FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
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).
English: Refer to the prescribing information for sofosbuvir/velpatasvir for more information.
Slovenian: Za več informacij glejte navodila za predpisovanje sofosbuvira/velpatasvira.
English: NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIBITOR Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Slovenian: Zaviralec ponovnega privzema noradrenalina in dopamina bupropion/efavirenz [150 mg enkratni odmerek (podaljšano sproščanje)/600 mg enkrat na dan]
English: Mean change from baseline-CD4 cell count
Slovenian: Povprečna sprememba od začetne vrednosti CD4
English: Artemether/lumefantrine/ Efavirenz (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Slovenian: Antimalariki artemeter/lumefantrin/ efavirenz (20/120 mg tablete, 6 odmerkov po 4 tablete v 3 dneh /600 mg enkrat na dan)
English: * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Slovenian: 300 mg/ritonavirjem 100 mg enkrat na dan zvečer brez efavirenza.
English: Ear and labyrinth disorders uncommon tinnitus†, vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni tinitus‡, vertigo
English: one 200 mg capsule
Slovenian: ena 200 mg kapsula
English: How to take SUSTIVA
Slovenian: Kako jemati zdravilo SUSTIVA
English: QT Prolonging Drugs
Slovenian: Zdravila, ki podaljšajo interval QT
English: It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
Slovenian: Priporočamo, da se efavirenz jemlje na prazen želodec, po možnosti zvečer pred spanjem.
English: Velpatasvir/ sofosbuvir/ voxilaprevir
Slovenian: velpatasvir/sofosbuvir/voksilaprevir ↓velpatasvir ↓voksilaprevir
English: 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).
Slovenian: Sočasna uporaba efavirenza skupaj z elbasvirom in grazoprevirom, saj obstaja možnost pomembnega zmanjšanja koncentracije elbasvira in grazoprevira v plazmi (glejte poglavje 4.5).
English: Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug metabolising enzymes and/or transport proteins by St. John's wort.
Slovenian: Sočasna uporaba šentjanževke lahko zmanjša koncentracije efavirenza v plazmi, ker šentjanževka inducira encime, ki presnavljajo zdravilo in/ali transportne proteine.
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Slovenian: Poleg hormonskih kontraceptivov je treba uporabljati tudi zanesljivo mehansko metodo kontracepcije (glejte poglavje 4.6).
English: At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.
Slovenian: Ob izhodišču so imeli mediano plazemsko HIV-1 RNA 5,88 log10 kopij/ml, mediana števila celic CD4+ je bila 1144 celic/mm3 in mediana odstotka CD4+ je bila 25 %.
English: Lopinavir concentrations: ↓ 30-40% Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Slovenian: Koncentracije lopinavirja: podobne kot pri lopinavirju/ritonavirju 400/100 mg dvakrat na dan brez efavirenza
English: The daily dose of rifabutin should be increased by 50% when administered with efavirenz.
Slovenian: Pri sočasni uporabi z efavirenzem je treba dnevni odmerek rifabutina povečati za 50 %.
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg once daily/600 mg once daily)
Slovenian: Selektivni zaviralci ponovnega privzema serotonina (SSRI) sertralin/efavirenz (50 mg enkrat na dan/600 mg enkrat na dan)
English: Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm3, or in PI or NNRTI experienced patients.
Slovenian: Efavirenza niso preučevali v nadzorovanih študijah pri bolnikih z napredovalo boleznijo HIV, to je pri bolnikih s CD4 < 50 celic/mm3, ali bolnikih, ki so se že zdravili z zaviralcem proteaze ali NNRTI.
English: Each SUSTIVA film-coated tablet contains 600 mg of the active substance efavirenz.
Slovenian: Ena filmsko obložena tableta SUSTIVA vsebuje 600 mg učinkovine efavirenza.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING CARTON TEXT FOR BLISTER INTERMEDIATE PACK, COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: BESEDILO NA KARTONSKI ŠKATLI ZA STIČNO OVOJNINO PRETISNIH OMOTOV, SESTAVNEM DELU MULTIPAKIRANJA (BREZ BLUE BOXA) 30 x 1 TABLET
English: Dose adjustment of buprenorphine or efavirenz may not be necessary when coadministered.
Slovenian: Pri sočasni uporabi prilagoditev odmerka buprenorfina ali efavirenza lahko ni potrebna.
English: Concomitant administration of glecaprevir/pibrentasvir with efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect.
Slovenian: Sočasna uporaba efavirenza in glekaprevira/pibrentasvira lahko pomembno zmanjša plazemsko koncentracijo glekaprevira in pibrentasvira, kar povzroči zmanjšan terapevtski učinek.
English: In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μM (29%) [mean ± S.D. (% C.V.)], steady state Cmin was 5.6 ± 3.2 μM (57%), and AUC was 184 ± 73 μM·h (40%).
Slovenian: Pri 35 bolnikih, ki so dobivali 600 mg efavirenza enkrat na dan, so bile v stanju dinamičnega ravnovesja Cmax 12,9 ± 3,7 µM (29 %) [povprečje ± S.D. (% C.V.)]
English: Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information.
Slovenian: Za več informacij glejte navodila za predpisovanje velpatasvira/sofosbuvira/ voksilaprevira.
English: Capsule core: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate
Slovenian: Jedro kapsule: natrijev lavrilsulfat, laktoza monohidrat, magnezijev stearat, natrijev karboksimetilškrob
English: Use of appropriate antihistamines and/or corticosteroids is recommended when efavirenz is restarted.
Slovenian: Pri ponovni uvedbi zdravljenja z efavirenzem pa priporočamo uporabo ustreznih antihistaminikov in/ali kortikosteroidov.
English: Recommendation concerning co-administration with efavirenz
Slovenian: Priporočilo glede sočasne uporabe z efavirenzem
English: At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Slovenian: Ob izhodišču so imeli mediano plazemsko HIV-1 RNA 4,8 log10 kopij/ml, mediana števila celic CD4+ je znašala 367 celic/mm in mediana odstotka CD4+ je znašala 18 %.
English: Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days (see section 4.5).
Slovenian: Na podlagi povezave med koncentracijo in QTc sta pri osebah z genotipom CYP2B6 *6/*6 po 14-dnevni uporabi dnevnega odmerka 600 mg povprečno podaljšanje QTc in zgornja meja njegovega 90-odstotnega intervala zaupanja 8,7 ms oziroma 11,3 ms (glejte poglavje 4.5).
English: You must remain under the care of your doctor while taking SUSTIVA.
Slovenian: Med jemanjem zdravila SUSTIVA morate ostati pod nadzorom zdravnika.
English: ZDV + 3TC
Slovenian: IDV + ZDV + 3TC 206
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Slovenian: Cmax: ↑ 11 % (↑ 3 do ↑ 19) (indukcija CYP3A4) Pri 46 % neokuženih prostovoljcih se je med jemanjem efavirenza in klaritromicina pojavil izpuščaj.
English: The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Slovenian: Pri zaužitju efavirenza skupaj s hrano se lahko poveča izpostavitev efavirenzu in lahko pride do večje pogostnosti neželenih učinkov (glejte poglavje 4.4).
English: Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Slovenian: V kliničnih študijah z efavirenzem so poročali o blagem do zmernem izpuščaju, ki je pri nadaljnjem zdravljenju običajno izginil.
English: 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.
Slovenian: V 48. tednu - pri uporabi analize ITT - je bil celotni delež bolnikov s HIV RNA < 400 kopij/ml 57 % (58/102) in celotni delež bolnikov s HIV RNA < 50 kopij/ml 43 % (44/102).
English: Ethinyloestradiol + Norgestimate/ Efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
Slovenian: HORMONSKI KONTRACEPTIVI peroralni: etinilestradiol+norgestimat/efavirenz (0,035 mg+0,25 mg enkrat na dan/ 600 mg enkrat na dan)
English: 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.
Slovenian: Zdravilo SUSTIVA je indiciran za kombinirano protivirusno zdravljenje odraslih, mladostnikov in otrok, starih tri mesece ali več in s telesno maso najmanj 3,5 kg, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1).
English: SUSTIVA can reduce or increase the amount of anticonvulsant in your blood.
Slovenian: Zdravilo SUSTIVA lahko zmanjša ali poveča količino zdravila proti krčem v krvi.
English: The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, and magnesium stearate.
Slovenian: Jedro tablete vsebuje še naslednje pomožne snovi: premrežen natrijev karmelozat, mikrokristalno celulozo, natrijev lavrilsulfat, hidroksipropilcelulozo, laktozo monohidrat in magnezijev stearat.
English: Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Slovenian: Jemanje efavirenza je treba prekiniti pri bolnikih, pri katerih se razvije hud izpuščaj, ki ga spremljajo mehurji, vlažno luščenje kože, ki prizadene tudi sluznico ali je prisotna zvišana telesna temperatura.
English: 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.
Slovenian: Pri sočasni uporabi efavirenza in vorikonazola je treba vzdrževalni odmerek vorikonazola povečati na 400 mg dvakrat na dan, odmerek efavirenza pa zmanjšati za 50 %, to je na 300 mg enkrat na dan.
English: A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
Slovenian: Pri jemanju indinavirja 1.000 mg q8h z efavirenzem 600 mg na dan so opazili podobno zmanjšanje izpostavljenosti indinavirju.
English: bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) midazolam or triazolam (used to help you sleep) pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole) triazole antifungal agents certain antimalarial treatments methadone (used to treat opiate addiction)
Slovenian: bepridil (za zdravljenje bolezni srca) cisaprid (za zdravljenje zgage) ergot alkaloide (kot na primer ergotamin, dihidroergotamin, ergonovin in metilergonovin) (za zdravljenje migrene in klaster glavobolov) midazolam ali triazolam (uporabljata se za lažje spanje) pimozid, imipramin, amitriptilin ali klomipramin (za zdravljenje določenih duševnih stanj) elbasvir ali grazoprevir (za zdravljenje hepatitisa C) šentjanževko (Hypericum perforatum) (rastlinski pripravek, ki se uporablja pri depresiji in tesnobi) flekainid, metoprolol (uporabljata se za zdravljenje nerednega srčnega utripa) določene antibiotike (makrolidi, fluorokinoloni, imidazoli) triazolske antimikotike določene antimalarike metadon (uporablja se za zdravljene odvisnosti od opiatov)
English: NFV + NRTIs
Slovenian: EFV + IDV + NRTI-ji
English: one 100 mg capsule
Slovenian: ena 100 mg kapsula
English: Saquinavir/ritonavir/Efavirenz
Slovenian: sakvinavir/ritonavir/efavirenz
English: Gastrointestinal disorders common abdominal pain, diarrhoea, nausea, vomiting uncommon pancreatitis
Slovenian: Bolezni prebavil pogosti bolečine v trebuhu, driska, navzea, bruhanje občasni pankreatitis
English: Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Slovenian: Pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila iz razreda NNRTI-jev, je izkušenj z efavirenzem malo.
English: Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with nelfinavir and an NRTI in antiretroviral-naive and NRTI-experienced paediatric patients.
Slovenian: Študija PACTG 382 je bila odprta študija za oceno farmakokinetike, varnosti, prenašanja in protivirusnega delovanja zdravila SUSTIVA v kombinaciji z nelfinavirjem in nukleozidnim zaviralcem reverzne transkriptaze (NRTI) pri pediatričnih bolnikih, ki se še niso zdravili s protiretrovirusnimi zdravili, vendar so se že zdravili z NRTI.
English: 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).
Slovenian: Efavirenza se ne sme jemati hkrati s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ali ergot alkaloidi (npr. ergotaminom, dihidroergotaminom, ergonovinom in metilergonovinom), ker zaviranje njihovega metabolizma lahko povzroči resne, življenje ogrožajoče neželene učinke (glejte poglavje 4.3).
English: NNRTIs/Efavirenz
Slovenian: NNRTI-ji/efavirenz
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/001-004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/110/001
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Slovenian: IZ, interval zaupanja c S.N.P., standardna napaka povprečja d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
English: The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate.
Slovenian: Prašek v trdi kapsuli vsebuje še naslednje pomožne snovi: natrijev lavrilsulfat, laktozo monohidrat, magnezijev stearat in natrijev karboksimetilškrob.
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2 - 4 weeks.
Slovenian: Simptomi živčnega sistema se običajno pojavijo kmalu po začetku zdravljenja in običajno minejo po prvih 2 - 4 tednih.
English: Plasma trough concentrations of boceprevir were decreased when administered with efavirenz.
Slovenian: Najnižje plazemske koncentracije boceprevirja pred naslednjim odmerkom so se pri sočasni uporabi z efavirenzem zmanjšale.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/008 - bottle
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA(DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/99/110/008 - plastenka
English: SUSTIVA 200 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Slovenian: Zdravilo SUSTIVA 200 mg trde kapsule lahko jemljejo otroci in mladostniki, stari 3 mesece ali več, ki tehtajo najmanj 3,5 kg in ki so zmožni pogoltniti kapsule.
English: Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
Slovenian: Simptomi živčnega sistema se ponavadi pojavijo prvi dan ali v prvih dveh dneh terapije in v glavnem minejo po prvih 2 - 4 tednih.
English: SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Slovenian: Zdravilo SUSTIVA 50 mg trde kapsule lahko jemljejo otroci in mladostniki, stari 3 mesece ali več, ki tehtajo najmanj 3,5 kg in ki so zmožni pogoltniti kapsule.
English: 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.
Slovenian: V 48. tednu - pri uporabi analize ITT - je bil celotni delež bolnikov s HIV RNA < 400 kopij/ml 57 % (21/37) in celotni delež bolnikov s HIV RNA < 50 kopij/ml 46 % (17/37).
English: How to store SUSTIVA 6.
Slovenian: Shranjevanje zdravila SUSTIVA 6.
English: Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Slovenian: AUC: ↑ 11 % (↑ 5 do ↑ 18) Cmax: ↑ 16 % (↑ 6 do ↑ 26) Cmin: ↑ 13 % (↑ 1 do ↑ 26) (indukcija CYP3A4) Povečanje farmakokinetičnih parametrov efavirenza se ne smatra za klinično pomembno.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bristol-Myers Squibb Pharma EEIG
English: Ginkgo biloba extracts (a herbal preparation)
Slovenian: Izvlečke ginka (pripravek rastlinskega izvora).
English: Grapefuit juice should be avoided when taking SUSTIVA.
Slovenian: Med jemanjem zdravila SUSTIVA se je potrebno izogibati uživanju soka grenivke.
English: OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN NALEPKI ZA PLASTENKO
English: Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily)
Slovenian: klaritromicin/efavirenz (500 mg q12h/400 mg enkrat na dan)
English: When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist.
Slovenian: Ko gre vaša zaloga zdravila SUSTIVA h koncu, si ga priskrbite pri zdravniku oz. farmacevtu.
English: Your doctor may give you a different anticonvulsant.
Slovenian: Zdravnik vam bo morda predpisal drugo zdravilo proti krčem.
English: UNIQUE IDENTIFIED - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Atazanavir/ritonavir/Efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Slovenian: atazanavir/ritonavir/efavirenz (400 mg enkrat na dan/200 mg enkrat na dan/600 mg enkrat na dan, vse s hrano)
English: Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Slovenian: Za več informacij glejte navodila za predpisovanje glekaprevira/pibrentasvira.
English: The tablets are printed with inks containing hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) and titanium dioxide (E171).
Slovenian: Filmsko obložene tablete so potiskane s črnili, ki vsebujejo hipromelozo (E464), propilenglikol, karminsko kislino (E120), indigotin (E132) in titanov dioksid (E171).
English: Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Slovenian: Morda je treba prilagoditi odmerek atorvastatina (glejte Povzetek glavnih značilnosti zdravila za atorvastatin).
English: INFORMATION IN BRAILLE SUSTIVA 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI SUSTIVA 50 mg
English: Consider alternatives to efavirenz for coadministration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes.
Slovenian: Pri sočasni uporabi z zdravilom, ki ima znano tveganje za torsade de pointes, ali pri uporabi pri bolnikih z večjim tveganjem za torsade de pointes, je treba razmisliti o alternativah efavirenzu.
English: one 200 mg capsule + one 50 mg capsule
Slovenian: ena 200 mg kapsula + ena 50 mg kapsula
English: 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.
Slovenian: V 48. tednu - pri uporabi analize ITT - je bil celotni delež bolnikov s HIV RNA < 400 kopij/ml 77 % (33/43) in celotni delež bolnikov s HIV RNA < 50 kopij/ml 70 % (30/43).
English: three 100 mg capsules + one 50 mg capsule
Slovenian: tri 100 mg kapsule + ena 50 mg kapsula
English: SUSTIVA 100 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Slovenian: Zdravilo SUSTIVA 100 mg trde kapsule lahko jemljejo otroci in mladostniki, stari 3 mesece ali več, ki tehtajo najmanj 3,5 kg in ki so zmožni pogoltniti kapsule.
English: Indinavir/Efavirenz (800 mg q8h/200 mg once daily)
Slovenian: indinavir/efavirenz (800 mg q8h/200 mg enkrat na dan)
English: Hepatitis C antivirals Boceprevir/Efavirenz (800 mg 3 times daily/600 mg once daily)
Slovenian: Zdravila za zdravljenje hepatitisa C boceprevir/efavirenz (800 mg 3-krat na dan/600 mg enkrat na dan)
English: SUSTIVA contains efavirenz and may cause dizziness, impaired concentration, and drowsiness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo SUSTIVA vsebuje efavirenz in lahko povzroči omotico, motnje koncentracije in zaspanost.
English: EU/1/99/110/010 - blister
Slovenian: EU/1/99/110/010 - pretisni omot
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg twice daily/600 mg once daily)
Slovenian: CCR5 antagonisti maravirok/efavirenz (100 mg dvakrat na dan/600 mg enkrat na dan)
English: Nelfinavir/Efavirenz (750 mg q8h/600 mg once daily)
Slovenian: nelfinavir/efavirenz (750 mg q8h/600 mg enkrat na dan)
English: NRTIs and NNRTIs NRTIs/Efavirenz
Slovenian: NRTI-ji in NNRTI-ji NRTI-ji/efavirenz
English: The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
Slovenian: Kapsule so potiskane s črnili, ki vsebujejo karminsko kislino (E120), indigotin (E132) in titanov dioksid (E171).
English: Resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Slovenian: Če se efavirenz uporablja kot monoterapija, se lahko hitro pojavi rezistentni virus.
English: Simeprevir/Efavirenz (150 mg once daily /600 mg once daily)
Slovenian: simeprevir/efavirenz (150 mg enkrat na dan/600 mg enkrat na dan)
English: Intermittent monotherapy and sequential reintroduction of antiretroviral agents is not advisable because of the increased potential for selection of resistant virus.
Slovenian: Zaradi povečanega tveganja za selekcijo rezistentnega virusa ne priporočamo intermitentne monoterapije in kasnejše ponovne uvedbe protiretrovirusnih zdravil.
English: Each hard capsule contains 28.5 mg of lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom Ena trda kapsula vsebuje 28,5 mg laktoze (v obliki monohidrata).
English: Dose adjustment of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
Slovenian: Morda je treba prilagoditi odmerek simvastatina (glejte Povzetek glavnih značilnosti zdravila za simvastatin).