FrancophonIA/ELRC3.0 huggingface dataset:
English: For further information on interactions with medicinal products see section 4.5.
Croatian: Za potpune informacije o interakcijama s drugim lijekovima vidjeti dio 4.5.
English: Very common side effects (may affect more than 1 in 10 people) - skin rash.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - kožni osip.
English: No changes in methadone dosage were required based on clinical status during or after the period of INTELENCE co-administration.
Croatian: Nisu bile tražene nikakve promjene u doziranju metadona temeljem kliničkog statusa, tijekom ili nakon razdoblja istodobne primjene lijeka INTELENCE.
English: Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Croatian: Stevens-Johnsonov sindrom a, multiformni eritem vrlo rijetko toksična epidermalna nekroliza a, DRESS
English: The differences were less pronounced for unbound etravirine exposure.
Croatian: Razlike su bile manje izražene za izloženost nevezanom etravirinu.
English: Trial characteristics - Design: randomised (1:1), double-blinded, placebo-controlled.
Croatian: - Plan ispitivanja: randomizirano (1:1), dvostruko slijepo, placebom kontrolirano.
English: Effect of food on absorption
Croatian: Utjecaj hrane na apsorpciju
English: An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Croatian: Intravenska formulacija etravirina nije dostupna, pa je prema tome apsolutna bioraspoloživost etravirina nepoznata.
English: In clinical trials, Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
Croatian: U kliničkim su ispitivanjima Stevens-Johnsonov sindrom i multiformni eritem prijavljeni rijetko (< 0,1%).
English: Based on animal data the malformative risk is unlikely in humans.
Croatian: Na temelju podataka dobivenih iz ispitivanja na životinjama, malo je vjerovatan rizik od malformacija kod ljudi.
English: A potential increased risk of liver enzymes increase cannot be excluded.
Croatian: Ne može se isključiti mogući povećani rizik porasta jetrenih enzima.
English: Given the increased etravirine exposure during pregnancy, caution should be applied for those pregnant patients that require concomitant medicinal products or have comorbidities that may further increase etravirine exposure.
Croatian: S obzirom na povećanu izloženost etravirinu tijekom trudnoće, potreban je oprez kod trudnih bolesnica kojima je potrebna istodobna primjena lijekova ili imaju komorbiditet koji mogu dodatno povećati izloženost etravirinu.
English: If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (laktoza), obratite se liječniku prije uzimanja ovog lijeka.
English: In most cases, INTELENCE can be combined with anti-HIV medicines belonging to another class.
Croatian: U većini slučajeva INTELENCE se može kombinirati s lijekovima protiv HIV-a koji pripadaju drugoj skupini.
English: It is therefore important to contact your doctor immediately if you develop a rash.
Croatian: Stoga je važno da se odmah obratite svom liječniku ako Vam se razvije osip.
English: INTELENCE might interact with other medicines.
Croatian: INTELENCE može međusobno djelovati s drugim lijekovima.
English: How to take INTELENCE
Croatian: Kako uzimati INTELENCE
English: Patients should be instructed to swallow the tablet(s) whole with a liquid such as water.
Croatian: Bolesnike treba uputiti da progutaju tabletu(e) cijele s tekućinom kao što je voda.
English: Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines.
Croatian: Nadalje, važno je pažljivo pročitati Upute o lijeku priložene uz te lijekove.
English: When prescribing INTELENCE to females, prescribers should be aware that the incidence of rash was higher in females (see section 4.8).
Croatian: Kad propisuju INTELENCE ženama, propisivači moraju biti svjesni da je incidencija osipa veća u žena (vidjeti dio 4.8).
English: Because 14-OH-clarithromycin has reduced activity against Mycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC.
Croatian: Budući da 14-OHklaritromicin ima smanjeno djelovanje protiv kompleksa Mycobacterium avium (MAC), sveukupno djelovanje protiv ovog patogena može se promijeniti; stoga se za liječenje MAC-a trebaju razmotriti alternative klaritromicinu.
English: Lactose intolerance and lactase deficiency
Croatian: Nepodnošenje laktoze i nedostatak laktaze
English: Concomitant use of PDE-5 inhibitors with INTELENCE may require dose adjustment of the PDE-5 inhibitor to attain the desired clinical effect.
Croatian: Istodobna primjena PDE-5 inhibitora i lijeka INTELENCE može zahtijevati prilagodbu doze PDE-5 inhibitora kako bi se postigao željeni klinički učinak.
English: The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see sections 4.2 and 5.2).
Croatian: Vrsta i incidencija nuspojava u bolesnika > 55 godina starosti bili su slični onima u mlađih bolesnika (vidjeti dijelove 4.2 i 5.2).
English: Maraviroc/darunavir/ ritonavir
Croatian: Maravirok/darunavir/ ritonavir
English: No interaction is expected for either INTELENCE or enfuvirtide when co-administered.
Croatian: Ne očekuje se nikakva interakcija bilo za INTELENCE ili enfuvirtid kad se primjenjuju istodobno.
English: Summary of efficacy results
Croatian: Sažetak rezultata djelotvornosti
English: Examples are: low red blood cells.
Croatian: snižene crvene krvne stanice.
English: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Croatian: Izloženost klaritromicinu smanjeno je etravirinom; međutim, koncentracije aktivnog metabolita, 14-OHklaritromicina,povećale su se.
English: Treatment with INTELENCE should be discontinued if a severe cutaneous reaction develops.
Croatian: Liječenje lijekom INTELENCE treba prekinuti ako se razvije teška kožna reakcija.
English: In the dog, changes were observed in the liver and gall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose (200 mg twice daily).
Croatian: U pasa, promjene su opažene u jetri i žučnom mjehuru pri izloženostima otprilike 8 puta višoj od izloženosti opažene u čovjeka pri preporučenoj dozi (200 mg dva puta dnevno).
English: Etravirine N = 101
Croatian: Etravirin N = 101
English: Follow your doctor's instruction carefully on which medicines can be combined.
Croatian: Pažljivo se pridržavajte liječničkih uputa o tome koji se lijekovi mogu uzimati zajedno.
English: Treatment-experienced adult patients
Croatian: Prethodno liječeni odrasli bolesnici
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG04.
Croatian: Farmakoterapijska skupina: antivirotici za sustavnu primjenu, nenukleozidni inhibitori reverzne transkriptaze, ATK oznaka: J05AG04.
English: FC subgroups are based on the select patient populations in DUET-1 and DUET-2 and are not meant to represent definitive clinical susceptibility breakpoints for etravirine.
Croatian: Podskupine FC temelje se na izabranim populacijama bolesnika u ispitivanjima DUET-1 i DUET-2 i ne smatra se da predstavljaju konačne prijelomne točke kliničke osjetljivosti za etravirin.
English: Use in children and adolescents 6 years of age and older and weighing at least 16 kg The doctor will work out the right dose based on the weight of the child.
Croatian: Primjena u djece i adolescenata u dobi od 6 godina ili starijih i težine najmanje 16 kg Liječnik će odrediti ispravnu dozu na osnovi težine djeteta.
English: There were no new clinically relevant safety findings in the mothers or in the newborns in this trial.
Croatian: U ovom ispitivanju nisu zabilježeni novi klinički značajni sigurnosni podaci ni u majki ni u novorođenčadi.
English: Based on these trial results, etravirine is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
Croatian: Na temelju rezultata tih ispitivanja, etravirin se ne preporučuje za primjenu u kombinaciji s N(t)RTI samo u bolesnika koji su imali virološki neuspjeh u režimu liječenja s NNRTI i N(t)RTI.
English: After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours.
Croatian: Nakon peroralne primjene s hranom, maksimalna koncentracija etravirina u plazmi obično se postiže unutar 4 sata.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Croatian: Zaključci vezani uz važnost pojedinačnih mutacija ili mutacijskih obrazaca podliježu promjeni s dodatnim podacima te se preporučuje uvijek konzultirati važeće sustave za tumačenje za analize rezultata ispitivanja rezistencije.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Terapiju treba započeti liječnik koji ima iskustva u liječenju HIV infekcije.
English: These can be seen in the results of blood and/or urine tests.
Croatian: To se može vidjeti iz nalaza krvnih pretraga i/ili pretraga mokraće.
English: The distribution of etravirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Croatian: Raspodjela etravirina u odjeljke osim plazme (npr. cerebrospinalna tekućina, sekrecije genitalnog trakta) nije procijenjena u ljudi.
English: If you take more INTELENCE than you should Contact your doctor or pharmacist immediately.
Croatian: Ako uzmete više lijeka INTELENCE nego što ste trebali Odmah kontaktirajte svoga liječnika ili ljekarnika.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with INTELENCE in one or more subsets of the paediatric population in human immunodeficiency virus infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka INTELENCE u jednoj ili više podskupina pedijatrijske populacije u infekciji virusom humane imunodeficijencije, uvjeti zadani po Planu istraživanja u pedijatrijskoj populaciji (PIP-u), za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: INTELENCE is not a cure for HIV infection.
Croatian: INTELENCE ne dovodi do izlječenja HIV infekcije.
English: As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Croatian: Budući da je etravirin u velikoj mjeri vezan na proteine plazme, nije vjerojatno da će značajno biti uklonjen hemodijalizom ili peritonejskom dijalizom (vidjeti dio 4.2.)
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki upalni simptom treba procijeniti i ako je potrebno uvesti liječenje.
English: Results from a mass balance study with radioactive
Croatian: Rezultati ispitivanja masene bilance s radioaktivnim C
English: INTELENCE tablet(s) should be taken orally, following a meal (see section 5.2).
Croatian: INTELENCE tabletu(e) mora se uzeti peroralno, nakon obroka (vidjeti dio 5.2).
English: Significantly fewer patients in the etravirine arm reached a clinical endpoint (AIDS-defining illness and/or death) as compared to the placebo arm (p = 0.0408).
Croatian: Značajno manje bolesnika u skupini liječenoj etravirinom dostiglo je kliničku mjeru ishoda (AIDSvezana bolest i/ili smrt) u odnosu na skupinu koja je primala placebo (p = 0,0408).
English: Not studied, but no interaction expected based on the renal elimination pathway of ribavirin.
Croatian: Nije ispitivano, ali ne očekuje se nikakva interakcija temeljem eliminacije ribavirina renalnim putem.
English: In addition, etravirine demonstrates a fold change (FC) in EC50 ≤ 3 against 60% of 6,171 NNRTI-resistant clinical isolates.
Croatian: Osim toga, etravirin pokazuje stupanj promjene (eng. fold change, FC) kod EC50 ≤ 3 nasuprot 60% od 6171 kliničkih izolata otpornih na NNRTI.
English: • 1 or more NNRTI resistance-associated mutations (RAMs) at screening or from prior genotypic analysis (i.e., archived resistance)
Croatian: • 1 ili više mutacija povezanih s NNRTI rezistencijom (RAM, eng. resistance-associated mutations) na probiru ili u prethodnoj genotipizaciji (tj. (arhivirana rezistencija)
English: No significant pharmacokinetic differences have been observed between males and females.
Croatian: Nisu opažene značajne farmakokinetičke razlike između muškaraca i žena.
English: The observed hepatocellular findings in female mice are generally considered to be rodent specific, associated with liver enzyme induction, and of limited relevance to humans.
Croatian: Opaženi hepatocelularni nalazi u ženki miševa općenito se smatraju specifičnim za glodavce, povezani s indukcijom jetrenih enzima i od ograničenog su značaja kod ljudi.
English: Severe cutaneous and hypersensitivity reactions
Croatian: Teške kožne reakcije i reakcije preosjetljivosti
English: ANTIBIOTICS Azithromycin
Croatian: ANTIBIOTICI Azitromicin
English: Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in faeces.
Croatian: Nepromijenjeni etravirin odgovoran je za 81,2% do 86,4% primijenjene doze u stolici.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS Sildenafil 50 mg single dose
Croatian: INHIBITORI FOSFODIESTRAZE TIPA 5 (PDE-5) Sildenafil 50 mg, jednokratna doza
English: Do not stop taking INTELENCE without talking to your doctor first HIV therapy may increase your sense of well-being.
Croatian: Nemojte prestati uzimati INTELENCE prije nego što se posavjetujete sa svojim liječnikom HIV terapija može poboljšati
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane redoslijedom prema manjoj ozbiljnosti.
English: Interactions between etravirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not done as “ND”, confidence interval as “CI”).
Croatian: Interakcije između etravirina i istovremeno primijenjenih lijekova navedene su u tablici 1 (povećanje je označeno kao „↑“, smanjenje kao „↓“, nema promjene kao „↔“, nije bilo provedeno kao „NP“, interval pouzdanosti kao „CI“).
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily Note: In drug-drug interaction studies, different formulations and/or doses of etravirine were used which led to similar exposures and, therefore, interactions relevant for one formulation are relevant for the other.
Croatian: Ispitivanje je provedeno s tenofovirdizoproksilfumaratom 300mg primijenjenim jedanput dnevno Napomena: U ispitivanjima interakcije lijekova primjenjivale su se različite formulacije i/ili doze etravirina koje su dovele do sličnog stupnja izloženosti, stoga su interakcije koje vrijede za jednu formulaciju relevantne i za druge formulacije.
English: Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Croatian: Preporučuje se pojačano kliničko i laboratorijsko praćenje supresije HIV-a i HCV-a.
English: Etravirine is also a weak inhibitor of P-glycoprotein.
Croatian: Etravirin je također slabi inhibitor P-glikoproteina.
English: This breakpoint might be lower in antiretroviral combination therapy not including a boosted protease inhibitor.
Croatian: Ta bi točka promjene mogla biti niža u terapiji antiretrovirusnim lijekovima koja ne uključuje pojačani inhibitor proteaze.
English: It is not recommended to combine etravirine with tipranavir/ritonavir, due to a marked pharmacokinetic interaction (76% decrease of etravirine AUC) that could significantly impair the virologic response to etravirine.
Croatian: Ne preporučuje se zajedno primjenjivati etravirin i tipranavir/ritonavir zbog značajne farmakokinetičke interakcije (76%-tno smanjenje AUC etravirina), koje mogu značajno utjecati na virološki odgovor na etravirin.
English: The results below are pooled data from the two trials.
Croatian: Rezultati koji slijede odnose se na udružene podatke iz dva ispitivanja.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy.
Croatian: Prijavljeni su slučajevi osteonekroze, osobito u bolesnika s općepoznatim čimbenicima rizika, uznapredovalom HIV bolešću ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji.
English: HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.
Croatian: Majke zaražene HIV-om ne smiju dojiti, budući da postoji mogućnost prijenosa HIV-a na dijete.
English: These adverse reactions were observed in other clinical trials than DUET-1 and DUET-2.
Croatian: Ove nuspojave bile su zabilježene u ostalim kliničkim ispitivanjima osim DUET-1 i DUET-2.
English: Etravirine is primarily metabolised and eliminated by the liver.
Croatian: Etravirin se prvenstveno metabolizira i eliminira putem jetre.
English: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Croatian: Interakcije i preporuke kod doziranja s drugim lijekovima Lijekovi po terapijskim skupinama
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Croatian: Iako se smatra da je etiologija višestruka (uključuje uporabu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), prijavljeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom HIV infekcijom i/ili dugotrajnom izloženošću KART-u.
English: Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped.
Croatian: Liječnik će Vam savjetovati kako postupati s tim simptomima i morate li prestati uzimati INTELENCE.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: U nekih bolesnika koji uzimaju kombiniranu antiretrovirusnu terapiju može se razviti bolest kostiju koja se naziva osteonekroza (odumiranje koštanog tkiva prouzročeno prestankom opskrbe kosti krvlju).
English: Treatment differences are based on Least Square Means from an ANCOVA model including the stratification factors.
Croatian: Razlike liječenja dobiju se na temelju prosječnih vrijednosti najmanjih kvadrata iz modela ANCOVA uključujući faktore stratifikacije.
English: In view of the limited data available in hepatitis B and/or C co-infected patients, particular caution should be paid when INTELENCE is used in these patients (see sections 4.4 and 4.8).
Croatian: S obzirom na to da su raspoloživi podaci za bolesnike koji imaju koinfekciju virusom hepatitisa B i/ili C ograničeni, potrebno je posebno paziti kad se INTELENCE koristi kod tih bolesnika (vidjeti dio 4.4 i 4.8).
English: Very rare side effects (may affect up to 1 in 10,000 people) - severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) - teške reakcije preosjetljivosti s karakterističnim osipom praćenim vrućicom i upalom organa kao što je hepatitis.
English: INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Croatian: INTELENCE je lijek koji se koristi pri liječenju infekcija uzrokovanih virusom humane imunodeficijencije (HIV).
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgija
English: INTELENCE works by reducing the amount of HIV in your body.
Croatian: INTELENCE djeluje na način da smanjuje količinu HIV-a u Vašem tijelu.
English: What INTELENCE contains - The active substance is etravirine.
Croatian: Što INTELENCE sadrži - Djelatna tvar je etravirin.
English: Increased unbound exposure could be expected.
Croatian: Može se očekivati povećana izloženost nevezanom dijelu.
English: flatulence, constipation, mouth inflammation, dry mouth; - night sweats, itching, dry skin; - Change in some values of your blood cells or chemistry.
Croatian: suha usta; - noćna znojenja, svrbež, suha koža; - promjene u nekim vrijednostima Vaših krvnih stanica ili kemijskih nalaza.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Experience in geriatric patients is limited: in the Phase III trials, 6 patients aged 65 years or older and 53 patients aged 56-64 years received etravirine.
Croatian: Iskustvo vezano uz primjenu lijeka kod gerijatrijskih bolesnika ograničeno je: u kliničkim ispitivanjima faze III, 6 bolesnika u dobi od 65 godina ili starijih i 53 bolesnika u dobi od 56 do 64 godine primalo je etravirin.
English: NARCOTIC ANALGESICS Methadone individual dose ranging from 60 mg to 130 mg once daily
Croatian: OPIJATNI ANALGETICI Metadon pojedinačna doza u rasponu od 60 mg do 130 mg jedanput dnevno
English: The systemic exposure (AUC) to etravirine was decreased by about 50% when etravirine was administered under fasting conditions, as compared to administration following a meal.
Croatian: Sistemska izloženost (AUC) etravirinu bila je smanjena za oko 50% kada je etravirin primjenjivan natašte u usporedbi s primjenom nakon obroka.
English: INTELENCE should optimally be combined with other antiretrovirals that exhibit activity against the patient's virus (see section 5.1).
Croatian: INTELENCE je optimalno koristiti u kombinaciji s drugim antiretrovirusnim lijekovima koji pokazuju aktivnost protiv virusa u bolesnika (vidjeti dio 5.1).
English: Tenofovir disoproxil 245 mg once daily tenofovir
Croatian: Tenofovirdizoproksil 245 mg jedanput dnevno tenofovir
English: 0.5 mg single dose digoxin
Croatian: 0,5 mg jednokratna doza digoksin
English: Rare side effects (may affect up to 1 in 1,000 people) - stroke; - severe skin rash with blisters or peeling skin, particularly around the mouth or eyes; this may occur in children and adolescents more frequently than in adults.
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - moždani udar; - težak kožni osip praćen mjehurićima ili ljuštenjem kože, osobito oko usta ili očiju; to se češće javlja u djece i adolescenata nego u odraslih.
English: Unchanged etravirine was not detected in urine.
Croatian: Nepromijenjeni etravirin nije otkriven u mokraći.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with INTELENCE.
Croatian: Preporučuje se pratiti međunarodni omjer normalizacije (INR) kada se varfarin kombinira s lijekom INTELENCE.
English: INTELENCE is used in combination with other anti-HIV medicines to treat adults and children 6 years of age and older who are infected by HIV and who have used other anti-HIV medicines before.
Croatian: INTELENCE se koristi u kombinaciji s drugim lijekovima protiv HIV-a za liječenje odraslih i djece u dobi od 6 godina i više koji su inficirani HIV-om, a koji su ranije koristili druge lijekove protiv HIV-a.