FrancophonIA/ELRC3.0 huggingface dataset:
English: As Efavirenz/Emtricitabine/Tenofovir disoproxil Krka may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka može prouzročiti oštećenje bubrega, pa se preporučuje praćenje funkcije bubrega (vidjeti dijelove 4.4 i 4.8 Sažetak sigurnosnog profila).
English: Cmax: ↓ 23% (↓ 30 to ↑ 16)
Croatian: Cmax: ↓ 23% (↓ 30 do ↑ 16)
English: If a patient misses a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka by more than 12 hours and it is almost time for the next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, a prošlo je više od 12 sati i uskoro je vrijeme za uzimanje sljedeće doze, bolesnik ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati lijek prema svom uobičajenom rasporedu.
English: Symptoms of your hepatitis may become worse after discontinuation of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Vaši simptomi hepatitisa možda će se pogoršati nakon prekida uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: If therapy with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is discontinued, consideration should be given to the long half-life of efavirenz (see section 5.2) and long intracellular half-lives of emtricitabine and tenofovir.
Croatian: U slučaju prekida terapije lijekom Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, nužno je uzeti u obzir dugo poluvrijeme efavirenza (vidjeti dio 5.2) te duga unutarstanična poluvremena emtricitabina i tenofovira.
English: A multiple-dose study of efavirenz showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Turcotte Class A) compared with controls.
Croatian: U ispitivanju efavirenza s primjenom višestrukih doza nisu utvrđeni značajni učinci na farmakokinetiku efavirenza u bolesnika s blagim oštećenjem funkcije jetre (stadij A Child-Pugh-Turcotte) u usporedbi s kontrolnom skupinom.
English: → If you are taking any of these medicines, tell your doctor immediately.
Croatian: Uzimate li bilo koji od tih lijekova, bez odlaganja to recite svojem liječniku.
English: Cmax: ↓ 45% (CYP3A4 or P-gp induction - effect on elbasvir)
Croatian: Cmax: ↓ 45% (indukcija CYP3A4 ili P-gp-a - učinak na elbasvir)
English: No data are available on the safety and efficacy of efavirenz/emtricitabine/tenofovir disoproxil in combination with other antiretroviral agents.
Croatian: Nema dostupnih podataka o sigurnosti i djelotvornosti efavirenza/emtricitabina/tenofovirdizoproksila u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Pregnancies have occurred in women taking efavirenz, a component of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, while using a contraceptive implant, although it has not been established that the efavirenz therapy caused the contraceptive to fail.
Croatian: U žena koje su uzimale efavirenz koji je jedna od djelatnih tvari lijekaEfavirenz/Emtricitabine/Tenofovir disoproxil Krka, a istodobno su koristile i kontracepcijski implantat zabilježeni su slučajevi trudnoća, iako nije ustanovljeno da je terapija efavirenzom uzrokovala neučinkovitost kontraceptiva.
English: As a result, the amounts of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka or other medicines in your blood may be affected.
Croatian: Kao rezultat toga može doći do utjecaja na količine lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka i drugih lijekova u Vašoj krvi.
English: It is recommended that Efavirenz/Emtricitabine/Tenofovir disoproxil Krka be taken on an empty stomach, preferably at bedtime.
Croatian: Preporučuje se uzimanje lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka na prazan želudac, po mogućnosti prije spavanja.
English: Both HIV and the ingredients of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka may pass through breast milk and cause serious harm to your baby.
Croatian: HIV i sastojci lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka mogu se prenijeti majčinim mlijekom i ozbiljno naštetiti Vašem djetetu.
English: The mean (%CV) tenofovir exposure increased from 2,185 ng•h/ml (12%) in patients with normal renal function, to 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) and 15,985 ng•h/ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Croatian: Srednja je vrijednost (% koeficijenta varijacije, CV) izloženosti tenofoviru porasla s 2185 ng•h/ml (12%) u ispitanika s normalnom funkcijom bubrega na 3064 ng•h/ml (30%), 6009 ng•h/ml (42%) i 15 985 ng•h/ml (45%), u bolesnika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega.
English: Periodic safety update reports
Croatian: - Periodička izvješća o neškodljivosti
English: Stopping Efavirenz/Emtricitabine/Tenofovir disoproxil Krka can seriously affect your response to future treatment.
Croatian: Prestanak uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka može ozbiljno ugroziti Vašu reakciju na buduće liječenje.
English: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is stopped your doctor may recommend that you resume hepatitis B treatment.
Croatian: Ako prestajete s uzimanjem lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, Vaš će liječnik možda preporučiti nastavak liječenja hepatitisa B.
English: High density polyethylene (HDPE) bottle with a child-resistant tamper evident polypropylene closure with integrated a silica gel desiccant.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu s evidencijom otvaranja i integriranim silikagelom kao sredstvom za sušenje.
English: The most frequently reported adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Croatian: Najčešće zabilježene nuspojave u bolesnika koji su liječeni do 48 tjedana u ispitivanju AI266073 za koje se smatra da su moguće ili vjerojatno povezane s efavirenzom/emtricitabinom/tenofovirdizoproksilom bile su psihijatrijski poremećaji (16%), poremećaji živčanog sustava (13%) i poremećaji probavnog sustava (7%).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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, life-threatening events (see section 4.3).
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka se ne smije uzimati istodobno s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ili ergot alkaloidima (na primjer ergotamin, dihidroergotamin, ergonovin i metilergonovin) jer inhibicija njihovih metabolizama može dovesti to ozbiljnih i po život opasnih učinaka (vidjeti dio 4.3).
English: Cmax: ↓ 87% (CYP3A4 or P-gp induction - effect on grazoprevir)
Croatian: Cmax: ↓ 87% (indukcija CYP3A4 ili P-gp-a - učinak na grazoprevir)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes, such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka kontraindiciran je za istodobnu primjenu s lijekovima za koje je poznato da produljuju QTc interval i mogu dovesti do torsade de pointes, kao što su: antiaritmici skupina IA i III, neuroleptici i antidepresivi, određeni antibiotici uključujući neke lijekove iz sljedećih skupina: makrolidi, fluorokinoloni, antimikotici derivati imidazola i triazola, određeni nesedacijski antihistaminici (terfenadin, astemizol), cisaprid, flekainid, određeni antimalarici i metadon (vidjeti dio 4.3).
English: Interrupting treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja lijekom Efavirenz/Emtricitabine/Tenofovir disoproxil Krka također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok.
English: You do not need to take another tablet if you were sick more than 1 hour after taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Drugu tabletu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sat nakon uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Croatian: U nerođenih životinja i djece žena koje su tijekom trudnoće uzimale efavirenz zabilježene su ozbiljne urođene mane.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka tablets should be swallowed whole with water, once daily.
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka tablete treba cijele progutati s vodom, jednom dnevno.
English: Women should not get pregnant during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and for 12 weeks thereafter.
Croatian: Žene ne bi smjele zatrudnjeti tijekom liječenja lijekom Efavirenz/Emtricitabine/Tenofovir disoproxil Krka niti 12 tjedana nakon prekida liječenja.
English: Nervous system symptoms are common with efavirenz, one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Simptomi živčanog sustava česti su kod efavirenza, jedne od komponenti lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka primjenjivati u kombinaciji s darunavirom/ritonavirom, treba primjenjivati režim darunavira/ritonavira 600/100 mg dvaput na dan.
English: If you do miss a dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Croatian: Ako ipak propustite uzeti jednu dozu lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka a to ste primijetili prije nego je proteklo 12 sati od vremena kada lijek obično uzimate, uzmite dozu čim možete, a potom sljedeću dozu uzmite u redovito vrijeme.
English: Since Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a fixed dose combination product, the dose of efavirenz cannot be altered (see section 4.5).
Croatian: Budući da je Efavirenz/Emtricitabine/Tenofovir disoproxil Krka kombinirani lijek s fiksnim dozama, doza efavirenza ne može se mijenjati (vidjeti dio 4.5).
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir.
Croatian: Istodobna primjena simeprevira s efavirenzom, sastojkom lijeka Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, rezultirala je značajno smanjenim koncentracijama simeprevira u plazmi zbog indukcije CYP3A efavirenzom, što može dovesti do gubitka terapijskog učinka simeprevira.
English: In a 144-week open-label randomised clinical study (GS 01-934) in antiretroviral-naïve patients, where efavirenz, emtricitabine and tenofovir disoproxil were used as individual formulations (or as efavirenz and the fixed combination of emtricitabine and tenofovir disoproxil from week 96 to 144), genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ml at week 144 or early study drug discontinuation (see section on Clinical experience).
Croatian: In vivo rezistencija (bolesnici koji prije nisu bili liječeni antiretrovirusnim lijekovima) U otvorenom randomiziranom kliničkom ispitivanju u trajanju od 144 tjedna (GS-01-934) u kojem su bolesnicima koji prije nisu bili liječeni antiretrovirusnim lijekovima davani efavirenz, emtricitabin i tenofovirdizoproksil u pojedinačnim formulacijama (ili kao efavirenz i fiksna kombinacija doza emtricitabina i tenofovirdizoproksila od 96. do 144. tjedna), izvršena je genotipizacija izolata virusa HIV-1 iz plazme svih bolesnika s potvrđenom koncentracijom HIV RNA > 400 kopija/ml u 144. tjednu ili u slučaju ranog prekida uzimanja ispitivanog lijeka (vidjeti dio Klinička iskustva).
English: See section 2 “Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains sodium”.
Croatian: Pogledajte dio 2. „Efavirenz/Emtricitabine/Tenofovir disoproxil Krka sadrži natrij”.
English: That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Efavirenz/Emtricitabine /Tenofovir disoproxil Krka Efavirenz/Emtricitabine /Tenofovir disoproxil Krka is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) That use of Efavirenz/Emtricitabine /Tenofovir disoproxil Krka should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Croatian: - u bolesnika inficiranih HIV-om postoji povećani rizik od bolesti bubrega povezan s lijekovima koji sadrže tenofovirdizoproksil, kao što je Efavirenz/Emtricitabine /Tenofovir disoproxil Krka - ne preporučuje se davanje lijeka Efavirenz/Emtricitabine /Tenofovir disoproxil Krka bolesnicima s umjerenim ili teškim oštećenjem funkcije bubrega (klirens kreatinina < 50 ml/min) - treba izbjegavati primjenu lijeka Efavirenz/Emtricitabine /Tenofovir disoproxil Krka istodobno s primjenom ili nakon nedavne primjene nefrotoksičnih lijekova.
English: The mean (%CV) emtricitabine exposure increased from 12 µg•h/ml (25%) in subjects with normal renal function to 20 µg•h/ml (6%), 25 µg•h/ml (23%) and 34 µg•h/ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Croatian: Srednja je vrijednost (% koeficijenta varijacije, CV) izloženosti emtricitabinu porasla s 12 µg•h/ml (25%) u ispitanika s normalnom funkcijom bubrega na 20 µg•h/ml (6%), 25 µg•h/ml (23%) i 34 µg•h/ml (6%), u bolesnika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega.
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of efavirenz/emtricitabine/tenofovir disoproxil on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.1).
Croatian: Predviđa se da je izloženost tenofoviru (AUC) približno 30% manja nakon uzimanja efavirenza/emtricitabina/tenofovirdizoproksila na prazan želudac, u usporedbi s uzimanjem pojedinačne komponente tenofovirdizoproksila s hranom (vidjeti dio 5.1).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka must be taken every day.
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka se mora uzimati svaki dan.
English: Dose adjustment: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is co-administered with rifampicin to patients weighing 50 kg or more, an additional 200 mg/day (800 mg total) of efavirenz may be considered (see section 4.5).
Croatian: Prilagođavanje doze: Ako se Efavirenz/Emtricitabine/Tenofovir disoproxil Krka istodobno primjenjuje s rifampicinom u bolesnika tjelesne težine 50 kg ili više, može se uzeti u obzir davanje dodatnih 200 mg efavirenza dnevno (ukupno 800 mg) (vidjeti dio 4.5).
English: The Summary of Product Characteristics HIV renal educational brochure, including the creatinine clearance slide ruler
Croatian: - sažetak opisa svojstava lijeka - edukativna brošura o utjecaju terapije za liječenje HIV-a na bubrege, uključujući i klizno ravnalo za klirens kreatinina
English: Norelgestromin (active metabolite): AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
Croatian: norelgestromin (aktivni metabolit): AUC: ↓ 64% (↓ 62 do ↓ 67) Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85)
English: Carbamazepine can reduce the amount of efavirenz, one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, in your blood.
Croatian: Karbamazepin može smanjiti koncentraciju efavirenza, jedne od komponenti lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, u krvi.
English: In a 144-week open-label randomised clinical study (GS-01-934) antiretroviral treatment-naïve HIV-1 infected patients received either a once-daily regimen of efavirenz, emtricitabine and tenofovir disoproxil or a fixed combination of lamivudine and zidovudine administered twice daily and efavirenz once daily (please refer to the Summary of Product Characteristics for emtricitabine/tenofovir disoproxil).
Croatian: U otvorenom randomiziranom kliničkom ispitivanju (GS-01-934) u trajanju od 144 tjedana, bolesnici inficirani virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnom terapijom primali su ili efavirenz, emtricitabin i tenofovirdizoproksil po režimu doziranja jedanput na dan ili fiksnu kombinaciju lamivudina i zidovudina davanu dvaput na dan te efavirenz jedanput na dan (pročitajte sažetak opisa svojstava lijeka za emtricitabin/tenofovirdizoproksil).
English: Efavirenz is an NNRTI of HIV-1.
Croatian: Efavirenz je nenukleozidni inhibitor reverzne transkriptaze (NNRTI) virusa HIV-1.
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, sodium laurilsulfate, croscarmellose sodium, ferric oxide red (E172), magnesium stearat, sodium stearyl fumarate.
Croatian: Jezgra tablete: mikrokristalična celuloza, hidroksipropilceluloza, natrijev laurilsulfat, umrežena karmelozanatrij, crveni željezov oksid (E172), magnezijev stearat i natrijev stearilfumarat.
English: The safety and efficacy of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka in children under the age of 18 years have not been established (see section 5.2).
Croatian: Sigurnost i djelotvornost lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka u djece mlađe od 18 godina nisu ustanovljene (vidjeti dio 5.2).
English: Posaconazole/Efavirenz (-/400 mg q.d.)
Croatian: posakonazol/efavirenz (-/400 mg q.d.)
English: What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil
Croatian: Što morate znati prije nego počnete uzimati Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Iz tog razloga trebate nastaviti s poduzimanjem gore navedenih mjera kontracepcije još 12 tjedana nakon prestanka uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: While taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka you may still develop infections or other illnesses associated with HIV infection.
Croatian: I tijekom uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka može doći do razvoja infekcija i drugih bolesti povezanih s infekcijom virusom HIV-a.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka može smanjiti količinu atovakvona/progvanila ili artemetera/lumefantrina u krvi.
English: LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/Efavirenz (10 mg q.d./600 mg q.d.)
Croatian: LIJEKOVI ZA SMANJENJE LIPIDA Inhibitori HMG Co-A reduktaze atorvastatin/efavirenz (10 mg q.d./600 mg q.d.)
English: Efavirenz/emtricitabine/tenofovir disoproxil was administered on an empty stomach (see section 4.2).
Croatian: Efavirenz/emtricitabin/tenofovirdizoproksil je davan na prazan želudac (vidjeti dio 4.2).
English: Lumefantrine: AUC: ↓ 21% Cmax: ↔
Croatian: lumefantrin: AUC: ↓ 21% Cmax: ↔
English: Since efavirenz is principally metabolised by the CYP system, caution should be exercised in administering Efavirenz/Emtricitabine/Tenofovir disoproxil Krka to patients with mild hepatic impairment.
Croatian: Budući da se efavirenz primarno metabolizira putem CYP sustava, potreban je oprez pri davanju lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka bolesnicima s blagim oštećenjem funkcije jetre.
English: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is stopped, speak to your doctor before you restart taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka tablets.
Croatian: Ako ste prestali s uzimanjem lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, razgovarajte s liječnikom prije nego počnete ponovno uzimati tablete Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: These are listed under Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, at the start of section 2.
Croatian: Ti su lijekovi navedeni pod Nemojte uzimati Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, na početku dijela 2.
English: Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir (see section 4.3 and Table 1).
Croatian: Istodobna primjena Efavirenz/Emtricitabine/Tenofovir disoproxil Krka i elbasvira/grazoprevira kontraindicirana je jer može dovesti do gubitka virološkog odgovora na elbasvir/grazoprevir (vidjeti dio 4.3 i tablicu 1).
English: Use of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka in combination with saquinavir as the sole protease inhibitor is not recommended.
Croatian: Ne preporučuje se davanje lijeka Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka u kombinaciji sa sakvinavirom kao jedinim inhibitorom proteaze.
English: Rare renal failure (acute and chronic), acute tubular necrosis,
Croatian: Rijetko zatajenje bubrega (akutno i kronično), akutna tubularna nekroza, nefritis (uključujući akutni intersticijski nefritis) nefrogeni dijabetes insipidus
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.2).
Croatian: Predviđa se izloženost tenofoviru (AUC) približno 30% manja nakon uzimanja lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka na prazan želudac, u usporedbi s uzimanjem pojedinačne komponente tenofovirdizoproksila s hranom (vidjeti dio 5.2).
English: Treatment-emergent adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of efavirenz/emtricitabine/tenofovir disoproxil, include:
Croatian: Nuspojave povezane s primjenom efavirenza/emtricitabina/tenofovirdizoproksila Nuspojave koje su se pojavile tijekom liječenja i za koje se smatra da su moguće ili vjerojatno povezane s efavirenzom/emtricitabinom/tenofovirdizoproksilom zabilježene u ispitivanju AI266073 (trajanje 48 tjedana, n = 203), a koje nisu povezane s nekom od pojedinačnih komponenti efavirenza/emtricitabina/tenofovirdizoproksila uključuju:
English: AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36% (UGT1A1 induction)
Croatian: AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36% (indukcija UGT1A1)
English: In the prior-NNRTI stratum, response rates were 98.9% vs 97.4% for efavirenz/emtricitabine/tenofovir disoproxil and SBR patients respectively; a difference (95%CI) of 1.4% (-4.0%, 6.9%)].
Croatian: U skupini bolesnika koji su prethodno liječeni NNRTI lijekovima stope odgovora bile su 98,9% u bolesnika koji su primali efavirenz/emtricitabin/tenofovirdizoproksil u usporedbi s 97,4% u SBR bolesnika: razlika (95%CI) od 1,4% (-4,0%, 6,9%)].