Hold the capsule with the cap facing up and pull the cap away from the body of the capsule.
Slovenian: Kapsulo držite tako, da je pokrovček kapsule obrnjen navzgor, nato pa ga ločite od telesa kapsule.
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 2).
Slovenian: Izpostavitev raltegravirju (substratu za UGT1A1) se v prisotnosti efavirenza zmanjša (glejte poglavje 4.5, Preglednica 2).
English: Medicines that impact heart rhythm: Medicines used to treat heart rhythm problems such as flecainide or metoprolol.
Slovenian: Zdravila, ki vplivajo na srčni ritem: zdravila za zdravljenje težav s srčnim ritmom: kot sta flekainid ali metoprolol.
English: 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).
Slovenian: Pripravki rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), zaradi nevarnosti znižanja plazemskih koncentracij in zmanjšanja kliničnih učinkov efavirenza (glejte poglavje 4.5).
English: Other macrolide antibiotics (e.g.,erythromycin)/Efavirenz
Slovenian: Drugi makrolidni antibiotiki (npr. eritromicin)/efavirenz
English: Warfarin or acenocoumarol (medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
Slovenian: Varfarin ali acenokumarol (zdravili za zmanjšanje strjevanja krvi): zdravnik vam bo morda moral prilagoditi odmerek varfarina ali acenokumarola.
English: In clinical studies, 26% of patients treated with 600 mg of efavirenz experienced skin rash compared with 17% of patients treated in control groups.
Slovenian: V kliničnih študijah se je kožni izpuščaj pojavil pri 26 % bolnikov, zdravljenih s 600 mg efavirenza, v primerjavi s 17 % bolnikov iz kontrolne skupine.
English: As of July 2013, the Antiretroviral Pregnancy Registry (APR) has received prospective reports of 904 pregnancies with first trimester exposure to efavirenz-containing regimens, resulting in 766 live births.
Slovenian: Od julija 2013 so v Register nosečnosti za protiretrovirusna zdravila (Antiretroviral Pregnancy Registry - APR) prejeli prospektivna poročila o 904 nosečnostih, pri katerih so bile ženske v prvem trimesečju izpostavljene režimu zdravljenja z efavirenzem.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (eg, cyclosporine, tacrolimus, sirolimus)/Efavirenz
Slovenian: IMUNOSUPRESIVI Imunosupresivi, ki se presnavljajo s CYP3A4 (npr. ciklosporin, takrolimus, sirolimus)/efavirenz
English: Dark yellow and white, printed with "SUSTIVA" on the dark yellow cap and "50 mg" on the white body.
Slovenian: Trde kapsule so temno rumene in bele barve in imajo napis »SUSTIVA« na temno rumenem delu in "50 mg" na belem.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for efavirenz, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za efavirenz je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART) lahko nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: Uncommon (affects 1 to 10 users in 1,000) nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts blurred vision a feeling of spinning or tilting (vertigo) pain in the abdomen (stomach) caused by inflammation of the pancreas allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome) yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver breast enlargement in males angry behaviour, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period) whistling, ringing or other persistent noise in the ears tremor (shaking) flushing
Slovenian: Občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov) razdražljivost, pozabljivost, zmedenost, napadi krčev, nenormalne misli zamegljen vid občutek vrtenja (vrtoglavica) bolečine v trebuhu (želodcu) zaradi vnetja trebušne slinavke alergijska reakcija (preobčutljivost), ki lahko povzroči hude kožne reakcije (multiformni eritem, Stevens-Johnsonov sindrom) porumenelost kože ali oči, srbenje ali bolečina v trebuhu (želodcu) zaradi vnetja jeter povečanje prsi pri moških jeza, vpliv na razpoloženje, videnje ali slišanje stvari, ki jih v resnici ni (halucinacije), manija (duševno stanje, za katerega so značilna obdobja povečane aktivnosti, vznesenosti ali razdražljivosti), paranoja, misli na samomor, katatonija (stanje pri katerem bolnik v nekem obdobju ostane negiben in onemel) piskanje, zvonjenje ali drugi nenehni zvoki v ušesih tremor (tresenje) zardevanje
English: Cochineal carminic acid (E120)
Slovenian: Karminska kislina (E120)
English: Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Slovenian: Rezultate učinkovitosti v študijah ACTG 364 in 020 prikazuje preglednica 4.
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 5 by weight ranges that correspond to the recommended doses.
Slovenian: Farmakokinetični parametri efavirenza v stanju dinamičnega ravnovesja pri pediatričnih bolnikih so bili predvideni s populacijskim modelom farmakokinetike in so povzeti v preglednici 5, razvrščeni po telesni masi, ki ustreza priporočenim odmerkom.
English: Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil is not recommended unless needed for dose adjustment (for example, with rifampicin).
Slovenian: Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in dizoproksiltenofovirat, ne priporočamo, razen če je to potrebno za prilagoditev odmerka (npr. z rifampicinom).