natgillin/translations-raw huggingface dataset:
Component of a multipack, can't be sold separately.
Pakiranje je del pakiranja z več enotami in se ne izdaja posamezno.
This medicine contains 9.98 mg lactose (as monohydrate) per tablet.
To zdravilo vsebuje 9,98 mg laktoze (v obliki monohidrata) na tableto.
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 indinavirja in efavirenza primerljivi s podatki za neokužene prostovoljce.
When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics.
Pri predpisovanju zdravil, ki se jemljejo hkrati z efavirenzem, mora zdravnik upoštevati ustrezni povzetek glavnih značilnosti zdravila.
If you take too much Efavirenz Teva, contact your doctor or nearest emergency department for advice.
Če vzamete preveč zdravila Efavirenz Teva, se posvetujte z zdravnikom ali z najbližjo urgenco.
The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 4 by weight ranges that correspond to the recommended doses of the capsules.
Pediatrična populacija Farmakokinetični parametri efavirenza v stanju dinamičnega ravnovesja pri pediatričnih bolnikih so bili predvideni s populacijskim modelom farmakokinetike in so povzeti v preglednici 4, razvrščeni po telesni masi, ki ustreza priporočenim odmerkom kapsul.
Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “q8h” or “q12h”).
Interakcije med efavirenzem in zaviralci proteaze, protiretrovirusnimi učinkovinami, ki niso zaviralci proteaze, in drugimi neprotiretrovirusnimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓”, brez spremembe z “↔”, ter enkrat na 8 ur oz. 12 ur z oznako “q8h” oz. “q12h”).
- Medicines that impact heart rhythm: Medicines used to treat heart rhythm problems: such as flecainide or metoprolol.
- Zdravila, ki vplivajo na srčni ritem: - zdravila za zdravljenje težav s srčnim ritmom: kot sta flekainid ali metoprolol.
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni 'brez natrija'.
Efavirenz has been studied in over 9,000 patients.
Povzetek profila varnosti Efavirenz so preučevali pri več kot 9.000 bolnikih.
(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
(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
- The dose for Efavirenz Teva may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Efavirenz Teva).
- Odmerek zdravila Efavirenz Teva bo morda treba povečati ali zmanjšati v primeru, da jemljete še kakšna druga zdravila (glejte poglavje Druga zdravila in zdravilo Efavirenz Teva).
- If you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.
- če imate hudo bolezen jeter - če imate bolezen srca, kot so sprememba ritma ali hitrosti bitja srca, počasen srčni utrip ali hudo bolezen srca.
What Efavirenz Teva is and what it is used for
Kaj je zdravilo Efavirenz Teva in za kaj ga uporabljamo
- severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
- huda oblika depresije - misel na samomor - samomorilni poskusi (ne smrtni) 0,4 % - agresivno vedenje - paranoidne reakcije
Teva, your doctor may need to adjust your dose of the calcium channel blocker.
Efavirenz Teva, vam bo zdravnik morda moral prilagoditi odmerek zaviralca kalcijevih kanalčkov.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
naj se v primeru teh simptomov izogibajo potencialno nevarnim opravilom, kakršna sta vožnja ali upravljanje strojev.
A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death.
V nekaj postmarketinških poročilih o odpovedi jeter, vključno s primeri pri bolnikih brez predhodne bolezni jeter ali drugih odkritih dejavnikov tveganja, je bil opisan tudi fulminantni potek, ki je v nekaterih primerih napredoval do transplatacije ali smrti.
- Medicines used to treat bacterial infections including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
- Zdravila za zdravljenje bakterijskih okužb, vključno s tuberkulozo in z AIDS-om povezano okužbo z Mycobacterium avium: klaritromicin, rifabutin, rifampicin.
Efavirenz is a NNRTI of HIV-1.
Mehanizem delovanja Efavirenz je NNRTI HIV-1.
- a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- anamnezo simptomatskih srčnih aritmij ali s klinično pomembno bradikardijo ali s kongestivnim srčnim popuščanjem skupaj z zmanjšanim iztisnim deležem levega prekata.
Table 1: Interactions between efavirenz and other medicinal products in adults
Interakcije med efavirenzem in drugimi zdravili pri odraslih
paranoia, psychosis†, suicide attempt, suicide ideation, catatonia*
halucinacije, manija, paranoja, psihoza†, poskus samomora, misli na samomor, katatonija*
It is recommended that efavirenz be taken on an empty stomach.
Priporočamo, da se efavirenz jemlje na prazen želodec.
Efavirenz Teva with food and drink
Zdravilo Efavirenz Teva skupaj s hrano in pijačo
- certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
- določeni antibiotiki, vključno z učinkovinami iz naslednjih razredov: makrolidi, fluorokinoloni,
(CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
(indukcija CYP3A4) Pri 46 % neokuženih prostovoljcih se je med jemanjem efavirenza in klaritromicina pojavil izpuščaj.
If you notice any symptoms of infection, please tell your doctor immediately.
Če opazite kakršne koli znake okužbe, prosimo, da to takoj poveste zdravniku.
Although the aetiology 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 in/ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
Each film-coated tablet contains 9.98 mg lactose (as monohydrate).
Ena filmsko obložena tableta vsebuje 9,98 mg laktoze (v obliki monohidrata).
If you have severe liver disease, do not take Efavirenz Teva (see section 2,
Če imate hudo bolezen jeter, ne jemljite zdravila Efavirenz Teva (glejte poglavje 2, NE jemljite zdravila Efavirenz Teva).
Taking Efavirenz Teva on an empty stomach may reduce the undesirable effects.
Jemanje zdravila Efavirenz Teva na tešče lahko zmanjša neželene učinke.
What Efavirenz Teva is and what it is used for What you need to know before you take Efavirenz Teva How to take Efavirenz Teva Possible side effects
Kaj je zdravilo Efavirenz Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Efavirenz Teva Kako jemati zdravilo Efavirenz Teva Možni neželeni učinki
If efavirenz and telaprevir are coadministered, telaprevir 1,125 mg every 8 hours should be used.
Pri sočasni uporabi efavirenza in telaprevirja je treba uporabiti telaprevir v odmerku 1,125 mg vsakih 8 ur.
- Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy, breast-feeding and fertility).
- Hormonske kontraceptive, kot so kontracepcijske tablete, kontraceptivi v obliki injekcij (na primer Depo-Provera) ali kontracepcijski vsadki (na primer Implanon): uporabljati morate tudi zanesljivo mehansko obliko kontracepcije (glejte Nosečnost in dojenje).
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 je majhna zaradi različnih vezavnih mest in različnega mehanizma delovanja.
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Other formulations are available for these patients.
Zdravilo Efavirenz filmsko obložene tablete niso primerne za otroke, katerih telesna teža je manj kot 40 kg. Za te bolnike so na voljo druge formulacije.
Injection:
injekcija).
Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking another NNRTI.
Efavirenza ne priporočamo bolnikom, ki so imeli med jemanjem drugega NNRTI življenje ogrožajočo reakcijo na koži (npr. Stevens-Johnsonov sindrom).
(Inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
(zaviranje oksidativne presnove, pri kateri sodelujejo encimi CYP) Kadar so efavirenz dajali skupaj s 500 mg ali 600 mg ritonavirja dvakrat na dan, bolniki te kombinacije niso dobro prenašali (pojavili so se na primer omotica, navzea, parestezija in zvišane vrednosti jetrnih encimov).
In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
V podskupini 1.008 odraslih bolnikov, ki so v nadzorovanih kliničnih študijah prejemali dnevno 600 mg efavirenza v kombinaciji z ZP-ji in/ali NRTI-ji, so bili najpogostejši neželeni učinki, ki so bili vsaj zmerne jakosti in so o njih poročali pri vsaj 5 % bolnikov: izpuščaj (11,6 %), omotica (8,5 %), navzea (8,0 %), glavobol (5,7 %) in utrujenost
Efavirenz may be an inducer of CYP2C19 and CYP2C9; however inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Efavirenz morda inducira CYP2C19 in CYP2C9, vendar so opazili tudi inhibicijo in vitro, in zato skupni učinek sočasne uporabe s substrati za ta encima ni jasen (glejte poglavje 5.2).
30 film-coated tablets 30 x 1 film-coated-tablets 90 x 1 film-coated tablets 90 film-coated tablets
30 filmsko obloženih tablet 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 90 filmsko obloženih tablet
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Dva od treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
Evening Cmax: ↔
Cmax zvečer: ↔
Frequency is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to
Pogostnost je definirana z uporabo sledečega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000)
Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 1).
Izpostavitev raltegravirju (substratu za UGT1A1) se v prisotnosti efavirenza zmanjša (glejte poglavje 4.5, Preglednica 1).
A multiple-dose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Študija z večkratnim odmerjanjem ni pokazala nobenega pomembnega učinka na farmakokinetiko efavirenza pri bolnikih z blago okvaro jeter (razred A po Child Pugh-u) v primerjavi s kontrolno skupino.
Rash was more common in children than in adults treated with efavirenz.
Izpuščaj se je pojavljal bolj pogosto pri otrocih kakor pri odraslih, zdravljenih z efavirenzom.
Phenytoin, phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
fenitoin, fenobarbital in drugi antikonvulzivi, ki so substrati izoencimov CYP450
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
Čeprav navzkrižna rezistenca efavirenza z ZP ni dokumentirana, trenutno nimamo dovolj podatkov o učinkovitosti uporabe kombiniranega zdravljenja, ki vključuje ZP, po neuspelem zdravljenju z režimom, ki je vključeval tudi zdravilo efavirenz.
†These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Informacije pridobljene v času trženja zdravila †Te neželene učinke so odkrili med spremljanjem zdravila na trgu; vendar pa so bile pogostnosti določene z uporabo podatkov iz 16 kliničnih preskušanj (n = 3.969).
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).
dnevni večkratni odmerki 200 - 400 mg na dan povzročili manjšo akumulacijo zdravila od pričakovane (22 - 42 % manjšo) in krajši končni razpolovni čas v primerjavi z enkratnim odmerkom
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 long-term treatment in study 006).
Jetrni encimi: povišanje (AST) in (ALT) na več kot petkratno zgornjo mejo normalnih vrednosti (ZMN) so opazili pri 3 % od 1.008 bolnikov, zdravljenih s 600 mg efavirenza (5-8 % po dolgotrajnem zdravljenju v študiji 006).
Uncommon Erythema multiforme, Stevens-Johnson syndrome* Rare
pogosti srbenje občasni multiformni eritem, Stevens-Johnsonov sindrom*
In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
V študijah in vitro efavirenz ni inhibiral CYP2E1; CYP2D6 in CYP1A2 pa je inhibiral šele pri koncentracijah, ki so bile precej višje od tistih,
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 nadzorovani študiji (006 in ACTG 364) z efavirenzem v kombinaciji z NRTI 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 okuženih bolnikih, ki še niso prejemali protiretrovirusnih zdravil in tistih, ki so že bili zdravljeni z NRTI.
Efavirenz Teva taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Zdravilo Efavirenz Teva v kombinaciji z drugimi protiretrovirusnimi zdravili zmanjšuje količino virusa v krvi.
Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Zdravilo Efavirenz Teva je treba dajati v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
EFV + NRTIs NFV + NRTIs Study 020
EFV + NFV + NRTI-ji EFV + NRTI-ji NFV + NRTI-ji Študija 020
(S.E.M.d)
(S.N.P.d)
Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism which may be clinically relevant in some patients.
Pokazalo se je, da efavirenz inducira CYP3A4 in CYP2B6, s čimer povzroči indukcijo svoje lastne presnove, kar je lahko pri nekaterih bolnikih klinično pomembno.
Efavirenz Teva is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
Če boste začeli z jemanjem zdravila Efavirenz Teva zato, ker dosedanji način zdravljenja ni preprečil razmnoževanja virusa, morate hkrati začeti jemati tudi drugo protivirusno zdravilo, ki ga do sedaj še niste jemali.
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 malo podatkov kaže, da je lahko tako pri ženskah kot pri bolnikih iz Azije ali s Pacifiških otokov izpostavljenost efavirenzu večja, izgleda da ti bolniki zdravila ne prenašajo nič slabše.
Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Zdravilo Efavirenz Teva, ki vsebuje učinkovino efavirenz, spada v razred protiretrovirusnih zdravil, imenovanih nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Več kot 100-kratno izgubo dovzetnosti so opazili proti HIV različicam, ki so imele poleg drugih aminokislinskih substitucij na
NNRTIs/efavirenz
NNRTI /efavirenz
Film-coated tablet Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other
Rumene filmsko obložene tablete, v obliki kapsule z oznako "Teva" na eni strani in številko "7541" na drugi strani.
Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine and tenofovir disoproxil.
Specifičnih študij interakcij z efavirenzem in zdravili NRTI, razen z lamivudinom, zidovudinom in dizoproksiltenofoviratom, niso opravili.
Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Podobna povišanja so opazili tudi pri bolnikih na kontrolnem režimu (5 %
Among co-infected patients, 3% of those treated with efavirenz and 2% in the control arm discontinued because of liver disorders (see section 4.4).
Med sočasno okuženimi bolniki je 3 % tistih, ki so jemali efavirenz, in 2 % bolnikov iz kontrolne skupine prekinilo zdravljenje zaradi bolezni jeter (glejte poglavje 4.4).
- Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
- Sertralin (zdravilo za zdravljenje depresije): zdravnik vam bo morda spremenil odmerek sertralina.
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 študijah efavirenza in pri katerih je bilo zdravljenje neuspešno (povratek virusnega bremena), so določili občutljivost na NNRTI.
What you need to know before you take Efavirenz Teva Do NOT take Efavirenz Teva
Kaj morate vedeti, preden boste vzeli zdravilo Efavirenz Teva NE jemljite zdravila Efavirenz Teva
Skin and subcutaneous tissue disorders Very common Rash (11.6%)*
Bolezni jeter, žolčnika in žolčevodov občasni akutni hepatitis redki odpoved jeter‡,* Bolezni kože in podkožja zelo pogosti izpuščaj (11,6 %)*
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).
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).
If you could get pregnant while receiving Efavirenz Teva, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Če med jemanjem zdravila Efavirenz Teva obstaja možnost zanositve, morate uporabljati zanesljivo mehansko kontracepcijo (na primer kondom) skupaj z drugimi metodami kontracepcije, vključno s peroralno kontracepcijo (tableto) ali drugimi hormonskimi kontraceptivi (na primer vsadki,
- Warfarin or acenocoumarol (medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
- Varfarin ali acenokumarol (zdravilo za preprečevanje strjevanja krvi): zdravnik vam bo morda moral prilagoditi odmerek varfarina ali acenokumarola.
As a result, the amounts of Efavirenz Teva or other medicines in your blood may be affected.
Posledično se lahko spremeni količina zdravila Efavirenz Teva ali drugih zdravil v krvi.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na stični ovojnini in škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- Efavirenz Teva film-coated tablets are not suitable for children weighing less than 40 kg. - The dose for children weighing 40 kg or more is 600 mg once daily.
- Filmsko obložene tablete Efavirenz Teva niso namenjene otrokom, ki tehtajo manj kot 40 kg. - Odmerek za otroke, težke 40 kg ali več, je 600 mg enkrat na dan.
If you see any signs of a severe rash with blistering or fever, stop taking Efavirenz Teva and tell your doctor at once.
Če opazite kateri koli znak hudega izpuščaja z mehurji ali zvišano telesno temperaturo, prenehajte jemati zdravilo Efavirenz Teva in se takoj posvetujte z zdravnikom.
Clinically significant interactions are not expected since vigabatrin and
Klinično pomembnih interakcij ni pričakovati,
Study number/ Treatment regimensb n % (95% C.I.c) % (95% C.I.c) cells/mm3
Številka študije/ režimi zdravljenja b n % (95-odstotni IZ c)
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.
Študija 006, randomizirano, odprto preskušanje, je primerjala efavirenz + zidovudin + lamivudin ali efavirenz + indinavir z indinavirjem + zidovudinom + lamivudinom pri 1.266 bolnikih, ki se pred začetkom študije še niso smeli zdraviti z efavirenzem, lamivudinom, NNRTI ali ZP.
(CYP3A4 induction) * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
(indukcija CYP3A4) *v primerjavi z atazanavirjem 300 mg/ ritonavirjem 100 mg enkrat na dan zvečer brez efavirenza.
The most notable unwanted effects reported with efavirenz in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
Najbolj opazni neželeni učinki, o katerih so poročali pri zdravilu Efavirenz Teva v kombinaciji z drugimi zdravili proti HIV, so kožni izpuščaji in simptomi, povezani z boleznimi živčevja.