FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 4 by weight ranges that correspond to the recommended doses of the capsules.
Croatian: Farmakokinetički parametri za efavirenz u stanju dinamičke ravnoteže u pedijatrijskih bolesnika predviđeni su farmakokinetičkim modelom populacije i prikazani u tablici 4 prema t rasponima tjelesne težine koji odgovaraju preporučenim dozama kapsula.
English: - Medicines used to treat bacterial infections including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Croatian: - Lijekove za liječenje bakterijskih infekcija, uključujući tuberkulozu i s AIDS-om povezan Mycobacterium avium kompleks: klaritromicin, rifabutin, rifampicin.
English: If you take too much Efavirenz Teva, contact your doctor or nearest emergency department for advice.
Croatian: Uzmete li previsoku dozu Efavirenza Teva, javite se liječniku ili u najbližu hitnu službu radi savjeta.
English: Mean Cmax µg/mL
Croatian: Cmax µg/ml
English: paranoia, psychosis†, suicide attempt, suicide ideation, catatonia*
Croatian: halucinacije, manija, paranoja, psihoza†, pokušaj samoubojstva, suicidalne misli, katatonija*
English: In HIV-1 infected patients (n=6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
Croatian: U bolesnika s HIV-1 infekcijom (n=6) farmakokinetika indinavira i efavirenza općenito je bila usporediva s onom u nezaraženih dobrovoljaca.
English: What Efavirenz Teva looks like and contents of the pack
Croatian: Kako Efavirenz Teva izgleda i sadržaj pakiranja
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost te pojave nije poznata (vidjeti dio 4.4).).
English: If you take more Efavirenz Teva than you should
Croatian: Ako uzmete više lijeka Efavirenz Teva nego što ste trebali
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh Class B or C) affects efavirenz pharmacokinetics.
Croatian: Nije bilo dovoljno podataka o tome utječe li umjereno ili teško oštećenje jetre (Child-Pugh stadij B ili C) na farmakokinetiku efavirenza.
English: Since no dose recommendation for itraconazole can be made, alternative antifungal treatment should be considered.
Croatian: Budući se ne može dati preporuka za dozu itrakonazola, mora se razmotriti primjena nekog drugog antifungalnog lijeka
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Croatian: Bolesnici s već oštećenom funkcijom jetre, uključujući kronični aktivni hepatitis, imaju veću učestalost poremećaja jetrene funkcije tijekom kombinirane antiretrovirusne terapije te se zbog toga moraju nadzirati u skladu s uobičajenom praksom.
English: Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Croatian: Bolesnike treba pomno nadzirati zbog mogućih nuspojava ovisnih od dozi, a posebno poremećaja živčanog sustava (vidjeti dijelove 4.3 i 4.4).
English: If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.
Croatian: Ako se zbog sumnje na nepodnošenje lijeka prekine kombinirano liječenje bilo kojim antiretrovirusnim lijekom, ozbiljno treba razmotriti i istodobni prekid liječenja svim antiretrovirusnim lijekovima.
English: Efavirenz is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2) and not recommended in patients with moderate hepatic impairment because of insufficient data to determine whether dose adjustment is necessary.
Croatian: Efavirenz je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 5.2) i ne preporučuje se u bolesnika s umjerenim oštećenjem jetre jer nema dovoljno podataka o tome je li potrebna prilagodba doze.
English: - Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when you start or stop taking Efavirenz Teva, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Croatian: - Imunosupresive kao što su ciklosporin, sirolimus ili takrolimus (lijekovi za sprečavanje odbacivanja presađenog organa): kad počnete ili prestanete uzimati Efavirenz Teva, liječnik će Vam pažljivo nadzirati koncentraciju imunosupresiva u plazmi i možda će morati prilagođavati njihovu dozu.
English: Rash was more common in children than in adults treated with efavirenz.
Croatian: Osip se puno češće pojavljuje u djece nego u odraslih liječenih efavirenzom.
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Croatian: Vidjeti Sažetak opisa svojstava lijeka za lijekove koji sadržavaju maravirok.
English: If you stop taking Efavirenz Teva When your Efavirenz Teva supply starts to run low, get more from your doctor or pharmacist.
Croatian: Ako prestanete uzimati Efavirenz Teva Kad se Vaša zaliha lijeka Efavirenz Teva približi kraju, nabavite novo pakovanje od svog liječnika ili ljekarnika.
English: Efavirenz has been studied in over 9,000 patients.
Croatian: Sažetak sigurnosnog profila Efavirenz je ispitan na više od 9000 bolesnika.
English: Special populations
Croatian: Posebne skupine
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 tenofovir disoproksil.
English: The clinical effect of this dose adjustment has not been adequately evaluated.
Croatian: Klinički učinak ove prilagodbe doze nije dovoljno procijenjen.
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.
Croatian: Ako liječenje Efavirenzom Teva započinjete zato što Vaše dosadašnje liječenje nije spriječilo umnožavanje virusa, istodobno morate početi uzimati drugi lijek, koji do sada niste uzimali.
English: If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Croatian: Primijete li se znakovi pogoršanja bolesti jetre ili trajnog povišenja serumskih transaminaza više od 5 puta iznad gornje granice normale, treba procijeniti opravdanost nastavka liječenja efavirenzom s obzirom na moguće rizike značajnih toksičnih učinaka na jetru.
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Croatian: Efavirenz u kombinaciji s darunavirom/ritonavirom 800/100 mg jedanput na dan može dovesti do suboptimalnih Cmin darunavira.
English: (UGT1A1 induction)
Croatian: (indukcija UGT1A1)
English: The clinical significance of asymptomatic increases in serum amylase is unknown.
Croatian: Nije poznat klinički značaj asimptomatskog porasta amilaze u serumu.
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 napraviti krvne pretrage kako bi provjerio kako radi jetra ili Vam može propisati neki drugi lijek.
English: - Film-coated tablet: yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other - Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30 x 1 / 90 x 1 film-coated tablets (in perforated unit dose blisters) or a multi-pack bundle or carton containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet).
Croatian: - Filmom obložena tableta: žuta filmom obložena tableta oblika kapsule, s oznakom “Teva” na jednoj i “7541” na drugoj strani - Efavirenz Teva dostupan je u pakiranjima sa 30, 90 filmom obloženih tableta ili 30 x 1/90 x 1 filmom obloženih tableta (u perforiranim blisterima djeljivim na jedinične doze) ili višestrukom pakovanju u paketu ili u kutiji sa 90 filmom obloženih tableta (3 pakovanja sa 30 x 1 filmom obložena tableta).
English: bone problems.
Croatian: o probleme s kostima.
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Croatian: Inducirajući učinak gospine trave može potrajati najmanje dva tjedna nakon prestanka primjene (vidjeti dio 4.3).
English: - Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy, breast-feeding and fertility).
Croatian: - Hormonske kontraceptive, kao što su tablete za sprečavanje trudnoće, kontraceptivi u injekciji (npr. Depo-Provera) ili kontracepcijski implantat (npr. Implanon): morate koristiti i pouzdanu mehaničku metodu kontracepcije (vidjeti Trudnoća, dojenje i plodnost).
English: Efavirenz Teva taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Croatian: Uzimanje lijeka Efavirenz Teva u kombinaciji s drugim antiretrovirusnim lijekovima smanjuje količinu virusa u krvi.
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
Croatian: Efavirenz je nekompetitivni inhibitor reverzne transkriptaze HIV-1, bez značajne inhibicije reverzne transkriptaze HIV-2 ili staničnih DNK polimeraza (α, β, γ ili δ).
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 stopa bolesnika s odgovorom (ispitanici koji nisu završili liječenje nisu analizirani; engl. the non-completer equals failure analysis, [NC=F]), za one bolesnike koji su iz bilo kojeg razloga ranije prekinuli ispitivanje, ili one koji su propustili jedno mjerenje HIV-RNK kojemu je prethodilo ili je nakon njega uslijedilo mjerenje s rezultatima iznad granice određivanja laboratorijskog testa, pretpostavljeno je da imaju HIV-RNK iznad 50 ili iznad 400 kopija/ml u vrijeme propuštenog mjerenja.
English: Lipid disorders should be managed as clinically appropriate
Croatian: Poremećaje lipida potrebno je prikladno klinički liječiti.
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicines used in combination with efavirenz.
Croatian: Obrazac aminokiselinskih zamjena u reverznoj transkriptazi udruženih s rezistencijom na efavirenz bio je neovisan o drugim antivirusnim lijekovima u kombinaciji s efavirenzom.
English: Carcinogenicity studies in male mice, male and female rats were negative.
Croatian: Istraživanja kancerogenosti kod mužjaka miševa te kod mužjaka i ženki štakora bila su negativna.
English: - abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness,
Croatian: - neuobičajeni snovi, poteškoće s koncentracijom, omaglica, glavobolja, poteškoće sa spavanjem,
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Croatian: Efavirenz može biti induktor CYP2C19 i CYP2C9; međutim in vitro je zabilježena i inhibicija, tako da neto učinak istodobne primjene sa supstratima tih enzima nije razjašnjen (vidjeti dio 5.2).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Croatian: Odgovarajući primjeri su citomegalovirusni retinitis, opće i/ili lokalizirane infekcije mikobakterijama i upala pluća izazvana Pneumocystis jiroveci (prije poznata kao
English: Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Croatian: Efavirenz Teva, koji sadrži djelatnu tvar efavirenz, pripada skupini antiretrovirusnih lijekova koji se nazivaju nenukleozidni inhibitori reverzne transkriptaze (NNRTI).
English: Responder rates were highest in patients who switched NRTIs.
Croatian: Stope bolesnika s odgovorom bile su najveće među bolesnicima koji su promijenili NRTI.
English: If you are affected your doctor may suggest that you take Efavirenz Teva at bedtime and on an empty stomach.
Croatian: Ako se u Vas pojave opisani simptomi, liječnik Vam može predložiti da Efavirenz Teva uzimate prije spavanja i na prazan želudac.
English: Study number/ Treatment regimensb n % (95% C.I.c) % (95% C.I.c) cells/mm3
Croatian: Broj ispitivanja/ Terapijski protokoli b n % (95% C.I.c) % (95% C.I.c) stanica/mm3 (S.E.M.d)
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike treba uputiti da potraže liječničku pomoć osjete li stalnu tupu bol i povremenu bol ili ukočenost zglobova ili imaju poteškoća u kretanju.
English: In clinical controlled trials, frequently reported adverse reactions included, but were not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Croatian: U kontroliranim kliničkim ispitivanjima često su zabilježene sljedeće (ali ne samo ove) nuspojave: omaglica, nesanica, somnolencija, smanjena koncentracija i neuobičajeni snovi.
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 RT u virusnim izolatima u bolesnika koji su imali značajan povrat (rebound) virusnog opterećenja tijekom kliničkih ispitivanja primjene efavirenza u kombinaciji s indinavirom ili zidovudinom + lamivudinom.
English: These problems tend to occur more often in those who have a history of mental illness.
Croatian: Te nuspojave češće se javljaju u bolesnika koji su bolovali od neke psihičke bolesti.
English: If you notice any symptoms of infection, please tell your doctor immediately.
Croatian: Primijetite li bilo kakve simptome infekcije, odmah obavijestite svog liječnika.
English: The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Croatian: Cmax i Cmin aktivnog metabolita karbamazepin epoksida ostale su nepromijenjene.
English: Implant: Etonogestrel/efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Croatian: Implantat: Etonogestrel/efavirenz Može se očekivati smanjena izloženost etonogestrelu (indukcija CYP3A4).
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.
Croatian: U kliničkim je ispitivanjima 26% bolesnika liječenih efavirenzom od 600 mg imalo kožni osip, u odnosu na 17% onih u kontrolnim skupinama.
English: Each film-coated tablet contains 9.98 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 9,98 mg laktoze (u obliku hidrata).
English: Pregnancies have occurred in women taking Efavirenz Teva while using a contraceptive implant, although it has not been established that the Efavirenz Teva therapy caused the contraceptive to fail.
Croatian: Trudnoća je nastupila u žena koje su uzimale Efavirenz Teva i koristile kontracepcijski implantat, premda nije potvrđeno da je liječenje lijekom Efavirenz Teva spriječilo djelovanje kontraceptiva.
English: Concomitant administration of sofosbuvir/velpatasvir with efavirenz resulted in a reduction (approximately 50%) in the systemic exposure of velpatasvir.
Croatian: Istodobna primjena sofosbuvira/velpatasvira s efavirenzom uzrokovala je smanjenje (približno 50%) sistemske izloženosti
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 1).
Croatian: Izloženost raltegraviru (supstrat UGT1A1) smanjena je u prisustvu efavirenza (vidjeti dio 4.5, Tablicu 1).
English: †These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Croatian: † Ove nuspojave zabilježene su tijekom praćenja nakon stavljanja lijeka u promet; no, učestalost je određena na temelju podataka iz 16 kliničkih ispitivanja (n=3969).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: Talk to your doctor before taking Efavirenz Teva
Croatian: Obratite se svom liječniku prije nego što uzmete Efavirenz Teva.
English: The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Croatian: Potencijal križne rezistencije između efavirenza i NRTI-ja je također je nizak zbog različitih veznih mjesta i mehanizama djelovanja.
English: Efavirenz plasma exposure may be increased in patients with the homozygous G516T genetic variant of the CYP2B6 isoenzyme.
Croatian: Koncentracija efavirenza u plazmi može biti povišena u bolesnika s homozigotnom G516T genskom inačicom izoenzima CYP2B6.
English: In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Croatian: U bolesnika koji se liječe drugim lijekovima s hepatotoksičnim učinkom, također se preporučuje praćenje jetrenih enzima.
English: Efavirenz Teva may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Croatian: Moguće su interakcije Efavirenza Teva s nekim drugim lijekovima, uključujući biljne pripravke kao što su ekstrakti Ginkga bilobe.
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Croatian: U bolesnika koji istodobno primaju antikonvulzive koji se primarno metabolizira u jetri kao što su fenitoin, karbamazepin i fenobarbital može biti potrebno povremeno provjeravati koncentracije u plazmi.
English: Thirteen isolates previously characterised as efavirenz-resistant were also resistant to nevirapine and delavirdine.
Croatian: Trinaest izolata, za koje je prethodno ustanovljeno da su rezistentni na efavirenz, bilo je rezistentno i na nevirapin i delavirdin.
English: If efavirenz and telaprevir are coadministered, telaprevir 1,125 mg every 8 hours should be used.
Croatian: U slučaju istovremene primjene efavirenza i telaprevira, telaprevir 1,125 mg potrebno je primjenjivati svakih 8 sati.
English: The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
Croatian: Preporučena doza efavirenza u kombinaciji s nuklezoidnim analozima inhibitora reverzne transkriptaze (engl. nucleoside analogue reverse transcriptase inhibitors, NRTIs) s inhibitorom proteaze ili bez njega (vidjeti dio 4.5), je 600 mg peroralno, jedanput na dan.
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 niti druge prepoznatljive čimbenike rizika (vidjeti dio 4.8).
English: 30 film-coated tablets 30 x 1 film-coated-tablets 90 x 1 film-coated tablets 90 film-coated tablets
Croatian: 30 filmom obloženih tableta 30 x 1 filmom obložena tableta 90 x 1 filmom obloženih tableta 90 filmom obloženih tableta
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 in vitro podaci upućuju da efavirenz inhibira CYP2C9 i CYP2C19, postoje kontradiktorna izvješća i o povećanoj i o smanjenoj izloženosti supstratima tih enzima tijekom njihove istodobne primjene s efavirenzom in vivo.
English: - Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Croatian: - Lijekove za snižavanje masnoća u krvi (statine): atorvastatin, pravastatin, simvastatin.
English: There is no experience in patients with severe renal failure and close safety monitoring is recommended in this population.
Croatian: Budući da nema iskustva kod primjene u bolesnika s teškim zatajenjem bubrega, u toj se skupini preporuča strogi sigurnosni nadzor.
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Croatian: U tim je studijama efavirenz primjenjivan u dozi od 600 mg jedanput na dan; doza indinavira bila je 1000 mg svakih 8 sati kad se primjenjivao u kombinaciji s efavirenzom, odnosno 800 mg svakih 8 sati kad se primjenjivao bez efavirenza.
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Croatian: Nema dovoljno podataka o podnošljivosti efavirenza s niskom dozom ritonavira (100 mg jedanput ili dvaput na dan).
English: Efavirenz has also been shown to induce UGT1A1.
Croatian: Efavirenz također inducira UGT1A1.
English: - Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
Croatian: - Sertralin (lijek za liječenje depresije): liječnik će Vam možda trebati promijeniti dozu sertralina.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing antiretroviral therapy and subjects receiving no antiretroviral therapy.
Croatian: U tromjesečnom ispitivanju interakcija lijekova nisu ustanovljene značajne razlike u farmakokinetičkim parametrima MPA između ispitanika koji su primali antiretrovirusnu terapiju koja je sadržavala efavirenz i ispitanika koji nisu primali antiretrovirusnu terapiju.
English: Taking these medicines with Efavirenz Teva could create the potential for serious and/or life-threatening side effects or stop Efavirenz Teva from working properly.
Croatian: Uzimanje ovih lijekova s Efavirenzom Teva može dovesti do razvoja ozbiljnih i/ili po život opasnih nuspojava ili spriječiti ispravno djelovanje Efavirenza Teva.
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.
Croatian: Iako nije dokazana ukrižena rezistencija efavirenza s inhibitorima proteaze, zasad nema dovoljno podataka o djelotvornosti naknadne primjene kombinirane terapije inhibitorima proteaze nakon neuspjeha terapije koja je sadržavala efavirenz.