natgillin/translations-raw huggingface dataset:
Concomitant systemic use of itraconazole or ketoconazole and etravirine may increase plasma concentrations of etravirine.
Istodobna sistemska primjena itrakonazola ili ketokonazola i etravirina može povećati koncentracije etravirina u plazmi.
Etravirine exhibits activity against wild type HIV-1 in T-cell lines and primary cells with median EC50 values ranging from 0.9 to 5.5 nM. Etravirine demonstrates activity against HIV-1 group M (subtypes A, B, C, D, E, F, and G) and HIV-1 group O primary isolates with EC50 values ranging from 0.3 to 1.7 nM and from 11.5 to 21.7 nM, respectively.
Etravirin pokazuje aktivnost protiv primarnog izolata HIV-1 iz skupine M (podtipovi A, B, C, D, E, F i G) uz vrijednosti EC50 u rasponu od 0,3 do 1,7 nM, i primarnog izolata HIV-1 iz skupine O uz vrijednosti EC50 u rasponu od 11,5 do 21,7 nM.
Metabolism and nutrition disorders common diabetes mellitus, hyperglycaemia, hypercholesterolaemia, increased low density lipoprotein (LDL), hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia, anorexia
Poremećaji metabolizma i prehrane često dijabetes melitus, hiperglikemija, hiperkolesterolemija, povišen lipoprotein niske gustoće (LDL), hipertrigliceridemija, hiperlipidemija, dislipidemija, anoreksija
Not de novo ENF
Nije de novo ENF
Geometric Mean ± Standard Deviation Median (Range)
Geometrijska srednja vrijednost ± standardna devijacija
Dolutegravir + darunavir/ritonavir 50 mg once daily + 600/100 mg twice daily
Dolutegravir + darunavir/ritonavir 50 mg jedanput dnevno + 600/100 mg dva puta dnevno
Rash was mostly self-limiting and generally resolved within 1 week on continued therapy.
Osip je bio većinom samo-ograničavajući i općenito se povukao tijekom 1 tjedna na neprekinutoj terapiji.
Co-administration of etravirine with medicinal products primarily metabolised by CYP3A4 may result in decreased plasma concentrations of such medicinal products, which could decrease or shorten their therapeutic effects.
Istovremena primjena etravirina s lijekovima koje primarno metabolizira izoenzim CYP3A4 može rezultirati smanjenom koncentracijom tih lijekova u plazmi, što bi moglo smanjiti ili skratiti njihove terapijske učinke.
Most often, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy.
Osip je najčešće bio blag do umjeren, makularno/papularne vrste, i pojavio se u drugom tjednu liječenja.
Treatment-experienced paediatric patients (6 years to less than 18 years of age) PIANO is a single-arm, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of etravirine in 101 antiretroviral treatment-experienced HIV-1 infected paediatric patients 6 years to less than 18 years of age and weighing at least 16 kg.
Prethodno liječeni pedijatrijski bolesnici (u dobi od 6 do manje od 18 godina) PIANO je ispitivanje faze II s jednom skupinom, u kojem je procijenjena farmakokinetika, sigurnost, podnošljivost i djelotvornost etravirina u 101 pedijatrijskog bolesnika zaraženog HIVom-1, u dobi od 6 do manje od 18 godina i težine najmanje 16 kg, koji je prethodno liječen antiretrovirusnim lijekovima.
Etravirine (200 mg twice daily), evaluated in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, demonstrated that exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure (see section 5.2).
U ispitivanju s 15 trudnica, procijenjen je etravirin (200 mg dva puta dnevno) u kombinaciji s drugim antiretrovirusnim lijekovima tijekom drugog i trećeg tromjesečja trudnoće i postpartalnog razdoblja, pri čemu se pokazalo da je izloženost ukupnom etravirinu općenito veća tijekom trudnoće u odnosu na postpartalno razdoblje, što se manje pokazalo za izloženost nevezanom etravirinu (vidjeti dio 5.2).
Etravirine significantly reduced plasma concentrations of dolutegravir.
Etravirin je značajno smanjio koncentracije dolutegravira u plazmi.
The safety and efficacy of etravirine in children less than 6 years of age and weighing less than 16 kg have not yet been established (see section 5.2).
Pedijatrijska populacija (u dobi manje od 6 godina) Sigurnost i djelotvornost etravirina u djece mlađe od 6 godina i težine manje od 16 kg nisu još ustanovljene (vidjeti dio 5.2).
The combination of oestrogen- and/or progesterone-based contraceptives and INTELENCE can be used without dose adjustment.
Kombinaciju kontracepcijskih sredstava na bazi estrogena i/ili progesterona i INTELENCE može se koristiti bez prilagodbe doze.
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time.
U slučaju da bolesnik propusti dozu lijeka INTELENCE unutar 6 sati od njenog uobičajenog vremena uzimanja, bolesnik ju mora uzeti čim prije nakon obroka, a potom sljedeću dozu treba uzeti u uobičajeno vrijeme uzimanja.
Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response).
Pripisane vrijednosti izračunate prema algoritmu TLOVR (TLOVR = vrijeme do gubitka virološkog odgovora).
INTELENCE can be co-administered with proton pump inhibitors without dose adjustments.
INTELENCE se može primjenjivati istodobno s inhibitorima protonske pumpe bez prilagodbe doze.
If a patient vomits within 4 hours of taking the medicine, another dose of INTELENCE should be taken following a meal as soon as possible.
Ako bolesnik povraća unutar 4 sata od uzimanja lijeka, potrebno je što prije uzeti drugu dozu lijeka INTELENCE nakon obroka.
INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and is therefore not recommended (see sections 4.2 and 4.4).
INTELENCE nije ispitan kod bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) i stoga se ne preporučuje (vidjeti dio 4.2 i
Etravirine is expected to decrease plasma concentrations of cyclosporine, sirolimus and tacrolimus.
Očekuje se da će etravirin smanjiti koncentracije ciklosporina, sirolimusa i takrolimusa u plazmi.
≥ 1 log10 decrease from baseline at week 24, n (%)
≥ 1 log10 pad u odnosu na početnu vrijednost u 24. tjednu, n (%)
40 mg once daily etravirine
40 mg jedanput dnevno etravirin
Viral load < 400 copies/ml at week 24, n (%)
Virusno opterećenje < 400 kopija/ml u 24. tjednu, n (%)
Carbazamepine, phenobarbital and phenytoin are expected to decrease plasma concentrations of etravirine.
Očekuje se da karbazamepin, fenobarbital i fenitoin smanjuju koncentraciju etravirina u plazmi.
It is not recommended to co-administer INTELENCE with indinavir.
Ne preporučuje se istodobno primjenjivati INTELENCE i indinavir.
Severe cutaneous adverse reactions have been reported with etravirine.
Prijavljene su teške kožne nuspojave s etravirinom.
INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets
INTELENCE 25 mg tablete INTELENCE 100 mg tablete INTELENCE 200 mg tablete
Etravirine 200 mg twice daily N = 575
Etravirin 200 mg dva puta dnevno N = 575
The mean change in plasma HIV-1 RNA from baseline to week 48 was -1.53 log10 copies/ml, and the mean CD4 cell count increase from baseline was 156 x 10
Srednja promjena vrijednosti u odnosu na početnu vrijednost HIV-1 RNK u plazmi do 48. tjedna bila je -1,53 log10 kopija/ml, a porast u odnosu na početnu vrijednost srednje vrijednosti broja CD4 stanica bio je 156 x 10
In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the etravirine containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
U kliničkim ispitivanjima faze III DUET-1 i DUET-2 mutacije koje su se najčešće razvile u bolesnika s neuspjelim virološkim odgovorom na način liječenja etravirinom bile su V108I, V179F, V179I, Y181C i Y181I i obično su se pojavljivale u pozadini višestrukih drugih NNRTI mutacija povezanih s rezistencijom (RAM).
TMC125-C213 6 to < 12 years ETR N = 41
TMC125-C213 6 do < 12 godina ETR N = 41
ANTIMALARIALS Artemether/ Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether
80/480 mg, 6 doza u 0., 8., 24., 36., 48. i
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
Most frequently, rash was mild to moderate, occurred in the second week of therapy, and was infrequent after week 4.
Najčešće je osip bio blag do umjeren, pojavio se u drugom tjednu liječenja, a nakon 4 tjedna bio je rijedak.
Manufacturer Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy
Janssen, 04100 Borgo San Michele, Latina, Italija
Baseline genotype or phenotype and virologic outcome analyses In DUET-1 and DUET-2, the presence at baseline of 3 or more of the following mutations: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A and G190S, (etravirine RAMs) was associated with a decreased virologic response to etravirine (see table 5).
Početni genotip ili fenotip i analize virološkog ishoda U ispitivanjima DUET-1 i DUET-2, prisutnost 3 ili više sljedećih mutacija: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A i G190S, (etravirin RAMs) na početku, bila je povezana sa smanjenim virološkim odgovorom na etravirin (vidjeti tablicu 5).
Psychiatric disorders common anxiety, insomnia, sleep disorders uncommon confusional state, disorientation, nightmares,
Psihijatrijski poremećaji često anksioznost, nesanica, poremećaji spavanja manje često stanje smetenosti, dezorijentiranost, noćne more, nervoza, abnormalni snovi
Table 2: Adverse reactions observed with etravirine in clinical trials and post-marketing experience
Tablica 2: Nuspojave zabilježene uz etravirin u kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet Klasifikacija organskih sustava
No significant effect on tenofovir and etravirine PK parameters is seen.
Nije opažen značajni učinak na farmakokinetičke parametre tenofovira i etravirina.
Viral load < 50 copies/ml at week 24, n (%)
Virusno opterećenje < 50 kopija/ml u 24. tjednu, n (%)
HIV PIs - Boosted with low-dose ritonavir Atazanavir/ritonavir
Inhibitori proteaze (IP) HIV-a - pojačani s niskom dozom ritonavira Atazanavir/ritonavir
Cmax ↓ 0.55 (0.40-0.75) N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) Cmin ND
Cmax ↓ 0,55 (0,40-0,75) N-desmetil-sildenafil AUC ↓ 0,59 (0,52-0,68) Cmin ND
Placebo arms N = 569
Skupine na placebu N = 569
Immune system disorders common drug hypersensitivity uncommon immune reconstitution syndrome
Poremećaji imunološkog sustava često preosjetljivost na lijek manje često sindrom imunološke rekonstitucije
The pharmacokinetics of etravirine in paediatric patients less than 6 years of age are under investigation.
Pedijatrijska populacija (dobi manje od 6 godina) Farmakokinetika etravirina u pedijatrijskih bolesnika dobi manje od 6 godina je u fazi istraživanja.
Change from baseline in log10 viral load (copies/ml) at week 24, mean (SE) and median (range)
Promjena u odnosu na početnu vrijednost log10 virusnog opterećenja (kopija/ml) u 24. tjednu, srednja vrijednost (SE) i medijan (raspon)
If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
Ako bolesnik povraća nakon više od 4 sata nakon uzimanja lijeka, bolesnik ne treba uzeti drugu dozu do idućeg uobičajenog vremena uzimanja po rasporedu.
If you vomit more than 4 hours after taking INTELENCE, then you do not need to take another dose until your regularly scheduled dose.
Ako povraćate nakon više od 4 sata nakon uzimanja lijeka INTELENCE, tada ne trebate uzeti drugu dozu do idućeg uobičajenog vremena uzimanja doze po rasporedu.
A decreased virologic response to etravirine was observed in patients with viral strains harbouring 3 or more among the following mutations V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, and G190A/S (see section 5.1).
Smanjeni virološki odgovor na etravirin primijećen je kod bolesnika koji imaju sojeve virusa s 3 ili više sljedećih mutacija: V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V i G190A/S (vidjeti dio 5.1).
Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
Janssen 04100 Borgo San Michele Latina
INTELENCE should only be used with dolutegravir when co-administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.
INTELENCE se smije uzimati s dolutegravirom jedino kada se istodobno primjenjuju atazanavir/ritonavir, darunavir/ritonavir ili lopinavir/ritonavir.
ANTIMYCOBACTERIALS Rifampicin
LIJEKOVI Rifampicin
Rash was mostly self-limiting and generally resolved within 1 to 2 weeks on continued therapy.
Osip je uglavnom bio samo-ograničavajuć i općenito se povukao unutar 1 do 2 tjedna uz neprekinuto liječenje.
Integrase Strand Transfer Inhibitors Dolutegravir
Inhibitori prijenosa niza integraze Dolutegravir
Pharmacokinetics of etravirine
Farmakokinetika etravirina srednja vrijednost
Concomitant use of etravirine with efavirenz or nevirapine may cause a significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of etravirine.
Istodobna primjena etravirina s efavirenzom ili nevirapinom može prouzročiti značajno smanjenje koncentracije etravirina u plazmi i gubitak terapijskog učinka etravirina.
400/100 mg twice daily lopinavir
400/100 mg dva puta dnevno lopinavir
Co-administration of etravirine with daclatasvir may decrease daclatasvir concentrations.
Istodobna primjena etravirina s daklatasvirom može sniziti koncentracije daclatasvira.
150 mg twice daily etravirine
150 mg dva puta dnevno etravirin
Dolutegravir + Lopinavir/ritonavir 50 mg once daily + 400/100 mg twice daily dolutegravir AUC ↓ 0.29 (0.26-0.34) Cmin ↓ 0.12 (0.09-0.16) Cmax ↓ 0.48 (0.43-0.54) etravirine
Dolutegravir + Lopinavir/ritonavir 50 mg jedanput dnevno + 400/100 mg dva puta dnevno dolutegravir AUC ↓ 0,29 (0,26-0,34) Cmin ↓ 0,12 (0,09-0,16) Cmax ↓ 0,48 (0,43-0,54) etravirin
The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
Klinički podaci su ograničeni te se ne može isključiti povećani rizik kožnih reakcija kod bolesnika koji su prethodno imali slučajeve kožnih reakcija povezanih s nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI).
Cmax ↔ 0.91 (0.58-1.42) etravirine
Cmax ↔ 0,91 (0,58-1,42) etravirin
If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule.
Ukoliko bolesnik propusti dozu dulje od 6 sati od uobičajenog vremena uzimanja, bolesnik ne smije uzeti propuštenu dozu, nego jednostavno ponovno nastaviti s uobičajenim rasporedom uzimanja lijeka.
Reused/not used ENF
Ponovo primjenjivan/nije primjenjivan ENF
Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
Lijekovi koji induciraju CYP3A4, CYP2C9 ili CYP2C19 mogu povećati klirens etravirina, što rezultira smanjenjem koncentracije etravirina u plazmi.
150/600/100 mg twice daily maraviroc
150/600/100 mg dva puta dnevno maravirok
AUC ↑ 1.41 (1.22-1.62) Cmin ND
AUC ↑ 1,41 (1,22-1,62) Cmin NP
There was no teratogenicity with etravirine in rats and rabbits at exposures equivalent to those observed in humans at the recommended clinical dose.
Etravirin nije pokazao teratogenost u štakora i kunića pri izloženostima jednakim onim opaženima u čovjeka pri preporučenoj kliničkoj dozi.
- The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
- Drugi sastojci su hipromeloza, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid,
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
Placental transfer has been seen in pregnant rats, but it is not known whether placental transfer of etravirine also occurs in pregnant women.
Prijelaz etravirina kroz placentu opažen je u skotnih ženki štakora, ali nije poznato dolazi li do tog prijelaza i u trudnica.
- In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
- Nakon što počnete uzimati lijekove za liječenje HIV infekcije dodatno uz oportunističke infekcije, također se mogu javiti autoimuni poremećaji (stanje u kojem imunološki sustav napada zdravo tjelesno tkivo).
TMC125-C213 12 to < 18 years ETR N = 60
TMC125-C213 12 do< 18 godina ETR N = 60
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Neki od mnogih čimbenika rizika za razvoj te bolesti mogu biti duljina kombinirane antiretrovirusne terapije, primjena kortikosteroida, konzumacija alkohola, teška imunosupresija, veći indeks tjelesne mase.
Each subject served as her own control, and with an intra-individual comparison, the total etravirine Cmin, Cmax and AUC12h values were 1.2-, 1.4- and 1.4-fold higher, respectively, during the 2
Svaka ispitanica bila je sama sebi kontrola s intraindividualnom usporedbom, vrijednosti ukupnog etravirina Cmin, Cmax i AUC12h bile su 1,2-; 1,4- odnosno 1,4-puta više tijekom drugog tromjesečja trudnoće u usporedbi s postpartalnim razdobljem, te 1,1-; 1,4- odnosno 1,2- puta više tijekom trećeg tromjesečja trudnoće u usporedbi s postpartalnim razdobljem.
Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Pomoćna tvar s poznatim učinkom Jedna tableta sadrži manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
Uncommon side effects (may affect up to 1 in 100 people) - decreased number of white blood cells; - symptoms of infection (for example enlarged lymph nodes and fever); - abnormal dreams, confusion, disorientation, nervousness, nightmares; - drowsiness, trembling, fainting, seizures, disturbance in attention; - dizziness, sluggishness; - angina, irregular heart rhythm; - difficulty breathing; - retching, inflammation of the pancreas, vomiting blood; - liver problems such as hepatitis, enlarged liver; - excessive sweating, swelling of the face and/or throat; - swelling of breasts in men.
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - smanjen broj bijelih krvnih stanica; - simptomi infekcije (primjerice povećani limfni čvorovi i vrućica); - neuobičajeni snovi, smetenost, dezorijentacija, nervoza, noćne more; - omamljenost, drhtanje, kratkotrajna nesvjestica, napadaji, poremećaj pažnje; - omaglica, tromost; - angina, nepravilan srčani ritam; - otežano disanje; - dizanje želuca, upala gušterače, povraćanje krvi; - problemi s jetrom poput hepatitisa, povećana jetra; - prekomjerno znojenje, oticanje lica i/ili grla; - oticanje dojki u muškaraca.
Concomitant use of etravirine with rilpivirine may cause a decrease in the plasma concentration of rilpivirine and loss of therapeutic effect of rilpivirine.
Istodobna primjena etravirina s rilpivirinom može uzorkovati smanjenje koncentracije rilpivirina u plazmi i gubitak terapijskog učinka rilpivirina.
Darunavir/ritonavir 600/100 mg twice daily darunavir
Darunavir/ritonavir 600/100 mg dva puta dnevno darunavir
The plastic bottle comes with a child resistant cap and should be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Plastična boca ima sigurnosni zatvarač za djecu i treba je otvarati na sljedeći način:
Tipranavir/ritonavir 500/200 mg twice daily tipranavir
Tipranavir/ritonavir 500/200 mg dva puta dnevno tipranavir
Tell your doctor if you take: - dolutegravir, maraviroc, amprevanir/ritonavir and fosamprenavir/ritonavir (anti-HIV medicine) - amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and quinidine (medicines to treat certain heart disorders, e.g., abnormal heart beat) - warfarin (a medicine used to reduce clotting of the blood).
Recite svom liječniku ako uzimate: - dolutegravir, maravirok, amprevanir/ritonavir i fosamprenavir/ritonavir (lijekovi protiv HIV-a) - amiodaron, bepridil, digoksin, disopiramid, flekainid, lidokain, meksiletin, propafenon i kinidin
Vascular disorders common hypertension rare haemorrhagic stroke
Krvožilni poremećaji često hipertenzija rijetko hemoragijski moždani udar
Concomitant use of etravirine with indinavir may cause a significant decrease in the plasma concentration of indinavir and loss of therapeutic effect of indinavir.
Istodobna primjena etravirina s indinavirom može uzorkovati značajno smanjenje koncentracije indinavira u plazmi i gubitak terapijskog učinka indinavira.
Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when co-administered with INTELENCE.
Kada se antiaritmici primjenjuju istovremeno s lijekom INTELENCE opravdan je oprez i ako je moguće nadzor terapijske koncentracije antiaritmika.
It is not recommended to co-administer INTELENCE with nelfinavir.
Ne preporučuje se istodobno primjenjivati INTELENCE i nelfinavir.
Do not use after 8 weeks of first opening the bottle.
Nemojte koristiti nakon što prođe 8 tjedana od prvog otvaranja boce.
Patients with coexisting conditions
Bolesnici s pratećim bolestima
- The other ingredients are hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.
- Drugi sastojci su hipromeloza, silicificirana mikrokristalična celuloza, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid, umrežena karmelozanatrij i magnezijev stearat.
Co-administration of Intelence and daclatasvir is not recommended.
Ne preporučuje se istodobna primjena lijeka Intelence i daklatasvira.
Boosted protease inhibitors, like darunavir/ritonavir, show a higher barrier to resistance compared to other classes of antiretrovirals.
U usporedbi s ostalim skupinama antiretrovirusnih lijekova, pojačani inhibitori proteaze kao što su darunavir/ritonavir predstavljaju veću prepreku razvoju rezistencije.
Medicinal products that are affected by the use of etravirine
Lijekovi na koje utječe primjena etravirina
Lovastatin, rosuvastatin and simvastatin are CYP3A4 substrates and co-administration with etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor.
Lovastatin, rosuvastatin i simvastatin supstrati su za CYP3A4 i njihova istovremena primjena s etravirinom može rezultirati nižim koncentracijama inhibitora HMG Co-A reduktaze u plazmi.
Norethindrone
Noretindron
INTELENCE contains the active substance etravirine.
INTELENCE sadrži djelatnu tvar etravirin.
If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet(s) as soon as possible.
Ukoliko primijetite da niste uzeli lijek unutar 6 sati od vremena kada obično uzimate INTELENCE, tabletu(e) uzmite što je prije moguće, uvijek nakon obroka.
TMC125-C213 6 to < 18 years ETR N = 101
TMC125-C213 6 do < 18 godina ETR N = 101
HIV-1 RNA log10 mean change from baseline (log10 copies/ml) CD4 cell count mean change from baseline (x 10
Prosječna promjena HIV-1 RNK log10 u odnosu na početnu vrijednost (log10 kopija/ml) Prosječna promjena broja CD4 stanica od početne (x 10
Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
Tablica 9: Farmakokinetički rezultati ukupnog etravirina nakon primjene 200 mg etravirina dva puta dnevno, kao dijela antiretrovirusne terapije tijekom drugog tromjesečja trudnoće, trećeg tromjesečja trudnoće, te postpartalno.