FrancophonIA/ELRC3.0 huggingface dataset:
English: • do not put pressure on the center of the capsule, as this can cause it to break.
Croatian: • nemojte kapsulu pritiskati na sredini jer je tako možete slomiti.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking lenalidomide
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lenalidomid:
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Croatian: Taj zahtjev uključuje žene u reproduktivnoj dobi koje primjenjuju apsolutnu i neprekinutu apstinenciju.
English: • Loss of sex drive (libido)
Croatian: • gubitak spolne želje (libida)
English: • Lung infection (9.4% [9.4% after the start of maintenance treatment]) from CALGB 100104
Croatian: • infekcija pluća (9,4 % [9,4% nakon početka terapije održavanja]) iz CALGB 100104
English: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
Croatian: • da se bolesnica pridržava uvjeta Programa prevencije trudnoće, uključujući potvrdu o odgovarajućoj razini razumijevanja
English: Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.
Croatian: Multipli mijelom je vrsta raka koja pogađa određene vrste bijelih krvnih stanica, zvane plazma stanice.
English: Starting dose (10 mg)
Croatian: Početna doza (10 mg)
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Croatian: Treba poduzeti mjere kako bi se smanjili svi promjenjivi čimbenici rizika (npr. pušenje, hipertenzija i hiperlipidemija).
English: Although it was observed at maternotoxic levels they may be attributable to a direct effect.
Croatian: Iako je to primijećeno pri maternalno toksičnim dozama, moglo bi se pripisati izravnom učinku.
English: Medianf (min, max), months: all surviving patients
Croatian: Medijanf (min, maks), mjeseci: svi preživjeli bolesnici
English: Both patient populations presented a median age of 63 years, with a comparable male to female ratio.
Croatian: Obje populacije bolesnika imale su medijan dobi od 63 godine s usporedivim omjerom muškaraca i žena.
English: • Pneumonia (9.8%)
Croatian: • pneumonija (9,8 %)
English: • Dose is modified based upon clinical and laboratory findings (see section 4.4).
Croatian: • Doziranje se mijenja na temelju kliničkih i laboratorijskih nalaza (vidjeti dio 4.4).
English: • Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat
Croatian: • povišeni krvni tlak ili pad krvnog tlaka, spori, brzi ili nepravilni otkucaji srca
English: • Explanation of the risk of neuropathy with long term use
Croatian: • objašnjenje rizika od neuropatije prilikom dugoročne primjene
English: No interaction study has been performed with oral contraceptives.
Croatian: Nije provedeno ispitivanje interakcija s oralnim kontraceptivima.
English: Common Sepsis◊, Sinusitis◊
Croatian: Često sepsa◊, sinusitis◊
English: • You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
Croatian: • Ne smijete uzimati lenalidomid ako ste trudni jer se očekuje da će naškoditi nerođenom djetetu.
English: • That the patient should tell their doctor about any adverse events
Croatian: • da bolesnik mora obavijestiti svog liječnika o bilo kojoj nuspojavi
English: • Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Croatian: • sindrom lize tumora - metaboličke komplikacije koje mogu nastati tijekom liječenja raka, a ponekad i bez liječenja.
English: • If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
Croatian: • Ako je prošlo manje od 12 sati od propuštanja doze, bolesnik može uzeti dozu.
English: The median age was 73 in the 3 arms.
Croatian: Medijan dobi u 3 skupine iznosio je 73 godine.
English: It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide .
Croatian: Važno je napomenuti da mali broj bolesnika može razviti dodatne vrste raka te je moguće da se taj rizik poveća s liječenjem lenalidomidom; stoga Vaš liječnik treba pomno procijeniti korist i rizik liječenja prilikom propisivanja lenalidomida.
English: • Need for adequate contraception and definition of adequate contraception
Croatian: • potreba za odgovarajućom kontracepcijom i definicijom odgovarajuće kontracepcije
English: • Febrile neutropenia (6.0%)
Croatian: • febrilna neutropenija (6,0 %)
English: However, dexamethasone is known to be a weak to moderate inducer of CYP3A4 and is likely to also affect other enzymes as well as transporters.
Croatian: Međutim, poznato je da je deksametazon slabi do umjereni induktor CYP3A4 te je vjerojatno da će također utjecati na druge enzime, kao i transportere.
English: b The 95% CI about the median.
Croatian: b 95 % CI interval pouzdanosti oko medijana.
English: • if you have had blood clots in the past - you have an increased risk of developing blood clots in the veins and arteries during treatment
Croatian: • ako ste u prošlosti imali krvni ugrušak - za Vas tada postoji povećan rizik od nastanka krvnog ugruška u venama i arterijama tijekom liječenja
English: Multiple dosing does not cause marked medicinal product accumulation.
Croatian: Višestruke doze ne dovode do značajne akumulacije lijeka.
English: PML was reported several months to several years after starting the treatment with lenalidomide.
Croatian: PML je zabilježen nekoliko mjeseci do nekoliko godina nakon početka liječenja lenalidomidom.
English: 2 In countries where the 7.5 mg capsule is available.
Croatian: 2 U zemljama u kojima je dostupna kapsula od 7,5 mg.
English: In vitro, lenalidomide is a substrate of P-gp, but is not a P-gp inhibitor.
Croatian: In vitro, lenalidomid je supstrat P-gp-a, ali nije inhibitor P-gp-a.
English: • Impaired balance, difficulty moving
Croatian: • poremećaj ravnoteže, poteškoće pri kretanju.
English: • Pneumonias (10.6%; combined term) from IFM 2005-02
Croatian: • pneumonije (10,6 % kombinirano) iz IFM 2005-02
English: A conservative approach was applied to determine the adverse reactions from CALGB 100104.
Croatian: Primijenjen je konzervativni pristup za određivanje nuspojava iz CALGB 100104.
English: • do not break, open or chew the capsules.
Croatian: • Nemojte lomiti, otvarati ili žvakati kapsule.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
Croatian: • Potvrđuje da razumije rizike i nužne mjere opreza povezane s primjenom lenalidomida.
English: The MAH should agree on the implementation of the patient card system in each Member State.
Croatian: Nositelj odobrenja treba dogovoriti uvođenje sustava kartica za bolesnike u svakoj državi članici.
English: If you forget to take lenalidomideIf you forget to take lenalidomide at your regular time and
Croatian: Ako ste zaboravili uzeti lenalidomid u svoje redovno vrijeme i
English: Your doctor may check you for changes to your skin such as red spots or rashes.
Croatian: Liječnik će možda provjeriti imate li promjena na koži kao što su crvene mrlje ili osip.
English: If any of the above applies to you, tell your doctor before starting treatment.
Croatian: Ako se bilo što od ovoga odnosi na Vas, obavijestite liječnika prije početka liječenja.
English: Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse.
Croatian: Lenalidomid može zaustaviti pogoršanje znakova i simptoma multiplog mijeloma.
English: • Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception
Croatian: • potreba za odgovarajućom kontracepcijom (čak i ako žena ima amenoreju) i definicija odgovarajuće kontracepcije
English: A second analysis that identified events that occurred after the start of maintenance treatment suggests that the frequencies described in Table 1 may be higher than actually observed during the maintenance treatment period.
Croatian: Druga analiza koja je identificirala događaje koji su nastali nakon početka terapije održavanja ukazuje da učestalosti opisane u Tablici 1 mogu biti više od stvarno opaženih u razdoblju terapije održavanja.
English: Table 4: Summary of overall efficacy data
Croatian: Tablica 4: Sažeti prikaz ukupnih podataka djelotvornosti
English: Lactose intolerance
Croatian: Intolerancija laktoze
English: Lenalidomide has minor or moderate influence on the ability to drive and use machines.
Croatian: Lenalidomid malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: c Based on Cox proportional hazards model comparing the hazard functions associated with the indicated treatment arms.
Croatian: c Na temelju Coxova modela proporcionalnih hazarda kojim se uspoređuju funkcije hazarda povezane s navedenim terapijskim skupinama.
English: Patients with known risk factors for infections should be closely monitored.
Croatian: Bolesnike s poznatim čimbenicima rizika za infekcije treba pomno pratiti.
English: The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Croatian: Rizik od venske tromboembolije postoji narednih 4 do 6 tjedana nakon prekida liječenja kombiniranim oralnim kontraceptivima.
English: • Guidance on handling lenalidomide for patients, caregivers and family members
Croatian: • smjernice za rukovanje lenalidomidom za bolesnike, njegovatelje i članove obitelji
English: g Best assessment of adjudicated response during the treatment phase of the study (for definitions of each response category, Data cut-off date = 24 May 2013).
Croatian: g Najbolja procjena odgovora tijekom faze liječenja u ispitivanju (za definicije svake kategorije odgovora zaključni datum podataka bio je
English: Patients should be advised to promptly report febrile episodes, a treatment interruption and/or dose reductions may be required (see section 4.2).
Croatian: Bolesnike treba savjetovati da brzo prijave febrilne epizode, možda će biti potreban prekid liječenja i/ili smanjenje doze (vidjeti dio 4.2).
English: • Disposal of unwanted medicine
Croatian: • zbrinjavanje neželjenog lijeka
English: Lenalidomide is poorly metabolized as 82% of the dose is excreted unchanged in urine.
Croatian: Lenalidomid se slabo metabolizira jer se 82 % doze izlučuje nepromijenjeno mokraćom.
English: Recommended dose adjustments in patients with impaired renal function are described in section 4.2.
Croatian: Preporučene prilagodbe doze u bolesnika s oštećenom funkcijom bubrega opisane su u dijelu 4.2.
English: • Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Croatian: • ozbiljne alergijske reakcije koje mogu početi kao osip u jednom području, ali se šire na druga područja s opsežnim gubitkom kože po cijelom tijelu (Stevens-Johnsonov sindrom (SJS) i/ili toksična epidermalna nekroliza (TEN))
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML, potrebno je prekinuti daljnje doziranje dok se ne isključi PML.
English: Interactions with P-glycoprotein (P-gp) inhibitors
Croatian: Interakcije s inhibitorima P-glikoproteina (P-gp)
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans Obligations of the health care professional in relation to the prescribing of Lenalidomide Accord
Croatian: • potrebu za izbjegavanjem fetalne izloženosti zbog teratogenosti lenalidomida u životinja i očekivanog teratogenog učinka lenalidomida u ljudi Obveze zdravstvenih radnika u vezi s propisivanjem lijeka Lenalidomid Accord
English: • the capsules can be taken either with or without food.
Croatian: • Kapsule se mogu uzeti s hranom ili bez nje.
English: Thus, lenalidomide can be administered with or without food.
Croatian: Stoga se lenalidomid može primjenjivati s hranom ili bez nje.
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Croatian: U suradnji sa svakim nacionalnim nadležnim tijelom uveden je nacionalno kontroliran sustav distribucije.
English: • Premature ovarian failure confirmed by a specialist gynaecologist
Croatian: • prerano zatajivanje rada jajnika koje je potvrdio specijalist ginekologije
English: • Difficulty getting an erection
Croatian: • poteškoće u postizanju erekcije
English: • Weight loss
Croatian: • gubitak težine
English: Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms.
Croatian: Liječnici trebaju nadzirati bolesnike u redovitim intervalima i trebaju uzeti u obzir PML kod diferencijalne dijagnoze u bolesnika s novim ili pogoršanim neurološkim simptomima, kognitivnim ili bihevioralnim znakovima ili simptomima.
English: Not Known Interstitial pneumonitis
Croatian: Nepoznato intersticijski pneumonitis
English: 5 mg once daily.
Croatian: 5 mg jednom dnevno.
English: Also, some other medicines can affect the way lenalidomide works.
Croatian: Isto tako, drugi lijekovi mogu utjecati na djelovanje lenalidomida.
English: Prior to prescribing (and where appropriate, and in agreement with the National Competent Authority, prior to dispensing) all healthcare professionals who intend to prescribe (and dispense) Lenalidomide Accord are provided with a physician information pack containing the following:
Croatian: Prije propisivanja (gdje je to prikladno, a u dogovoru s nadležnim državnim tijelom i prije izdavanja) svi zdravstveni radnici koji namjeravaju propisivati (i izdavati) Lenalidomid Accord dobiti paket s informacijama za liječnike koji sadrži sljedeće:
English: • Certain types of skin tumour
Croatian: • određeni tipovi tumora kože
English: Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition.
Croatian: Liječnik će Vam možda morati prilagoditi dozu lenalidomida ili prekinuti liječenje na temelju rezultata krvnih pretraga i Vašeg općeg stanja.
English: • Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood
Croatian: • promjene hormona štitnjače u krvi, niske razine kalcija, fosfata ili magnezija u krvi
English: Initial dose and regimen for Rd and Rd18 were adjusted according to age and renal function (see section 4.2).
Croatian: Početna doza i režim za Rd i Rd18 bili su prilagođeni prema dobi i funkciji bubrega (vidjeti dio 4.2).
English: • Increases in your blood sugar level (diabetes)
Croatian: • porast razine šećera u krvi (dijabetes)
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should use effective method of contraception.
Croatian: Žene u reproduktivnoj dobi / Kontracepcija u muškaraca i žena Žene u reproduktivnoj dobi moraju koristiti učinkovitu metodu kontracepcije.
English: If PML is confirmed, lenalidomide must be permanently discontinued.
Croatian: U slučaju da se PML potvrdi, primjena lenalidomida mora se trajno prekinuti.
English: If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.
Croatian: Ako uzimate lenalidomid u kombinaciji s drugim lijekovima, u uputama za te lijekove morate potražiti dodatne informacije o tome kako se koriste i kakvi su im učinci.
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential).
Croatian: • dob ≥ 50 godina te prirodno amenoroična tijekom ≥ 1 godine (amenoreja nakon terapije protiv raka ili u razdoblju dojenja ne isključuje reproduktivni potencijal)
English: Stevens-Johnson Syndrome^, Toxic epidermal necrolysis^
Croatian: Stevens-Johnsonov sindrom^, toksična epidermalna nekroliza^
English: It has also been shown to delay multiple myeloma from coming back following treatment.
Croatian: Pokazalo se također da je odgodio povratak multiplog mijeloma nakon liječenja.
English: If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Croatian: Ako ste ove simptome imali prije početka liječenja lenalidomidom, obavijestite liječnika ako dođe do promjene simptoma.
English: • A fall in the number of red blood cells which may cause anaemia leading to tiredness and weakness
Croatian: • pad broja crvenih krvnih stanica koji može prouzročiti anemiju koja vodi do umora i slabosti
English: Regular monitoring of visual ability is recommended.
Croatian: Preporučuje se redovito praćenje vida.
English: Patients with multiple myeloma are prone to develop infections including pneumonia.
Croatian: Bolesnici s multiplim mijelomom skloni su razvoju infekcija uključujući pneumoniju.
English: Enhanced clinical and laboratory monitoring is warranted notably during the first weeks of treatment.
Croatian: Bolesnike se mora intenzivno klinički i laboratorijski nadzirati, osobito tijekom prvih tjedana liječenja.
English: These patients should be monitored closely, especially during the first cycle or dose-escalation, and appropriate precautions taken.
Croatian: Te bolesnike treba pomno nadzirati, osobito tijekom prvog ciklusa liječenja ili povišenja doze, te poduzimati odgovarajuće mjere opreza.
English: • Anaemia (5.3%)
Croatian: • anemija (5,3 %).
English: The prescriber must ensure that for women of childbearing potential:
Croatian: Propisivač mora osigurati za žene u reproduktivnoj dobi:
English: Data cut-off dates: 17 Dec 2009 and 01 Feb 2016
Croatian: Zaključni datumi podataka: 17. prosinca 2009. i 01. veljače 2016.
English: • Description and management of hypersensitivity and angioedema
Croatian: • opis i zbrinjavanje preosjetljivosti i angioedema
English: Therefore, induction leading to reduced efficacy of medicinal products, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Croatian: Stoga se indukcija koja dovodi do smanjene djelotvornosti lijekova, uključujući i hormonske kontraceptive, ne očekuje kod primjene samog lenalidomida.
English: At doses of 5 to 25 mg/day, half-life in plasma is approximately 3 hours in healthy volunteers and ranges from 3 to 5 hours in patients with multiple myeloma,.
Croatian: Pri dozama od 5 do 25 mg/dan, poluvijek u plazmi iznosi približno 3 sata u zdravih dobrovoljaca i kreće se u rasponu od 3 do 5 sati u bolesnika s multiplim mijelomom.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.
Croatian: Odluku o primjeni antitrombotskih profilaktičkih mjera treba donijeti nakon pažljive procjene postojećih čimbenika rizika za svakog pojedinog bolesnika.
English: • Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
Croatian: • promjene razine proteina u krvi što može prouzročiti oticanje arterija (vaskulitis)
English: Lenalidomide should not be used in children and adolescents from birth to less than 18 years because of safety concerns (see section 5.1).
Croatian: Lenalidomid se ne smije primjenjivati u djece i adolescenata, u dobi od rođenja pa do 18. godine, zbog sigurnosnih razloga (vidjeti dio 5.1).
English: • if you are pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men').
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću jer se očekuje da će lenalidomid štetno djelovati na nerođeno dijete (pogledajte dio 2 „Trudnoća, dojenje i kontracepcija - informacije za žene i muškarce“).
English: In both studies, treatment was to continue until disease progression.
Croatian: U oba ispitivanja liječenje se trebalo nastaviti do napredovanja bolesti.
English: Table 7 summarises the results of the follow-up efficacy analyses - pooled studies MM-009 and MM-010.
Croatian: Tablica 7 sažima rezultate analiza praćenja djelotvornosti - udružena ispitivanja MM-009 i MM-010.
English: Lenalidomide is taken in treatment cycles, each cycle lasting 28 days (see above ‘Treatment cycle').
Croatian: Lenalidomid se uzima u ciklusima liječenja, a svaki ciklus traje 28 dana (pogledajte prethodni tekst „Ciklus liječenja“).
English: Treatment cycle
Croatian: Ciklus liječenja
English: Other special warnings and precautions for use
Croatian: Druga posebna upozorenja i mjere opreza pri uporabi
English: If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above.
Croatian: Ako bolesnica trenutno primjenjuje kombiniranu oralnu kontracepciju, treba je zamijeniti nekom od prethodno navedenih djelotvornih metoda.
English: Educational materials, prescribing and dispensing restrictions In order to assist patients in avoiding foetal exposure to lenalidomide, the marketing authorisation holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of lenalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Croatian: Edukacijski materijali, ograničenja propisivanja i izdavanja lijeka Kako bi pomogao bolesnicima u izbjegavanju fetalne izloženosti lenalidomidu, nositelj odobrenja će zdravstvene radnike snabdjeti edukacijskim materijalima da naglasi upozorenja o očekivanoj teratogenosti lenalidomida, pruži savjet o kontracepciji prije početka liječenja te ponudi smjernice o potrebi testiranja na trudnoću.
English: Do not use this medicine if you notice any damage or signs of tampering to the pack.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo koje znakove oštećenja ili neovlaštenog rukovanja pakiranjem lijeka.
English: Patients with newly diagnosed multiple myeloma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Croatian: Bolesnike s novodijagnosticiranim multiplim mijelomom u dobi od 75 godina i starije treba pažljivo procijeniti prije nego što se razmatra liječenje (vidjeti dio 4.4).
English: Cases of allergic reaction/hypersensitivity reactions have been reported.
Croatian: Prijavljeni su slučajevi alergijskih reakcija/reakcija preosjetljivosti.
English: The capsules should be swallowed whole, preferably with water, either with or without food.
Croatian: Kapsule treba gutati cijele, po mogućnosti s vodom, s hranom ili bez nje.
English: Hepatitis B virus status should be established before initiating treatment with lenalidomide.
Croatian: Status s obzirom na virus hepatitisa B treba ustanoviti prije započinjanja liječenja lenalidomidom.
English: If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.
Croatian: Ako ste u dobi od 75 godina ili stariji, ili imate umjerene do teške tegobe s bubrezima - liječnik će Vas pažljivo pregledati prije početka liječenja.
English: • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Croatian: • Čak i ako žena u reproduktivnoj dobi ima amenoreju, mora se pridržavati svih savjeta za djelotvornu kontracepciju.
English: Most of the invasive SPMs were solid tumour malignancies.
Croatian: Većina invazivnih drugih primarnih zloćudnih bolesti bili su zloćudni solidni tumori.
English: • before treatment
Croatian: • prije liječenja