FrancophonIA/ELRC3.0 huggingface dataset:
English: Stocrin must always be taken in combination with other anti-HIV medicines.
Slovenian: Vedno ga jemljite le v kombinaciji z drugimi zdravili proti HIV.
English: When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Slovenian: Pri uporabi efavirenza z majhnim odmerkom ritonavirja, je treba upoštevati možnost povečanja pogostnosti neželenih učinkov, povezanih z efavirenzem, zaradi morebitnih farmakodinamičnih interakcij.
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1 % of patients treated with efavirenz.
Slovenian: O hudem izpuščaju, ki ga spremljajo mehurji, vlažno luščenje kože ali ulceracije, so poročali pri manj kot 1 % bolnikov, zdravljenih z efavirenzem.
English: 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 %).
Slovenian: 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 (5,5 %).
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-ji 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 dobivali protiretrovirusnih zdravil in tistih, ki so že bili zdravljeni z NRTI-ji.
English: Rash was reported more frequently in children (in a clinical study including 57 children who received efavirenz during a 48-week period, rash was reported in 46 %) and was more often of higher grade than in adults (severe rash was reported in 5.3 % of children).
Slovenian: Izpuščaj je bil pri otrocih bolj pogost (v klinični študiji, ki je vključevala 57 otrok, zdravljenih z efavirenzem v obdobju 48 tednov, so o izpuščaju poročali pri 46 %) in pogosteje hujši kot pri odraslih (o hudi obliki izpuščaja so poročali pri 5,3 % otrok).
English: uncommon affect lability, aggression, confusional state, euphoric mood, hallucination, mania, paranoia, psychosis
Slovenian: občasni čustvena labilnost, nasilno vedenje, zmedenost, evforično razpoloženje, halucinacije, manija, paranoja, psihoza
English: • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose,
Slovenian: • Pomožne snovi v jedru tablete so: premrežen natrijev karmelozat, mikrokristalna celuloza,
English: Efavirenz tablets must only be administered to children who are able to reliably swallow tablets.
Slovenian: Efavirenz tablete smemo dati le otrokom, ki so tablete zmožni pogoltniti.
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: Co-administration of higher doses of either efavirenz or carbamazepine has not been studied.
Slovenian: Sočasne uporabe večjih odmerkov obeh, efavirenza ali karbamazepina, niso preučevali.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenzcontaining antiretroviral therapy and subjects receiving no antiretroviral therapy.
Slovenian: V 3-mesečni študiji interakcij med učinkovinami niso ugotovili pomembnih razlik v farmakokinetičnih parametrih medroksiprogesteronacetata (MPA) med osebami, ki so bile na protiretrovirusnem zdravljenju, ki je vključevalo efavirenz, in osebami brez protiretrovirusnega zdravljenja.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe z virusom HIV pojavijo tudi avtoimune bolezni (stanje, ko imunski sistem napade zdravo telesno tkivo).
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: Stocrin contains lactose in each 600-mg daily dose.
Slovenian: Zdravilo Stocrin vsebuje laktozo v vsakem 600-mg dnevnem odmerku.
English: Concomitant administration of STOCRIN with elbasvir/grazoprevir is contraindicated (see section 4.3) because it may lead to loss of virologic response to elbasvir/grazoprevir.
Slovenian: Sočasna uporaba zdravila STOCRIN z elbasvirjem/grazoprevirjem je kontraindicirana (glejte poglavje 4.3), saj lahko vodi do izgube virološkega odziva na elbasvir/grazoprevir.
English: Stocrin 30 mg/ml oral solution is supplied in bottles of 180 ml.
Slovenian: Stocrin 30 mg/ml peroralna raztopina je na voljo v 180 ml plastenkah.
English: If you could get pregnant while receiving Stocrin, 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 Stocrin 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, injekcijo).
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.
Slovenian: Je protiretrovirusno zdravilo, ki zmanjšuje količino virusa v krvi in se tako bori proti okužbi z virusom humane imunske pomanjkljivosti (HIV).
English: Stocrin may make hormonal contraceptives less likely to work.
Slovenian: Zdravilo Stocrin lahko zmanjša delovanje hormonskih kontraceptivov.
English: In the study of 57 children, 3.5 % of patients experienced nervous system symptoms of moderate intensity, predominantly dizziness.
Slovenian: V študiji, v katero je bilo vključenih 57 otrok, so se zmerno močni simptomi živčnega sistema, predvsem omotica, pojavili pri 3,5 % bolnikov.
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Slovenian: Tako so lahko nekateri neželeni učinki (na primer omotica,
English: STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the film-coated tablets.
Slovenian: Peroralna raztopina STOCRIN je indicirana za kombinirano protivirusno zdravljenje z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) okuženih odraslih, mladostnikov in otrok, starih 3 leta ali več, ki ne morejo pogoltniti filmsko obloženih tablet.
English: maraviroc the combination tablet containing efavirenz, emtricitabine and tenofovir should not be taken with Stocrin unless recommended by your doctor since it contains efavirenz, the active ingredient of Stocrin.
Slovenian: kombinirano tableto, ki vsebuje efavirenz, emtricitabin in tenofovir ne smete jemati skupaj z zdravilom Stocrin, razen če vam je tako svetoval zdravnik, saj vsebuje efavirenz, ki je učinkovina v zdravilu Stocrin.
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 kontrolnega kraka prekinilo zdravljenje zaradi bolezni jeter (glejte poglavje 4.4).
English: Co-administration of efavirenz with a 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: Stocrin is not recommended for children under the age of 3 years or weighing less than 13 kg because it has not been adequately studied in these patients.
Slovenian: Uporaba zdravila Stocrin ni priporočljiva pri otrocih, mlajših od 3 let ali lažjih od 13 kg, saj pri teh bolnikih ni bila ustrezno raziskana.
English: Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm
Slovenian: Efavirenza niso preučevali v nadzorovanih študijah pri bolnikih z napredovalo boleznijo HIV, to je pri bolnikih s CD4 < 50 celic/mm
English: , completed suicide
Slovenian: , samomor
English: Efavirenz must not be administered with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations caused by induction of drug metabolising enzymes and/or transport proteins and which are expected to result in the loss of virologic response of elbasvir/grazoprevir (see section 4.5).
Slovenian: Efavirenza se ne sme jemati z elbasvirjem/grazoprevirjem zaradi pričakovanega pomembnega znižanja plazemskih koncentracij elbasvirja in grazoprevirja, ki nastopi zaradi induciranja encimov, ki presnavljajo zdravilo, in/ali transportnih proteinov, zaradi česar se pričakuje izgubo virološkega odziva na elbasvir/grazoprevir (glejte poglavje 4.5).
English: sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate.
Slovenian: natrijev lavrilsulfat, hidroksipropilceluloza, laktoza monohidrat in magnezijev stearat.
English: Diltiazem or similar medicines (called calcium channel blockers which are medicines typically used for high blood pressure or heart problems): when you start taking Stocrin, your doctor may need to adjust your dose of the calcium channel blocker.
Slovenian: Diltiazem ali podobna zdravila (imenovana zaviralci kalcijevih kanalov in so zdravila, ki se običajno uporabljajo za zvišan krvni tlak ali težave s srcem): ko boste začeli jemati zdravilo Stocrin, vam bo zdravnik morda moral prilagoditi odmerek zaviralca kalcijevih kanalov.
English: Turn the bottle the right way up and remove the syringe.
Slovenian: Plastenko postavite pokonci in odstranite brizgo.
English: How to take Stocrin
Slovenian: Kako jemati zdravilo Stocrin
English: Paediatric population: ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/kg given three times a day) and one or more NRTIs.
Slovenian: Pediatrična populacija: ACTG 382 je nenadzorovana študija, ki še poteka pri 57-ih pediatričnih bolnikih (starih 3 do 16 let), zdravljenih z NRTI-ji, in analizira farmakokinetiko, protivirusno aktivnost in varnost efavirenza v kombinaciji z nelfinavirjem (20-30 mg/kg trikrat na dan) in enim ali več NRTI-jem.
English: Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz (see section 5.3).
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z efavirenzem opraviti nosečnostni test (glejte poglavje 5.3).
English: Cmin: ↓ 8 % (↑ 14 to ↓ 25) Norelgestromin (active metabolite):
Slovenian: Cmin: ↓ 8 % (↑ 14 do ↓ 25) norelgestromin (aktivni presnovek):
English: If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with Stocrin.
Slovenian: Če ste imeli izpuščaj med jemanjem drugega NNRTI-ja, je pri vas večja možnost pojava izpuščaja zaradi zdravila Stocrin.
English: Outer carton: 2D barcode carrying the unique identifier included.
Slovenian: Škatla: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax
Slovenian: Filmska obloga: hipromeloza (E464), titanov dioksid (E171), makrogol 400, rumeni železov oksid (E172), karnauba vosek
English: Efavirenz film-coated tablets must only be administered to children who are able to reliably swallow tablets.
Slovenian: Efavirenz filmsko obložene tablete smemo dati le otrokom, ki so tablete zmožni pogoltniti.
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: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
Slovenian: Zdravila za zdravljenje okužbe z virusom hepatitisa C: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glekaprevir/pibrentasvir in sofosbuvir/velpatasvir/voksilaprevir.
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: Colourless to slightly yellow clear liquid.
Slovenian: peroralna raztopina brezbarvna do svetlo rumena bistra tekočina
English: Each carton contains 1 bottle of 90 film-coated tablets.
Slovenian: Ena škatla vsebuje 1 plastenko z 90 filmsko obloženimi tabletami.
English: • You must remain under the care of your doctor while taking Stocrin.
Slovenian: • Med jemanjem zdravila Stocrin morate ostati pod nadzorom zdravnika.
English: In 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 M, steady state Cmin was 5.6 M, and AUC was 216 M·h.
Slovenian: Pri 49 pediatričnih bolnikih, ki so dobivali odmerek, ekvivalenten 600 mg odmerku efavirenza (odmerek prilagojen glede na izračunano velikost telesa na podlagi telesne mase), je bila Cmax v stanju dinamičnega ravnovesja 14,1 M, Cmin v stanju dinamičnega ravnovesja 5,6 M in AUC 216 M∙h.
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: 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,
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,
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: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms (see section 4.4).
Slovenian: Najopaznejši neželeni učinki, povezani z efavirenzem, so izpuščaj in simptomi živčnega sistema (glejte poglavje 4.4).
English: See section Description of selected adverse reactions for more details.
Slovenian: Za več podrobnosti glejte poglavje Opis izbranih neželenih učinkov.
English: 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: Stocrin may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Slovenian: Med zdravilom Stocrin in drugimi zdravili, vključno s pripravki rastlinskega izvora, kot so izvlečki ginka (Ginkgo biloba), lahko pride do medsebojnega vpliva.
English: What Stocrin looks like and contents of the pack
Slovenian: Izgled zdravila Stocrin in vsebina pakiranja
English: • To measure the dose accurately, keep the bottle upside down and push the plunger in slowly until the top of the black ring (the edge nearest the syringe tip) lines up with the dose.
Slovenian: • Za natančno odmerjanje držite plastenko narobe in bat počasi potiskajte navzgor, dokler vrh bata ni v višini želenega odmerka.
English: STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm
Slovenian: Uporabe zdravila STOCRIN še niso dovolj preučili pri bolnikih z napredovano boleznijo HIV, to je pri bolnikih z vrednostjo CD4 < 50 celic/mm
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: • The dose for adults is 600 mg once daily.
Slovenian: • Odmerek za odrasle je 600 mg enkrat na dan.
English: • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
Slovenian: • Filmska obloga vsebuje: hipromelozo (E464), titanov dioksid (E171), makrogol 400, rumeni železov oksid (E172) in karnauba vosek.
English: Warfarinor acenocoumarol(medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
Slovenian: Varfarinali acenokumarol(zdraviliza zmanjšanje strjevanja krvi): zdravnik vam bo morda moral prilagoditi odmerek varfarina ali acenokumarola.
English: In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
Slovenian: Da bi bolniki bolje prenašali neželene učinke na živčni sistem, priporočamo v prvih dveh do štirih tednih zdravljenja in pri bolnikih, pri katerih se ti simptomi nadaljujejo, odmerjanje zvečer pred spanjem (glejte poglavje 4.8).
English: Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate
Slovenian: Jedro tablete: premrežen natrijev karmelozat, mikrokristalna celuloza, natrijev lavrilsulfat, hidroksipropilceluloza, laktoza monohidrat, magnezijev stearat
English: Table 1 Paediatric dose to be administered once daily
Slovenian: Preglednica 1 Pediatrični odmerki za uporabo enkrat na dan
English: HDPE bottles with a child-resistant polypropylene closure containing 180 ml of oral solution.
Slovenian: Plastenka iz HDPE s polipropilenskim za otroke varnim zamaškom, ki vsebuje 180 ml peroralne raztopine.
English: • The dose for adults is 24 ml once daily.
Slovenian: • Odmerek za odrasle je 24 ml enkrat na dan.
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Slovenian: Zdravila za zdravljenje bakterijskih okužb, vključno s tuberkulozo in z AIDS-om povezanookužbo z Mycobacteriumavium: klaritromicin, rifabutin, rifampicin.
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: These adverse reactions were identified through post-marketing surveillance but not reported as drug-related events for efavirenz-treated patients in 16 clinical trials.
Slovenian: Te neželene učinke so odkrili med spremljanjem zdravila na trgu, vendar o njih v 16 kliničnih preizkušanjih pri bolnikih, zdravljenjih z efavirenzem, niso poročali kot o z zdravilom povezanih neželenih učinkih.
English: • The dose for children weighing 40 kg or more is 600 mg once daily.
Slovenian: • Odmerek za otroke, ki tehtajo 40 kg ali več, je 600 mg enkrat na dan.
English: Other macrolide antibiotics (e.g., erythromycin)/Efavirenz
Slovenian: Drugi makrolidni antibiotiki (npr. eritromicin)/efavirenz
English: EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
Slovenian: EFV + NFV + NRTI-ji EFV + NRTI-ji NFV + NRTI-ji
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 vrednostma na tešče (glejte poglavje 4.4).
English: This effect is due to an induction of CYP3A4 or P-gp by efavirenz and is expected to result in the loss of virologic response of elbasvir/grazoprevir.
Slovenian: Ta učinek nastopi, saj efavirenz inducira CYP3A4 ali P-gp, zaradi česar se pričakuje izgubo virološkega odziva na elbasvir/grazoprevir.