FrancophonIA/ELRC3.0 huggingface dataset:
English: Efavirenz must not be administered with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations caused by induction of drug metabolising enzymes and/or transport proteins and which are expected to result in the loss of virologic response of elbasvir/grazoprevir (see section 4.5).
Croatian: Efavirenz se ne smije primjenjivati istodobno s elbasvirom/grazoprevirom zbog očekivanog značajnog sniženja koncentracija elbasvira i grazoprevira u plazmi uzrokovanih indukcijom enzima koji metaboliziraju lijek i/ili transportnih proteina, za koje se očekuje da će dovesti do gubitka virološkog odgovora elbasvira/grazoprevira (vidjeti dio 4.5).
English: Concomitant administration of atovaquone/proguanil with efavirenz should be avoided.
Croatian: Istodobnu primjenu atovakona/progvanilklorida s efavirenzom treba izbjegavati.
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: Kad se efavirenz primjenjuje istodobno s antikonvulzivom koji je supstrat izoenzima CYP450 mora se periodički kontrolirati koncentracija antikonvulziva.
English: maraviroc the combination tablet containing efavirenz, emtricitabine and tenofovir should not be taken with Stocrin unless recommended by your doctor since it contains efavirenz, the active ingredient of Stocrin.
Croatian: - maravirok - kombinirana tableta koja sadrži efavirenz, emtricitabin i tenofovir ne smije se uzimati s lijekom Stocrin, osim ako Vam tako nije preporučio Vaš liječnik, zato što taj lijek sadrži efavirenz, djelatnu tvar lijeka Stocrin.
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 jedini lijek u liječenju HIV-a niti ga se smije kao jedinog dodavati neučinkovitom protokolu liječenja.
English: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms (see section 4.4).
Croatian: Najizraženije nuspojave povezane s primjenom efavirenza su osip i simptomi živčanog sustava (vidjeti dio 4.4).
English: Other macrolide antibiotics (e.g., erythromycin)/Efavirenz
Croatian: drugi makrolidni antibiotici (npr. eritromicin)/efavirenz
English: Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Croatian: Pri prilagodbi doze blokatora kalcijevih kanala treba se voditi kliničkim odgovorom (vidjeti sažetak opisa svojstava lijeka za blokator kalcijevih kanala).
English: When prescribing medicinal products concomitantly with efavirenz, physicians should refer to the corresponding Summary of Product Characteristics.
Croatian: Prilikom propisivanja lijekova istodobno s efavirenzom, liječnici moraju proučiti odgovarajući sažetak opisa svojstava lijeka za te lijekove.
English: Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when you start or stop taking Stocrin, 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 koji se koriste za sprječavanje odbacivanja presađenog organa): kada počnete ili prestanete uzimati Stocrin, liječnik će Vam pažljivo nadzirati koncentraciju imunosupresiva u plazmi i možda će morati prilagođavati njihovu dozu.
English: • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
Croatian: • Film ovojnica sadrži: hipromelozu (E464), titanijev dioksid (E171), makrogol 400, žuti željezov oksid (E172) i karnauba vosak.
English: Dose (ml) Children 3 - < 5 years
Croatian: Doza (ml) Djeca 3 - < 5 godina Odrasli i djeca u dobi od 5 godina i starija
English: Consider alternatives to efavirenz for co-administration with a drug with a known risk of Torsade de Pointes or when to be administered to patients at higher risk of Torsade de Pointes.
Croatian: Razmotrite primjenu alternativne terapije umjesto istodobne primjene efavirenza s lijekom za koji je poznato da postoji rizik od torsade de pointes ili u bolesnika s povećanim rizikom od torsade de pointes.
English: The mean baseline CD4 cell count was 341 cells/mm
Croatian: Srednja vrijednost početnog broja CD4 stanica iznosila je 341 stanica/mm
English: STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the film-coated tablets.
Croatian: STOCRIN oralna otopina je indicirana u kombiniranom antivirusnom liječenju odraslih, adolescenata i djece u dobi od 3 godine i starije zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), koji ne mogu gutati filmom obložene tablete.
English: • The dose for adults is 600 mg once daily.
Croatian: • Doza lijeka za odrasle je 600 mg jedanput na dan.
English: Stocrin contains lactose in each 600-mg daily dose.
Croatian: Stocrin sadrži laktozu u jednoj dnevnoj dozi od 600 mg.
English: The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Croatian: Dozu lopinavir/ritonavir tableta mora se povisiti na 500/125 mg dvaput na dan kada se primjenjuju istodobno s efavirenzom u dozi od 600 mg jedanput na dan.
English: Efavirenz regimen (n=1,008)
Croatian: protokol s efavirenzom (n=1008)
English: • Stocrin must be taken with other medicines that act against the HIV virus.
Croatian: • Stocrin se mora uzimati s drugim lijekovima koji djeluju protiv HIV-a.
English: Always notify your doctor immediately if you have these symptoms or any side effects while taking Stocrin.
Croatian: Odmah obavijestite svog liječnika ako se tijekom uzimanja lijeka Stocrin pojave opisani simptomi ili bilo koja druga nuspojava.
English: Paediatric population: ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/kg given three times a day) and one or more NRTIs.
Croatian: Pedijatrijska populacija: u tijeku je ispitivanje ACTG 382, nekontrolirano ispitivanje u koje je uključeno 57 djece (3-16 godina) koja su već primala NRTI-je, a u kojem se ispituju farmakokinetika, antivirusno djelovanje i sigurnost primjene efavirenza u kombinaciji s nelfinavirom (20-30 mg/kg triput na dan) i jednim ili više NRTI-ja.
English: Study Number/ Treatment Regimens n % (95 % C.I.
Croatian: Broj ispitivanja/ Protokoli liječenja n % (95% C.I. c) % (95% C.I.
English: Efavirenz has not been evaluated in children below 3 years of age or who weigh less than 13 kg.
Croatian: Efavirenz nije ispitivan u djece mlađe od 3 godine niti u djece čija je tjelesna težina manja od 13 kg.
English: The mean CD4 cell counts were increased by 63  34.5 cells/mm
Croatian: Srednja vrijednost broja CD4 stanica porasla je za 63 ± 34,5 stanica/mm u odnosu na početne vrijednosti.
English: For this reason, efavirenz oral solution should not be given to children less than 3 years of age.
Croatian: Zbog toga se oralna otopina efavirenza ne smije davati djeci mlađoj od 3 godine.
English: Dose adjustments of diltiazem should be guided by clinical response (refer to the Summary of Product Characteristics for diltiazem).
Croatian: Pri prilagodbi doze diltiazema treba se voditi kliničkim odgovorom (vidjeti sažetak opisa svojstava lijeka za diltiazem).
English: If you take too much Stocrin contact your doctor or nearest emergency department for advice.
Croatian: Ako uzmete više lijeka Stocrin nego što ste trebali Uzmete li previše lijeka Stocrin, javite se liječniku ili u najbližu hitnu službu radi savjeta.
English: Efavirenz film-coated tablets must only be administered to children who are able to reliably swallow tablets.
Croatian: Efavirenz filmom obložene tablete smiju se davati samo djeci koja sigurno mogu progutati tablete.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of
Croatian: Nema utjecaja (↔) jednako smanjenje procjene srednje vrijednosti omjera od ≤20% ili povećanje procjene srednje vrijednosti omjera od ≤25%
English: Outer carton: STOCRIN 600 mg
Croatian: Kutija: STOCRIN 600 mg
English: In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 M (29 %) [mean ± S.D. (% C.V.)], steady state Cmin was 5.6 ± 3.2 M (57 %), and AUC was 184 ± 73 M·h (40 %).
Croatian: U 35 bolesnika koji su primali efavirenz u dozi od 600 mg jedanput na dan u stanju dinamičke ravnoteže Cmax je iznosila 12,9 ± 3,7 μM (29%) [srednja vrijednost ± S.D. (% C.V.)], Cmin 5,6 ± 3,2 μM (57%), a AUC 184 ± 73 μM h (40%).
English: How to store Stocrin
Croatian: Kako čuvati Stocrin
English: Concomitant administration of STOCRIN with elbasvir/grazoprevir is contraindicated (see section 4.3) because it may lead to loss of virologic response to elbasvir/grazoprevir.
Croatian: Kontraindicirana je istodobna primjena lijeka STOCRIN s elbasvirom/grazoprevirom (vidjeti dio 4.3) jer može dovesti do gubitka virološkog odgovora elbasvira/grazoprevira.
English: STOCRIN 50 mg film-coated tablets Yellow, round, debossed with “113” on one side.
Croatian: STOCRIN 50 mg filmom obložene tablete Žuta, okrugla, s utisnutom oznakom "113" na jednoj strani.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism which may be clinically relevant in some patients.
Croatian: Utvrđeno je da efavirenz inducira izoenzime CYP3A4 i CYP2B6, a time i vlastiti metabolizam, što u nekih bolesnika može biti klinički značajno.
English: • The other ingredients are: medium chain triglycerides, benzoic acid (E210) and strawberry/mint flavour.
Croatian: • Drugi sastojci su: trigliceridi srednje duljine lanca, benzoatna kiselina (E210) i aroma jagode/mente.
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 u trenutku uvođenja kombiniranog antiretrovirusnog liječenja može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene i uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: When taken with rifampicin in patients weighing 50 kg or greater, increasing efavirenz daily dose to 800 mg may provide exposure similar to a daily dose of 600 mg, when taken without rifampicin.
Croatian: Kod istodobne primjene rifampicina u bolesnika tjelesne težine 50 kg ili više, povećanje dnevne doze efavirenza na 800 mg može pružiti sličnu izloženost kao kod primjene dnevne doze od 600 mg bez rifampicina.
English: AUC: ↓ 7 % (↓ 23 to ↑ 13) * Cmax: ↑ 23 % (↓ 1 to ↑ 53) * Efavirenz:
Croatian: AUC: ↓ 7% (↓ 23 do ↑ 13)* Cmax: ↑ 23% (↓ 1 do ↑ 53)* efavirenz:
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
Croatian: lijekove koji se koriste za liječenje infekcije virusom hepatitisa C: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glekaprevir/pibrentasvir i sofosbuvir/velpatasvir /voksilaprevir.
English: Elbasvir/grazoprevir
Croatian: elbasvir/grazoprevir elbasvir:
English: Stocrin is not recommended for children under the age of 3 years or weighing less than 13 kg because it has not been adequately studied in these patients
Croatian: Stocrin se ne preporučuje za djecu mlađu od 3 godine ili djecu tjelesne težine manje od 13 kg jer u tih bolesnika nije ispitan na odgovarajući način
English: Information regarding post-marketing surveillance 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: The most notable unwanted effects reported with Stocrin in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
Croatian: Najčešće nuspojave povezane s primjenom lijeka Stocrin u kombinaciji s drugim lijekovima za liječenje HIV-a su kožni osip i simptomi živčanog sustava.
English: Co-administration with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations (see section 4.5).
Croatian: Istodobna primjena s elbasvirom/grazoprevirom zbog očekivanog značajnog sniženja koncentracija elbasvira i grazoprevira u plazmi (vidjeti dio 4.5).
English: Outer carton: STOCRIN 30 mg/ml
Croatian: Kutija: STOCRIN 30 mg/ml
English: This loss is due to significant decreases in elbasvir and grazoprevir plasma concentrations caused by CYP3A4 or P-gp induction (refer to the Summary of Product Characteristics for elbasvir/grazoprevir for additional information).
Croatian: Ovaj se gubitak događa zbog značajnog sniženja koncentracija elbasvira i grazoprevira u plazmi uzrokovanog indukcijom CYP3A4 ili P-gp-a (za dodatne informacije vidjeti sažetak opisa svojstava lijeka za elbasvir/grazoprevir).
English: 3, or after failure of protease inhibitor (PI) containing regimens.
Croatian: 3, ili u onih u kojih nije uspjelo liječenje protokolima s inhibitorom proteaze (IP).
English: In a single-dose study, half life was doubled in the single patient with severe hepatic impairment (Child-Pugh Class C), indicating a potential for a much greater degree of accumulation.
Croatian: U ispitivanju s primjenom jednokratne doze lijeka u jedinog bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) poluvijek efavirenza bio je dvostruko dulji, što upućuje na mogućnost puno veće kumulacije lijeka.
English: • The dose for Stocrin may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Stocrin).
Croatian: • Dozu lijeka Stocrin možda će trebati povisiti ili sniziti ako uzimate i neke druge lijekove
English: In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
Croatian: Radi lakšeg podnošenja nuspojava živčanog sustava, preporučuje se uzimanje lijeka prije spavanja u prva dva do četiri tjedna liječenja te u bolesnika koji i nakon toga imaju navedene simptome (vidjeti dio 4.8).
English: Each carton contains 1 bottle of 30 film-coated tablets.
Croatian: Jedna kutija sadrži 1 bocu s 30 filmom obloženih tableta.
English: Sofosbuvir/velpatasvir sofosbuvir/velpatasvir/voxilaprevir
Croatian: Sofosbuvir/velpatasvir sofosbuvir/velpatasvir/voksilaprevir sofosbuvir: Cmax ↑38%
English:  Efavirenz 50 mg, 200 mg and 600 mg film-coated tablets are available.
Croatian: * dostupne su efavirenz 50 mg, 200 mg i 600 mg filmom obložene tablete.
English: AUC: ↑ 11 % (↑ 5 to ↑ 18) Cmax: ↑ 16 % (↑ 6 to ↑ 26) Cmin: ↑ 13 % (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Croatian: AUC: ↑ 11% (↑ 5 do ↑ 18) Cmax: ↑ 16% (↑ 6 do ↑ 26) Cmin: ↑ 13% (↑ 1 do ↑ 26) (indukcija CYP3A4) Povišenje vrijednosti farmakokinetičkih parametara efavirenza ne smatra se klinički značajnim.
English: Nervous system symptoms of moderate-to-severe intensity were experienced by 19 % (severe 2.0 %) of patients compared to 9 % (severe 1 %) of patients receiving control regimens.
Croatian: Simptomi živčanog sustava umjerenog do jakog intenziteta zabilježeni su u 19% bolesnika koji su primali efavirenz (teški 2%), u odnosu na 9% bolesnika u kontrolnoj skupini (teški 1%).
English: Table 1 Paediatric dose to be administered once daily*
Croatian: Tablica 1 Doza za djecu koju treba primjenjivati jedanput na dan*
English: Stocrin is not recommended for children under the age of 3 years or weighing less than 13 kg because it has not been adequately studied in these patients.
Croatian: Stocrin se ne preporučuje za djecu mlađu od 3 godine ili djecu tjelesne težine manje od 13 kg jer u tih bolesnika nije ispitan na odgovarajući način.
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 npr. Gravesova bolest i autoimuni hepatitis); međutim, prijavljeno vrijeme do pojave je različito i ti se događaji mogu javiti više mjeseci nakon uvođenja liječenja.
English: A multiple-dose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Croatian: Ispitivanje s višekratnim dozama nije pokazalo značajan učinak na farmakokinetiku efavirenza u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh stadij A) u odnosu na kontrolnu skupinu.
English: AUC: ↑ 20 % (↑ 8 to ↑ 34) Cmax: ↑ 21 % (↑ 10 to ↑ 33) The combination was generally well tolerated.
Croatian: AUC: ↑ 20% (↑ 8 do ↑ 34) Cmax: ↑ 21% (↑ 10 do ↑ 33) Ova se kombinacija općenito dobro podnosila.
English: AUC: ↔* (↓ 9 to ↑ 10) Cmax: ↑ 17 %* (↑ 8 to ↑ 27) Cmin: ↓ 42 %* (↓ 31 to ↓ 51)
Croatian: AUC: ↔* (↓ 9 do ↑ 10) Cmax: ↑ 17%* (↑ 8 do ↑ 27) Cmin: ↓ 42%* (↓ 31 do ↓ 51)
English: AUC: ↓ 36 % C12: ↓ 21 % Cmax: ↓ 36 % (UGT1A1 induction)
Croatian: AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36% (indukcija UGT1A1)
English: AUC: ↑ 7 % (↑ 1 to ↑ 14) Cmax: ↑ 16 % (↑ 2 to ↑ 32) These changes are not considered clinically significant.
Croatian: AUC: ↑ 7% (↑ 1 do ↑ 14) Cmax: ↑ 16% (↑ 2 do ↑ 32) Ove se promjene ne smatraju klinički značajnima.
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: 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: Jetreni enzimi u bolesnika istodobno zaraženih virusom hepatitisa B ili C Prema podacima dugoročnog ispitivanja iz ispitivanja 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 probiru na hepatitis B (pozitivan površinski antigen) i/ili hepatitis C (pozitivno protutijelo na hepatitis C).
English: STOCRIN 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: STOCRIN je indiciran u kombiniranom antivirusnom liječenju odraslih, adolescenata i djece u dobi od 3 godine i starije zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1).
English: • Stocrin oral solution may be taken with or without food.
Croatian: •Stocrin oralna otopina može seuzimati shranom ili bez nje.
English: STOCRIN 200 mg film-coated tablets Yellow, round, debossed with “223” on one side.
Croatian: STOCRIN 200 mg filmom obložene tablete Žuta, okrugla, s utisnutom oznakom "223" na jednoj strani.
English: This effect is due to an induction of CYP3A4 or P-gp by efavirenz and is expected to result in the loss of virologic response of elbasvir/grazoprevir.
Croatian: Do ovog učinka dolazi zbog indukcije CYP3A4 ili P-glikoproteina (P-gp) efavirenzom te se očekuje da će ta indukcija dovesti do gubitka virološkog odgovora elbasvira/grazoprevira.
English: • The dose for adults is 24 ml once daily.
Croatian: •Doza lijeka za odrasle je 24ml jedanput na dan.
English: The dose of Stocrin oral solution must be measured using the oral syringe supplied in the carton.
Croatian: Dozu Stocrin oralne otopine morate odmjeriti pomoću štrcaljke za oralnu primjenu koja se nalazi u pakiranju.
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: The AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30 % and 43 % respectively, when given with a high-fat meal, relative to fasted conditions.
Croatian: Nakon primjene jednokratne doze od 240 mg oralne otopine efavirenza s punomasnim obrokom u nezaraženih odraslih dobrovoljaca AUC je porastao 30%, a Cmax 43% u usporedbi s primjenom lijeka natašte.
English: There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour and catatonia.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi teške depresije, samoubojstava, deluzija, psihotičnog ponašanja i katatonije.
English: In 17 paediatric patients receiving an investigational oral solution similar to the commercial formulation adjusted on the basis of body size to be equivalent to an adult 600 mg capsule dose, the steady-state Cmax was 11.8 M, steady state Cmin was 5.2 M, and AUC was 188 M·h.
Croatian: U 17 pedijatrijskih bolesnika koji su primili ispitivanu oralnu otopinu koja je bila slična onoj dostupnoj na tržištu, u dozi prilagođenoj prema veličini tijela tako da odgovara dozi za odrasle od 600 mg u obliku tvrde kapsule, Cmax u stanju dinamičke ravnoteže iznosio je 11.8 M, Cmin je bio 5.2 M, a AUC 188 M·h.
English: If efavirenz and telaprevir are coadministered, telaprevir 1,125 mg every 8 hours should be used.
Croatian: Ako se efavirenz i telaprevir primjenjuju istodobno, telaprevir u dozi od 1125 mg treba primijeniti svakih 8 sati.
English: Sertraline(a medicine used to treat depression):your doctor may need to change your dose of sertraline.
Croatian: sertralin (lijek koji se koristi za liječenje depresije): liječnik će Vam možda trebati promijeniti dozu sertralina.
English: Co-administration of efavirenz with a fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil, is not recommended unless needed for dose adjustment (for example, with rifampicin).
Croatian: Ne preporučuje se istodobna primjena efavirenza s tabletama koje sadrže fiksnu kombinaciju efavirenza, emtricitabina i tenofovirdizoproksila,osim ako nije potrebno zbog prilagodbe doze (na primjer, s rifampicinom).
English: • The dose for children weighing 40 kg or more is 600 mg once daily.
Croatian: • Doza lijeka za djecu tjelesne težine 40 kg ili više je 600 mg jedanput na dan.
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 može povećati učestalost nuspojava (vidjeti dio 4.8).