FrancophonIA/ELRC3.0 huggingface dataset:
English: A multiple-dose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Slovenian: 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.
English: Rash was more common in children than in adults treated with efavirenz.
Slovenian: Izpuščaj se je pojavljal bolj pogosto pri otrocih kakor pri odraslih, zdravljenih z efavirenzom.
English: Phenytoin, phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Slovenian: fenitoin, fenobarbital in drugi antikonvulzivi, ki so substrati izoencimov CYP450
English: 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.
Slovenian: 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.
English: †These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Slovenian: 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).
English: 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).
Slovenian: 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
English: 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).
Slovenian: 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).
English: Uncommon Erythema multiforme, Stevens-Johnson syndrome* Rare
Slovenian: pogosti srbenje občasni multiformni eritem, Stevens-Johnsonov sindrom*
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,
English: 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.
Slovenian: 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.
English: Efavirenz Teva taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Slovenian: Zdravilo Efavirenz Teva v kombinaciji z drugimi protiretrovirusnimi zdravili zmanjšuje količino virusa v krvi.
English: Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Slovenian: Zdravilo Efavirenz Teva je treba dajati v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
English: EFV + NRTIs NFV + NRTIs Study 020
Slovenian: EFV + NFV + NRTI-ji EFV + NRTI-ji NFV + NRTI-ji Študija 020
English: (S.E.M.d)
Slovenian: (S.N.P.d)
English: 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.
Slovenian: Pokazalo se je, da efavirenz inducira CYP3A4 in CYP2B6, s čimer povzroči indukcijo svoje lastne presnove, kar je lahko pri nekaterih bolnikih klinično pomembno.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Slovenian: Zdravilo Efavirenz Teva, ki vsebuje učinkovino efavirenz, spada v razred protiretrovirusnih zdravil, imenovanih nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
English: Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Slovenian: Več kot 100-kratno izgubo dovzetnosti so opazili proti HIV različicam, ki so imele poleg drugih aminokislinskih substitucij na
English: NNRTIs/efavirenz
Slovenian: NNRTI /efavirenz
English: Film-coated tablet Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other
Slovenian: Rumene filmsko obložene tablete, v obliki kapsule z oznako "Teva" na eni strani in številko "7541" na drugi strani.
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine and tenofovir disoproxil.
Slovenian: Specifičnih študij interakcij z efavirenzem in zdravili NRTI, razen z lamivudinom, zidovudinom in dizoproksiltenofoviratom, niso opravili.
English: Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Slovenian: Podobna povišanja so opazili tudi pri bolnikih na kontrolnem režimu (5 %
English: 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).
Slovenian: 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).
English: - Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
Slovenian: - Sertralin (zdravilo za zdravljenje depresije): zdravnik vam bo morda spremenil odmerek sertralina.
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.
English: What you need to know before you take Efavirenz Teva Do NOT take Efavirenz Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Efavirenz Teva NE jemljite zdravila Efavirenz Teva
English: Skin and subcutaneous tissue disorders Very common Rash (11.6%)*
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni akutni hepatitis redki odpoved jeter‡,* Bolezni kože in podkožja zelo pogosti izpuščaj (11,6 %)*
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: 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).
Slovenian: 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,
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 (zdravilo za preprečevanje strjevanja krvi): zdravnik vam bo morda moral prilagoditi odmerek varfarina ali acenokumarola.
English: As a result, the amounts of Efavirenz Teva or other medicines in your blood may be affected.
Slovenian: Posledično se lahko spremeni količina zdravila Efavirenz Teva ali drugih zdravil v krvi.
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Slovenian: 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.
English: - 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.
Slovenian: - 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.
English: If you see any signs of a severe rash with blistering or fever, stop taking Efavirenz Teva and tell your doctor at once.
Slovenian: Če opazite kateri koli znak hudega izpuščaja z mehurji ali zvišano telesno temperaturo, prenehajte jemati zdravilo Efavirenz Teva in se takoj posvetujte z zdravnikom.
English: Clinically significant interactions are not expected since vigabatrin and
Slovenian: Klinično pomembnih interakcij ni pričakovati,
English: Study number/ Treatment regimensb n % (95% C.I.c) % (95% C.I.c) cells/mm3
Slovenian: Številka študije/ režimi zdravljenja b n % (95-odstotni IZ c)
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 začetkom študije še niso smeli zdraviti z efavirenzem, lamivudinom, NNRTI ali ZP.
English: (CYP3A4 induction) * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Slovenian: (indukcija CYP3A4) *v primerjavi z atazanavirjem 300 mg/ ritonavirjem 100 mg enkrat na dan zvečer brez efavirenza.
English: The most notable unwanted effects reported with efavirenz in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
Slovenian: 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.
English: Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz.
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z efavirenzem opraviti nosečnostni test.
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 uporabljenih zdravil in rastlinski pripravek (šentjanževka), zaradi katerih lahko pride do resnih interakcij.
English: Atazanavir (pm):
Slovenian: atazanavir (popoldne):
English: If
Slovenian: Ko
English: Efavirenz Teva film-coated tablets are not recommended for children under the age of 3 years or weighing less than 40 kg.
Slovenian: Uporaba zdravila Efavirenz Teva filmsko obložene tablete ni priporočljiva pri otrocih, mlajših od 3 let ali lažjih od 40 kg.
English: Efficacy results for study
Slovenian: Rezultati učinkovitosti za študijo 006
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored.
Slovenian: je zdravljenje z vorikonazolom končano, je potrebno ponovno uvesti začetni odmerek efavirenza.
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: triazole antifungal agents certain antimalarial treatments methadone (used to treat opiate addiction)
Slovenian: triazolske antimikotike določene antimalarike metadon (uporablja se za zdravljene odvisnosti od opiatov)
English: The net effect of coadministration is not clear
Slovenian: Skupni učinek sočasne uporabe ni jasen.
English: White opaque PVC/PVdC-aluminium or aluminium-aluminium blisters in a carton containing 30 or 90 film-coated tablets.
Slovenian: Bel, prozoren PVC/PVdC-aluminij ali aluminij-aluminij pretisni omot v škatli, ki vsebuje po 30 ali 90 filmsko obloženih tablet.
English: (Decrease in itraconazole concentrations: CYP3A4 induction)
Slovenian: (zmanjšanje koncentracij itrakonazola: indukcija CYP3A4)
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, je malo (glejte poglavje 4.8).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKERBE IN UPORABE
English: 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.
Slovenian: Pri bolnikih, okuženih s HIV-1 (n = 9), ki so vsaj en mesec dobivali 200 do 600 mg efavirenza enkrat na dan, je bila njegova koncentracija v cerebrospinalni tekočini v območju od 0,26
English: The film-coating agent contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin and iron oxide yellow.
Slovenian: Filmska obloga: hipromeloza, laktoza monohidrat, titanov dioksid, makrogol/PEG 3350, triacetin in rumeni železov oksid.
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).
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Efavirenz Teva.
Slovenian: Zato morate upoštevati zgoraj opisana navodila glede kontracepcije še 12 tednov po prenehanju zdravljenja z zdravilom Efavirenz Teva.
English: Contents of the pack and other information What Efavirenz Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Efavirenz Teva
English: The mechanism of the effect on velpatasvir is induction of CYP3A and CYP2B6 by efavirenz.
Slovenian: Mehanizem učinka na velpatasvir je indukcija CYP3A in CYP2B6
English: Mean AUC(0-24) µM·h
Slovenian: AUC(0-24)
English: Efavirenz Teva contains efavirenz and may cause dizziness, impaired concentration, and drowsiness.
Slovenian: Zdravilo Efavirenz Teva vsebuje efavirenz in lahko povzroči omotico, motnje koncentracije in zaspanost.
English: - Bupropion (a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
Slovenian: - Bupropion (zdravilo za zdravljenje depresije ali za pomoč pri prenehanju kajenja): zdravnik vam bo morda spremenil odmerek bupropiona.
English: EU/1/11/742/001 (30 x 1 - blister PVC/PVDC/alu) EU/1/11/742/002 (30 - blister PVC/PVDC/alu) EU/1/11/742/003 (90 - blister PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - blister alu/alu) EU/1/11/742/007 (30 - blister alu/alu) EU/1/11/742/008 (90 - blister alu/alu) EU/1/11/742/011 (90 x 1 - blister PVC/PVDC/alu)
Slovenian: EU/1/11/742/001 (30 x 1 - pretisni omot PVC/PVDC/alu) EU/1/11/742/002 (30 - pretisni omot PVC/PVDC/alu) EU/1/11/742/003 (90 - pretisni omot PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - pretisni omot alu/alu) EU/1/11/742/007 (30 - pretisni omot alu/alu) EU/1/11/742/008 (90 - pretisni omot alu/alu) EU/1/11/742/011 (90 x 1 - pretisni omot PVC/PVDC/alu)
English: Norbuprenorphine:
Slovenian: norbuprenorfin:
English: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Slovenian: Zdravilo Efavirenz je indicirano za kombinirano protivirusno zdravljenje odraslih, mladostnikov in otrok, starih tri leta ali več, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1).
English: 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).
Slovenian: Pri neokuženih prostovoljcih sta bili AUC in Cmax po enkratnem odmerku 600 mg filmsko obložene tablete efavirenza ob obroku z veliko maščobami povečani za 28 % (90-odstotni IZ: 22-33 %) oziroma 79 % (90-odstotni IZ: 58 - 102 %) v primerjavi z vrednostima na tešče (glejte poglavje 4.4).
English: - Medicines used to treat fungal infections (antifungals):
Slovenian: - Zdravila za zdravljenje glivičnih okužb (antimikotiki):
English: Each film-coated tablet contains 600 mg efavirenz.
Slovenian: Ena filmsko obložena tableta vsebuje 600 mg efavirenza.
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme, psychiatric adverse reactions including severe depression, death by suicide, and psychosis-like behaviour, and seizures have been reported in patients treated with efavirenz.
Slovenian: Pri bolnikih, zdravljenih z efavirenzem, so poročali o hudih kožnih reakcijah, kot sta Stevens-Johnsonov sindrom in multiformni eritem, o psihiatričnih neželenih učinkih, vključno s hudo depresijo, smrtjo zaradi samomora in vedenjem, podobnem psihozi, ter o krčih.
English: Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients
Slovenian: Preglednica 4: Predvidena farmakokinetika efavirenza v stanju dinamičnega ravnovesja (kapsule/posutje kapsul) pri pediatričnih bolnikih, okuženih z virusom HIV
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: Neželeni učinki na jetrih 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: How to store Efavirenz Teva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Efavirenz Teva Vsebina pakiranja in dodatne informacije
English: - itchy rash caused by a reaction to sunlight - liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Slovenian: - srbeč izpuščaj, ki nastane zaradi reakcije na sonce - odpoved jeter, ki je v določenih primerih smrtna ali vodi do presaditve jeter.
English: The potential for cross-resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Slovenian: Možnost navzkrižne rezistence med efavirenzem in zaviralci proteaze je majhna, ker pri tem sodelujejo različni tarčni encimi.
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 2ali 3-krat na teden v kombinaciji z efavirenzem, je treba po potrebi podvojiti odmerek rifabutina.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/efavirenz
Slovenian: IMUNOSUPRESIVI Imunosupresivi, ki se presnavljajo s CYP3A4 (npr. ciklosporin, takrolimus, sirolimus)/efavirenz
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 Registru nosečnic, ki so se med nosečnostjo zdravile s protiretrovirusnimi zdravili (Antiretroviral Pregnancy Registry - APR), prejeli prospektivna poročila o 904 nosečnostih, pri katerih so bile ženske v prvem trimesečju izpostavljene režimu zdravljenja z efavirenzem.
English: c S.E.M., standard error of the mean.
Slovenian: c IZ, interval zaupanja d S.N.P., standardna napaka povprečja.
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: Vkliničnih študijah se je kožni izpuščaj pojavil pri 26 % bolnikov, zdravljenih s 600 mg efavirenza, v primerjavi s 17 % bolnikov iz kontrolne skupine.
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section
Slovenian: Za oceno stopnje jetrne bolezni je treba periodično opravljati laboratorijske teste (glejte poglavje 4.2).
English: Other macrolide antibiotics (e.g. erythromycin)/efavirenz
Slovenian: Drugi makrolidni antibiotiki (npr. eritromicin)/efavirenz
English: Co-administration 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).
Slovenian: Sočasna uporaba s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin), ker bi kompeticija z efavirenzem za CYP3A4 lahko povzročila inhibicijo metabolizma in ustvarila možnost za resne in/ali življenje ogrožajoče neželene učinke [na primer srčne aritmije, podaljšano sedacijo ali depresijo dihanja] (glejte poglavje 4.5).