FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with newly diagnosed multiple myeloma aged 75 years and older who received lenalidomide, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation.
Croatian: U bolesnika s novodijagnosticiranim multiplim mijelomom u dobi od 75 godina i starijih koji su primali lenalidomid, zabilježena je veća incidencija ozbiljnih nuspojava i nuspojava koje su dovele do obustave liječenja.
English: The capsules should not be opened, broken or chewed.
Croatian: Kapsule se ne smiju otvarati, lomiti ili žvakati.
English: • Breathlessness especially when lying down (which may be a symptom of heart failure)
Croatian: • nedostatak zraka, posebice u ležećem položaju (što može biti simptom zatajenja srca).
English: Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants.
Croatian: Farmakoterapijska skupina: imunosupresivi, drugi imunosupresivi.
English: The MAH should agree the final text of the healthcare profesional's information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Croatian: Nositelj odobrenja treba dogovoriti s nadležnim državnim tijelom pojedine države članice končani tekst paketa s informacijama za zdravstvene radnike te osigurati da materijali sadrže ključne elemente opisane u nastavku.
English: The patient should continue anticoagulation therapy during the course of lenalidomide treatment.
Croatian: Bolesnik treba nastaviti antikoagulacijsku terapiju tijekom liječenja lenalidomidom.
English: Lenalidomide Accord must be given to you by healthcare professionals with experience in treating multiple myeloma,.
Croatian: Lenalidomid Accord Vam moraju dati zdravstveni radnici s iskustvom u liječenju multiplog mijeloma.
English: Very Common Depression, Insomnia Uncommon Loss of libido
Croatian: Vrlo često depresija, nesanica Manje često gubitak libida
English: • Pregnancy test dates and results
Croatian: • datume i rezultate testova na trudnoću.
English: Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b
Croatian: Ukupni odgovor: CR, VGPR ili PR Trajanje odgovora (mjeseci) Medijana (95 % CI)b
English: Once parameters have returned to baseline, treatment at a lower dose may be considered.
Croatian: Nakon povratka parametara na početne vrijednosti može se razmišljati o liječenju nižom dozom.
English: If powder from lenalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako prašak lenalidomida dođe u kontakt s kožom, kožu treba odmah temeljito oprati vodom i sapunom.
English: Blood donation You should not donate blood during treatment and for 1 week after the end of treatment.
Croatian: Ne smijete darivati krv tijekom liječenja i još 1 tjedan nakon završetka liječenja.
English: Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Croatian: Obavijestite liječnika ako imate jaku bol u trbuhu, vrućicu, mučninu, povraćanje, krv u stolici ili promjene u ritmu pražnjenja crijeva.
English: Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, meningitis herpes zoster or ophthalmic herpes zoster requiring a temporary hold or permanent discontinuation of the treatment with lenalidomide and adequate antiviral treatment.
Croatian: Neki slučajevi reaktivacije herpes zostera rezultirali su diseminiranim herpes zosterom, herpes zoster meningitisom ili oftalmičkim herpes zosterom, što je zahtijevalo privremeni ili trajni prekid liječenja lenalidomidom i odgovarajuće liječenje protiv virusa.
English: • Hives, itching, increased sweating, dehydration
Croatian: • koprivnjača, svrbež, pojačano znojenje, dehidracija
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant
Croatian: Novodijagnosticirani multipli mijelom: bolesnici koji nisu prikladni za transplantaciju
English: • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
Croatian: • Razumije potrebu za djelotvornom kontracepcijom, bez prekida, 4 tjedna prije početka liječenja te tijekom cjelokupnog trajanja liječenja kao i 4 tjedna nakon završetka liječenja.
English: Pancreatitis, Gastrointestinal perforation (including diverticular, intestinal and large intestine perforations)^
Croatian: Nepoznato pankreatitis, gastrointestinalna perforacija (uključujući perforacije divertikula, tankog i debelog crijeva)^
English: In total 1623 patients were enrolled into the study, with 535 patients randomised to Rd, 541 patients randomised to Rd18 and 547 patients randomised to MPT.
Croatian: U ispitivanje je bilo uključeno ukupno 1623 bolesnika, s tim da je 535 bolesnika randomizirano na Rd, 541 bolesnik bio je randomiziran na Rd18, a 547 bolesnika bilo je randomizirano na MPT.
English: 10 mg once daily1
Croatian: 10 mg jednom dnevno1
English: As a precaution, and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception.
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 trebaju upotrebljavati prezervative tijekom trajanja liječenja, za vrijeme prekida liječenja i tjedan dana nakon završetka liječenja ako im je partnerica trudna ili u reproduktivnoj dobi te ne primjenjuje kontracepciju.
English: Hydroxylenalidomide and N-acetyl-lenalidomide represent 4.59% and 1.83% of the excreted dose, respectively.
Croatian: Hidroksi-lenalidomid i N-acetil-lenalidomid predstavljaju 4,59 %, odnosno 1,83 % izlučene doze.
English: • you will have pregnancy tests under the supervision of your doctor (before every treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation) AND
Croatian: • podvrgnut ćete se testiranju na trudnoću pod nadzorom liječnika (prije svakog liječenja, svaka 4 tjedna tijekom liječenja i 4 tjedna nakon završetka liječenja), osim kad je potvrđeno da su jajovodi prekinuti i zatvoreni kako bi se spriječilo da jajašce dospije u maternicu (sterilizacija podvezivanjem jajovoda) OSIM TOGA
English: The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Croatian: Test treba potvrditi da bolesnica nije trudna u vrijeme početka liječenja lenalidomidom.
English: A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Croatian: Test na trudnoću pod liječničkim nadzorom treba provesti tijekom konzultacija kada se propisuje lenalidomid ili 3 dana prije posjeta liječniku propisivaču kada bolesnica primjenjuje djelotvornu kontracepciju najmanje 4 tjedna.
English: Description of the PPP and categorisation of patients based on sex and childbearing potential
Croatian: Opis Programa prevencije trudnoće i kategorizacija bolesnika na temelju spola i reproduktivne dobi
English: • you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment.
Croatian: • morate koristiti djelotvornu metodu kontracepcije 4 tjedna prije početka liječenja, tijekom liječenja i sve do 4 tjedna nakon završetka liječenja.
English: The primary endpoint was PFS defined from randomisation to the date of progression or death, whichever occurred first; the study was not powered for the overall survival endpoint.
Croatian: Primarni je ishod bio PFS, definiran kao vrijeme od randomizacije do datuma progresije bolesti ili smrti, štogod se dogodilo prije; ispitivanje nije omogućilo ishod ukupnog preživljenja.
English: 0.25 mg/kg ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
Croatian: 0,25 mg/kg ª Ako je neutropenija jedina toksičnost kod bilo koje razine doza, dodajte čimbenik stimulacije rasta kolonije granulocita (G-CSF) i održavajte razinu doze lenalidomida.
English: Capsules should not be opened or crushed.
Croatian: Kapsule se ne smiju otvarati ni drobiti.
English: Lenalidomide Accord hard capsules are available in OPA-AL-PVC/Aluminium foil perforated unit dose blister.
Croatian: Lenalidomid Accord tvrde kapsule su dostupne u perforiranom blisteru od OPA AL/PVC/aluminijske folije s jediničnim dozama.
English: • if you have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), see also section 4 “Possible side effects”).
Croatian: • ako ste u prošlosti imali kombinaciju bilo kojih od sljedećih simptoma: osip na licu ili prošireni osip, crvenilo kože, visoku temperaturu, simptome nalik gripi, povećane limfne čvorove (znakove teške kožne reakcije koja se naziva reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS), vidjeti također dio 4 „Moguće nuspojave“).
English: Mild suppression of white blood cell count was observed at 1 mg/kg/day corresponding to approximately the same human dose based on AUC comparisons.
Croatian: Blaga supresija broja leukocita opažena je pri dozama od 1 mg/kg/dan koje odgovaraju približno istoj dozi za ljude temeljem usporedbi vrijednosti AUC-a.
English: • Infection of the lung and the upper respiratory tract, breathlessness
Croatian: • infekcija pluća i gornjih dišnih puteva, nedostatak zraka
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans
Croatian: • da je lenalidomid teratogen za životinje te se očekuje da će biti teratogen i za ljude
English: Blood and Lymphatic System Disorders
Croatian: Poremećaji krvi i limfnog sustava
English: 5 mg (days 1-21 every 28 days)
Croatian: 5 mg (od 1. do 21. dana svakih 28 dana)
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors.
Croatian: Infarkt miokarda prijavljen je u bolesnika koji su primali lenalidomid, posebice u onih s poznatim čimbenicima rizika.
English: • XY genotype, Turner syndrome, uterine agenesis.
Croatian: • XY genotip, Turnerov sindrom, ageneza maternice.
English: A majority of lenalidomide is eliminated through urinary excretion.
Croatian: Većina lenalidomida eliminira se putem mokraće.
English: b: Two-tailed continuity-corrected chi-square test.
Croatian: b: Dvostrani hi-kvadrat test s korigiranim kontinuitetom.
English: • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
Croatian: • Shvaća potrebu započinjanja liječenja odmah po izdavanju lenalidomida nakon negativnog testa na trudnoću.
English: • a chemotherapy medicine called ‘melphalan' and
Croatian: • s kemoterapijskim lijekom pod nazivom ‘melfalan' i
English: • That Lenalidomide Accord may cause venous and arterial thromboembolism
Croatian: • da Lenalidomid Accord može izazvati vensku i arterijsku tromboemboliju
English: Before and during the treatment with lenalidomide you will have regular blood tests as it may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).
Croatian: Prije i tijekom liječenja lenalidomidom podvrgavat ćete se redovitim pretragama krvi jer on može prouzročiti pad broja krvnih stanica koje pomažu u borbi protiv infekcije (leukociti) i pomažu u zgrušavanju krvi (trombociti).
English: The following can be considered to be examples of suitable methods of contraception:
Croatian: Sljedeće se metode kontracepcije smatraju djelotvornima:
English: Acute myeloid leukaemia Multiple myeloma
Croatian: Akutna mijeloična leukemija Multipli mijelom
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the lenalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Croatian: Nakon što je bolesnik stabiliziran na antikoagulansima te su sve komplikacije tromboembolijskog događaja zbrinute, može se opet početi s liječenjem lenalidomidom u početnoj dozi ovisno o procjeni odnosa koristi i rizika.
English: Gastrointestinal Disorders
Croatian: Gastrointestinalni poremećaji
English: Patients aged < 65 years at diagnosis who had undergone ASCT and had achieved at least a stable disease response at the time of hematologic recovery were eligible.
Croatian: Bolesnici prikladni za ispitivanje bili su oni u dobi <65 godina u vrijeme postavljanja dijagnoze, koji su bili podvrgnuti transplantaciji autolognih matičnih stanica i postigli barem stabilan odgovor u vrijeme hematološkog oporavka.
English: Lenalidomide works by affecting the body's immune system and directly attacking the cancer.
Croatian: Lenalidomid djeluje na imunološki sustav te izravno napada stanice raka.
English: • Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).
Croatian: • opaženi su rijetki slučajevi oštećenja mišića (bol u mišićima, mišićna slabost ili oticanje) što može dovesti do tegoba s bubrezima (rabdomioliza), a neki od njih pojavili su se kada se lenalidomid primjenjivao sa statinom (vrsta lijekova za snižavanje kolesterola)
English: 58.9 (56.0, NE) 56.7 (50.1, NE) 48.5 (44.2, 52.0)
Croatian: 58,9 (56,0, NP) 56,7 (50,1, NP) 48,5 (44,2; 52,0)
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
Croatian: U skladu s lokalnom praksom, testovima na trudnoću osjetljivosti od najmanje 25 mIU/mL, moraju se pod liječničkim nadzorom podvrgnuti žene u reproduktivnoj dobi kako je to opisano u nastavku.
English: Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
Croatian: S obzirom na to da lenalidomid iskazuje antineoplastičnu aktivnost, mogu se pojaviti komplikacije sindroma lize tumora.
English: Not Known Acute hepatic failure^, Hepatitis toxic^
Croatian: Nepoznato akutno zatajenje jetre^, toksični hepatitis^
English: All patient brochures should contain the following elements:
Croatian: Sve knjižice za bolesnike trebaju sadržavati sljedeće elemente:
English: Concomitant administration of erythropoietic agents or previous history of thromboembolic events may also increase thrombotic risk in these patients.
Croatian: Istodobna primjena eritropoetskih lijekova ili prethodna anamneza tromboembolijskih događaja može također povećati trombotski rizik u tih bolesnika.
English: Uncommon Hypercoagulation, Coagulopathy
Croatian: Manje često hiperkoagulacija, koagulopatija
English: Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
Croatian: Od 353 bolesnika u ispitivanjima MM-009 i MM-010 koji su primali lenalidomid/deksametazon, 45,6 % bilo je u dobi od 65 godina ili više.
English: Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Croatian: Istodobna primjena s lenalidomidom u dozi od 10 mg jedanput na dan povećala je plazmatsku izloženost digoksinu (0,5 mg, pojedinačna doza) za 14 % uz interval pouzdanosti od 90 % [0,52 %28,2 %].
English: Metabolism and Nutrition Disorders
Croatian: Poremećaji metabolizma i prehrane
English: Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Croatian: Treba uzeti u obzir profilaktičku primjenu antibiotika, posebice u bolesnica s neutropenijom.
English: On day 1 of next cycle, continue G-CSF as needed and maintain dose of lenalidomide if neutropenia was the only DLT.
Croatian: 1. dana sljedećeg ciklusa, nastavite terapiju G-CSF-om prema potrebi i održavajte dozu lenalidomida ako je neutropenija bila jedina toksičnost koja ograničava dozu.
English: Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4
Croatian: Lenalidomid se izravno veže na cereblon, komponentu kulin-RING E3 kompleksa ubikvitin ligaze koja uključuje protein 1 (DDB1) koji se veže na oštećeno mjesto deoksiribonukleinske kiseline (DNK), kulin 4 (CUL4) i regulator kulina 1 (Roc1).
English: • Bleeding or bruising in the absence of injury
Croatian: • Krvarenje ili nastanak modrica koje nisu prouzročene ozljedama
English: What Lenalidomide Accord is used for Lenalidomide Accord is used in adults for multiple myeloma.
Croatian: Za što se koristi Lenalidomid Accord Lenalidomid Accord se primjenjuje u odraslih za liječenje multiplog mijeloma.
English: Fatigue, dizziness, somnolence, vertigo and blurred vision have been reported with the use of lenalidomide.
Croatian: Umor, omaglica, somnolencija, vrtoglavica i zamagljen vid prijavljeni su kod uporabe lenalidomida.
English: Other medicines and Lenalidomide Accord
Croatian: Drugi lijekovi i Lenalidomid Accord
English: Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression.
Croatian: Terapiju održavanja lenalidomidom treba započeti nakon odgovarajućeg hematološkog oporavka poslije transplantacije autolognih matičnih stanica bez dokaza progresije.
English: For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥1,5 x 109/L with a platelet count ≥ 100 x 109/L at the beginning of a new cycle).
Croatian: U slučaju hematološke toksičnosti, doza lenalidomida može se ponovno uvesti pri sljedećoj višoj razini doze (sve do početne doze) kada se poboljša funkcija koštane srži (bez hematološke toksičnosti u najmanje 2 uzastopna ciklusa: ABN ≥ 1,5 x 109/L uz broj trombocita ≥ 100 x 109/L na početku novog ciklusa).
English: Patients should not donate blood during therapy or for 1 week following discontinuation of lenalidomide.
Croatian: Bolesnici ne smiju darivati krv tijekom liječenja ili tijekom tjedan dana nakon prekida liječenja lenalidomidom.
English: What Lenalidomide Accord is and what it is used for
Croatian: Što je Lenalidomid Accord i za što se koristi
English: Common Deep vein thrombosis^,◊,d
Croatian: Često duboka venska tromboza^,◊,d
English: Lenalidomide may also cause blood clots in the veins (thrombosis).
Croatian: Lenalidomid može također prouzročiti nastanak ugrušaka u venama (tromboza).
English: Lenalidomide interruption or discontinuation should be considered for grade 2 or 3 skin rash.
Croatian: Prekid ili obustavu liječenja lenalidomidom treba razmotriti u slučaju kožnog osipa 2. ili 3. stupnja.
English: • if you have kidney problems - your doctor may adjust your dose of lenalidomide if you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or raised cholesterol levels
Croatian: • ako ste imali srčani udar, ako ste ikad imali krvni ugrušak ili ako pušite, imate povišeni krvni tlak ili povišene razine kolesterola
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Croatian: U idealnom slučaju testiranje na trudnoću treba obaviti isti dan kad i propisivanje i izdavanje lijeka.
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy
Croatian: • prethodna obostrana salpingoovarijektomija ili histerektomija
English: In two phase III placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
Croatian: U dva placebom kontrolirana ispitivanja faze III, 353 bolesnika s multiplim mijelomom bilo je izloženo kombinaciji lenalidomid/deksametazon, a 351 bolesnik kombinaciji placebo/deksametazon.
English: Elderly No dedicated clinical studies have been conducted to evaluate pharmacokinetics of lenalidomide in the elderly.
Croatian: Nisu provedena klinička ispitivanja koja bi procijenila farmakokinetiku lenalidomida posebice u starijih osoba.
English: An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day.
Croatian: Ispitivanje embriofetalnog razvoja provedeno je na majmunima koji su primili lenalidomid u dozama od 0,5 do 4 mg/kg/dan.
English: No dose adjustments are required for patients with mild renal impairment and multiple myeloma.
Croatian: Nisu potrebne prilagodbe doza za bolesnike s blagim oštećenjem funkcije bubrega i multiplim mijelomom.
English: These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Croatian: Te testove na trudnoću treba provoditi na dan posjeta liječniku prilikom kojeg se propisuje lijek ili 3 dana prije posjeta propisivaču.
English: Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
Croatian: Slučajevi su većinom zabilježeni kod bolesnika koji su istovremeno uzimali deksametazon ili su ranije liječeni drugom imunosupresivnom kemoterapijom.
English: Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Croatian: Žene u reproduktivnoj dobi moraju primjenjivati jednu djelotvornu metodu kontracepcije 4 tjedna prije početka liječenja, tijekom liječenja i tijekom 4 tjedna nakon završetka liječenja lenalidomidom te čak u slučaju prekida liječenja, osim ako se bolesnica obveže na apsolutnu i neprekinutu apstinenciju koja će se potvrđivati mjesečno.
English: Very Common Renal failure (including acute)◊
Croatian: Vrlo često zatajenje bubrega (uključujući akutno zatajenje)◊
English: Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: System Organ Class / Preferred Term
Croatian: Klasifikacija organskih sustava / preporučeni pojam
English: The lenalidomide arm was discontinued, as a proactive safety measure, after observing an imbalance of SPMs (see section 4.4).
Croatian: Skupina lenalidomida prekinula je ispitivanje, kao proaktivna mjera sigurnosti, nakon opažanja neuravnoteženosti s obzirom na druge primarne maligne bolesti (vidjet dio 4.4).
English: Some of these cases have progressed to acute hepatic failure resulting in discontinuation of lenalidomide and adequate antiviral treatment.
Croatian: U nekim od tih slučajeva bolest je napredovala do akutnog zatajenja jetre, što je za posljedicu imalo prekid primjene lenalidomida i odgovarajuće liječenje protiv virusa.
English: All patients received prophylactic anticoagulation (low molecular weight heparin, warfarin, heparin, low-dose acetylsalicylic acid during the study.
Croatian: Tijekom ispitivanja, svi su bolesnici primili profilaktičku antikoagulaciju (heparin niske molekularne težine, varfarin, heparin, nisku dozu acetilsalicilatne kiseline).