FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Adverse reactions observed with etravirine in clinical trials and post-marketing experience
Croatian: Tablica 2: Nuspojave zabilježene uz etravirin u kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet Klasifikacija organskih sustava
English: No significant effect on tenofovir and etravirine PK parameters is seen.
Croatian: Nije opažen značajni učinak na farmakokinetičke parametre tenofovira i etravirina.
English: Viral load < 50 copies/ml at week 24, n (%)
Croatian: Virusno opterećenje < 50 kopija/ml u 24. tjednu, n (%)
English: HIV PIs - Boosted with low-dose ritonavir Atazanavir/ritonavir
Croatian: Inhibitori proteaze (IP) HIV-a - pojačani s niskom dozom ritonavira Atazanavir/ritonavir
English: Cmax ↓ 0.55 (0.40-0.75) N-desmethyl-sildenafil AUC ↓ 0.59 (0.52-0.68) Cmin ND
Croatian: Cmax ↓ 0,55 (0,40-0,75) N-desmetil-sildenafil AUC ↓ 0,59 (0,52-0,68) Cmin ND
English: Placebo arms N = 569
Croatian: Skupine na placebu N = 569
English: Immune system disorders common drug hypersensitivity uncommon immune reconstitution syndrome
Croatian: Poremećaji imunološkog sustava često preosjetljivost na lijek manje često sindrom imunološke rekonstitucije
English: The pharmacokinetics of etravirine in paediatric patients less than 6 years of age are under investigation.
Croatian: Pedijatrijska populacija (dobi manje od 6 godina) Farmakokinetika etravirina u pedijatrijskih bolesnika dobi manje od 6 godina je u fazi istraživanja.
English: Change from baseline in log10 viral load (copies/ml) at week 24, mean (SE) and median (range)
Croatian: Promjena u odnosu na početnu vrijednost log10 virusnog opterećenja (kopija/ml) u 24. tjednu, srednja vrijednost (SE) i medijan (raspon)
English: 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.
Croatian: Ako bolesnik povraća nakon više od 4 sata nakon uzimanja lijeka, bolesnik ne treba uzeti drugu dozu do idućeg uobičajenog vremena uzimanja po rasporedu.
English: If you vomit more than 4 hours after taking INTELENCE, then you do not need to take another dose until your regularly scheduled dose.
Croatian: 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.
English: 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).
Croatian: 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).
English: Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
Croatian: Janssen 04100 Borgo San Michele Latina
English: INTELENCE should only be used with dolutegravir when co-administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.
Croatian: INTELENCE se smije uzimati s dolutegravirom jedino kada se istodobno primjenjuju atazanavir/ritonavir, darunavir/ritonavir ili lopinavir/ritonavir.
English: ANTIMYCOBACTERIALS Rifampicin
Croatian: LIJEKOVI Rifampicin
English: Rash was mostly self-limiting and generally resolved within 1 to 2 weeks on continued therapy.
Croatian: Osip je uglavnom bio samo-ograničavajuć i općenito se povukao unutar 1 do 2 tjedna uz neprekinuto liječenje.
English: Integrase Strand Transfer Inhibitors Dolutegravir
Croatian: Inhibitori prijenosa niza integraze Dolutegravir
English: Pharmacokinetics of etravirine
Croatian: Farmakokinetika etravirina srednja vrijednost
English: 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.
Croatian: Istodobna primjena etravirina s efavirenzom ili nevirapinom može prouzročiti značajno smanjenje koncentracije etravirina u plazmi i gubitak terapijskog učinka etravirina.
English: 400/100 mg twice daily lopinavir
Croatian: 400/100 mg dva puta dnevno lopinavir
English: Co-administration of etravirine with daclatasvir may decrease daclatasvir concentrations.
Croatian: Istodobna primjena etravirina s daklatasvirom može sniziti koncentracije daclatasvira.
English: 150 mg twice daily etravirine
Croatian: 150 mg dva puta dnevno etravirin
English: 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
Croatian: 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
English: 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.
Croatian: 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).
English: Cmax ↔ 0.91 (0.58-1.42) etravirine
Croatian: Cmax ↔ 0,91 (0,58-1,42) etravirin
English: 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.
Croatian: 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.
English: Reused/not used ENF
Croatian: Ponovo primjenjivan/nije primjenjivan ENF
English: Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
Croatian: Lijekovi koji induciraju CYP3A4, CYP2C9 ili CYP2C19 mogu povećati klirens etravirina, što rezultira smanjenjem koncentracije etravirina u plazmi.
English: 150/600/100 mg twice daily maraviroc
Croatian: 150/600/100 mg dva puta dnevno maravirok
English: AUC ↑ 1.41 (1.22-1.62) Cmin ND
Croatian: AUC ↑ 1,41 (1,22-1,62) Cmin NP
English: There was no teratogenicity with etravirine in rats and rabbits at exposures equivalent to those observed in humans at the recommended clinical dose.
Croatian: Etravirin nije pokazao teratogenost u štakora i kunića pri izloženostima jednakim onim opaženima u čovjeka pri preporučenoj kliničkoj dozi.
English: - The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
Croatian: - Drugi sastojci su hipromeloza, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid,
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Croatian: Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
English: Placental transfer has been seen in pregnant rats, but it is not known whether placental transfer of etravirine also occurs in pregnant women.
Croatian: Prijelaz etravirina kroz placentu opažen je u skotnih ženki štakora, ali nije poznato dolazi li do tog prijelaza i u trudnica.
English: - 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.
Croatian: - 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).
English: TMC125-C213 12 to < 18 years ETR N = 60
Croatian: TMC125-C213 12 do< 18 godina ETR N = 60
English: 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.
Croatian: 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.
English: 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
Croatian: 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.
English: Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
English: 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.
Croatian: 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.
English: Concomitant use of etravirine with rilpivirine may cause a decrease in the plasma concentration of rilpivirine and loss of therapeutic effect of rilpivirine.
Croatian: Istodobna primjena etravirina s rilpivirinom može uzorkovati smanjenje koncentracije rilpivirina u plazmi i gubitak terapijskog učinka rilpivirina.
English: Darunavir/ritonavir 600/100 mg twice daily darunavir
Croatian: Darunavir/ritonavir 600/100 mg dva puta dnevno darunavir
English: 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.
Croatian: Plastična boca ima sigurnosni zatvarač za djecu i treba je otvarati na sljedeći način:
English: Tipranavir/ritonavir 500/200 mg twice daily tipranavir
Croatian: Tipranavir/ritonavir 500/200 mg dva puta dnevno tipranavir
English: 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).
Croatian: 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
English: Vascular disorders common hypertension rare haemorrhagic stroke
Croatian: Krvožilni poremećaji često hipertenzija rijetko hemoragijski moždani udar
English: Concomitant use of etravirine with indinavir may cause a significant decrease in the plasma concentration of indinavir and loss of therapeutic effect of indinavir.
Croatian: Istodobna primjena etravirina s indinavirom može uzorkovati značajno smanjenje koncentracije indinavira u plazmi i gubitak terapijskog učinka indinavira.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when co-administered with INTELENCE.
Croatian: Kada se antiaritmici primjenjuju istovremeno s lijekom INTELENCE opravdan je oprez i ako je moguće nadzor terapijske koncentracije antiaritmika.
English: It is not recommended to co-administer INTELENCE with nelfinavir.
Croatian: Ne preporučuje se istodobno primjenjivati INTELENCE i nelfinavir.
English: Do not use after 8 weeks of first opening the bottle.
Croatian: Nemojte koristiti nakon što prođe 8 tjedana od prvog otvaranja boce.
English: Patients with coexisting conditions
Croatian: Bolesnici s pratećim bolestima
English: - The other ingredients are hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.
Croatian: - Drugi sastojci su hipromeloza, silicificirana mikrokristalična celuloza, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid, umrežena karmelozanatrij i magnezijev stearat.
English: Co-administration of Intelence and daclatasvir is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Intelence i daklatasvira.
English: Boosted protease inhibitors, like darunavir/ritonavir, show a higher barrier to resistance compared to other classes of antiretrovirals.
Croatian: U usporedbi s ostalim skupinama antiretrovirusnih lijekova, pojačani inhibitori proteaze kao što su darunavir/ritonavir predstavljaju veću prepreku razvoju rezistencije.
English: Medicinal products that are affected by the use of etravirine
Croatian: Lijekovi na koje utječe primjena etravirina
English: 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.
Croatian: 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.
English: Norethindrone
Croatian: Noretindron
English: INTELENCE contains the active substance etravirine.
Croatian: INTELENCE sadrži djelatnu tvar etravirin.
English: If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet(s) as soon as possible.
Croatian: 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.
English: TMC125-C213 6 to < 18 years ETR N = 101
Croatian: TMC125-C213 6 do < 18 godina ETR N = 101
English: HIV-1 RNA log10 mean change from baseline (log10 copies/ml) CD4 cell count mean change from baseline (x 10
Croatian: Prosječna promjena HIV-1 RNK log10 u odnosu na početnu vrijednost (log10 kopija/ml) Prosječna promjena broja CD4 stanica od početne (x 10
English: Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
Croatian: 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.
English: darunavir/cobicistat (anti-HIV medicine) - carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures) - rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine
Croatian: darunavir/kobicistat (lijekovi protiv HIV-a) - karbamazepin, fenobarbital, fenitoin (lijekovi za sprječavanje napadaja) - rifampicin, budući da je kontraindiciran s pojačanim inhibitorima proteaze i rifapentin (lijekovi za liječenje nekih infekcija poput tuberkuloze) - pripravci koji sadrže gospinu travu (Hypericum perforatum) (biljni pripravak koji se koristi za depresiju) - daklatasvir, simeprevir (lijekovi za liječenje hepatitis C infekcije).
English: If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet as soon as possible.
Croatian: Ukoliko primijetite da niste uzeli lijek unutar 6 sati od vremena kada obično uzimate INTELENCE, tabletu uzmite što je prije moguće, uvijek nakon obroka.
English: INTELENCE contains sodium
Croatian: INTELENCE sadrži natrij
English: The bottle contains 2 little pouches (desiccants) to keep the tablets dry.
Croatian: Boca sadrži 2 male vrećice (sredstvo za sušenje) kako bi se tablete očuvale suhima.
English: Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.
Croatian: Očekuje se da će rifampicin i rifapentin smanjiti koncentracije etravirina u plazmi.
English: Change from baseline in CD4 cell count (x 10
Croatian: Promjena u odnosu na početnu vrijednost broja stanica CD4 (x 10
English: INTELENCE and these antifungals can be used without dose adjustments.
Croatian: INTELENCE i ovi antimikotici mogu se primjenjivati bez prilagodbe doze.
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
Croatian: Janssen-Cilag A/S Tlf: +45 45 94 82 82 jacdk@its.jnj.com
English: Simultaneously, plasma concentrations of itraconazole or ketoconazole may be decreased by etravirine.
Croatian: Istovremeno, etravirin može smanjiti koncentracije itrakonazola ili ketokonazola u plazmi.
English: Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side.
Croatian: Bijela do bjelkasta ovalna tableta s utisnutim natpisom „T125“ na jednoj strani i „100“ na drugoj strani.
English: INTELENCE can be used with these NRTIs without dose adjustment.
Croatian: INTELENCE se može primjenjivati s ovim NRTI bez prilagodbe doze.
English: Your doctor will have to check your blood - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections) - clarithromycin, rifabutin (antibiotics) - artemether/lumefantrine (a medicine to treat malaria) - diazepam (medicines to treat trouble with sleeping and/or anxiety) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) - boceprevir (a medicine to treat hepatitis C infection) - atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines) - cyclosporine, sirolimus, tacrolimus (immunosuppressants - medicines used to dampen down your immune system) - sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension) - clopidogrel (a medicine to prevent blood clots).
Croatian: - flukonazol, itrakonazol, ketokonazol, posakonazol, vorikonazol (lijekovi za liječenje gljivičnih infekcija) - klaritromicin, rifabutin (antibiotici) - artemeter/lumefantrin (lijek za liječenje malarije) - diazepam (lijekovi za liječenje problema sa spavanjem i/ili tjeskobu) - deksametazon (kortikosteroid koji se primjenjuje kod različitih stanja kao što su upala i alergijske reakcije) - boceprevir (lijek za liječenje hepatitis C infekcije) - atorvastatin, fluvastatin, lovastatin, rozuvastatin, simvastatin (lijekovi koji snizuju kolesterol) - ciklosporin, sirolimus, takrolimus (imunosupresivi - lijekovi koji se koriste za prigušivanje
English: Co-administration of etravirine with atazanavir/cobicistat or darunavir/cobicistat may decrease plasma concentrations of the PI and/or cobicistat, which may result in loss of therapeutic effect and development of resistance.
Croatian: Istodobna primjena etravirina s atazanavirom/kobicistatom ili darunavirom/kobicistatom može sniziti koncentracije inhibitora proteaze i/ili kobicistata u plazmi, što može dovesti do gubitka tearpijskog učinka i razvoja rezistencije.
English: R(-) methadone AUC ↔ 1.06 (0.99-1.13) Cmin ↔ 1.10 (1.02-1.19) Cmax ↔ 1.02 (0.96-1.09) S(+) methadone AUC ↔ 0.89 (0.82-0.96) Cmin ↔ 0.89 (0.81-0.98) Cmax ↔ 0.89 (0.83-0.97) etravirine
Croatian: R(-) metadon AUC ↔ 1,06 (0,99-1,13) Cmin ↔ 1,10 (1,02-1,19) Cmax ↔ 1,02 (0,96-1,09) S(+) metadon AUC ↔ 0,89 (0,82-0,96) Cmin ↔ 0,89 (0,81-0,98) Cmax ↔ 0,89 (0,83-0,97) etravirin
English: Clarithromycin 500 mg twice daily clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
Croatian: Klaritromicin 500 mg dva puta dnevno klaritromicin AUC ↓ 0,61 (0,53-0,69) Cmin ↓ 0,47 (0,38-0,57) Cmax ↓ 0,66 (0,57-0,77) 14-OH-klaritromicin AUC ↑ 1,21 (1,05-1,39) Cmin ↔ 1,05 (0,90-1,22) Cmax ↑ 1,33 (1,13-1,56) etravirin
English: The trial population included PI-naïve, NNRTI-experienced patients with evidence of NNRTI resistance.
Croatian: Populacija u ispitivanju obuhvaćala je bolesnike koji prethodno nisu primali inhibitore proteaze, ali su liječeni s NNRTI i imali su dokazanu rezistenciju na NNRTI.
English: Common side effects (may affect up to 1 in 10 people) - allergic reactions (hypersensitivity); - diabetes, decrease of appetite; - anxiety, sleepiness, sleeplessness, sleep disorders; - tingling or pain in hands or feet, numbness, loss of skin sensibility, loss of memory tiredness; - blurred vision; - kidney failure, high blood pressure, heart attack, shortness of breath when exercising; - vomiting, heartburn, abdominal pain, distension of the abdomen, inflammation of the stomach,
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - alergijske reakcije (preosjetljivost); - šećerna bolest, smanjenje apetita; - tjeskoba, pospanost, nesanica, poremećaji spavanja; - trnci ili bol u šakama ili stopalima, utrnulost, gubitak osjeta kože, gubitak pamćenja, umor ; - zamagljen vid; - zatajenje bubrega, visoki krvni tlak, srčani udar, nedostatak zraka pri vježbanju; - povraćanje, žgaravica, bol u trbuhu, nadimanje trbuha, upala želuca,vjetrovi, zatvor, upala usta,
English: Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Croatian: Istovremena primjena etravirina i lijekova koji inhibiraju CYP3A4, CYP2C9 ili CYP2C19 može smanjiti klirens etravirina, što može rezultirati povećanom koncentracijom etravirina u plazmi.
English: These adverse reactions have been identified through postmarketing experience with etravirine.
Croatian: Ove nuspojave bile su zabilježene tijekom razdoblja nakon stavljanja etravirina u promet.
English: INTELENCE should be used in combination with a boosted PI. Rifampicin is contraindicated in combination with boosted PIs.
Croatian: Rifampicin je kontraindiciran u kombinaciji s pojačanim IP.
English: The bottle contains 3 little pouches (desiccants) to keep the tablets dry.
Croatian: Boca sadrži 3 male vrećice (sredstvo za sušenje) kako bi se tablete očuvale suhima.
English: Voriconazole 200 mg twice daily voriconazole AUC ↑ 1.14 (0.88-1.47) Cmin ↑ 1.23 (0.87-1.75) Cmax ↓ 0.95 (0.75-1.21) etravirine
Croatian: Vorikonazol 200 mg dva puta dnevno vorikonazol AUC ↑ 1,14 (0,88-1,47) Cmin ↑ 1,23 (0,87-1,75) Cmax ↓ 0,95 (0,75-1,21) etravirin
English: Etravirine 200 mg twice daily postpartum N = 10
Croatian: Etravirin 200 mg dva puta dnevno postpartalno N = 10
English: There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Croatian: Za primjenu lijeka INTELENCE kod populacije bolesnika starijih od 65 godina potreban je oprez s obzirom na to da su dostupni ograničeni podaci (vidjeti dio 5.2).
English: Each tablet contains 160 mg of lactose monohydrate.
Croatian: Jedna tableta sadrži 160 mg laktoze hidrata.