FrancophonIA/ELRC3.0 huggingface dataset:
English: The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the comparator arms in the pivotal multiple myeloma studies (see section 5.1).
Croatian: Podaci ključnih ispitivanja multiplog mijeloma nisu bili prilagođeni za dulje trajanje liječenja u skupinama koje su primale lenalidomid do progresije bolesti naspram onih koje su primale komparator (vidjeti dio 5.1).
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p) compared with MPp+p (13.7%).
Croatian: Kombinacija lenalidomida s melfalanom i prednizonom u bolesnika s novodijagnosticiranim multiplim mijelomom povezana je s većom učestalosti trombocitopenije 3. i 4. stupnja (40,4 % u MPR+R/MPR+p) u usporedbi s MPp+p (13,7 %).
English: Lenalidomide Accord 15 mg
Croatian: Lenalidomid Accord 15 mg
English: The patients at risk of TLS and TFR are those with high tumour burden prior to treatment.
Croatian: Rizik od sindroma lize tumora i reakcije razbuktavanja tumora postoji u onih bolesnika koji imaju veliko opterećenje tumorskom masom prije liječenja.
English: The adverse reactions observed in patients treated with lenalidomide are listed below by system organ class and frequency.
Croatian: Nuspojave primijećene u bolesnika liječenih zbog multiplog mijeloma navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
English: Each capsule contains 20 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 20 mg lenalidomida.
English: Myalgia, Musculoskeletal pain
Croatian: Često mialgija, mišićnokoštana bol
English: There was a higher rate of intolerance (grade 3 or 4 adverse events, serious adverse events, discontinuation) in patients with age > 75 years, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min when lenalidomide is given in combination.
Croatian: > 75 godina, ISS stupanj III, ECOG PS ≤ 2 ili CLcr < 60 mL/min kada se lenalidomid davao u kombinaciji.
English: Propylene glycol Iron oxide black (E172) Iron oxide yellow (E172) Potassium hydroxide Titanium dioxide (E171) Indigo carmine (E132)
Croatian: Tinta za označavanje šelak propilenglikol željezov oksid, crni (E172) željezov oksid, žuti (E172) kalijev hidroksid titanijev dioksid (E171) indigo karmin (E132)
English: Lenalidomide is excreted by the kidneys.
Croatian: Lenalidomid se izlučuje putem bubrega.
English: • Instructions to stop Lenalidomide Accord immediately upon suspicion of pregnancy
Croatian: Zahtjeve u slučaju trudnoće • upute za prekid uzimanja lijeka Lenalidomid Accord odmah nakon sumnje na trudnoću
English: Fall to < 30 x 109/L
Croatian: Padne na <30 x 109/L
English: Very Common
Croatian: Često osipi
English: • Algorithm for implementation of PPP
Croatian: • algoritam za primjenu Programa prevencije trudnoće
English: Not Known Acquired haemophilia
Croatian: Nepoznato stečena hemofilija
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients).
Croatian: Kombinacija lenalidomida s deksametazonom u bolesnika s multiplim mijelomom povezana je s višom incidencijom neutropenije 3. i 4. stupnja (9,9 %, odnosno 1,4 % u bolesnika liječenih lenalidomidom/deksametazonom u usporedbi s 2,3 % i 0,0 % u bolesnika koji su primali placebo/deksametazon).
English: Grade 4 febrile neutropenia was reported at similar frequencies in the lenalidomide maintenance arms compared to placebo maintenance arms in both studies (0.4% vs 0.5% [0.4% vs 0.5% after the start of maintenance treatment] in CALGB 100104 and 0.3% vs 0% in IFM 2005-02, respectively).
Croatian: Febrilna neutropenija 4. stupnja zabilježena je sličnom učestalošću u skupinama na terapiji održavanja lenalidomidom u usporedbi sa skupinama na terapiji održavanja placebom u oba ispitivanja (0,4 % naspram 0,5 % [0,4 % naspram 0,5 % nakon početka terapije održavanja] u ispitivanju CALGB 100104 te 0,3 % naspram 0 % u ispitivanju IFM 2005-02).
English: EU/1/18/1316/005 21x1 hard capsules
Croatian: EU/1/18/1316/005 21x1 tvrda kapsula
English: Stop lenalidomide dosing for remainder of cycleª
Croatian: Privremeno prekinuti liječenje lenalidomidom do kraja ciklusaª
English: Lenalidomide Accord 5 mg
Croatian: Lenalidomid Accord 5 mg
English: First fall to < 30 x 109/L
Croatian: Prvi put padne na < 30 x 109/L
English: Lenalidomide Accord 10 mg hard capsules Each hard capsule contains 10 mg of lenalidomide.
Croatian: Lenalidomid Accord 10 mg tvrde kapsule Jedna kapsula sadrži 10 mg lenalidomida.
English: First fall to < 25 x 109/L
Croatian: Prvi put padne na < 25 x 109/L
English: The adverse reactions from CALGB 100104 included events reported post-high dose melphalan and ASCT (HDM/ASCT) as well as events from the maintenance treatment period.
Croatian: • Novodijagnosticirani multipli mijelom: bolesnici koji su bili podvrgnuti transplantaciji autolognih matičnih stanica liječeni terapijom održavanja lenalidomidom Nuspojave od CALGB 100104 obuhvaćale su događaje nakon visoke doze melfalana (engl. high-dose melphalan, HDM) i ASCT-a (HDM/ACST) kao i događaje iz razdoblja održavanja.
English: The AUC was increased by approximately 2.5, 4 and 5-fold in subjects with moderate renal impairment, severe renal impairment, and end-stage renal disease, respectively, compared to the group combining subjects with normal renal function and subjects with mild renal impairment.
Croatian: U usporedbi sa skupinom sastavljenom od ispitanika s normalnom funkcijom bubrega i onih s blago oštećenom funkcijom bubrega, vrijednost AUC-a povećala se približno 2,5 puta u ispitanika s umjereno oštećenom funkcijom bubrega, približno 4 puta u onih s teško oštećenom funkcijom bubrega i približno 5 puta u bolesnika s terminalnim stadijem bubrežne bolesti.
English: Lenalidomide Accord 2.5 mg hard capsules Each hard capsule contains 2.5 mg of lenalidomide.
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule Jedna tvrda kapsula sadrži 2,5 mg lenalidomida.
English: ADRs reported in post-marketing use in patients treated with lenalidomide System Organ
Croatian: Tablica 3. Nuspojave na lijek nakon stavljanja lijeka u promet prijavljene u bolesnika liječenih lenalidomidom
English: Dexamethasone
Croatian: Deksametazona
English: Fall to < 0.5 x 109/L
Croatian: Padne na < 0,5 x 109/L
English: (95% CI 88.8, NE) in the lenalidomide arm versus 88.1 months (95% CI 80.7, 108.4) in the placebo arm.
Croatian: Medijan ukupnog vremena preživljenja bio je 105,9 mjeseci (95 % CI 88,8; NE) u skupini lenalidomida naspram 88,1 mjeseci (95 % CI 80,7; 108,4) u skupini placeba.
English: The safety and efficacy of lenalidomide was assessed in a phase III, multicenter, randomised, openlabel, 3-arm study (MM-020) of patients who were at least 65 years of age or older or, if younger than 65 years of age, were not candidates for stem cell transplantation because they declined to undergo stem cell transplantation or stem cell transplantation is not available to the patient due to cost or other reason.The study (MM-020) compared lenalidomide and dexamethasone (Rd) given for 2 different durations of time (i.e., until progressive disease [Arm Rd] or for up to eighteen 28-day cycles [72 weeks, Arm Rd18]) to melphalan, prednisone and thalidomide (MPT) for a maximum of twelve 42-day cycles (72 weeks).
Croatian: Sigurnost i djelotvornost lenalidomida procijenjena je u multicentričnom, randomiziranom, otvorenom ispitivanju faze III (MM-020) na 3 skupine bolesnika koji su bili u dobi od najmanje 65 godina ili stariji, a ako su bili mlađi od 65 godina, tada nisu bili kandidati za transplantaciju matičnih stanica jer su je odbili ili im transplantacija matičnih stanica nije bila dostupna zbog cijene ili drugih razloga.
English: Very Common Neutropenia^,◊, Thrombocytopenia^,◊,
Croatian: Vrlo često neutropenija^,◊,trombocitopenija^,◊,
English: Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT)
Croatian: Terapija održavanja lenalidomidom u bolesnika koji su bili podvrgnuti transplantaciji autolognih matičnih stanica
English: Lenalidomide in combination with dexamethasone in patients who are not eligible for stem cell transplantation
Croatian: Primjena lenalidomida u kombinaciji s deksametazonom u bolesnika koji nisu bili prikladni za transplantaciju matičnih stanica
English: Excipient with known effect Each hard capsule contains 33 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 33 mg laktoze.
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 3 or 4 thrombocytopenia compared to placebo maintenance (37.5% vs 30.3% [17.9% vs 4.1% after the start of maintenance treatment] in CALGB 100104 and 13.0% vs 2.9% in IFM 2005-02, respectively).
Croatian: Terapija održavanja lenalidomidom nakon transplantacije autolognih matičnih stanica povezana je s većom učestalošću trombocitopenije 3. i 4. stupnja u usporedbi s terapijom održavanja placebom (37,5 % naspram 30,3 % [17,9 % naspram 4,1 % nakon početka terapije održavanja] u ispitivanju CALGB 100104 i 13,0 % naspram 2,9 % u ispitivanju IFM 2005-02).
English: Grade 3-4 ADRs/Frequency
Croatian: Nuspojave na lijek 3. do 4. stupnja / učestalost
English: Lenalidomide Accord 15 mg hard capsules lenalidomide
Croatian: Lenalidomid Accord 15 mg tvrde kapsule lenalidomid
English: ADRs reported in clinical trials in patients with multiple myeloma treated with lenalidomide maintenance therapy
Croatian: Nuspojave lijeka prijavljene u kliničkim ispitivanjima u bolesnika s multiplim mijelomom liječenih terapijom održavanja lenalidomidom Klasifikacija organskih sustava / preporučeni pojam
English: Respiratory, Thoracic and Mediastinal Disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: Grade 3 or 4 thrombocytopenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (37.5% vs 30.3% [17.9% vs 4.1% after the start of maintenance treatment] in CALGB 100104 and 13.0% vs 2.9% in IFM 2005-02, respectively).
Croatian: Trombocitopenija 3. ili 4. stupnja zabilježena je većom učestalošću u skupinama na terapiji održavanja lenalidomidom u usporedbi sa skupinama na terapiji održavanja placebom u ispitivanjima koja su procjenjivala održavanje lenalidomidom u bolesnika s NDMM-om koji su podvrgnuti ASCT-u (37,5 % naspram 30,3 % [17,9 % naspram 4,1 % nakon početka terapije održavanja] u ispitivanju CALGB 100104 te 13,0 % naspram 2,9 % u ispitivanju IFM 2005-02).
English: Each capsule contains 2.5 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 2,5 mg lenalidomida.
English: EU/1/18/1316/010 21x1 hard capsules
Croatian: EU/1/18/1316/010 21x1 tvrda kapsula
English: EU/1/18/1316/011 21x1 hard capsules
Croatian: EU/1/18/1316/011 21x1 tvrda kapsula
English: Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is < 1.0 x 109/L, and/or platelet counts are < 75 x 109/L.
Croatian: Liječenje lenalidomidom ne smije se započeti ako je apsolutni broj neutrofila (ABN) <1,0 x 109/L i/ili broj trombocita <75 x 109/L.
English: Lenalidomide Accord 20 mg hard capsules
Croatian: Lenalidomid Accord 20 mg tvrde kapsule
English: Each capsule contains 7.5 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 7,5 mg lenalidomida.
English: Dose level -2
Croatian: 2. razina doze
English: How to store Lenalidomide Accord
Croatian: Kako čuvati Lenalidomid Accord
English: Dose level -5
Croatian: 5. razina doze
English: Return to ≥ 25 x 109/L
Croatian: Vrati se na ≥ 25 x 109/L
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Croatian: • Sažetak opisa svojstava lijeka, uputu o lijeku i označivanje.
English: Return to ≥ 0.5 x 109/L
Croatian: Povrat na ≥ 0,5 x 109/L
English: Eye Disorders
Croatian: Poremećaji oka
English: Co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Croatian: Potreban je oprez kod istodobne primjene lenalidomida s drugim mijelosupresivnim lijekovima.
English: The PFS benefit was observed both in the subgroup of patients with CR and in the subgroup of patients who had not achieved a CR.
Croatian: Korist u smislu preživljenja bez progresije bolesti opažena je u podskupini bolesnika s potpunim odgovorom i u podskupini bolesnika koji nisu postigli potpuni odgovor.
English: Brochure for women patients with childbearing potential
Croatian: Knjižica za bolesnice u reproduktivnoj dobi
English: Excipient with known effect Each hard capsule contains 36 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 36 mg laktoze.
English: ADRs reported in clinical studies in patients with multiple myeloma treated with lenalidomide in combination with dexamethasone, or with melphalan and prednisone System Organ
Croatian: Tablica 2. Nuspojave na lijek prijavljene u kliničkim ispitivanjima u bolesnika s multiplim mijelomom liječenih lenalidomidom u kombinaciji s deksametazonom, ili s melfalanom i prednizonom Klasifikacija organskih sustava / preporučeni pojam
English: Lenalidomide Accord 10 mg hard capsules
Croatian: Lenalidomid Accord 10 mg tvrde kapsule
English: Common Hypothyroidism
Croatian: Često hipotireoidizam
English: Lenalidomide Accord 5 mg hard capsules Each hard capsule contains 5 mg of lenalidomide.
Croatian: Lenalidomid Accord 5 mg tvrde kapsule Jedna tvrda kapsula sadrži 5 mg lenalidomida.
English: Return to ≥ 30 x 109/L
Croatian: Povrat na ≥30 x 109/L
English: Each capsule contains 25 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 25 mg lenalidomida.
English: Progression free survival Median [95% CI], weeks
Croatian: Preživljenje bez napredovanja bolesti Medijan [95 % CI], tjedni p < 0,001
English: The dose of dexamethasone was reduced to 40 mg orally once daily on days 1 to 4 of each 28-day cycle after the first 4 cycles of therapy.
Croatian: 40 mg peroralno jednom dnevno od 1. do 4. dana svakog 28-dnevnog ciklusa liječenja.
English: First fall to < 0.5 x 109/Lª
Croatian: Prvi put padne na < 0,5 x 109/Lª
English: Lenalidomide Accord 15 mg hard capsules Each hard capsule contains 15 mg of lenalidomide.
Croatian: Lenalidomid Accord 15 mg tvrde kapsule Jedna kapsula sadrži 15 mg lenalidomida.
English: Lenalidomide Accord 2.5 mg hard capsules
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule
English: Lenalidomide Accord 2.5 mg hard capsules:
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule:
English: A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Croatian: Na početku liječenja, svaki tjedan tijekom prvih 8 tjedana liječenja lenalidomidom te nakon toga svaki mjesec, treba obaviti pretrage kompletne krvne slike, uključujući broj bijelih krvnih stanica s diferencijalnim brojem stanica, broj trombocita, hemoglobin i hematokrit zbog moguće pojave citopenija.
English: Lenalidomide Accord 25 mg hard capsules EU/1/18/1316/011
Croatian: Lenalidomid Accord 25 mg tvrde kapsule EU/1/18/1316/011
English: Lenalidomide Accord 20 mg hard capsules EU/1/18/1316/010
Croatian: Lenalidomid Accord 20 mg tvrde kapsule EU/1/18/1316/010
English: Excipient with known effect Each hard capsule contains134 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 134 mg laktoze.
English: Tabulated summary of post-marketing adverse reactions
Croatian: Sažeti tablični prikaz nuspojava zabilježenih nakon stavljanja lijeka u promet
English: Lenalidomide treatment must not be started if the ANC is < 1.5 x 109/L, and/or platelet counts are < 75 x 109/L.
Croatian: Liječenje lenalidomidom ne smije se započeti ako je ABN < 1,5 x 109/L i/ili broj trombocita < 75 x 109/L.
English: Lenalidomide Accord 25 mg hard capsules
Croatian: Lenalidomid Accord 25 mg tvrde kapsule
English: Each capsule contains 10 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 10 mg lenalidomida.
English: Common Abnormal liver function tests
Croatian: Često abnormalni testovi jetrene funkcije
English: Each capsule contains 15 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 15 mg lenalidomida.
English: Each capsule contains 5 mg of lenalidomide.
Croatian: Jedna kapsula sadrži 5 mg lenalidomida.
English: Lenalidomide Accord 10 mg hard capsules:
Croatian: Lenalidomid Accord 10 mg tvrde kapsule:
English: Lenalidomide Accord 7.5 mg hard capsules
Croatian: Lenalidomid Accord 7,5 mg tvrde kapsule
English: Lenalidomide treatment must not be started if the ANC is < 1.0 x 109/L, and/or platelet counts are < 50 x 109/L.
Croatian: Liječenje lenalidomidom ne smije se započeti ako je ABN < 1,0 x 109/L i/ili broj trombocita < 50 x 109/L.
English: Dose level -3
Croatian: 3. razina doze
English: WARNING: Risk of severe birth defects.
Croatian: • opis rizika od pojave druge primarne zloćudne bolesti.
English: How Lenalidomide Accord works
Croatian: Kako Lenalidomid Accord djeluje
English: Lenalidomide Accord 7.5 mg are gelatin hard capsules size “4” approximately 14.0 mm to 14.8 mm in length, opaque lavender cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “7.5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 7,5 mg su želatinske tvrde kapsule veličine „4“ dugačke približno 14,0 mm do 14,8 mm, s neprozirnom kapicom boje lavande i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „7.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Resume lenalidomide at starting dose once daily
Croatian: Nastaviti s lenalidomidom pri početnoj dozi jednom dnevno
English: How to take Lenalidomide Accord 4.
Croatian: Kako uzimati Lenalidomid Accord 4. Moguće nuspojave
English: HR [95% CI]; p-value MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p Follow-up (months) Median (min, max): all patients Investigator-assessed Myeloma response n (%) CR PR Stable Disease (SD) Response Not Evaluable (NE) Investigator-assessed Duration of response (CR+PR) (months) Mediana (95% CI)
Croatian: Praćenje (mjeseci) Medijan (min, maks): svi bolesnici Odgovor mijeloma prema procjeni ispitivača n (%) CR PR Stabilna bolest (SD) Odgovor se ne može procijeniti (NE) Trajanje odgovora (CR+PR) prema procjeni ispitivača (mjeseci) Medijana (95 % CI)
English: First fall to < 0.5 x 109/L
Croatian: Prvi put padne na < 0,5 x 109/L
English: How and when to take lenalidomide swallow the capsules whole, preferably with water.
Croatian: • Kapsule progutajte cijele, po mogućnosti s vodom.
English: Lenalidomide Accord 15 mg hard capsules
Croatian: Lenalidomid Accord 15 mg tvrde kapsule
English: Lenalidomide Accord 25 mg are gelatin hard capsules size “0” approximately 21.0 mm to 21.8 mm in length, white opaque cap and body with “LENALIDOMIDE” printed on cap in black and “25 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 25 mg su želatinske tvrde kapsule veličine „0“ dugačke približno 21,0 mm do 21,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „25 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: The study was unblinded upon the recommendations of the data monitoring committee after surpassing the threshold for a preplanned interim analysis of PFS. After unblinding, patients in the placebo arm were allowed to cross over to receive lenalidomide before disease progression.
Croatian: Nakon otkrivanja slijepe šifre ispitivanja, bolesnici u skupini placeba mogli su preći u skupinu lenalidomida prije napredovanja bolesti.
English: Lenalidomide Accord 10 mg hard capsules EU/1/18/1316/006
Croatian: Lenalidomid Accord 10 mg tvrde kapsule EU/1/18/1316/006
English: Lenalidomide Accord 5 mg hard capsules
Croatian: Lenalidomid Accord 5 mg tvrde kapsule
English: Lenalidomide Accord 7.5 mg hard capsules:
Croatian: Lenalidomid Accord 7,5 mg tvrde kapsule:
English: Lenalidomide Accord 20 mg are gelatin hard capsules size “1” approximately 19.0 mm to 19.8 mm in length, opaque green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “20 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 20 mg su želatinske tvrde kapsule veličine „1“ dugačke približno 19,0 do 19,8 mm, s neprozirnom zelenom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „20 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Return to ≥ 50 x 109/L
Croatian: Vrati se na ≥ 50 x 109/L
English: Resume lenalidomide at next lower dose level (dose level -1, -2 or -3) once daily.
Croatian: Nastaviti s lenalidomidom pri sljedećoj nižoj razini doze (1., 2. ili 3. razina doze) jednom dnevno; ne primjenjivati doze ispod 5 mg jednom dnevno
English: • Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless,
Croatian: • bol u prsnom košu koji se širi u ruke, vrat, čeljust, leđa ili želudac, osjećaj oznojenosti i nedostatka zraka, osjećaj mučnine ili povraćanje - to mogu biti simptomi srčanog udara (infarkt miokarda)
English: Lenalidomide Accord 15 mg hard capsules:
Croatian: Lenalidomid Accord 15 mg tvrde kapsule:
English: Excipient with known effect Each hard capsule contains50 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 50 mg laktoze.
English: Excipient with known effect Each hard capsule contains100 mg of lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 100 mg laktoze.
English: • Stroke, fainting
Croatian: • moždani udar, nesvjestica
English: Gelatin hard capsules size “0” approximately 21.0 mm to 21.8 mm in length, white opaque cap and body with “LENALIDOMIDE” printed on cap in black and “25 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „0“ dugačke približno 21,0 mm do 21,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „25 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Lenalidomide Accord 2.5 mg hard capsules EU/1/18/1316/001
Croatian: Lenalidomid Accord 2,5 mg tvrde kapsule EU/1/18/1316/001
English: Gelatin hard capsules size “4” approximately 14.0 mm to 14.8 mm in length, opaque lavender cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “7.5 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Želatinske tvrde kapsule veličine „4“ dugačke približno 14,0 mm do 14,8 mm, s neprozirnom kapicom boje lavande i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „7.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: Lenalidomide Accord 7.5 mg hard capsules EU/1/18/1316/005
Croatian: Lenalidomid Accord 7,5 mg tvrde kapsule EU/1/18/1316/005
English: Dose level- 4
Croatian: 4. razina doze
English: For men taking lenalidomide
Croatian: Za muškarce koji uzimaju lenalidomid
English: • Posology
Croatian: • žgaravica
English: Lenalidomide Accord 10 mg are gelatin hard capsules size “3” approximately 15.4 mm to 16.2 mm in length, leaf green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “10 mg” printed on body in green, containing white to off white coloured powder.
Croatian: Lenalidomid Accord 10 mg su želatinske tvrde kapsule veličine „3“ dugačke približno 15,4 do 16,2 mm, sa zelenom kapicom boje lista i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „10 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
English: There have been rare reports of TLS in patients with MM treated with lenalidomide.
Croatian: Sindrom lize tumora rijetko je zabilježen u bolesnika s multiplim mijelomom liječenih lenalidomidom.