FrancophonIA/ELRC3.0 huggingface dataset:
English: Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer.
Croatian: Lenalidomid je općenito topljiviji u organskim otapalima, ali iskazuje najveću topljivost u puferu HCl-a od 0,1 N.
English: Do not use while pregnant or breastfeeding.
Croatian: Ne primjenjivati u trudnoći ili u razdoblju dojenja.
English: 1 The dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment and is tolerating the treatment.
Croatian: 1 Doza se može povećati na 15 mg jednom dnevno nakon 2 ciklusa ako bolesnik ne odgovara na liječenje te podnosi liječenje.
English: Lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification, at the physician's discretion.
Croatian: Lenalidomid se može nastaviti primjenjivati u bolesnika s reakcijom razbuktavanja tumora (engl. tumour flare reaction, TFR) 1. ili 2. stupnja bez prekida ili promjene doze, prema odluci liječnika.
English: The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.
Croatian: Mehanizam djelovanja lenalidomida uključuje antineoplastična, antiangiogena, proeritropoetska i imunomodulatorska svojstva.
English: • Increase in pain, tumour size, redness around the tumour
Croatian: • povećanje bola, veličine tumora, crvenila oko tumora
English: If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and 1 week after the end of treatment, even if you have had a vasectomy.
Croatian: Ako je Vaša partnerica trudna ili može zatrudnjeti, a ne upotrebljava djelotvorne metode kontracepcije, morate koristiti prezervative tijekom liječenja i još 1 tjedan nakon završetka liječenja, čak i ako ste bili podvrgnuti vazektomiji.
English: This is because lenalidomide can affect the way some other medicines work.
Croatian: To je potrebno zbog toga što lenalidomid može utjecati na djelovanje drugih lijekova.
English: In the presence of lenalidomide, cereblon binds substrate proteins Aiolos and Ikaros which are lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in cytotoxic and immunomodulatory effects.
Croatian: U prisutnosti lenalidomida, cereblon veže proteine supstrate Aiolos i Ikaros koji su limfocitni transkripcijski faktori, što vodi do njihove ubikvitinacije i naknadne degradacije, a rezultat su citotoksični i imunomodulatorni učinci.
English: What Lenalidomide Accord is and what it is used for 2.
Croatian: Što je Lenalidomid Accord i za što se koristi 2.
English: The following dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease.
Croatian: Sljedeće prilagodbe doza preporučuju se na početku liječenja i tijekom liječenja za bolesnike s umjereno ili teško oštećenom funkcijom bubrega ili terminalnim stadijem bubrežne bolesti.
English: In this study, two methods were used to classify renal function: the urinary creatinine clearance measured over 24 hours and the creatinine clearance estimated by CockcroftGault formula.
Croatian: U tom ispitivanju, funkcija bubrega klasificirana je na dva načina: prema klirensu kreatinina u mokraći mjerenom tijekom 24 sata, i klirensu kreatinina procijenjenom Cockcroft-Gaultovom formulom.
English: Infection with or without neutropenia
Croatian: Infekcija uz prisutnu neutropeniju ili bez nje
English: Caution should be exercised when lenalidomide is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Croatian: Potreban je oprez kada se lenalidomid primjenjuje u bolesnika koji su prethodno bili zaraženi HBV-om, uključujući bolesnike koji su anti-HBc pozitivni ali HBsAg negativni.
English: • press only one end of the capsule out to push it through the foil
Croatian: • da biste je istisnuli kroz foliju pritisnite je samo na jednom kraju
English: • some medicines used for heart problems - such as digoxin
Croatian: • neke lijekove za liječenje srca - poput digoksina
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Croatian: U literaturi je zabilježena moguća križna reakcija između lenalidomida i talidomida.
English: These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Croatian: Te bolesnike treba tijekom cijele terapije pomno pratiti zbog znakova i simptoma aktivne infekcije HBV-om.
English: • She should be capable of complying with effective contraceptive measures
Croatian: • Žena mora biti u stanju pridržavati se mjera djelotvorne kontracepcije.
English: Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with medicinal products that inhibit cytochrome P450 enzymes is not likely to result in metabolic medicinal product interactions in humans.
Croatian: Rezultati in vitro ispitivanja ljudskog metabolizma pokazuju da se lenalidomid ne metabolizira enzimima citokroma P450, što upućuje na to da nije vjerojatno da će primjena lenalidomida s lijekovima koji inhibiraju enzime citokroma P450 rezultirati metaboličkim interakcijama lijekova u ljudi.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovoga lijeka.
English: Population pharmacokinetic analyses indicate that body weight (33- 135 kg), gender, race and type of haematological malignancy do not have a clinically relevant effect on lenalidomide clearance in adult patients.
Croatian: Analize populacijske farmakokinetike ukazuju da tjelesna težina (33 - 135 kg), spol, rasa i vrsta hematološke zloćudne bolesti nemaju klinički značajan učinak na klirens lenalidomida u odraslih bolesnika.
English: On dialysis days, the dose should be administered following dialysis.
Croatian: Na dane dijalize dozu treba primijeniti nakon dijalize.
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Croatian: Taj sustav uključuje kartice za bolesnika i/ili ekvivalentni dokument za kontrolu propisivanja i/ili izdavanja lijeka te prikupljanje detaljnih podataka povezanih s indikacijom, kako bi se na nacionalnom teritoriju pažljivo nadzirala upotreba lijeka izvan odobrenih indikacija.
English: The renal clearance of lenalidomide exceeds the glomerular filtration rate and therefore is at least actively secreted to some extent.
Croatian: Bubrežni klirens lenalidomida premašuje stopu glomerularne filtracije te se stoga barem do neke mjere izlučuje u aktivnom obliku.
English: ^see section 4.8 description of selected adverse reactions
Croatian: Vidjeti dio 4.8 Opis odabranih nuspojava
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported (see section 4.4 Thyroid disorders).
Croatian: Prijavljeni su slučajevi hipotireoidizma i slučajevi hipertireoidizma (vidjeti dio 4.4 Poremećaji funkcije štitne žlijezde).
English: Other sources of information
Croatian: Ostali izvori informacija:
English: Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Croatian: Promjene u mekom tkivu i kosturu fetusa također su primijećene pri dozama od 10 i 20 mg/kg/dan.
English: • Cloudy vision (cataract)
Croatian: • zamućenje vida (katarakta)
English: • Grade 4 neutropenia (see section 4.4).
Croatian: • neutropenija 4. stupnja (vidjeti dio 4.4).
English: Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
Croatian: Bolesnici mogu nastaviti terapiju lenalidomidom i deksametazonom do napredovanja bolesti ili nepodnošenja liječenja.
English: The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance > 50 mL/min to more than 9 hours in subjects with reduced renal function < 50 mL/min.
Croatian: Poluvijek lenalidomida povećao se od približno 3,5 sata u ispitanika s klirensom kreatinina > 50 mL/min na više od 9 sati u ispitanika sa smanjenom funkcijom bubrega < 50 mL/min.
English: After initiation of lenalidomide therapy, subsequent lenalidomide dose modification in renally impaired patients should be based on individual patient treatment tolerance, as described above.
Croatian: Nakon početka terapije lenalidomidom, naknadne izmjene doze lenalidomida u bolesnika s oštećenom funkcijom bubrega treba temeljiti na podnošljivosti liječenja svakog pojedinog bolesnika, kako je opisano u prethodnom tekstu.
English: Consequently, patients with known risk factors for thromboembolism - including prior thrombosisshould be closely monitored.
Croatian: Kao posljedica toga bolesnike s poznatim čimbenicima rizika za tromboemboliju - uključujući prethodnu trombozu - treba pomno nadzirati.
English: However, in the main multiple myeloma registration trials where the efficacy and safety were established for lenalidomide, the medicinal product was administered without regard to food intake.
Croatian: No, u glavnim ispitivanjima multiplog mijeloma u svrhu registracije lijeka u kojima su utvrđene djelotvornost i sigurnost za lenalidomid, lijek je primjenjivan bez obzira na unos hrane.
English: Serious side effects which may affect more than 1 in 10 people (very common) Lenalidomide may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising.
Croatian: Ozbiljne nuspojave koje se mogu javiti u više od 1 na 10 osoba (vrlo često) Lenalidomid može smanjiti broj bijelih krvnih stanica koje sprječavaju infekcije te također i broj stanica koje pomažu zgrušavanju krvi (trombociti), što može dovesti do poremećaja zgrušavanja poput krvarenja iz nosa i nastanka modrica.
English: • Need to provide patients with appropriate patient educational brochure and patient card
Croatian: • potreba da bolesnici dobiju odgovarajuće edukacijske knjižice i kartice za bolesnike.
English: The median age was 71 in the MPR+R and MPR+p arms and 72 in the MPp+p arm.
Croatian: Medijan dobi bio je 71 godina u skupinama MPR+R i MPR+p i 72 godine u skupini MPp+p.
English: • Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience
Croatian: • opis i zbrinjavanje rizika od tromboembolije uključujući stope incidencije iz kliničkih ispitivanja i iskustva nakon stavljanja lijeka u promet
English: Reactivation of hepatitis B has been reported rarely in patients receiving lenalidomide who have previously been infected with the hepatitis B virus (HBV).
Croatian: Reaktivacija hepatitisa B rijetko je zabilježena u bolesnika koji su primali lenalidomid, a prethodno su bili zaraženi virusom hepatitisa B (HBV).
English: There are no data available for patients with moderate to severe hepatic impairment.
Croatian: Nema dostupnih podataka za bolesnika s umjerenim do teškim oštećenjem funkcije jetre.
English: • Bleeding within the skull
Croatian: • krvarenje unutar lubanje
English: Prophylactic antithrombotic medicinal products should be recommended, especially in patients with additional thrombotic risk factors.
Croatian: Treba preporučiti profilaktičke antitrombotike, posebice u bolesnika s dodatnim čimbenicima rizika za trombozu.
English: In total 614 patients were randomised: 307 patients to lenalidomide and 307 patients to placebo.
Croatian: Ukupno je randomizirano 614 bolesnika: 307 bolesnika u skupinu lenalidomida i 307 bolesnika u skupinu placeba.
English: For other grade 3 or 4 toxicities judged to be related to lenalidomide, treatment should be stopped and only restarted at next lower dose level when toxicity has resolved to ≤ grade 2 depending on the physician's discretion.
Croatian: U slučaju drugih toksičnosti 3. ili 4. stupnja, za koje se procjenjuje da su povezane s lenalidomidom, liječenje treba privremeno prekinuti, te se smije ponovno započeti samo pri sljedećoj nižoj razini doze kad se toksičnost smanji na ≤ 2. stupnja, ovisno o odluci liječnika.
English: Co-administration with a high-fat and high-calorie meal in healthy volunteers reduces the extent of absorption, resulting in an approximately 20% decrease in area under the concentration versus time curve (AUC) and 50% decrease in Cmax in plasma.
Croatian: Istodobna primjena punomasnih i visokokaloričnih obroka u zdravih dobrovoljaca smanjuje opseg apsorpcije što rezultira približno 20%-tnim smanjenjem površine ispod krivulje koncentracija/vrijeme (AUC) i 50%-tnim smanjenjem Cmax u plazmi.
English: Repeated oral administration of 75, 150 and 300 mg/kg/day to rats for up to 26 weeks produced a reversible treatment-related increase in kidney pelvis mineralisation in all 3 doses, most notably in females.
Croatian: Ponovljena peroralna primjena doza od 75, 150 i 300 mg/kg/dan u štakora u trajanju do 26 tjedana dovela je do reverzibilnog porasta mineralizacije pijelona bubrega povezanog s liječenjem u sve tri doze, a ta je pojava bila najviše zapažena u ženki.
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms; notably, approximately 50% of the patients enrolled in each arm had the following characteristics; ISS Stage III, and creatinine clearance < 60 mL/min.
Croatian: Demografski podaci i uz bolest povezane karakteristike bolesnika prije ispitivanja bile su dobro ujednačene u sve 3 skupine; posebice, približno 50 % bolesnika uključenih u svaku skupinu imalo je sljedeće karakteristike: ISS stadij III i klirens kreatinina < 60 mL/min.
English: The patient card shall contain the following elements:
Croatian: Kartica za bolesnika će sadržavati sljedeće elemente:
English: As a precaution and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide must meet the following conditions:
Croatian: Kao mjera opreza te imajući u vidu posebne populacije s produljenim vremenom eliminacije poput bolesnika s oštećenjem funkcije bubrega, svi muški bolesnici koji uzimaju lenalidomid moraju ispuniti sljedeće uvjete:
English: • Need to provide comprehensive advice and counselling to patients
Croatian: • potreba za obuhvatnim objašnjenjima i savjetovanjem bolesnika
English: Population pharmacokinetic analyses included patients with ages ranging from 39 to 85 years old and indicate that age does not influence lenalidomide clearance (exposure in plasma).
Croatian: Analize populacijske farmakokinetike uključile su bolesnike s rasponom dobi od 39 do 85 godina i ukazuju da dob ne utječe na klirens lenalidomida (izloženost u plazmi).
English: Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
Croatian: Intrauterini ulošci koji oslobađaju bakar se općenito ne preporučuju zbog mogućih rizika od infekcije u vrijeme umetanja te gubitka krvi menstrualnim krvarenjem, što može ugroziti bolesnicu s neutropenijom ili trombocitopenijom.
English: The no observed adverse effect level (NOAEL) was considered to be less than 75 mg/kg/day, and is approximately 25-fold greater than the human daily exposure based on AUC exposure.
Croatian: Smatra se da je razina neuočljivog štetnog učinka (engl. no observable adverse effect level (NOAEL)) manja od 75 mg/kg/dan te je približno 25 puta veća od dnevne doze izloženosti u ljudi na temelju AUC izloženosti.
English: It is not known whether the effect will be different in the clinical use (higher lenalidomide doses and concomitant treatment with dexamethasone).
Croatian: Nije poznato hoće li učinak biti različit u kliničkoj primjeni (veće doze lenalidomida i istodobno liječenje s deksametazonom).
English: • Brief background on lenalidomide and its licensed indication
Croatian: • kratku povijest lenalidomida i njegove odobrene indikacije
English: • Sore inflamed mouth, dry mouth, difficulty swallowing
Croatian: • bolna upaljena usta, suha usta, otežano gutanje
English: The Educational brochures for patients should be of 3 types:
Croatian: Trebaju postojati 3 vrste edukacijskih knjižica za bolesnike:
English: In total 459 patients were enrolled into the study, with 152 patients randomised to MPR+R, 153 patients randomised to MPR+p and 154 patients randomised to MPp+p.
Croatian: U ispitivanje je bilo uključeno ukupno 459 bolesnika, s tim da je 152 bolesnika bilo randomizirano na MPR+R, 153 bolesnika bilo je randomizirano na MPR+p, a 154 bolesnika bilo je randomizirano na MPp+p.
English: The Educational Health Care Professional's Kit shall contain the following elements:
Croatian: Edukacijski materijal za zdravstvene radnike sadržavat će sljedeće elemente:
English: The contribution of renal excretion to total clearance in subjects with normal renal function was 90%, with 4% of lenalidomide eliminated in faeces.
Croatian: Doprinos izlučivanja bubrezima ukupnom klirensu u ispitanika s normalnom funkcijom bubrega bio je 90 %, a 4 % lenalidomida eliminiralo se stolicom.
English: • Dose adjustments, during treatment and restart of treatment, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
Croatian: • Prilagodbe doza tijekom liječenja ili ponovnog početka liječenja preporučuju se za zbrinjavanje trombocitopenije i neutropenije 3. ili 4. stupnja ili druge toksičnosti 3. ili 4. stupnja za koje se procjenjuje da su povezane s lenalidomidom.
English: Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when lenalidomide is combined with medicinal products known to be associated with liver dysfunction.
Croatian: Preporučuje se nadzor jetrene funkcije, posebice u slučaju prošle ili istodobne virusne infekcije jetre ili kada se lenalidomid kombinira s lijekovima za koje je utvrđeno da su povezani s disfunkcijom jetre.
English: The increased risk of secondary primary malignancies associated with lenalidomide is relevant also in the context of NDMM after stem cell transplantation.
Croatian: Povećan rizik drugih primarnih malignih bolesti povezanih s lenalidomidom relevantan je također u kontekstu NDMM-a nakon transplantacije matičnih stanica.
English: Newly diagnosed multiple myeloma (NDMM)
Croatian: Novodijagnosticirani multipli mijelom (NDMM)
English: • Renal failure (including acute) (6.3%)
Croatian: • zatajenje bubrega (uključujući akutno zatajenje) (6,3 %).
English: Pack size of 7x1 or 21x1 capsules.
Croatian: Veličina pakiranja od 7x1 ili 21x1 kapsula.
English: • Infections of all types
Croatian: • sve vrste infekcija
English: • some medicines used to treat raised cholesterol - such as statins
Croatian: • neke lijekove za liječenje povišenog kolesterola, poput statina
English: For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met:
Croatian: Lenalidomid je kontraindiciran za žene u reproduktivnoj dobi, osim ako se ispune svi sljedeći zahtjevi:
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Croatian: Pojedinosti Programa prevencije trudnoće, uključujući uspostavljanje nacionalnih mjera za procjenu učinkovitosti i sukladnosti s Programom prevencije trudnoće, treba dogovoriti s nadležnim državnim tijelima u svakoj državi članici i isti ustrojiti prije stavljanja lijeka na tržište.
English: Patients should be carefully assessed for their ability to tolerate lenalidomide in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min (see sections 4.2 and 4.8).
Croatian: Bolesnicima se mora pažljivo procijeniti sposobnost podnošenja lenalidomida davanog u kombinaciji, vodeći računa o dobi i o vrijednostima ISS stupanj III, ECOG PS ≤ 2 ili CLcr < 60 mL/min (vidjeti dijelove 4.2 i 4.8).
English: Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
Croatian: Stoga se preporučuje nadzor koncentracije digoksina tijekom liječenja lenalidomidom.
English: • Pregnancy test regime o Advice on suitable tests o Before commencing treatment o During treatment based on method of contraception o After finishing treatment
Croatian: • režim testiranja na trudnoću o savjeti o prikladnim testovima o prije početka liječenja o tijekom liječenja na temelju metode kontracepcije o nakon završetka liječenja
English: You must not breast-feed when taking lenalidomide , as it is not known if lenalidomide passes into human milk.
Croatian: Ne smijete dojiti dok uzimate lenalidomid jer nije poznato izlučuje li se lenalidomid u majčino mlijeko.
English: Common Depression, Insomnia
Croatian: Često depresija, nesanica
English: • Abnormal liver test results
Croatian: • abnormalni rezultati jetrenih testova
English: Prescriptions for women of childbearing potential can be for a maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 12 weeks.
Croatian: Ženama u reproduktivnoj dobi na jedan recept se može propisati terapija za najviše 4 tjedna, a svim drugim bolesnicima za najviše 12 tjedana.
English: • When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 ‘What lenalidomide is used for').
Croatian: • Kada se lenalidomid koristi za liječenje multiplog mijeloma u bolesnika koji ne mogu imati transplantaciju koštane srži ili su imali druge terapije, uzima se u kombinaciji s drugim lijekovima (pogledajte dio 1 „Za što se koristi lenalidomid”).
English: The European Medicines Agency has waived the obligation to submit the results of studies with lenalidomide in all subsets of the paediatric population in multiple myeloma, (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela je obvezu podnošenja rezultata ispitivanja lenalidomida u svim podskupinama pedijatrijske populacije u liječenju multiplog mijeloma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Carcinogenicity studies with lenalidomide have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti s lenalidomidom.
English: Rare cases of rhabdomyolysis have been observed, some of them when lenalidomide is administered with a statin.
Croatian: Opaženi su rijetki slučajevi rabdomiolize, neki od njih pojavili su se kada je lenalidomid primjenjivan sa statinom.
English: • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
Croatian: • Shvaća potrebu i prihvaća podvrgnuti se testiranju na trudnoću svaka 4 tjedna osim u slučaju potvrđenog podvezivanja jajovoda.