FrancophonIA/ELRC3.0 huggingface dataset:
English: PD = progressive disease; PR = partial response; R = lenalidomide; SD = stable disease; VGPR = very good partial response.
Croatian: PD = progresivna bolest (engl. progressive disease); PR = djelomični odgovor; R = lenalidomid; SD = stabilna bolest (engl. stable disease); VGPR = vrlo dobar djelomični odgovor.
English: Abnormal liver function tests were commonly reported and were generally asymptomatic and reversible upon dosing interruption.
Croatian: Često su prijavljeni abnormalni rezultati testova funkcije jetre, a općenito su bili asimptomatski i reverzibilni nakon prekida liječenja.
English: In patients, as well as in healthy volunteers, the maximum concentration (Cmax) and area-under-theconcentration time curve (AUC) increase proportionally with increases in dose.
Croatian: U bolesnika, kao i u zdravih dobrovoljaca, maksimalna koncentracija (Cmax) i površina ispod krivulje za koncentraciju u vremenu (AUC) povećavaju se proporcionalno s porastom doze.
English: The adverse reactions described in Table 1 included events reported post-HDM/ASCT as well as events from the maintenance treatment period.
Croatian: Nuspojave opisane u Tablici 1 obuhvaćale su događaje nakon HDM/ACST-a kao i događaje iz razdoblja održavanja.
English: Lenalidomide (N = 231)
Croatian: Lenalidomid (N = 231)
English: • Documentation of childbearing status potential
Croatian: • dokumentaciju o statusu reproduktivnog potencijala
English: In the event of overdose, supportive care is advised.
Croatian: U slučaju predoziranja savjetuje se potporno liječenje.
English: • Local contact details for reporting of any suspected pregnancy
Croatian: • lokalni kontakt podaci za prijavljivanje svake sumnje na trudnoću
English: Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see ‘Contraception' below).
Croatian: Stoga, morate primjenjivati djelotvorne metode kontracepcije ako ste žena u plodnoj dobi (pogledajte ispod odjeljak „Kontracepcija“).
English: Lenalidomide has a potential for acute toxicity; minimum lethal doses after oral administration were > 2000 mg/kg/day in rodents.
Croatian: Lenalidomid ima potencijal za akutnu toksičnost; minimalne letalne doze nakon peroralne primjene bile su > 2000 mg/kg/dan u glodavaca.
English: • if you have had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or difficulty breathing
Croatian: • ako ste imali alergijsku reakciju dok ste uzimali talidomid (još jedan lijek koji se koristi za liječenje multiplog mijeloma), poput osipa, svrbeža, oticanja, omaglice ili otežanog disanja.
English: The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Croatian: Nositelj odobrenja će provoditi Program prevencije trudnoće u svakoj državi članici.
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Croatian: Ako bolesnik iskusi bilo kakve tromboembolijske događaje, liječenje se mora prekinuti te početi sa standardnom antikoagulacijskom terapijom.
English: Due to the teratogenic potential, lenalidomide must be prescribed under a Pregnancy Prevention Programme (see section 4.4) unless there is reliable evidence that the patient does not have childbearing potential.
Croatian: Zbog teratogenog potencijala, lenalidomid se mora propisivati u okviru Programa prevencije trudnoće (vidjeti dio 4.4), osim ako postoji pouzdan dokaz da bolesnica nije u reproduktivnoj dobi.
English: Dose adjustment (days 1 to 21 of repeated 28-day cycles)
Croatian: Prilagodba doze (od 1. do 21. dana u ponavljajućim 28-dnevnim ciklusima)
English: • Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
Croatian: • Razumiju očekivani teratogeni rizik ako stupaju u spolne odnose s trudnicom ili ženom u reproduktivnoj dobi.
English: Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
Croatian: Popis provjere za liječnike koji osigurava da su bolesnici uključeni u odgovarajuće savjetovanje vezano za liječenje, metode kontracepcije i prevenciju trudnoće koje je prikladno za njihov spol i reproduktivni status.
English: Renal function (CLcr)
Croatian: Bubrežna funkcija (CLcr)
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: 7.5 mg once daily2 15 mg every other day
Croatian: 7,5 mg jednom dnevno2 15 mg svaki drugi dan
English: • You must not become pregnant while taking lenalidomide.
Croatian: • Ne smijete zatrudnjeti dok uzimate lenalidomid.
English: • Changes to the colour of your skin, sensitivity to sunlight
Croatian: • promjena boje kože, osjetljivost na sunčevu svjetlost
English: The mechanisms of severe drug-induced hepatotoxicity remain unknown although, in some cases, pre-existing viral liver disease, elevated baseline liver enzymes, and possibly treatment with antibiotics might be risk factors.
Croatian: Mehanizam teške jatrogene hepatotoksičnosti ostaje nepoznat, iako u nekim slučajevima prethodno postojeća virusna bolest jetre, povišene početne razine jetrenih enzima i moguće liječenje antibioticima mogu biti čimbenici rizika.
English: The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Croatian: Procjena u pogledu PML-a treba se zasnivati na neurološkom pregledu, magnetskoj rezonanciji mozga i analizi cerebrospinalne tekućine u pogledu DNK pozitivne na JC virus (JCV) pomoću lančane reakcije polimerazom (PCR) ili biopsiji mozga uz testiranje na JCV.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Croatian: Bolesnike treba uputiti da potraže liječničku pomoć ako razviju simptome poput nedostatka zraka, bolova u prsištu, oticanja ruku ili nogu.
English: In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Croatian: U ovim ispitivanjima kunići su primili 3, 10 i 20 mg/kg/dan peroralno.
English: For women taking lenalidomide Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Croatian: Prije početka liječenja pitajte svog liječnika možete li zatrudnjeti, čak i ako mislite da to nije vjerojatno.
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported.
Croatian: Prijavljeni su slučajevi hipotireoidizma i slučajevi hipertireoidizma.
English: Common Fall, Contusion^
Croatian: Često pad, kontuzija^
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako Vam se u bilo kojem trenutku tijekom ili nakon liječenja: javi zamagljen vid, gubitak vida ili dvoslike, otežan govor, slabost u ruci ili nozi, promjena u načinu hoda ili problemi s ravnotežom, neprolazna utrnulost, smanjen osjet ili gubitak osjeta, gubitak pamćenja ili smetenost.
English: Lenalidomide is produced as a racemic mixture.
Croatian: Lenalidomid se proizvodi kao racemična smjesa.
English: Of the 704 patients evaluated in the MM-009 and MM-010 studies, 44.6% were aged 65 or over.
Croatian: Od 704 bolesnika koji su procijenjeni u ispitivanju MM-009 i MM-010, 44,6 % bilo je u dobi od 65 godina ili više.
English: Very Common Pneumonias◊,a, Neutropenic infection
Croatian: Vrlo često pneumonije◊,a, neutropenijska infekcija
English: If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Croatian: Ako se lenalidomid uzima tijekom trudnoće, očekuje se teratogeni učinak lenalidomida na ljude.
English: • Infection of the sinuses that surround the nose
Croatian: • infekcija sinusa oko nosa
English: Not applicable ª Dose reduction for both medicinal products can be managed independently
Croatian: Nije primjenjivo a Smanjivanje doze za oba lijeka može se provoditi neovisno.
English: There is an increased risk of rhabdomyolysis when statins are administered with lenalidomide, which may be simply additive.
Croatian: Postoji povećan rizik od rabdomiolize kada se statini primjenjuju s lenalidomidom, koji može biti jednostavno aditivan.
English: In addition to the above adverse reactions identified from the pivotal clinical trials, the following table is derived from data gathered from post-marketing data.
Croatian: Osim prethodno navedenih nuspojava primijećenih u ključnim kliničkim ispitivanjima, sljedeća tablica dobivena je iz podataka prikupljenih nakon stavljanja lijeka u promet.
English: The Cmax was similar between healthy subjects and patients with renal impairment.
Croatian: Vrijednost Cmax bila je slična između zdravih ispitanika i bolesnika s oštećenjem funkcije bubrega.
English: Talk to your doctor if you are not sure.
Croatian: Provjerite s liječnikom ako niste sigurni.
English: There is no specific experience in the management of lenalidomide overdose in patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
Croatian: Ne postoji specifično iskustvo u zbrinjavanju bolesnika u slučaju predoziranja lenalidomidom, iako su u ispitivanjima raspona doza neki bolesnici bili izloženi dozama do 150 mg, a u ispitivanjima pojedinačne doze neki bolesnici bili su izloženi dozama do 400 mg.
English: Elderly and people with kidney problems
Croatian: Stariji i osobe koje imaju tegoba s bubrezima
English: It is recommended to press only on one end of the capsule to remove it from the blister thereby reducing the risk of capsule deformation or breakage.
Croatian: Pri vađenju kapsule iz blistera preporučuje se pritisnuti samo jedan kraj kapsule, čime se smanjuje rizik od deformacije ili lomljenja kapsule.
English: Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Croatian: Liječnici koji propisuju lijek trebaju pažljivo procijeniti koju dozu deksametazona primijeniti, uzimajući u obzir bolesnikovo zdravstveno stanje i stadij bolesti.
English: • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraceptioninformation for women and men').
Croatian: • Ako možete zatrudnjeti, osim ako ste poduzeli sve potrebne mjere za sprječavanje trudnoće (pogledajte dio 2 „Trudnoća, dojenje i kontracepcija - informacije za žene i muškarce“).
English: Patients who had previous allergic reactions while treated with thalidomide should be monitored closely, as a possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Croatian: Bolesnike koji su imali prethodne alergijske reakcije za vrijeme liječenja talidomidom treba pomno nadzirati jer je u literaturi zabilježena moguća križna reakcija između lenalidomida i talidomida.
English: Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms.
Croatian: Liječnici trebaju upozoriti bolesnike na znakove i simptome tih reakcija i uputiti ih da odmah potraže medicinsku pomoć ako se navedeni simptomi pojave.
English: d The p-value is based on the unstratified log-rank test of Kaplan-Meier curve differences between the indicated treatment arms.
Croatian: d p-vrijednost temelji se na nestratificiranom log-rang testu Kaplan-Meierove krivulje razlika između navedenih terapijskih skupina.
English: Stop using lenalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite primjenjivati lenalidomid ako razvijete navedene simptome i obratite se liječniku ili odmah zatražite medicinsku pomoć.
English: These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Croatian: Ove komplikacije prouzročene su produktima raspada umirućih stanica raka i mogu uključivati sljedeće: promjene u kemijskom sastavu krvi; povišeni kalij, fosfor i mokraćnu kiselinu te sniženi kalcij što posljedično vodi do promjena u funkciji bubrega, srčanih otkucaja, do napadaja i ponekad smrti.
English: Treatment with lenalidomide may cause virus to become active again, in patients who carry the virus, resulting in a recurrence of the infection.
Croatian: Liječenje lenalidomidom može prouzročiti ponovnu aktivaciju virusa u bolesnika koji ga nose, što rezultira ponovnom pojavom infekcije.
English: The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance to the national implemented patient card system.
Croatian: Bolesnike i bolesnice propisivač mora upoznati s očekivanim teratogenim rizikom i strogim mjerama prevencije trudnoće kako je to navedeno u Programu prevencije trudnoće, i dati im odgovarajuću edukacijsku brošuru za bolesnike, karticu za bolesnika i/ili neki drugi ekvivalentni dokument u skladu sa sustavom kartica za bolesnike uvedenim na nacionalnoj razini.
English: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
Croatian: • venska tromboembolija (duboka venska tromboza, plućna embolija) (vidjeti dio 4.4)
English: Summary of results of efficacy analyses as of cut-off date for extended follow-uppooled studies MM-009 and MM-010 (cut-offs 23 July 2008 and 2 March 2008, respectively)
Croatian: Sažetak rezultata analize djelotvornosti na datum završetka produljenog praćenjaudružena ispitivanja MM-009 i MM-010 (zaključni datumi 23. srpnja 2008. odnosno 2. ožujka
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘Tumour Lysis Syndrome').
Croatian: To može dovesti do stanja u kojem se tumori razgrađuju i prouzročiti pojavu neuobičajenih razina kemijskih tvari u krvi, što može dovesti do zatajenja bubrega (to se stanje naziva 'sindrom lize tumora').
English: However with a longer follow-up, the difference in overall survival in favour of lenalidomide/ low dose dexamethasone tends to decrease.
Croatian: Međutim, uz dulje praćenje uočeno je da razlika u ukupnom preživljenju u korist lenalidomida/niske doze deksametazona pokazuje tendenciju smanjenja.
English: What you need to know before you take Lenalidomide Accord 3.
Croatian: Što morate znati prije nego počnete uzimati Lenalidomid Accord 3.
English: It is important to dose adjust patients with renal impairment in order to avoid plasma levels which may increase the risk for higher haematological adverse reactions or hepatotoxicity.
Croatian: Važno je prilagoditi dozu bolesnicima s oštećenjem funkcije bubrega kako bi se izbjegle plazmatske razine koje mogu povećati rizik od pojačanih hematoloških nuspojava ili hepatotoksičnosti.
English: Very Common Rash, Dry skin
Croatian: Vrlo često osip, suha koža
English: Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide .
Croatian: Nemojte voziti ili upravljati strojevima ako osjećate omaglicu, umor, pospanost, vrtoglavicu ili imate zamagljen vid nakon što ste uzeli lenalidomid.
English: However, it is not known whether there is an interaction during clinical use (concomitant treatment with dexamethasone).
Croatian: Međutim, nije poznato postoji li interakcija tijekom kliničke primjene (istodobno liječenje s deksametazonom).
English: Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Croatian: Stoga je teratogeni učinak lenalidomida očekivan i lenalidomid je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: In general, study subjects had advanced-stage disease: of the total study population, 41% had ISS stage III, 9% had severe renal insufficiency (creatinine clearance [CLcr] < 30 mL/min).
Croatian: Sveukupno, ispitanici su imali uznapredovali stupanj bolesti: od ukupne populacije u ispitivanju 41 % imao je ISS stadij III, 9 % imalo je tešku bubrežnu insuficijenciju (klirens kreatinina [CLcr] < 30 mL/min).
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Croatian: Nositelj odobrenja dogovorit će pojedinosti kontrolirane distribucije lijeka s nadležnim državnim tijelima te mora provoditi taj program na državnoj razini kako bi osigurao da će:
English: A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic agents.
Croatian: Ako je koncentracija hemoglobina iznad 12 g/dl, treba obustaviti liječenje eritropoetskim lijekovima.
English: Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
Croatian: Praćenje (mjeseci) Medijanf (min, maks): svi bolesnici Odgovor mijelomag n (%)
English: • some medicines used to thin the blood - such as warfarin
Croatian: • neke lijekove za razrjeđivanje krvi - poput varfarina
English: Other intrinsic factors
Croatian: Drugi intrinzični čimbenici
English: Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity.
Croatian: Prekid ili obustavu liječenja lenalidomidom treba razmotriti u slučaju drugih oblika kožnih reakcija, ovisno o njihovoj težini.
English: Myocardial infarction (including acute)^,◊, Atrial fibrillation◊,
Croatian: Često infarkt miokarda (uključujući akutni)^,◊, fibrilacija atrija◊,
English: Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Croatian: Deksametazon je slabi do umjereni induktor enzima i njegov učinak na varfarin nije poznat.
English: You must follow the Lenalidomide Pregnancy Prevention Programme
Croatian: Morate se pridržavati Programa prevencije trudnoće za lenalidomid.
English: Lenalidomide is rapidly absorbed following oral administration in healthy volunteers, under fasting conditions, with maximum plasma concentrations occurring between 0.5 and 2 hours post-dose.
Croatian: Lenalidomid se brzo apsorbira nakon oralne primjene u zdravih dobrovoljaca natašte, s maksimalnim koncentracijama u plazmi između 0,5 i 2 sata nakon doziranja.
English: The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
Croatian: Djelotvornost steroidnih kontraceptiva može biti umanjena tijekom istodobnog liječenja deksametazonom (vidjeti dio 4.5).
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake Rok valjanosti odnosno „EXP“.
English: Peripheral neuropathies (excluding motor neuropathy), Dizziness, Tremor, Dysgeusia, Headache
Croatian: Vrlo često periferne neuropatije (isključujući motoričku neuropatiju), omaglica, tremor, disgeuzija, glavobolja
English: These cells collect in the bone marrow and divide, becoming out of control.
Croatian: Te se stanice nakupljaju u koštanoj srži i dijele, ponašajući se nekontrolirano.
English: • how much lenalidomide you should take
Croatian: • koliko lenalidomida morate uzeti
English: What Lenalidomide Accord looks like and contents of the pack
Croatian: Kako Lenalidomid Accord izgleda i sadržaj pakiranja
English: Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Croatian: Lenalidomid nije službeno ispitivan u bolesnika s oštećenom funkcijom jetre i ne postoje specifične preporuke za doziranje.
English: Common Atrial fibrillation◊, Bradycardia
Croatian: Često fibrilacija atrija◊, bradikardija
English: However, renal impairment did not alter the oral absorption of lenalidomide.
Croatian: Međutim, oštećenje funkcije bubrega nije promijenilo oralnu apsorpciju lenalidomida.
English: All patients should be advised to seek medical attention promptly at the first sign of infection (eg, cough, fever, etc) thereby allowing for early management to reduce severity.
Croatian: Svim bolesnicima treba savjetovati da na prvi znak infekcije (npr. kašalj, vrućica itd.) što prije potraže medicinsku pomoć čime će omogućiti da se ranim zbrinjavanjem umanji težina.
English: If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Croatian: Ako za bolesnicu nije utvrđena djelotvorna kontracepcija, bolesnicu je potrebno uputiti odgovarajuće osposobljenom zdravstvenom radniku za savjet o kontracepciji kako bi je mogla početi primjenjivati.
English: In plasma, the relative exposures of the S- and Renantiomers of lenalidomide are approximately 56% and 44%, respectively.
Croatian: U plazmi, relativne izloženosti S- i R- enantiomera lenalidomida iznose približno 56 % odnosno 44 %.
English: a: Two-tailed log rank test comparing survival curves between treatment groups.
Croatian: a: Dvostrani log-rang test koji uspoređuje krivulje preživljenja između skupina liječenja.
English: Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Croatian: Lenalidomid je strukturno srodan talidomidu, za koji se zna da uzrokuje tešku perifernu neuropatiju.
English: Findings from this study indicate that lenalidomide produced external malformations including non-patent anus and malformations of upper and lower extremities (bent, shortened, malformed, malrotated and/or absent part of the extremities, oligo and/or polydactyly) in the offspring of female monkeys who received the active substance during pregnancy.
Croatian: Nalazi iz ispitivanja upućuju na to da je lenalidomid prouzročio vanjske malformacije, uključujući neprohodni anus i malformacije na gornjim i donjim ekstremitetima (savijeni, skraćeni, malformirani, malrotirani i/ili odsutni dijelove ekstremiteta, oligo i/ili polidaktilija) u potomaka ženki majmuna koje su primale djelatnu tvar tijekom gravidnosti.
English: Adverse reactions have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical trials.
Croatian: U tablicama u nastavku nuspojave su navedene pod odgovarajućom kategorijom prema najvećoj učestalosti opaženoj u nekom od glavnih kliničkih ispitivanja.
English: Lenalidomide is not an enzyme inducer.
Croatian: Lenalidomid nije induktor enzima.
English: • You must also use effective methods of contraception (see ‘Contraception' below).
Croatian: • Također, morate primjenjivati djelotvorne metode kontracepcije (pogledajte ispod odjeljak