FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose reduction steps
Croatian: Koraci u smanjivanju doze
English: • an immunosuppressant medicine called ‘prednisone'.
Croatian: • s imunosupresivnim lijekom pod nazivom ‘prednizon'.
English: In the lenalidomide/low dose dexamethasone group, 20 patients (9.1%) underwent at least one dose interruption compared to 65 patients (29.3%) in the lenalidomide/standard dose dexamethasone arm.
Croatian: U skupini lenalidomid/niska doza deksametazona, 20 bolesnika (9,1 %) imalo je bar jedan prekid doze u usporedbi sa 65 bolesnika (29,3 %) u skupini lenalidomid/standardna doza deksametazona.
English: placebo/dex(N=351)
Croatian: placebo/deks (N = 351)
English: Venous and arterial thromboembolic events
Croatian: Događaji venske i arterijske tromboembolije
English: Uncommon Acquired Fanconi syndrome
Croatian: Manje često stečeni Fanconijev sindrom
English: In an in vitro study with human hepatocytes, lenalidomide, at various concentrations tested did not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4/5.
Croatian: U jednom in vitro ispitivanju s ljudskim hepatocitima, lenalidomid testiran u različitim koncentracijama nije inducirao CYP1A2, CYP2B6, CYP2C9, CYP2C19 i CYP3A4/5.
English: How much Lenalidomide to take
Croatian: Koliko lenalidomida uzeti
English: For women taking lenalidomide
Croatian: Za žene koje uzimaju lenalidomid
English: Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Croatian: Implantati i intrauterini ulošci koji otpuštaju levonorgestrel povezani su s povećanim rizikom od infekcije u vrijeme umetanja te s neredovitim vaginalnim krvarenjem.
English: Lenalidomide Accord as combination therapy (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Croatian: Lenalidomid Accord u kombiniranoj terapiji (vidjeti dio 4.2) indiciran je za liječenje odraslih bolesnika s prethodno neliječenim multiplim mijelomom (MM) koji nisu prikladni za transplantaciju.
English: If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Croatian: Ako prašak iz razlomljene kapsule lenalidomida dođe u dodir s kožom, odmah temeljito isperite kožu vodom i sapunom.
English: • Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of an allergic reaction
Croatian: • koprivnjača, osip, oticanje očiju, usta ili lica, otežano disanje ili svrbež, što mogu biti simptomi alergijske reakcije
English: • Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials
Croatian: • opis i zbrinjavanje neutropenije i trombocitopenije uključujući stope incidencije iz kliničkih ispitivanja
English: Resume lenalidomide and melphalan at dose level -1
Croatian: Nastaviti s lenalidomidom i melfalanom pri 1. razini doze
English: No dose adjustment is proposed for patients older than 75 years who are treated with lenalidomide in combination with melphalan and prednisone.
Croatian: Ne predlaže se prilagodba doze u bolesnika starijih od 75 godina koji su liječeni lenalidomidom u kombinaciji s melfalanom i prednizonom.
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Croatian: Izdavanje lenalidomida ženama u reproduktivnoj dobi treba uslijediti unutar 7 dana od propisivanja te nakon negativnog testa na trudnoću provedenog pod medicinskim nadzorom.
English: Acute myeloid leukaemia◊, Myelodysplastic syndrome◊, Squamous cell carcinoma of skin^,◊,**
Croatian: Često akutna mijeloična leukemija◊, mijelodisplastični sindrom◊, karcinom pločastih stanica kože^,◊,**
English: Safety advice for women of childbearing potential
Croatian: Sigurnosne savjete za žene u reproduktivnoj dobi
English: Patients were randomised (1:1:1) to 1 of 3 treatment arms.
Croatian: Bolesnici su bili randomizirani (1:1:1) u 1 od 3 terapijske skupine.
English: • Description and management of cutaneous reactions
Croatian: • opis i zbrinjavanje kožnih reakcija
English: Return to ≥ 1 x 109/L when neutropenia is the only observed toxicity
Croatian: Vrati se na ≥ 1 x 109/L, a neutropenija je jedina primijećena toksičnost
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Croatian: Prilikom primjene lenalidomida zabilježeni su slučajevi progresivne multifokalne leukoencefalopatije (PML), uključujući slučajeve s fatalnim ishodom.
English: Lenalidomide is primarily excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance (see section 4.4).
Croatian: Lenalidomid se prvenstveno izlučuje putem bubrega; bolesnici s većim stupnjem oštećenja funkcije bubrega mogu slabije podnositi liječenje (vidjeti dio 4.4).
English: • Fever and flu like symptoms including fever, muscle ache, headache, ear ache and chills
Croatian: • vrućica i simptomi nalik gripi uključujući vrućicu, bol u mišićima, glavobolju, uhobolju i zimicu
English: 21x1 hard capsules
Croatian: 21x1 tvrda kapsula
English: Treatment was to be continued until disease progression.
Croatian: Liječenje je trajalo bez prekida sve do progresije bolesti.
English: • Leg pain (which could be a symptom of thrombosis), chest pain or breathlessness (which may be a symptom of blood clots in the lungs, called pulmonary embolism)
Croatian: • bol u nogama (koji može biti simptom tromboze), bol u prsnom košu ili nedostatak zraka (što može biti simptom krvnih ugrušaka u plućima, zvanih plućna embolija)
English: Lenalidomide is present in human semen (< 0.01% of the dose) after administration of 25 mg/day and the medicinal product is undetectable in semen of a healthy subject 3 days after stopping the substance (see section 4.4).
Croatian: Lenalidomid je prisutan u ljudskoj spermi (< 0,01 % doze) nakon primjene 25 mg/dan, a lijek se ne može otkriti u spermi zdravih ispitanika 3 dana nakon prestanka uzimanja lijeka (vidjeti dio 4.4).
English: In a post-hoc analysis, lower mortality was observed in the lenalidomide/low dose dexamethasone arm 6.8% (15/220) compared to the lenalidomide/standard dose dexamethasone arm 19.3% (43/223), in the newly diagnosed multiple myeloma patient population, with a median follow up of 72.3 weeks.
Croatian: U post-hoc analizi, uočena je niža smrtnost u skupini koja je primala lenalidomid/nisku dozu deksametazona od 6,8 % (15/220) u usporedbi sa skupinom koja je primala lenalidomid/standardnu dozu deksametazona od 19,3 % (43/223) u populaciji bolesnika s novodijagnosticiranim multiplim mijelomom, s medijanom praćenja od 72,3 tjedna.
English: Pre-planned interim analyses of both studies showed that len/dex was statistically significantly superior (p < 0.00001) to dexamethasone alone for the primary efficacy endpoint, TTP (median follow-up duration of 98.0 weeks).
Croatian: Prethodno planirane interim analize za oba ispitivanja pokazale su da je kombinacija len/deks statistički značajno superiornija (p < 0,00001) u odnosu na sam deksametazon za primarni ishod, vrijeme do napredovanja bolesti (medijan vremena praćenja u trajanju od 98 tjedana).
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Croatian: Talidomid je poznata humana teratogena djelatna tvar koja uzrokuje teške životno ugrožavajuće urođene anomalije.
English: • Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine
Croatian: • stvaranje mnogo veće ili mnogo manje količine mokraće nego što je uobičajeno (što može biti simptom zatajenja bubrega), krv u mokraći
English: • Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse.
Croatian: • iznenadna ili blaga, ali pogoršavajuća bol u gornjem dijelu trbuha i/ili leđa, koja se nastavlja tijekom nekoliko dana, a može biti popraćena mučninom, povraćanjem, vrućicom i ubrzanim pulsom; ti simptomi mogu biti prouzročeni upalom gušterače
English: The DLT in these studies was essentially haematological.
Croatian: Glavna toksičnost koja je ograničavala dozu u tim ispitivanjima bila je u osnovi hematološka.
English: Lenalidomide Accord hard capsules should be taken orally at about the same time on the scheduled days.
Croatian: Lenalidomid Accord tvrde kapsule treba uzimati peroralno otprilike u isto vrijeme svakoga dana predviđenog za uzimanje lijeka.
English: • Brochure for women patients of childbearing potential and their partners
Croatian: • Knjižice za bolesnice u reproduktivnoj dobi i njihove partnere
English: The primary efficacy endpoint in the study was progression free survival (PFS).
Croatian: U ispitivanju, primarni ishod djelotvornosti bilo je preživljenje bez napredovanja bolesti (engl. progression-free survival, PFS).
English: Patients in the placebo/dexamethasone (placebo/dex) group took 1 placebo capsule on days 1 to 28 of each 28-day cycle.
Croatian: Bolesnici koji su primali placebo/deksametazon (placebo/deks) uzimali su jednu kapsulu placeba od 1. do 28. dana u svakom 28-dnevnom ciklusu.
English: In both studies, the baseline demographic and disease-related characteristics were comparable between the len/dex and placebo/dex groups.
Croatian: U oba ispitivanja, početne demografske i s bolešću povezane karakteristike bile su usporedive između skupina koje su primale len/deks i placebo/deks.
English: The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Croatian: Postotak bolesnika s multiplim mijelomom u dobi od 65 godina ili starijih nije se značajno razlikovao između skupina koje su primale lenalidomid/deksametazon i placebo/deksametazon.
English: Intracranial haemorrhage^, Transient ischaemic attack, Cerebral ischemia
Croatian: Manje često intrakranijalno krvarenje^, tranzitorna ishemijska ataka, cerebralna ishemija
English: Care should be taken in dose selection and monitoring of renal function is advised.
Croatian: Stoga je potrebno voditi brigu o odabiru doze te se savjetuje nadzor funkcije bubrega.
English: Patients between 18 and 70 years of age with active MM requiring treatment and without prior progression after initial therapy were eligible.
Croatian: Bolesnici prikladni za ispitivanje bili su oni u dobi između 18 i 70 godina s aktivnim multiplim mijelomom koji zahtijeva liječenje i bez progresije poslije početne terapije.
English: In vitro (bacterial mutation, human lymphocytes, mouse lymphoma, Syrian Hamster Embryo cell transformation) and in vivo (rat micronucleus) mutagenicity studies revealed no drug related effects at either the gene or chromosomal level.
Croatian: Ispitivanja mutagenosti in vitro (bakterijske mutacije, testovi na ljudskim limfocitima, limfomima miševa i stanicama embrija sirijskog hrčka) i in vivo (na mikrojezgri stanica štakora) nisu otkrila učinke povezane s lijekom bilo na razini gena ili kromosoma.
English: • Skin eruptions, skin cracking, flaking or peeling skin
Croatian: • izbijanje kožnih promjena, pucanje kože, perutanje ili ljuštenje kože
English: Results of these analyses subsequently led to an unblinding in both studies, in order to allow patients in the placebo/dex group to receive treatment with the len/dex combination.
Croatian: Rezultati tih analiza doveli su kasnije do otkrivanja slijepe šifre u oba ispitivanja kako bi se omogućilo da skupina koja je primala placebo/deks bude liječena kombinacijom len/deks.
English: Arrhythmia, QT prolongation, Atrial flutter, Ventricular extrasystoles
Croatian: Manje često aritmija, produljenje QT intervala, undulacija atrija, ventrikularne ekstrasistole
English: If you take more lenalidomide than you should If you take more lenalidomide than was prescribed, tell your doctor immediately.
Croatian: Ako uzmete više lenalidomida nego što Vam je propisano, odmah obavijestite svog liječnika.
English: • Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, itchy skin, rash, pain or swelling of the stomach -these may be symptoms of injury to the liver (hepatic disorder).
Croatian: • žuta pigmentacija kože, sluznice ili očiju (žutica), blijeda boja stolice, tamno obojena mokraća, svrbež na koži, osip, bol ili oticanje trbuha - to mogu biti simptomi oštećenja funkcije jetre (jetreni poremećaj)
English: Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in patients receiving concomitant medicinal products susceptible to induce bleeding (see section 4.8, Haemorrhagic disorders).
Croatian: Bolesnicima i liječnicima se savjetuje da obrate pozornost na pojavu znakova i simptoma krvarenja, uključujući petehije i epistakse, a posebice u bolesnika koji istodobno primaju lijekove koji mogu povećati sklonost krvarenju (vidjeti dio 4.8, Hemoragijski poremećaji).
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Croatian: Nepoznato virusne infekcije, uključujući reaktivaciju virusa herpes zostera i hepatitisa B
English: A fertility study in rats with lenalidomide doses up to 500 mg/kg (approximately 200 to 500 times the human doses of 25 mg and 10 mg, respectively, based on body surface area) produced no adverse effects on fertility and no parental toxicity.
Croatian: Ispitivanje utjecaja lenalidomida na plodnost u štakora u dozama do 500 mg/kg (približno 200 puta većim od doza za čovjeka od 25 mg, odnosno do 500 puta većim od doza za čovjeka od 10 mg, na osnovi površine tijela) nisu pokazala štetne učinke na plodnost te parentalnu toksičnost.
English: Repeated oral administration of 4 and 6 mg/kg/day to monkeys for up to 20 weeks produced mortality and significant toxicity (marked weight loss, reduced red and white blood cell and platelet counts, multiple organ haemorrhage, gastrointestinal tract inflammation, lymphoid, and bone marrow atrophy).
Croatian: Ponovljena peroralna primjena doza od 4 i 6 mg/kg/dan kod majmuna u trajanju do 20 tjedana dovela je do smrtnosti i značajne toksičnosti (znatan gubitak na težini, smanjeni broj eritrocita i leukocita te trombocita, krvarenje u više organa, upala probavnog sustava, atrofija limfoidnog tkiva i koštane srži).
English: Patients were randomised in a 1:1:1 ratio to one of 3 treatment arms.
Croatian: Bolesnici su randomizirani u omjeru 1:1:1 u jednu od 3 terapijske skupine.
English: In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or UGT1A1.
Croatian: In vitro ispitivanja pokazuju da lenalidomid nema inhibitorni učinak na CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A ili UGT1A1.
English: • Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice
Croatian: • potreba da se uputi na pregled i savjetovanje liječniku specijaliziranom ili iskusnom u zbrinjavanju teratologije i dijagnoze iste
English: Venous thromboembolic events, predominantly deep vein thrombosis and pulmonary embolism^,◊
Croatian: Vrlo često venska tromboembolija, pretežno duboka venska tromboza i plućna embolija^,◊
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Croatian: Programa prevencije trudnoće, osim ako postoji pouzdan dokaz da bolesnica nije u reproduktivnoj dobi.
English: • Understand the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception (even if the man has had a vasectomy), during treatment and for 1 week after dose interruptions and/or cessation of treatment.
Croatian: • Shvaćaju potrebu za uporabom prezervativa u slučaju spolne aktivnosti s trudnicom ili ženom u reproduktivnoj dobi koja ne primjenjuje djelotvornu kontracepciju (čak i ako je muškarac bio podvrgnut vazektomiji), tijekom liječenja i još 1 tjedan nakon prekida doze i/ili prestanka liječenja.
English: An open-label, randomised, multicenter, phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomised to the lenalidomide/low dose dexamethasone arm, and 223 were randomised to the lenalidomide/standard dose dexamethasone arm.
Croatian: Otvoreno, randomizirano, multicentrično ispitivanje faze III (ECOG E4A03) provedeno je u 445 bolesnika s novodijagnosticiranim multiplim mijelomom; 222 bolesnika bila su randomizirana u skupinu koja je primala lenalidomid/nisku dozu deksametazona, a 223 bolesnika randomizirana su u skupinu koja je primala lenalidomid/standardnu dozu deksametazona.
English: Common Hypokalaemia, Dehydration
Croatian: Često hipokalemija, dehidracija
English: • If you do become pregnant during your treatment with lenalidomide , you must stop the treatment and inform your doctor immediately.
Croatian: • Ako zatrudnite tijekom Vašeg liječenja lenalidomidom, morate prekinuti liječenje i odmah obavijestiti svog liječnika.
English: • The active substance is lenalidomide.
Croatian: • Djelatna tvar je lenalidomid.
English: Common Headache
Croatian: Često glavobolja
English: Pancytopenia◊, Haemolytic anaemia
Croatian: pancitopenija◊, hemolitička anemija
English: In vitro studies indicate that lenalidomide has no inhibitory effect on human bile salt export pump (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, and OCT2.
Croatian: In vitro ispitivanja pokazuju da lenalidomid nema inhibitorni učinak na humanu pumpu za izbacivanje žučnih soli (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3 i OCT2.
English: • Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).
Croatian: • virusne infekcije, uključujući herpes zoster (virusna bolest koja na koži uzrokuje bolan osip s mjehurićima) i ponovnu pojavu infekcije hepatitisa B (koja može prouzročiti žutu boju kože i očiju, tamnosmeđu boju mokraće, bol na desnoj strani trbuha, vrućicu i osjećaj mučnine ili povraćanje).
English: Despite the fact that 170 out of the 351 patients randomised to placebo/dex received lenalidomide after disease progression or after the studies were unblinded, the pooled analysis of overall survival demonstrated a statistically significant survival advantage for len/dex relative to placebo/dex (HR = 0.833, 95% CI = [0.687, 1.009], p=0.045).
Croatian: Unatoč činjenici da je od 351 bolesnika koji su bili nasumično dodijeljeni skupini koja je primala placebo/deks 170 primalo lenalidomid nakon napredovanja bolesti ili nakon otkrivanja slijepe šifre ispitivanja, udružene analize ukupnog preživljenja pokazale su statistički značajnu prednost preživljenja za len/deks u usporedbi sa skupinom koja je primala placebo/deks (HR = 0,833, 95 % CI = [0,687, 1,009], p = 0,045).
English: The demographic and disease-related characteristics were balanced across both arms.
Croatian: Demografski podaci i s bolešću povezane karakteristike bolesnika bile su uravnoteženi u obje skupine.
English: • National or other applicable specific arrangements for a prescription for Lenalidomide Accord to be dispensed
Croatian: • nacionalne i druge primjenjive specifične dogovore za recept za izdavanje lijeka Lenalidomid
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide maintenance than placebo were:
Croatian: Ozbiljne nuspojave opažene češće (≥5 %) za lenalidomid u terapiji održavanja nego za placebo bile su sljedeće:
English: These patients discontinued at a higher rate due to intolerance (Grade 3 or 4 adverse events and serious adverse events), when compared to patients < 75 years.
Croatian: U tih je bolesnika bila veća stopa obustave liječenja zbog nepodnošenja liječenja (nuspojave 3. ili 4. stupnja i ozbiljne nuspojave) u usporedbi s bolesnicima < 75godina.
English: Return to ≥ 0.5 x 109/L when dose-dependent haematological toxicities other than neutropenia are observed
Croatian: Vrati se na ≥ 0,5 x 109/L uz prisutne druge hematološke toksičnosti ovisne o dozi, osim neutropenije
English: • Loss of vision
Croatian: • gubitak vida
English: Cholestasis◊, Abnormal liver function tests◊
Croatian: Često kolestaza◊, abnormalni testovi jetrene funkcije◊
English: Multiple myeloma
Croatian: Multipli mijelom
English: Urticaria, Hyperhidrosis, Dry skin, Skin hyperpigmentation, Eczema, Erythema
Croatian: Često urtikarija, hiperhidroza, suha koža hiperpigmentacija kože, ekcem, eritem
English: Very Common Paraesthesia Common
Croatian: Vrlo često parestezija
English: ª The median is based on the Kaplan-Meier estimate ¤PFS2 (an exploratory endpoint) was defined for all patients (ITT) as time from randomisation to start of 3rd line antimyeloma therapy (AMT) or death for all randomised patients
Croatian: ¤ PFS2 (eksploratorni ishod) definiran je za sve bolesnike (ITT) kao vrijeme od randomizacije do početka 3. linije terapije protiv mijeloma
English: The safety and efficacy of lenalidomide was assessed in a phase III multicenter, randomised double blind 3 arm study (MM-015) of patients who were 65 years or older and had a serum creatinine < 2.5 mg/dL.
Croatian: Sigurnost i djelotvornost lenalidomida procijenjena je u multicentričnom, randomiziranom, dvostruko slijepom ispitivanju faze III (MM-015) na 3 skupine bolesnika u dobi od 65 godina ili starijih, koji su imali kreatinin u serumu < 2,5 mg/dL.
English: Uncommon Hypersensitivity^
Croatian: Manje često preosjetljivost^
English: Very Common Rashes, Pruritus
Croatian: Vrlo često osipi, pruritus
English: Pregnancy warning
Croatian: Upozorenje za trudnice
English: Therefore, lenalidomide is unlikely to cause any clinically relevant medicinal product interactions when co-administered with substrates of these enzymes.
Croatian: Stoga nije vjerojatno da će lenalidomid, kada se primijeni istodobno sa supstratima tih enzima, prouzročiti bilo kakve klinički značajne interakcije lijekova.
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide in combination with low dose dexamethasone (Rd and Rd18) than with melphalan, prednisone and thalidomide (MPT) were:
Croatian: Ozbiljne nuspojave opažene češće (≥ 5 %) za lenalidomid u kombinaciji s niskom dozom deksametazona (Rd i Rd18) nego za melfalan, prednizon i talidomid (MPT) bile su:
English: Common Myelodysplastic syndrome◊,*
Croatian: Često mijelodisplastični sindrom◊,*
English: In total, 353 patients were evaluated in the MM-009 study; 177 in the len/dex group and 176 in the placebo/dex group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the len/dex group and 175 in the placebo/dex group.
Croatian: Ukupno 353 bolesnika bila su procijenjena u ispitivanju MM-009; 177 u skupini koja je primala len/deks i 176 u skupini koja je primala placebo/deks te ukupno 351 bolesnik u ispitivanju MM-010; 176 u skupini koja je primala len/deks i 175 u skupini koja je primala placebo/deks.
English: In patients with Grade 3 or 4 TFR, withhold treatment with lenalidomide until TFR resolves to ≤ Grade 1 and patients may be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR (see section 4.4).
Croatian: U bolesnika s reakcijom razbuktavanja tumora 3. ili 4. stupnja, potrebno je uskratiti liječenje lenalidomidom dok se reakcija ne vrati na ≤ 1. stupnja, a zbrinjavanje simptoma u bolesnika može se provoditi prema smjernicama za liječenje reakcije razbuktavanja tumora 1. i 2. stupnja (vidjeti dio 4.4).
English: Skin and Subcutaneous Tissue Disorders
Croatian: Poremećaji kože i potkožnog tkiva
English: Moderate renal impairment (30  CLcr < 50 mL/min)
Croatian: Umjereno oštećenje funkcije bubrega (30  CLcr < 50 mL/min)