FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h.
Croatian: Geometrijska sredina Cmin indinavira (0,33 mg/l) kad se davao s ritonavirom i efavirenzom bila je viša od prosječne retrospektivne Cmin (0,15 mg/l) kad se indinavir davao sam u dozi od 800 mg q8h.
English: Other medicines and Efavirenz Teva You must not take Efavirenz Teva with certain medicines.
Croatian: Efavirenz Teva ne smijete uzimati s određenim lijekovima.
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Croatian: Istodobna primjena s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ili ergot alkaloidima (primjerice ergotaminom, dihidroergotaminom, ergonovinom i metilergonovinom) zbog toga što kompeticija efavirenza za CYP3A4 može uzrokovati inhibiciju metabolizma i povećati mogućnost ozbiljnih i/ili po život opasnih nuspojava [npr. srčane aritmije, produžena sedacija ili respiratorna depresija] (vidjeti dio 4.5).
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Croatian: Ako bolesnik već uzima gospinu travu, mora prestati, te provjeriti razinu virusa i po mogućnosti koncentraciju efavirenza.
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.
Croatian: Amilaza: u podskupini od 1008 bolesnika u kliničkom ispitivanju, opaženo je asimptomatsko povišenje vrijednosti amilaze u serumu više od 1,5 puta iznad gornje granice normale u 10% bolesnika liječenih efavirenzom i u 6% bolesnika u kontrolnom protokolu.
English: A causal relationship of these events to the use of efavirenz has not been established, and the denominator is unknown.
Croatian: Uzročna veza ovih događaja s primjenom efavirenza nije utvrđena i nije poznat zajednički nazivnik.
English: Delusion ‡, neurosis ‡, completed suicide‡,* Nervous system disorders Common Cerebellar co-ordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)* Uncommon Agitation, amnesia, ataxia, co-ordination abnormal, convulsions, thinking abnormal*, tremor†
Croatian: rijetko deluzije ‡, neuroza ‡, počinjeno samoubojstvo‡,* Poremećaji živčanog sustava često poremećaji cerebelarne koordinacije i ravnoteže†, poremećaji pažnje (3,6%), omaglica (8,5%), glavobolja (5,7%), somnolencija (2,0%)*
English: - The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core.
Croatian: - Drugi sastojci u jezgri su mikrokristalična celuloza, hidroksipropilceluloza, natrijev laurilsulfat, natrijev škroboglikolat (tip A), poloksamer 407 i magnezijev stearat.
English: No malformations were observed in foetuses from efavirenz-treated rats and rabbits.
Croatian: Nisu zabilježene malformacije fetusa kod ženki štakora i zečeva koje su primale efavirenz.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve su se reakcije obično javljale u prvih nekoliko tjedana ili mjeseci nakon uvođenja kombinirane antiretrovirusne terapije.
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 Efavirenz
Croatian: - Diltiazem ili slične lijekove (koji se zovu blokatori kalcijevih kanala, a to su lijekovi koji se obično primjenjuju kod povišenog krvnog tlaka ili srčanih tegoba): kad počnete uzimati Efavirenz Teva, liječnik će Vam možda trebati prilagoditi dozu blokatora kalcijevih kanala.
English: Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Croatian: Niže su navedene umjerene ili teže nuspojave kod kojih je ustanovljena barem moguća povezanost s protokolom liječenja (prema ocjeni ispitivača), a koje su zabilježene u kliničkim ispitivanjima s efavirenzom u preporučenim dozama u kombiniranoj terapiji (n=1008).
English: (Decrease in itraconazole concentrations: CYP3A4 induction)
Croatian: (Snižena koncentracija itrakonazola: indukcija CYP3A4)
English: Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Croatian: U jednog fetusa opažene su anencefalija i unilateralna anoftalmija sa sekundarnim povećanjem jezika, u drugog je zabilježena mikrooftalmija, a u trećega rascjep nepca.
English: Interaction not studied
Croatian: Nisu provedena ispitivanja interakcija
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (kao što su Gravesova bolest i autoimuni hepatits); međutim, prijavljeno vrijeme do pojave je različito i ti se događaji mogu javiti više mjeseci nakon uvođenja liječenja.
English: Always notify your doctor immediately if you have these symptoms or any side effects while taking Efavirenz Teva.
Croatian: Odmah obavijestite svog liječnika ako se tijekom uzimanja Efavirenza Teva pojave opisani simptomi ili bilo koja druga nuspojava.
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).
Croatian: Nakon primjene jednokratne doze od 600 mg efavirenz filmom obloženih tableta s punomasnim obrokom u nezaraženih dobrovoljaca, AUC je porastao 28% (90% Cl: 22-33%), a Cmax 79% (90% Cl: 58-102%) u usporedbi s primjenom lijeka natašte (vidjeti dio 4.4).
English: Efavirenz Teva may make hormonal contraceptives less likely to work.
Croatian: Efavirenz Teva može smanjiti djelotvornost hormonske kontracepcije.
English: Other macrolide antibiotics (e.g. erythromycin)/efavirenz
Croatian: Drugi makrolidni antibiotici (npr. eritromicin)/efavirenz
English: Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended, as it may decrease concentrations of velpatasvir and voxilaprevir.
Croatian: Istodobna primjena velpatasvira/sofosbuvira/voksilaprevir a s efavirenzom se ne preporučuje, jer može smanjiti koncentracije velpatasvira i voksilaprevira.
English: itraconazole.
Croatian: itrakonazol.
English: Since efavirenz is highly protein-bound, dialysis is unlikely to remove significant quantities of it from blood.
Croatian: Budući da se efavirenz u velikoj mjeri veže za proteine plazme, mala je vjerojatnost da bi se dijalizom uklonile značajne količine lijeka iz krvi.
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Croatian: To može ublažiti neke nuspojave (npr. omaglicu, pospanost).
English: For a summary of clinical and pharmacodynamic information, see section 5.1.
Croatian: Za sažetak kliničkih i farmakodinamičkih podataka vidjeti dio 5.1. 4.2 Doziranje i način primjene
English: if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Croatian: • Obavijestite svog liječnika: o ako ste bolovali od psihičkih bolesti, uključujući depresiju, ili ste bili ovisni o drogama ili alkoholu.
English: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika zaraženih HIV-om s teškim imunološkim deficitom pri uvođenju kombinirane antiretrovirusne terapije mogu se pojaviti upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, što može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: The choice of new antiretroviral agent(s) to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance (see section 5.1).
Croatian: Pri izboru novih antiretrovirusnih lijekova za kombiniranu primjenu s efavirenzom mora se misliti i na mogućnost razvoja virusne ukrižene rezistencije (vidjeti dio 5.1).
English: When efavirenz is co-administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Croatian: Kod primjene efavirenza istodobno s antikonvulzivom koji je supstrat izoenzima CYP450, mora se periodički kontrolirati koncentracija antikonvulziva.
English: Contact your doctor or pharmacist for advice.
Croatian: Posavjetujte se sa svojim liječnikom ili ljekarnikom.
English: Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Croatian: Zabilježen je više nego stostruki gubitak osjetljivosti protiv onih HIV inačica koje su pored drugih zamjena aminokiselina u reverznoj transkriptazi imale i zamjenu K103N.
English: Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment.
Croatian: Vidjeti u daljnjem tekstu i dio 5.3. Efavirenz se ne smije uzimati tijekom trudnoće, osim ako kliničko stanje bolesnice ne zahtijeva takvo liječenje.
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Croatian: (primjerice ritonavirom) ili hranom (primjerice sokom od grejpa) koji inhibiraju djelovanje CYP3A4 ili CYP2B6.
English: (CYP3A4 induction) Efavirenz:
Croatian: (indukcija CYP3A4) Efavirenz:
English: It is important to tell your doctor or pharmacist if you are taking any of the following: - Other medicines used for HIV infection:
Croatian: Važno je da obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova:
English: The administration of efavirenz with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Croatian: Primjena efavirenza s hranom može povećati izloženost efavirenzu (vidjeti dio 5.2) i povećati učestalost nuspojava (vidjeti dio 4.8).
English: Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Croatian: Efavirenz se ne smije primjenjivati kao monoterapija u liječenju HIV-a niti se dodatkom samo efavirenza smije dopunjavati neučinkoviti režim liječenja.
English: If efavirenz is co-administered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered (see section 4.5).
Croatian: Kod istodobne primjene s rifampicinom u bolesnika tjelesne težine od 50 kg ili veće može se razmotriti povećanje doze efavirenza na 800 m na dan (vidjeti dio 4.5).
English: What you need to know before you take Efavirenz Teva Do NOT take Efavirenz Teva
Croatian: Što morate znati prije nego počnete uzimati Efavirenz Teva
English: Cellulose, microcrystalline Hydroxypropylcellulose Sodium laurilsulfate Sodium starch glycolate (Type A) Poloxamer 407
Croatian: Jezgra celuloza, mikrokristalična hidroksipropilceluloza natrijev laurilsulfat natrijev škroboglikolat (tip A) poloksamer 407 magnezijev stearat
English: Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens.
Croatian: Efavirenz još nije dovoljno ispitan u bolesnika s uznapredovalom bolesti HIV-a, kao primjerice u bolesnika s brojem CD4 < 50 stanica /mm3 ili nakon neuspjeha kombiniranog liječenja inhibitorima proteaze (IP).
English: d S.E.M., standard error of the mean.
Croatian: d S.E.M., standardna pogreška srednje vrijednosti. ---, nije analizirano.
English: Package leaflet: information for the user Efavirenz Teva 600 mg film-coated tablets efavirenz
Croatian: Uputa o lijeku: Informacija za korisnika Efavirenz Teva 600 mg filmom obložene tablete efavirenz
English: Caution must be taken in any patient with a history of seizures.
Croatian: Potreban je oprez u svih bolesnika s napadajima u anamnezi.
English: EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
Croatian: IDV + NRTIs a NC = F, ispitanici koji ne završe = terapijski neuspjeh. b EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nukleozidni inhibitor reverzne transkriptaze; NFV, nelfinavir.
English: Liver enzymes in hepatitis B or C co-infected patients In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive).
Croatian: Prema podacima dugoročnog ispitivanja iz studije 006, 137 bolesnika na protokolu koji je uključivao efavirenz (medijan trajanja terapije 68 tjedana) i 84 bolesnika na kontrolnom protokolu (medijan trajanja 56 tjedana) bilo je seropozitivno na skriningu na hepatitis B (pozitivan površinski antigen) i/ili hepatitis C (pozitivno protutijelo na hepatitis C).
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Efavirenz Teva.
Croatian: liječnik će Vam možda morati provjeriti razinu antikonvulzivnog lijeka u krvi kako bi bio siguran da se nije promijenila zbog uzimanja Efavirenza Teva.
English: - Efavirenz Teva should never be used alone to treat HIV.
Croatian: - Efavirenz Teva nikada ne smijete uzimati kao jedini lijek za liječenje HIV infekcije.
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).
Croatian: Farmakokinetika efavirenza nije ispitivana u bolesnika s insuficijencijom bubrega, no s obzirom da se manje od 1% efavirenza izlučuje mokraćom u nepromijenjenom obliku, utjecaj oštećenja bubrega na eliminacija efavirenza trebao bi biti minimalan (vidjeti dio 4.4).
English: Efavirenz Teva may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of efavirenz in your blood.
Croatian: Efavirenz Teva može smanjiti koncentraciju vorikonazola u krvi, a vorikonazol može povećati koncentraciju efavirenza u krvi.
English: Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Croatian: Virusni izolati dobiveni iz mononuklearnih stanica periferne krvi bolesnika s dokazanim terapijskim neuspjehom u kliničkim ispitivanjima efavirenza (povrat virusnog opterećenja), ispitani su na osjetljivost na NNRTI-je.
English: In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Croatian: U ispitivanju intravenskih ovisnika zaraženih HIV virusom istodobna primjena efavirenza i metadona dovela je do sniženja koncentracije metadona u plazmi i znakova ustezanja od opijata.
English: Peak efavirenz plasma concentrations of 1.6-9.1 microM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Croatian: Vršne koncentracije efavirenza u plazmi od 1,6-9,1 μM postignute su u nezaraženih dobrovoljaca 5 sati nakon jednokratne primjene oralnih doza lijeka od 100 do 1600 mg.
English: Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Croatian: Psihijatrijski poremećaji često neuobičajeni snovi, anksioznost, depresija, nesanica * manje često emocionalna labilnost, agresija, stanje konfuzije, euforično raspoloženje,
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section
Croatian: U periodičkim se razmacima moraju napraviti laboratorijske pretrage zbog procjene bolesti jetre (vidjeti dio 4.2).
English: EFV + NRTIs NFV + NRTIs Study 020
Croatian: EFV + NRTIs NFV + NRTIs Ispitivanje 020 24 tjedna
English: You should not breast-feed your baby if you are taking Efavirenz Teva.
Croatian: Ne smijete dojiti ako uzimate Efavirenz Teva.
English: AUC: ↔ Cmax: ↑ 50% (↑ 20 to ↑ 80)
Croatian: AUC: ↔ Cmax: ↑ 50% (↑ 20 do ↑ 80)
English: It is recommended to be taken on an empty stomach preferably at bedtime.
Croatian: Preporučuje se uzimati ga na prazan želudac, po mogućnosti prije spavanja.
English: AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) *
Croatian: AUC: ↓ 7% (↓ 23 do ↑ 13) * Cmax: ↑ 23% (↓ 1 do ↑ 53) *
English: Efavirenz Teva 600 mg film-coated tablets
Croatian: Efavirenz Teva 600 mg filmom obložene tablete
English: AUC: ↓ 25% (↓ 16 to ↓32)
Croatian: AUC: ↓ 25% (↓ 16 do ↓32)
English: Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Croatian: Efavirenz se ne smije primjenjivati istodobno s terfenadinom, astemizolom, cisapridom, midazolamom, triazolamom, pimozidom, bepridilom ili alkaloidima ražene glavnice (kao što su ergotamin, dihidroergotamin, ergonovin i metilergonovin) jer inhibicija njihovog metabolizma može uzrokovati ozbiljne i po život opasne događaje (vidjeti dio 4.3).
English: How to take Efavirenz Teva
Croatian: Kako uzimati Efavirenz Teva
English: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Croatian: Efavirenz je indiciran u kombiniranom antivirusnom liječenju odraslih, adolescenata i djece u dobi od
English: - Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin,
Croatian: - Lijekove za liječenje konvulzija/napadaja (antikonvulzive): karbamazepin, fenitoin, fenobarbital.
English: (CYP3A4 and CYP2B6 induction)
Croatian: (indukcija CYP3A4 i CYP2B6)
English: There have been occasional postmarketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients.
Croatian: Nakon stavljanja lijeka u promet povremeno su prijavljeni izostanci kontraceptivnog učinka etonogestrela u bolesnika koji su uzimali efavirenz.
English: Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug-metabolising enzymes and/or transport proteins by St. John's wort.
Croatian: Koncentracija efavirenza u plazmi može se smanjiti zbog istodobne primjene gospine trave, jer ista inducira enzime koji metaboliziraju lijek i/ili transportne proteine.
English: The mean baseline CD4 cell count was 341 cells/mm3 and the mean baseline HIV-RNA level was 60,250 copies/ml.
Croatian: Prosječan početni broj CD4 stanica iznosio je 341 stanica/mm3, a prosječna početna vrijednost HIV-RNK bila je 60250 kopija/ml.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: - Methadone (a medicine used to treat opiate addiction): your doctor may recommend an alternative treatment.
Croatian: - Metadon (lijek za liječenje ovisnosti o opijatima): liječnik će Vam možda preporučiti zamjensko liječenje.
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme, psychiatric adverse reactions including severe depression, death by suicide, and psychosis-like behaviour, and seizures have been reported in patients treated with efavirenz.
Croatian: U bolesnika liječenih efavirenzom prijavljene su teške kožne reakcije poput Stevens-Johnsonovog sindroma i erythema multiforme, psihijatrijske nuspojave, uključujući tešku depresiju, samoubojstvo i psihotično ponašanje te napadaji.
English: Proguanil:
Croatian: Progvanil:
English: AUC: ↔*/** (↓ 10 to ↑ 26) Cmax: ↔*/** (↓ 5 to ↑ 26) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49)
Croatian: AUC: ↔*/** (↓ 10 do ↑ 26) Cmax: ↔*/** (↓ 5 do ↑ 26) Cmin: ↑ 12%*/** (↓ 16 do ↑ 49)
English: Clinically significant interactions are not expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Croatian: Klinički značajne interakcije se ne očekuju jer se vigabatrin i gabapentin izlučuju isključivo nepromijenjeni mokraćom i nije vjerojatno da će se natjecati za iste metaboličke enzime i puteve eliminacije s efavirenzom.
English: ZDV + 3TC a NC = F, noncompleter = failure.
Croatian: ZDV + 3TC a NC = F, ispitanici koji ne završe = terapijski neuspjeh. b C.I., interval pouzdanosti.
English: Efavirenz Teva contains sodium
Croatian: Efavirenz Teva sadrži natrij
English: These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Croatian: Ove se nuspojave mogu početi pojavljivati prvog ili u prva dva dana liječenja i obično nestaju nakon prva 2 do 4 tjedna.
English: (500/125 mg twice daily/ 600 mg once daily)
Croatian: (500/125 mg dvaput na dan/ 600 mg jedanput na dan)
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.
Croatian: Dugoročni rezultati nakon 168 tjedana ispitivanja 006 (ispitivanje je završilo 160 bolesnika liječenih kombinacijom efavirenz + indinavir, 196 bolesnika liječenih kombinacijom efavirenz + zidovudin + lamivudin te 127 bolesnika liječenih kombinacijom indinavir + zidovudin + lamivudin) ukazuju na održanost odgovora na liječenje s obzirom na udio bolesnika s HIV-RNK <400 kopija/ml, HIV-RNK <50 kopija/ml, te s obzirom na srednju vrijednost promjene od početnog broja CD4 stanica.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s kroničnim hepatitisom B ili C, prethodno liječeni kombiniranom antiretrovirusnom terapijom, izloženi su povećanom riziku od razvoja ozbiljnih i potencijalno smrtonosnih jetrenih nuspojava.
English: Lopinavir/ritonavir tablets/ efavirenz
Croatian: Lopinavir/ritonavir tablete/ efavirenz
English: Co-administration of higher doses of either efavirenz or carbamazepine has not been studied.
Croatian: Istovremena primjena većih doza bilo efavirenza ili karbamazepina nije ispitana.