FrancophonIA/ELRC3.0 huggingface dataset:
English: • hearing loss, loss of other senses b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Croatian: • gubitak sluha, gubitak drugih osjeta b) Bolesnici koji se liječe od granulomatoze s poliangitisom ili mikroskopskog poliangitisa Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: In particular, tell your doctor:
Croatian: • Karticu pokažite svakom liječniku,
English: Neutropenia , leucopenia, +febrile neutropenia, +thrombocyt openia
Croatian: Poremećaji krvi i limfnog sustava neutropenija, leukopenija, +febrilna neutropenija, +trombocitopenij a anemija, +pancitopenija, +granulocitopenij a poremećaji zgrušavanja,
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Croatian: Primjena rituksimaba ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
English: Transient increase in serum IgM levels3
Croatian: hemolitička anemija, limfadentopatija prolazno povećanje serumske razine IgM-a3
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during Riximyo therapy.
Croatian: Tijekom terapije lijekom Riximyo potrebno je redovito kontrolirati kompletnu krvnu sliku, uključujući broj neutrofila i trombocita.
English: You might get infections more easily during your treatment with Riximyo.
Croatian: Tijekom liječenja lijekom Riximyo možda ćete biti podložniji infekcijama.
English: b)
Croatian: A,
English: Repeated treatment courses with Riximyo are possible.
Croatian: Riximyo mogu se ponavljati.
English: pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Croatian: svrbež, urtikarija, iritacija grla, navale vrućine,
English: All physicians who are expected to prescribe Riximyo for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
Croatian: Svi liječnici za koje se očekuje da će propisivati lijek Riximyo za neonkološke indikacije dobit će sljedeće materijale:
English: Coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy
Croatian: Krvožilni poremećaji hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kutani), leukocitoklasti čni vaskulitis
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja bronhospazam4, bolest dišnog sustava, bol u prsima, dispneja,
English: Experience from non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Summary of the safety profile
Croatian: Iskustva s primjenom u ne-Hodgkinovu limfomu i kroničnoj limfocitnoj leukemiji
English: • mood disorders such as irritability and depression
Croatian: • poremećaji raspoloženja poput razdražljivosti i depresije • poremećaji kože poput svrbeža, koprivnjače i dobroćudnih kvržica
English: The HCP educational leaflet about Riximyo for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Riximyo treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Riximyo treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any - The need to provide patients with the Patient Alert Card with each infusion
Croatian: - Detaljne informacije o riziku od PML-a, nužnost pravodobne dijagnoze PML-a i odgovarajuće mjere za dijagnosticiranje PML-a - Bolesnicima treba objasniti rizik od infekcija i PML-a, uključujući simptome kojih moraju biti svjesni i napomenuti im da se odmah obrate svom liječniku ako primijete neki od njih.
English: Laboratory abnormalities
Croatian: Laboratorijski nalazi
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Croatian: 750 mg/m2, vinkristin 1,4 mg/m2 do najviše 2 mg prvog dana liječenja, prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u 8 ciklusa liječenja, ili rituksimaba u dozi od
English: Patients in the rituximab group who relapsed could receive an additional infusion of rituximab
Croatian: Bolesnicima u skupini liječenoj rituksimabom koji su doživjeli relaps mogla se primijeniti dodatna infuzija rituksimaba u dozi od 1000 mg te ponovno uvesti prednizon ili povećati njegova doza.
English: Riximyo is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Croatian: d) običnog pemfigusa Riximyo se primjenjuje za liječenje bolesnika s umjerenim do teškim običnim pemfigusom.
English: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial up to 23.06 mmol (or 530.1 mg) sodium per dose.
Croatian: Ovaj lijek sadrži do 2,3 mmol (ili 52,6 mg) natrija po bočici od 10 ml.
English: This is because some people have a fall in their blood pressure while they are being given Riximyo.
Croatian: 12 sati prije primjene lijeka Riximyo zato što nekim bolesnicima može pasti krvni tlak tijekom primjene lijeka Riximyo.
English: Hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva hipertonija, mialgija, artralgija, bol u leđima, bol u vratu, bol
English: This will take one hour.
Croatian: To će potrajati jedan sat.
English: Do not pass it to others.
Croatian: Nemojte ga davati drugima.
English: * Includes events with a fatal outcome.
Croatian: * Uključuje događaje sa smrtnim ishodom.
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Croatian: Trenutno dostupni podaci su opisani u dijelovima 4.8, 5.1 i 5.2.
English: This is called a ‘treatment cycle' and it is repeated every 4 weeks.
Croatian: To se naziva 'ciklus liječenja' i ponavlja se svaka 4 tjedna.
English: • you have enough blood cells, and
Croatian: • imate li dovoljno krvnih stanica, i
English: Dose reduction is not recommended.
Croatian: Ne preporučuje se smanjenje doze.
English: Predicted Value
Croatian: Predviđena vrijednost
English: Tests or checks
Croatian: Pretrage ili kontrole
English: • Your doctor may delay your dose and change the total number of cycles, depending on how you respond to the treatment.
Croatian: • Liječnik Vam može odgoditi dozu i promijeniti ukupni broj ciklusa ovisno o tome kako reagirate na liječenje.
English: Talk to your doctor if you are on a low salt diet.
Croatian: Razgovarajte s Vašim liječnikom ako ste na prehrani s niskim udjelom soli.
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti ili rukovati alatima ili strojevima.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA /DATUM OBNOVE ODOBRENJA
English: It is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial remission may take longer than 4 cycles to be obtained.
Croatian: Preporučuje se bolesnike liječiti s najmanje 4 ciklusa; međutim, za postizanje potpune ili djelomične remisije može biti potrebno više od 4 ciklusa.
English: An updated RMP should be submitted:
Croatian: Ažurirani, RMP treba dostaviti:
English: Overall survival (ITT population).
Croatian: Sveukupno preživljenje (ITT populacija)
English: Enterocolitis may lead to septic complications and may be associated with fatal outcome.
Croatian: Enterokolitis može dovesti do septičkih komplikacija i može biti povezan sa smrtnim ishodom.
English: • You will receive Dacogen every day for 5 days, then 3 weeks without the medicine.
Croatian: • Primat ćete Dacogen svaki dan tijekom 5 dana, a zatim ćete 3 tjedna biti bez lijeka.
English: This is a type of cancer that affects your blood cells.
Croatian: To je vrsta raka koja zahvaća Vaše krvne stanice.
English: You will usually receive at least 4 treatment cycles.
Croatian: Uobičajeno je primiti najmanje 4 ciklusa liječenja.
English: • Bleeding: including blood in the stools.
Croatian: • Krvarenje: uključujući krv u stolici.
English: Treatment for overdose should be supportive.
Croatian: Liječenje predoziranja treba biti potporno.
English: • Women must use effective contraception during treatment.
Croatian: • Žene moraju koristiti učinkovitu kontracepciju za vrijeme liječenja.
English: Results from a mass balance study with radioactive
Croatian: Rezultati dobiveni ispitivanjem masene bilance s radioaktivnim
English: Talk to your doctor about what your blood test results mean.
Croatian: Obratite se svom liječniku za objašnjenje značenja rezultata Vaših krvnih pretraga.
English: There is no direct experience of human overdose and no specific antidote.
Croatian: Nema direktnog iskustva s predoziranjem u ljudi ni specifičnog antidota.
English: TC (combined group) n = 243
Croatian: TC (kombinirana skupina) n = 243
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji put revidirana u MM/GGGG
English: Children and adolescents Dacogen is not for use in children or adolescents under the age of 18.
Croatian: Djeca i adolescenti Dacogen nije za primjenu u djece ili adolescenata mlađih od 18 godina.
English: Excretion of unchanged drug appears to play only a minor role in the elimination of decitabine.
Croatian: Čini se da izlučivanje nepromijenjenog lijeka ima samo manju ulogu u eliminaciji decitabina.
English: Evidence from the literature indicates that decitabine has carcinogenic potential.
Croatian: Dokaz iz literature pokazuje da decitabin ima kancerogeni potencijal.
English: It is the responsibility of the user to follow the recommended storage times and conditions and ensure that reconstitution has taken place in aseptic conditions.
Croatian: Odgovornost je korisnika slijediti preporučeno vrijeme i uvjete čuvanja te osigurati provedbu rekonstitucije u aseptičkim uvjetima.
English: Date of first authorisation: 20 September 2012 Date of latest renewal: 22 May 2017
Croatian: Datum posljednje obnove odobrenja: 22. svibnja 2017.
English: All subjects discontinued the study treatment.
Croatian: Svi ispitanici su prekinuli liječenje u ispitivanju.
English: It is unknown when it is safe for women to become pregnant after treatment has stopped.
Croatian: Nije poznato kada je za ženu sigurno da zatrudni nakon prestanka liječenja.
English: Studies have shown that decitabine is teratogenic in rats and mice (see section 5.3).
Croatian: Ispitivanja su pokazala da je decitabin teratogen u štakora i miševa (vidjeti dio 5.3).
English: If a dose is missed, treatment should be resumed as soon as possible.
Croatian: Ako se doza propusti, liječenje treba nastaviti što je prije moguće.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije primjene ovoga lijeka.
English: It also kills cancer cells.
Croatian: On također uništava stanice raka.
English: If you are given more Dacogen than you should
Croatian: Ako Vam se primijeni više Dacogena nego što je trebalo
English: This depends on your height and weight
Croatian: Doza ovisi o Vašoj visini i težini (tjelesna površina).
English: • Febrile neutropaenia (temperature ≥ 38.5°C and absolute neutrophil count < 1,000/µL)
Croatian: • febrilna neutropenija (temperatura ≥ 38,5°C i apsolutni broj neutrofila < 1000/µl)
English: Dacogen should not be infused through the same intravenous access/line with other medicinal products.
Croatian: Dacogen se ne smije davati kao infuzija kroz isti intravenski pristup/liniju s drugim lijekovima.
English: The cycle should be repeated every 4 weeks depending on the patient's clinical response and observed toxicity.
Croatian: Ciklus liječenja treba ponavljati svaka 4 tjedna, ovisno o kliničkom odgovoru bolesnika i opaženoj toksičnosti.
English: A central venous catheter is not required.
Croatian: Centralni venski kateter nije potreban.
English: • Talk to your doctor if you wish to freeze your eggs before starting treatment.
Croatian: • Razgovarajte sa svojim liječnikom ako želite zamrznuti svoja jajašca prije nego što započnete liječenje.
English: There was no evidence of dependencies on age, creatinine clearance, total bilirubin, or disease.
Croatian: Nije nađen dokaz za ovisnost o dobi, klirensu kreatinina, ukupnom bilirubinu ili bolesti.
English: Other medicines and Dacogen
Croatian: Drugi lijekovi i Dacogen
English: • other infection in any part of the body, caused by bacteria, virus or fungi
Croatian: • druga infekcija u bilo kojem dijelu tijela, uzrokovana bakterijom, virusom ili gljivicama
English: Tell your doctor immediately if you become pregnant during treatment with Dacogen.
Croatian: Odmah obavijestite svoga liječnika ako ste zatrudnjeli za vrijeme liječenja Dacogenom.
English: Reported adverse events were consistent with the known safety profile of Dacogen in adults (see section 4.8).
Croatian: Prijavljeni štetni događaji bili su u skladu s poznatim sigurnosnim profilom lijeka Dacogen u odraslih (vidjeti dio 4.8).
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues; ATC Code: L01BC08
Croatian: Farmakoterapijska skupina: antineoplastični lijekovi, antimetaboliti, analozi pirimidina; ATK oznaka: L01BC08
English: These results as well as other endpoints are shown in Table 2.
Croatian: Ti rezultati kao i druge mjere ishoda ispitivanja prikazane su u tablici 2.
English: • if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na decitabin ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6).
English: Therefore, caution should be exercised if these active substances are combined with decitabine.
Croatian: Stoga je potreban oprez ako se ove djelatne tvari kombiniraju s decitabinom.
English: The major circulating metabolites are not believed to be pharmacologically active.
Croatian: Za glavne cirkulirajuće metabolite ne vjeruje se da su farmakološki aktivni.
English: Therefore, caution should be recommended when driving a car or operating machines.
Croatian: Stoga treba preporučiti oprez pri upravljanju vozilima ili rukovanju strojevima.
English: Do not use Dacogen:
Croatian: Nemojte primjenjivati Dacogen:
English: • Difficultly with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body.
Croatian: • Teškoće pri kretanju, govoru ili razumijevanju ili gledanju; iznenadna teška glavobolja, napadaji, obamrlost ili slabost u bilo kojem dijelu tijela.
English: It is used in adults.
Croatian: Taj se lijek primjenjuje kod odraslih.
English: Data from the literature also indicate that decitabine has adverse effects on all aspects of the reproductive cycle, including fertility, embryo-foetal development and post-natal development.
Croatian: Literaturni podaci također pokazuju da decitabin ima štetne učinke na sve aspekte reprodukcijskog ciklusa uključujući plodnost, embriofetalni razvoj i razvoj poslije porođaja.
English: (thrombocytopaenia)
Croatian: (trombocitopenija)
English: The total dose per cycle was 100 mg/m
Croatian: Ukupna doza po ciklusu iznosila je 100 mg/m
English: • The dose is 20 mg/m2 body surface area.
Croatian: • Doza je 20 mg/m2 tjelesne površine.
English: From a microbiological point of view, the product should be used within the time period recommended above.
Croatian: S mikrobiološkog stajališta, lijek treba upotrijebiti u gore preporučenom vremenskom roku.
English: For situations where decitabine administration should be delayed, see section 4.2.
Croatian: Za situacije u kojima treba odgoditi primjenu decitabina, vidjeti dio 4.2.
English: Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The powder should be aseptically reconstituted with 10 ml of water for injections.
Croatian: Prašak treba aseptički rekonstituirati s 10 ml vode za injekcije.
English: • an infection,
Croatian: • infekciju,
English: Treatment may be delayed at the discretion of the treating physician, if the patient experiences myelosuppression-associated complications, such as those described below:
Croatian: Liječenje se može odgoditi prema odluci nadležnog liječnika, ako bolesnik ima komplikacije vezane uz mijelosupresiju, poput niže opisanih:
English: • You should not use Dacogen if you are pregnant as it may harm your baby.
Croatian: • Ne smijete primati Dacogen ako ste trudni, jer bi lijek mogao naškoditi Vašemu djetetu.
English: • Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care)
Croatian: • aktivna virusna, bakterijska ili gljivična infekcija (tj. koja zahtijeva liječenje intravenskim antiinfektivnim lijekovima ili opsežnu potpornu skrb)
English: In each study, decitabine PK was evaluated on the fifth day of the first treatment cycle.
Croatian: U svakom ispitivanju, farmakokinetika decitabina procijenjena je petog dana prvog ciklusa liječenja.
English: The difference did not reach statistical significance, however, there was a trend for improvement in survival with a 15% reduction in the risk of death for subjects in the Dacogen arm (Figure 1).
Croatian: Razlika nije dosegla statističku značajnost, međutim, postojao je trend poboljšanja preživljenja uz 15% manji rizik od smrti u ispitanika u skupini koja je primala Dacogen (slika 1).
English: Twenty-five percent of subjects had an ECOG performance status ≥ 2.
Croatian: Dvadeset i pet posto ispitanika imalo je ECOG funkcionalno stanje ≥ 2.
English: Also, some other medicines can affect the way Dacogen works.
Croatian: Osim toga, neki drugi lijekovi mogu utjecati djelovanje Dacogena.
English: In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay.
Croatian: U kliničkim je ispitivanjima, za otprilike trećinu bolesnika koji primaju Dacogen, bila potrebna odgoda doze.
English: Including enterocolitis infectious.
Croatian: Uključuje infektivni enterokolitis.
English: Population pharmacokinetic analysis showed that decitabine pharmacokinetics are not dependent on age (range studied 40 to 87 years; median 70 years).
Croatian: Analiza populacijske farmakokinetike pokazala je da farmakokinetika decitabina ne ovisi o dobi (ispitivani dobni raspon od 40 do 87 godina; medijan 70 godina).
English: • your liver and kidneys are working properly.
Croatian: • rade li Vam bubrezi i jetra pravilno.
English: • Talk to your doctor if you wish to conserve your sperm before starting treatment.
Croatian: • Razgovarajte sa svojim liječnikom ako želite pohraniti svoju spermu prije nego što započnete liječenje.
English: Myelosuppression caused by Dacogen is reversible.
Croatian: Mijelosupresija uzrokovana Dacogenom je reverzibilna.
English: The number of patients treated with Dacogen by racial group was White 209 (86.4%) and Asian 33 (13.6%).
Croatian: Broj bolesnika liječenih Dacogenom prema rasnoj pripadnosti bio je 209 (86,4%) bijelaca i 33 (13,6%) azijata.
English: Dacogen will be given to you by a doctor or nurse who is trained in giving this type of medicine.
Croatian: Dacogen će Vam dati liječnik ili medicinska sestra koji su osposobljeni za primjenu ove vrste lijeka.
English: Results from the human mass-balance study showed that unchanged decitabine in plasma accounted for approximately 2.4% of total radioactivity in plasma.
Croatian: Rezultati ispitivanja masene bilance u ljudi pokazali su da je nepromijenjeni decitabin u plazmi odgovoran za približno 2,4% ukupne radioaktivnosti u plazmi.
English: No new safety signal was observed in this paediatric study.
Croatian: U pedijatrijskom ispitivanju nije zabilježen novi sigurnosni signal.
English: The reasons for treatment discontinuation included disease progression (12 [70.6%] subjects), subjects proceeding to transplant (3 [17.6%]), investigator decision (1 [5.9%]), and “other” (1 [5.9%]).
Croatian: Razlozi za prekide liječenja uključivali su progresiju bolesti (12 [70,6%] ispitanika), ispitanike koji su išli na transplantaciju (3 [17,6%]), odluku ispitivača (1 [5,9%]) i “drugo” (1 [5,9%]).
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Croatian: Bolesnike je potrebno pratiti radi pojave znakova i simptoma infekcije i što prije liječiti.
English: If you forget your appointment to have Dacogen If you miss an appointment, make another one as soon as possible.
Croatian: Ako zaboravite na odlazak liječniku kako biste primili Dacogen Ako propustite posjetu, dogovorite sljedeću što je prije moguće.
English: This medicine will be given by your doctor or nurse.
Croatian: Ovaj lijek primijenit će Vam liječnik ili medicinska sestra.
English: What Dacogen is Dacogen is an anti-cancer medicine.
Croatian: Što je Dacogen Dacogen je lijek protiv raka.
English: Dacogen has moderate influence on the ability to drive and use machines.
Croatian: Dacogen umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.
Croatian: • Muškarci bi trebali koristiti učinkovitu kontracepciju za vrijeme liječenja te do 3 mjeseca nakon prestanka liječenja.
English: In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm had adverse events with an outcome of death during treatment or within 30 days after the last dose of study drug.
Croatian: U kliničkim ispitivanjima 30% bolesnika liječenih Dacogenom i 25% bolesnika liječenih u usporednoj skupini imalo je štetne događaje sa smrtnim ishodom tijekom liječenja ili unutar 30 dana nakon posljednje doze ispitivanog lijeka.
English: However, early clinical study data in published literature at doses greater than 20 times higher than the current therapeutic dose, reported increased myelosuppression including prolonged neutropaenia and thrombocytopaenia.
Croatian: Međutim, raniji podaci iz kliničkih ispitivanja objavljenih u literaturi za doze koje su više od 20 puta veće od sadašnjih terapijskih doza, navode povećanu mijelosupresiju uključujući produljenu neutropeniju i trombocitopeniju.
English: In the Dacogen treatment group, there was a higher incidence of treatment discontinuation due to adverse events in women compared to men (43% versus 32%).
Croatian: U skupini koja je liječena Dacogenom, prekid liječenja radi štetnih događaja je bio češći u žena nego u muškaraca (43% naspram 32%).
English: Plasma protein binding of decitabine is negligible (< 1%).
Croatian: Vezanje decitabina na proteine plazme zanemarivo je (< 1%).
English: Therefore, patients are at increased risk for severe infections (due to any pathogen such as bacterial, fungal and viral), with potentially fatal outcome (see section 4.8).
Croatian: Stoga u bolesnika postoji veći rizik za pojavu ozbiljnih infekcija (uzrokovanih bilo kojim patogenom, poput bakterija, gljivica ili virusa) s potencijalno smrtnim ishodom (vidjeti dio 4.8).
English: Complications of myelosuppression include infections and bleeding.
Croatian: Komplikacije mijelosupresije uključuju infekcije i krvarenje.