FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Edurant.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Edurant.
English: The Committee noted that Edurant causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Croatian: Odbor je napomenuo da Edurant uzrokuje manje nuspojava u ranim fazama terapije i ima prednost zato što se uzima kao jedna tableta jedanput na dan.
English: Edurant must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Edurant:
Croatian: Edurant se ne smije koristiti sa sljedećim lijekovima jer oni mogu prouzročiti snižene koncentracije rilpivirina u krvi te tako smanjiti i djelotvornost lijeka Edurant:
English: Treatment with Edurant should be started by a doctor experienced in treating HIV infection.
Croatian: Terapiju lijekom Edurant mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: A risk management plan has been developed to ensure that Edurant is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Edurant.
English: Why has Edurant been approved?
Croatian: Zašto je Edurant odobren?
English: The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes).
Croatian: Najčešće nuspojave lijeka Edurant (prijavljene kod više od 1 na 10 osoba) su glavobolja, nesanica, vrtoglavica, mučnina (osjećaj slabosti) i povišene razine ukupnog kolesterola, lipoproteinskog kolesterola niske gustoće (LDL), gušteračne amilaze (enzima koji se proizvodi u gušterači, a razgrađuje škrob u šećere) i transaminaza (jetrenih enzima).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edurant, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Edurant nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Croatian: Primjenjuje se samo u bolesnika koji prethodno nisu primili terapiju protiv HIV-a i u kojih razina HIV-a u krvi (virusno opterećenje) nije veća od 100 000 HIV 1-RNK kopija/ml.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Croatian: Inhibira djelovanje reverzne transkriptaze, enzima kojeg proizvodi HIV-1, a koji mu omogućuje proizvodnju većeg broja virusa u zaraženim stanicama.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Croatian: No, CHMP je napomenuo da postoji određeni rizik da HIV-1 razvije otpornost na rilpivirin te da se čini da je taj rizik manji u bolesnika s nižim virusnim opterećenjem.
English: What is the risk associated with Edurant?
Croatian: Koji su rizici povezani s lijekom Edurant?
English: The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Croatian: Djelatna tvar u lijeku Edurant, rilpivirin, je nenukleozidni inhibitor reverzne transkriptaze (NNRTI).
English: • systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
Croatian: • deksametazon (steroidni protuupalni lijek i imunosupresant), osim ako se primjenjuje kao terapija jednokratnom dozom
English: Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
Croatian: Edurant je davan u kombinaciji s fiksnim režimom protuvirusnih lijekova i nije uspoređivan s drugom terapijom.
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Croatian: • omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (inhibitori protonske pumpe koji se primjenjuju za snižavanje želučane kiseline)
English: Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Croatian: Edurant je ispitivan u dva glavna ispitivanja provedena na 1 368 odraslih bolesnika zaraženih HIV-om koji prethodno nisu liječeni.
English: Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Croatian: Stoga CHMP smatra da koristi od lijeka Edurant nadmašuju s njim povezane rizike u bolesnika s niskim opterećenjem virusom HIV-1 te je preporučio izdavanje odobrenja za stavljanje lijeka u promet za tu skupinu bolesnika.
English: Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Croatian: Edurant je također ispitivan u još jednom ispitivanju provedenom na 36 adolescenata (u dobi od 12 do 18 godina) zaraženih HIV-om koji prethodno nisu liječeni.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
Croatian: • karbamazepin, okskarbazepin, fenobarbital, fenitoin (lijekovi protiv napadaja)
English: Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: U kombinaciji s ostalim protuvirusnim lijekovima, Edurant se koristi za liječenje odraslih osoba i adolescenata starijih od 12 godina koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV 1) koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Edurant is a medicine that contains the active substance rilpivirine.
Croatian: Edurant je lijek koji sadrži djelatnu tvar rilpivirin.
English: In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood.
Croatian: U odraslih osoba, Edurant je, ako se uzimao u kombinaciji s drugim protuvirusnim lijekovima, bio jednako učinkovit kao i usporedni lijek u snižavanju razine virusa HIV-1 u krvi bolesnika.
English: By blocking this enzyme, Edurant, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Ako se uzima zajedno s drugim protuvirusnim lijekovima, inhibirajući taj enzim Edurant snižava količinu HIV-a u krvi i održava je na niskoj razini.
English: Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Croatian: Smatralo se da su bolesnici u kojih je nakon 48 tjedana terapije postignuto virusno opterećenje manje od 50 HIV-1 RNK kopija/ml odgovorili na terapiju.
English: In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.
Croatian: Edurant je uspoređen s efavirenzom, pri čemu su oba lijeka uzimana u kombinaciji s fiksnim režimom protuvirusnih lijekova koji se sastoji od tenofovirdizoproksila i emtricitabina ili dva druga nukleozidna ili nukleotidna inhibitora reverzne transkriptaze.
English: In the first study, Edurant was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine.
Croatian: Edurant je uspoređen s drugim NNRTI-om naziva efavirenz, pri čemu su oba lijeka uzimana u kombinaciji s fiksnim režimom protuvirusnih lijekova koji se sastoji od tenofovirdizoproksila i emtricitabina.
English: What is Edurant?
Croatian: Što je Edurant?
English: For the full list of all side effects reported with Edurant, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Edurant potražite u uputi o lijeku.
English: What benefit has Edurant shown during the studies?
Croatian: Koje su koristi lijeka Edurant utvrđene u ispitivanjima?
English: How is Edurant used?
Croatian: Kako se Edurant koristi?
English: The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Croatian: CHMP je zaključio da je Edurant, u kombinacija s drugim protuvirusnim lijekovima, bio jednako djelotvoran kao i glavni NNRTI koji se trenutno koristi za terapiju prve linije u bolesnika zaraženih virusom HIV-1.
English: What is Edurant used for?
Croatian: Za što se Edurant koristi?
English: How has Edurant been studied?
Croatian: Kako je Edurant ispitivan?
English: • St John's wort (a herbal antidepressant medicine).
Croatian: • gospina trava (biljni antidepresiv).
English: How does Edurant work?
Croatian: Kako djeluje Edurant?
English: The response rate was similar for both genders.
Croatian: Stopa odgovora bila je slična za oba spola.
English: This syndrome can be fatal.
Croatian: Taj sindrom može biti smrtonosan.
English: - you have any liver problems.
Croatian: - imate bilo kakve probleme s jetrom.
English: Observation is the recommended approach with intervention only in selected cases.
Croatian: Opažanje je preporučeni pristup s intervencijom u samo odabranim slučajevima.
English: You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Croatian: Nužno je da prijavite sve nove i izvanredne simptome i okolnosti svaki put kada posjetite liječnika.
English: Caution is needed in these patients.
Croatian: U ovih je bolesnika potreban oprez.
English: At Risk
Croatian: Pod rizikom
English: NEW CONCENTRATION
Croatian: NOVA KONCENTRACIJA
English: The same dose is recommended for adults and elderly.
Croatian: Ista se doza preporučuje za odrasle i starije bolesnike.
English: Confidence interval (CI)
Croatian: Interval pouzdanosti (CI)
English: AsV is present in plasma only at relatively low levels.
Croatian: AsV je prisutan u plazmi u relativno niskim razinama.
English: Vd is also weight dependent, increasing with increasing body weight.
Croatian: Vd također ovisi o težini i povećava se s porastom tjelesne težine.
English: Monitoring and management for these patients should be as described above.
Croatian: Nadzor i liječenje ovih bolesnika mora biti kako je to prethodno opisano.
English: The extent of accumulation of these metabolites is dependent on the dosing regimen.
Croatian: Opseg akumulacije ovih metabolita ovisi o režimu doziranja.
English: - In addition, you will receive electrocardiograms twice weekly.
Croatian: - Pored toga podvrgnut ćete se elektrokardiogramu dva puta tjedno.
English: TRISENOX is normally given by a doctor or a nurse.
Croatian: TRISENOX obično daje liječnik ili medicinska sestra.
English: Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci za djecu u dobi od 5 do 16 godina opisani su u dijelu 5.1, međutim, nije moguće dati preporuku o doziranju.
English: Differentiation syndrome
Croatian: Sindrom diferencijacije
English: From a microbiological point of view, the product must be used immediately.
Croatian: S mikrobiološkog stajališta lijek se mora upotrijebiti odmah.
English: In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Croatian: Osoblje mora biti obučeno u rukovanju i razrjeđivanju arsenovog trioksida i mora nositi odgovarajuću zaštitnu odjeću.
English: Kaplan-Meier estimates of 18-month survival for each study are shown below.
Croatian: Kaplan-Meierove procjene za 18-mjesečno preživljenje za svaku studiju prikazane su u nastavku.
English: If you are not sure, show the bottle or pack to your doctor.
Croatian: Ako niste sigurni, pokažite svom liječniku bocu ili pakiranje.
English: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
Croatian: Liječenje konsolidacijom mora početi 3 do 4 tjedna nakon dovršetka indukcijske terapije.
English: Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding.
Croatian: Volumen distribucije (Vd) za AsIII je velik (> 400 l) što ukazuje na značajnu raspodjelu u tkiva sa zanemarivim vezivanjem na proteine.
English: The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Croatian: Sigurnost i djelotvornost TRISENOXA u djece u dobi do 17 godina nisu ustanovljene.
English: The diluted solution must be clear and colourless.
Croatian: Razrijeđena otopina mora biti bistra i bezbojna.
English: While on treatment with TRISENOX, you may experience some of the following reactions:
Croatian: Dok se liječite TRISENOXOM, možete osjetiti neke od sljedećih reakcija:
English: Children and adolescents TRISENOX is not recommended in children and adolescents below 18 years of age.
Croatian: TRISENOX se ne preporučuje u djece i adolescenata mlađih od 18 godina.
English: Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Croatian: Bolesnici su težili toleranciji konsolidacije i održavanju terapije s manje toksičnosti nego u indukciji.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Grades ≥ 3
Croatian: Stupnjevi ≥ 3
English: TRISENOX is for single use only.
Croatian: TRISENOX je samo za jednokratnu uporabu.
English: She went onto consolidation without further evidence of QT prolongation.
Croatian: Ušla je u fazu konsolidacije bez daljnjeg dokaza produljenja QT intervala.
English: Do not save any unused portions for later administration.
Croatian: Nemojte čuvati nijedan neiskorišteni dio lijeka za kasniju primjenu.
English: This accumulation was slightly more than expected based on single-dose results.
Croatian: Ta je akumulacija bila nešto viša od očekivane na temelju rezultata za pojedinačnu dozu.
English: • cisapride (a medicine used to relieve certain stomach problems).
Croatian: • cisaprid (lijek koji se koristi za liječenje određenih problema u želucu).
English: - Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.
Croatian: - Praćenje kognitivnih funkcija i pokretljivosti ako ste pod rizikom od manjka vitamina B1.
English: However all cases were successfully managed with hydroxyurea therapy.
Croatian: Međutim, svi su slučajevi uspješno liječeni terapijom hidroksiurejom.
English: The effect of these medicines on your heartbeat can be made worse by TRISENOX.
Croatian: Učinak tih lijekova na Vaše otkucaje srca može se pogoršati uzimanjem TRISENOXA.
English: CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)
Croatian: OPREZ, PRIMIJETITE NOVU KONCENTRACIJU (2 mg/ml)
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of TRISENOX.
Croatian: Vaš će liječnik poduzeti sljedeće mjere opreza: - Provest će se testovi kako bi se provjerila količina kalija, magnezija, kalcija i kreatinina u Vašoj krvi prije prve doze TRISENOXA.
English: Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Croatian: Bolesnike se mora hospitalizirati na početku liječenja zbog simptoma bolesti te osigurati odgovarajući nadzor.
English: A central venous catheter is not required.
Croatian: Središnji venski kateter nije potreban.
English: Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
Croatian: Datum posljednje obnove odobrenja: 05. ožujka 2007.
English: 95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX
Croatian: 95% CI za razliku, 2-22 postotnih bodova p < 0,001 za neinferiornost p = 0,02 za superiornost kombinacije ATRA+TRISENOX
English: No data are available for children under 5 years.
Croatian: Nema dostupnih podataka o primjeni u djece mlađe od 5 godina.
English: Some cases recovered with vitamin B1 supplementation.
Croatian: U nekih je slučajeva nastupilo poboljšanje s nadoknadom vitamina B1.
English: Responses were seen across all age groups tested, ranging from 6 to 75 years.
Croatian: Reakcije su zapažene u svim testiranim dobnim skupinama, u rasponu od 6 do 75 godina.
English: You must be sure to tell your doctor about all medicines you are taking.
Croatian: Obavijestite svog liječnika o svim lijekovima koje uzimate.
English: Consolidation schedule
Croatian: Raspored konsolidacije
English: Monitor patients for the development of second primary malignancies.
Croatian: Nadzirite bolesnike zbog mogućeg razvoja druge primarne maligne bolesti.
English: Development of second primary malignancies
Croatian: Razvoj drugih primarnih malignih bolesti
English: Your doctor will decide exactly how long you must continue on therapy with TRISENOX.
Croatian: Liječnik će točno odrediti koliko dugo morate nastaviti liječenje TRISENOXOM.
English: Substances that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Croatian: Ne očekuje se da će tvari koje su supstrati za ove enzime P450 stupiti u interakciju s TRISENOXOM.
English: - if you are taking or have recently taken any medicine which may affect your liver.
Croatian: - ukoliko uzimate ili ste nedavno uzeli bilo koji drugi lijek koji može utjecati na jetru.
English: Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population.
Croatian: Ozbiljne nuspojave bile su česte (1-10%) i nisu bile neočekivane za populaciju u fazi relapsa/refraktornoj na liječenje.
English: Not evaluable RT-PCR for PML/ RAR
Croatian: RT-PCR za PML/ RARα
English: Hepatotoxicity (grade 3 or greater)
Croatian: Hepatotoksičnost (3. stupnja ili veća)
English: Not known (frequency cannot be estimated from the available data):
Croatian: < 1/100), te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Croatian: Ako ste trudni ili zatrudnite tijekom liječenja TRISENOXOM, obratite se svom liječniku za savjet.
English: TRISENOX must be administered intravenously over 1-2 hours.
Croatian: TRISENOX se mora primjenjivati intravenski tijekom 1-2 sata.
English: ATRA + Chemotherapy (n = 79)
Croatian: ATRA + kemoterapija (n = 79)
English: If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na arsenov trioksid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
Croatian: Ako se to dogodi, liječenje TRISENOXOM mora se odmah prekinuti, a Vaš će liječnik liječiti predoziranje arsenom.
English: 500 mg four times a day
Croatian: 500 mg četiri puta na dan
English: - You should have an electrical recording of the heart (electrocardiogram ECG) performed before your first dose.
Croatian: - Morate se podvrgnuti električnom snimanju rada srca (elektrokardiogram, EKG) prije prve doze.
English: Psychiatric disorders Confusional state
Croatian: Psihijatrijski poremećaji konfuzno stanje
English: The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Croatian: Pentavalentni metaboliti MMAV i DMAV, sporo se pojavljuju u plazmi (približno 10-24 sata nakon prve primjene arsenova trioksida), ali zbog njihova duljeg poluvremena, akumuliraju se više nakon višestrukog doziranja nego AsIII.
English: Now press your thumb on the coloured point and break the ampoule by holding firmly the body of the ampoule with the other hand.
Croatian: Potom pritisnite palcem na obojenu točku i prelomite ampulu držeći čvrsto tijelo ampule drugom rukom.
English: If complete remission has not occurred by day 60, dosing must be discontinued.
Croatian: Ako se potpuna remisija nije dogodila do 60. dana, doziranje se mora prekinuti.
English: Procedure for proper disposal
Croatian: Postupak za pravilno zbrinjavanje
English: Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Croatian: Elektrokardiogrami se moraju snimiti dvaput tjedno te češće za klinički nestabilne bolesnike tijekom indukcije i konsolidacije.
English: TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
Croatian: TRISENOX je indiciran za indukciju remisije i konsolidaciju u odraslih bolesnika s:
English: If complete remission has not occurred by day 50, dosing must be discontinued.
Croatian: Ako se potpuna remisija nije dogodila do 50. dana, doziranje se mora prekinuti.
English: 1000 mg four times a day
Croatian: 1000 mg četiri puta na dan
English: What TRISENOX is and what it is used for
Croatian: Što je TRISENOX i za što se koristi
English: The most commonly reported reactions were hyperglycaemia, hypokalaemia, neutropenia, and increased alanine amino transferase (ALT).
Croatian: Najčešće prijavljene nuspojave bile su hiperglikemija, hipokalemija, neutropenija i povećana razina alanin aminotransferaze (ALT).
English: 2-Year event-free survival (EFS)
Croatian: event-free survival, EFS)
English: Thereafter, penicillamine at a daily dose ≤ 1 g per day may be given.
Croatian: Nakon toga se može davati dnevna doza penicilamina ≤ 1 g po danu.
English: Each course of consolidation was initiated at haematological recovery from the previous course defined as absolute neutrophil count > 1.5 × 109/l and platelets > 100 × 109/l.
Croatian: Svaki ciklus konsolidacije započeo je pri hematološkom oporavku od prethodnog ciklusa definiranom kao apsolutni broj neutrofila > 1,5 × 109/l i trombocita > 100 × 109/l.
English: - If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously.
Croatian: - Ako ste pod rizikom od određenih tipova poremećenog srčanog ritma (primjerice, torsade de pointes ili produljenje QTc intervala), Vaše će srce biti pod stalnim nadzorom.