FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of the effect on velpatasvir is induction of CYP3A and CYP2B6 by efavirenz.
Croatian: Mehanizam djelovanja na velpatasvir je indukcija CYP3A i CYP2B6 efavirenzom.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Croatian: To je vrlo važno jer ako prestanete uzimati lijek, makar i na kratko, količina virusa opet može porasti.
English: If SUSTIVA 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.
Croatian: Ako liječenje lijekom SUSTIVA započinjete zato što Vaše dosadašnje liječenje nije spriječilo umnažanje virusa, istodobno morate početi uzimati drugi lijek, koji do sada niste uzimali.
English: Carcinogenicity studies in male mice, male and female rats were negative.
Croatian: Istraživanja kancerogenosti u mužjaka miševa te u mužjaka i ženki štakora bila su negativna.
English: In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose.
Croatian: U jednom su se ispitivanju simptomi živčanog sustava često pojavljivali u prvih 13 sata nakon uzimanja doze lijeka.
English: Dose adjustments of the immunosuppressant may be required.
Croatian: Može biti potrebno prilagođavati dozu imunosupresiva.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Croatian: Klinički ishod ovog opaženog smanjenja najnižih koncentracija boceprevira u plazmi nije direktno procijenjen.
English: The safety and efficacy of efavirenz in children below the age of 3 months or weighing less than 3.5 kg have not been established.
Croatian: Sigurnost i djelotvornost lijeka efavirenz u djece mlađe od 3 mjeseca ili u djece tjelesne težine manje od 3,5 kg nisu ustanovljene.
English: Efavirenz plasma exposure may be increased in patients with the homozygous G516T genetic variant of the CYP2B6 isoenzyme.
Croatian: Izloženost efavirenza u plazmi može biti povišena u bolesnika s homozigotnom G516T genskom inačicom izoenzima CYP2B6.
English: Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction.
Croatian: Izolirani porasti GGT-a u bolesnika liječenih efavirenzom mogu biti odraz indukcije enzima.
English: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms.
Croatian: Najizraženije nuspojave povezane s primjenom efavirenza su osip i simptomi živčanog sustava.
English: There is no specific antidote for overdose with efavirenz.
Croatian: Nema specifičnog antidota za predoziranje efavirenzom.
English: These drugs include:
Croatian: Bolesnici koji imaju:
English: An alternative anticonvulsant should be considered.
Croatian: Mora se razmotriti primjena drugog antikonvulziva.
English: Common (affects 1 to 10 users in 100) abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance stomach pain, diarrhoea, feeling sick (nausea), vomiting itching tiredness feeling anxious, feeling depressed
Croatian: Često (javljaju se u 1 do 10 na 100 korisnika) neuobičajeni snovi, poteškoće s koncentracijom, omaglica, glavobolja, poteškoće sa spavanjem, omamljenost, poteškoće s koordinacijom ili ravnotežom bol u trbuhu, proljev, mučnina, povraćanje svrbež umor osjećaj tjeskobe, depresivno raspoloženje
English: Rash was more common in children than in adults treated with SUSTIVA.
Croatian: Osip se puno češće pojavljuje u djece nego u odraslih liječenih lijekom SUSTIVA.
English: Dose adjustment of warfarin or acenocoumarol may be required.
Croatian: Može biti potrebno prilagoditi dozu varfarina ili acenokumarola.
English: Taking these medicines with SUSTIVA could create the potential for serious and/or life-threatening sideeffects or stop SUSTIVA from working properly.
Croatian: Uzimanje ovih lijekova s lijekom SUSTIVA može stvoriti mogućnost za nastup ozbiljnih i/ili po život opasnih nuspojava ili spriječiti ispravno djelovanje lijeka SUSTIVA.
English: In clinical studies 2% of patients treated with efavirenz discontinued therapy due to such symptoms.
Croatian: U kliničkim je ispitivanjima 2% bolesnika liječenih efavirenzom prekinulo terapiju zbog ovih simptoma.
English: Based on this new data, the PRAC considers that the statement that the interaction between etonogestrel and efavirenz has not been studied is no longer valid and that this statement should be removed from the SmPC of all efavirenz-containing products.
Croatian: Na temelju tih novih podataka PRAC smatra da navod kako interakcija između etonogestrela i efavirenza nije ispitivana više ne vrijedi te da je tu rečenicu potrebno ukloniti iz sažetaka opisa svojstava lijeka za sve lijekove koji sadrže efavirenz.
English: Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Croatian: Liječnik Vam može provesti krvne pretrage kako bi provjerio funkciju jetre ili Vam može propisati neki drugi lijek.
English: No additional food should be consumed for up to 2 hours after administration of efavirenz.
Croatian: Nikakva dodatna hrana ne smije se uzimati u razdoblju do 2 sata nakon uzimanja efavirenza.
English: On the basis of the scientific conclusions for efavirenz the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing efavirenz is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za efavirenz, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) efavirenz nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, coadministration of efavirenz and another NNRTI is not recommended.
Croatian: Kako se primjena dva NNRTI-ja nije pokazala korisnom u smislu djelotvornosti i sigurnosti, istodobna primjena efavirenza i drugog
English: SUSTIVA must be taken with other medicines that act against the HIV virus.
Croatian: SUSTIVA se mora uzimati s drugim lijekovima koji djeluju protiv HIV-a.
English: Each carton contains 1 bottle of 90 hard capsules.
Croatian: Jedna kutija sadrži 1 bočicu s 90 tvrdih kapsula.
English: Rash was reported more frequently in children (59 of 182 (32%) treated with efavirenz) and was more often of higher grade than in adults (severe rash was reported in 6 of 182 (3.3%) of children).
Croatian: Osip je u djece prijavljen češće nego u odraslih (59 od 182 (32%) liječenih efavirenzom) i češće je bio intenzivniji nego u odraslih (težak osip prijavljen je u 6 od 182 (3,3%) djece).
English: Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Croatian: Efavirenz se mora primjenjivati u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 4.5).
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 SUSTIVA.
Croatian: Iako nije dokazana križna rezistencija između efavirenza i inhibitora proteaze, zasad nema dovoljno podataka o djelotvornosti naknadne primjene kombinirane terapije temeljene na inhibitorima proteaze nakon neuspjeha terapije u koju je bila uključena SUSTIVA.
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).
Croatian: U nezaraženih je dobrovoljaca primjena višekratnih doza efavirenza od 200-400 mg na dan tijekom 10 dana dovela do manje akumulacije lijeka od predviđene (22-42% niže) i kraćeg terminalnog poluvremena u usporedbi s primjenom jednokratne doze (vidjeti niže).
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil.
Croatian: Specifična ispitivanja interakcija između efavirenza i NRTI-ja nisu provedena osim za lamivudin, zidovudin i tenofovirdizoproksil.
English: If you notice any symptoms of infection, please tell your doctor immediately.
Croatian: Primijetite li bilo kakve simptome infekcije, molimo odmah obavijestite svog liječnika.
English: Each film-coated tablet contains 249.6 mg of lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 249,6 mg laktoze (u obliku hidrata).
English: uncommon hepatitis acute rare hepatic failure‡,*
Croatian: manje često akutni hepatitis rijetko zatajenje jetre‡,*
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
Croatian: Prijavljena su dva dodatna slučaja (1 prospektivni i 1 retrospektivni) koja su uključivala događaje s oštećenjem neuralne cijevi s primjenom tableta s fiksnom kombinacijom efavirenza, emtricitabina i tenofovir dizoproksilfumarata.
English: Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash.
Croatian: Primjena odgovarajućih antihistaminika i/ili kortikosteroida može poboljšati podnošljivost lijeka i ubrzati nestajanje osipa.
English: Study Number/ Treatment Regimensb n % (95% C.I.c)
Croatian: Broj ispitivanja/ Režimi liječenjab n % (95% C.I.c)
English: Time to peak plasma concentrations (3 - 5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 - 7 days.
Croatian: Vrijeme potrebno za postizanje vršne koncentracije lijeka u plazmi (3-5 sati) nije se mijenjalo kod višekratnog doziranja, a koncentracija u stanju dinamičke ravnoteže u plazmi postizala se za 6-7 dana liječenja.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog: u Dodatku V.
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced a significant rebound in viral load during clinical studies of efavirenz in combination with indinavir or zidovudine + lamivudine.
Croatian: K103N je bila najčešće zabilježena zamjena u reverznoj transkriptazi virusnih izolata u bolesnika koji su imali značajan povrat (tzv. rebound) virusnog opterećenja tijekom kliničkih ispitivanja primjene efavirenza u kombinaciji s indinavirom ili zidovudinom + lamivudinom.
English: Ginkgo biloba extracts (a herbal preparation)
Croatian: ekstrakti Ginkga bilobe (biljni pripravak).
English: ↓glecaprevir ↓ pibrentasvir
Croatian: ↓glekaprevir ↓pibrentasvir
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Croatian: lijekove koji se koriste za liječenje bakterijskih infekcija, uključujući tuberkulozu i s AIDS-om povezan Mycobacterium avium kompleks: klaritromicin, rifabutin, rifampicin.
English: Your doctor may give you a different anticonvulsant.
Croatian: Liječnik Vam može propisati neki drugi antikonvulzivni lijek.
English: Nervous system disorders common cerebellar coordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)*
Croatian: Poremećaji živčanog sustava često poremećaji cerebelarne koordinacije i ravnoteže†, poremećaj pažnje (3,6%), omaglica (8,5%), glavobolja (5,7%), somnolencija (2,0%)*
English: uncommon hypercholesterolaemia*
Croatian: manje često hiperkolesterolemija*
English: Hold the capsule with the cap facing up and pull the cap away from the body of the capsule.
Croatian: Držite kapsulu u položaju s kapicom okrenutom prema gore te povucite i odvojite kapicu od tijela kapsule.
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when coadministered with efavirenz in vivo.
Croatian: Iako podaci in vitro upućuju na to da efavirenz inhibira CYP2C9 i CYP2C19, postoje proturječna izvješća i o povećanoj i o smanjenoj izloženosti supstratima tih enzima kod istodobne primjene s efavirenzom in vivo.
English: Table 2: Interactions between efavirenz and other medicinal products in adults
Croatian: Tablica 2: Interakcije između efavirenza i drugih lijekova u odraslih
English: No data are available to make a dose recommendation.
Croatian: Nema dostupnih podataka da bi se mogla dati preporuka za dozu.
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
Croatian: Istodobna primjena posakonazola i efavirenza mora se izbjegavati, osim ako je korist za bolesnika veća od rizika.
English: In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
Croatian: U analizi stope bolesnika koji su odgovorili na liječenje (bolesnici koji nisu završili liječenje smatrani su kao neuspjeh terapije; engl. the non-completer equals failure analysis, [NC=F]), za bolesnike koji su iz bilo kojeg razloga ranije prekinuli ispitivanje ili one koji su propustili jedno mjerenje vrijednosti HIV-RNK kojemu je prethodilo ili je nakon njega uslijedilo mjerenje s rezultatima iznad granice određivanja, smatralo se da imaju HIV-RNK iznad 50 ili iznad 400 kopija/ml u vrijeme propuštenog mjerenja.
English: Compounds or herbal preparations (for example Ginkgo biloba extracts and St. John's wort) which induce these enzymes may give rise to decreased plasma concentrations of efavirenz.
Croatian: Tvari ili biljni pripravci (npr. ekstrakti Ginkga bilobe i gospine trave) koji induciraju te enzime mogu povisiti smanjene koncentracije efavirenza u plazmi.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Croatian: Ispitivanja u ljudi i istraživanja in vitro na humanim jetrenim mikrosomima pokazala su da se efavirenz najvećim dijelom razgrađuje posredstvom sustava citokroma P450 do hidroksiliranih metabolita, nakon čega slijedi glukuronidacija ovih hidroksiliranih metabolita.
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 NRTIexperienced HIV-infected patients.
Croatian: Dva kontrolirana ispitivanja (006 i ACTG 364) u trajanju od oko godine dana u kojima je efavirenz primjenjivan u kombinaciji s NRTI-jima i/ili inhibitorima proteaze pokazale su smanjenje virusnoga opterećenja ispod granice određivanja metode i porast CD4 limfocita u bolesnika zaraženih HIV-om koji prethodno nisu primali antiretrovirusno liječenje, kao i u onih koji su primali NRTI-je.
English: If you could get pregnant while receiving SUSTIVA, 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).
Croatian: Ako biste mogli zatrudnjeti dok uzimate lijek SUSTIVA, morate koristiti pouzdanu mehaničku metodu kontracepcije (npr. prezervativ) zajedno s drugim metodama kontracepcije, uključujući kontracepcijske tablete (pilule) ili druge oblike hormonske kontracepcije (npr. implantat ili injekcije).
English: 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.
Croatian: U nekoliko izvješća o zatajenju jetre nakon stavljanja lijeka u promet, uključujući slučajeve bolesnika bez prethodne bolesti jetre i drugih prepoznatljivih čimbenika rizika, opisan je i fulminantni tijek, koji je u nekim slučajevima napredovao do transplantacije ili smrti.
English: Warfarin or acenocoumarol (medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
Croatian: varfarin ili acenokumarol (lijekove koji se koriste za smanjivanje zgrušavanja krvi): liječnik će Vam možda trebati prilagoditi dozu varfarina ili acenokumarola.
English: A third isolate which carried a substitution at position 236 of RT was not cross-resistant to efavirenz.
Croatian: Treći izolat sa zamjenom na mjestu 236 u reverznoj transkriptazi nije bio križno rezistentan na efavirenz.
English: If you forget to take SUSTIVA
Croatian: Ako ste zaboravili uzeti lijek SUSTIVA
English: In healthy adult subjects, the efavirenz AUC when administered as the contents of three 200 mg hard capsules mixed with 2 teaspoons of certain food vehicles (applesauce, grape jelly, yogurt or infant formula) met bioequivalency criteria for the AUC of the intact capsule formulation administered under fasted conditions.
Croatian: U zdravih, odraslih ispitanika, AUC za efavirenz uzet u obliku sadržaja tri tvrde kapsule od 200 mg pomiješanog s 2 čajne žličice određene hrane (umakom od jabuka, želeom od grejpa, jogurtom ili kašicom za bebe), zadovoljava kriterije bioekvivalentnosti za AUC kapsule uzete na prazan želudac.
English: The dose for children weighing 40 kg or more is 600 mg once daily.
Croatian: Doza lijeka za djecu tjelesne mase 40 kg ili veće je 600 mg jedanput na dan.
English: Study 020 showed similar activity in NRTI-experienced patients over 24 weeks.
Croatian: Ispitivanje 020 pokazalo je sličnu djelotvornost tijekom 24-tjedne primjene u bolesnika koji su već primali NRTIje.
English: The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudineresistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Croatian: Slobodne koncentracije efavirenza potrebne za 90- do 95%-tnu inhibiciju divljih tipova laboratorijskih i kliničkih izolata rezistentnih na zidovudin in vitro, kretale su se između 0,46 i 6,8 nM u limfoblastoidnim staničnim linijama, mononuklearnim stanicama periferne krvi (PBMC) i u kulturama makrofaga/monocita.
English: Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Croatian: Nepostojane konvulzije zapažene su u nekih majmuna koji su efavirenz primali ≥1 godine u dozama kojima je postignut 4 do 13 puta viši AUC u plazmi od onog u ljudi koji su primali preporučenu dozu lijeka (vidjeti dijelove 4.4 i 4.8).
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).
Croatian: Nakon stavljanja lijeka u promet prijavljeno je nekoliko slučajeva zatajenja jetre u bolesnika koji nisu imali postojeću bolest jetre ni druge prepoznatljive čimbenike rizika (vidjeti dio 4.8).
English: When using efavirenz with lowdose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Croatian: Kad se efavirenz primjenjuje s niskom dozom ritonavira, mora se uzeti u obzir mogućnost povećane incidencije štetnih događaja povezanih s efavirenzom zbog moguće farmakodinamičke interakcije.
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when coadministered with efavirenz.
Croatian: Postoji mogućnost sniženja ili povišenja plazmatske koncentracije fenitoina, fenobarbitala i drugih antikonvulziva koji su supstrati izoenzima CYP450 kad se primjenjuju istodobno s efavirenzom.
English: Thirteen isolates previously characterised as efavirenz-resistant were also resistant to nevirapine and delavirdine.
Croatian: 13 izolata za koje je prethodno ustanovljeno da su rezistentni na efavirenz bilo je rezistentno i na nevirapin i delavirdin.
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Croatian: fenitoin, fenobarbital i drugi antikonvulzivi koji su supstrati izoenzima CYP450
English: If you are taking any of these medicines, tell your doctor immediately.
Croatian: Ako uzimate neke od ovih lijekova, o tome odmah obavijestite svog liječnika.
English: Two of three delavirdineresistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Croatian: Dva od tri ispitana klinička izolata rezistentna na delavirdin bila su križno rezistentna na efavirenz i imala su zamjenu K103N.
English: Severe rash occurred in less than 1% of patients treated with efavirenz, and 1.7% discontinued therapy because of rash.
Croatian: Jak osip pojavio se u manje od 1% bolesnika liječenih efavirenzom, a 1,7% bolesnika prekinulo je liječenje zbog osipa.
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Croatian: d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
English: Women should not get pregnant during treatment with SUSTIVA and for 12 weeks thereafter.
Croatian: Žene ne smiju zatrudnjeti tijekom liječenja i 12 tjedana nakon završetka liječenja lijekom SUSTIVA.
English: Tests may show: increased liver enzymes in the blood increased trigycerides (fatty acids) in the blood
Croatian: Pretrage mogu pokazati: povišene vrijednosti jetrenih enzima u krvi povišene vrijednosti triglicerida (masnih kiselina) u krvi
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Croatian: Stoga teoretski, efavirenz u početku može povećati izloženost supstratima CYP3A4 pa je potreban oprez sa supstratima CYP3A4 uskog terapijskog indeksa (vidjeti dio 4.3).
English: If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Croatian: Prekine li se liječenje efavirenzom, mora se razmotriti i prekid liječenja drugim antiretrovirusnim lijekovima kako bi se izbjegao razvoj rezistentnih virusa (vidjeti dio 4.8).
English: Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Croatian: Kod prilagodbe doze mora se uzeti u obzir podnošljivost i virološki odgovor u pojedinog bolesnika (vidjeti dio 5.2).
English: Each carton contains 1 bottle of 30 filmcoated tablets.
Croatian: Jedna kutija sadrži 1 bočicu s 30 filmom obloženih tableta.
English: Capsule sprinkle: for patients at least 3 months old and weighing at least 3.5 kg who cannot swallow capsules, the capsule contents can be administered with a small amount of food using the capsule sprinkle method of administration (see section 6.6 for instructions).
Croatian: Posipanje sadržaja kapsule: za bolesnike od najmanje 3 mjeseca starosti i tjelesne težine od najmanje 3,5 kg koji ne mogu progutati kapsulu, sadržaj kapsule može se primijeniti s malom količinom hrane koristeći kao način primjene posipanje sadržaja kapsule (vidjeti dio 6.6 za upute).