natgillin/translations-raw huggingface dataset:
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).
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).
Grade 3-4 ADRs/Frequency
Nuspojave na lijek 3. do 4. stupnja / učestalost
Lenalidomide Accord 15 mg hard capsules lenalidomide
Lenalidomid Accord 15 mg tvrde kapsule lenalidomid
ADRs reported in clinical trials in patients with multiple myeloma treated with lenalidomide maintenance therapy
Nuspojave lijeka prijavljene u kliničkim ispitivanjima u bolesnika s multiplim mijelomom liječenih terapijom održavanja lenalidomidom Klasifikacija organskih sustava / preporučeni pojam
Respiratory, Thoracic and Mediastinal Disorders
Poremećaji dišnog sustava, prsišta i sredoprsja
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).
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).
Each capsule contains 2.5 mg of lenalidomide.
Jedna kapsula sadrži 2,5 mg lenalidomida.
EU/1/18/1316/010 21x1 hard capsules
EU/1/18/1316/010 21x1 tvrda kapsula
EU/1/18/1316/011 21x1 hard capsules
EU/1/18/1316/011 21x1 tvrda kapsula
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.
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.
Lenalidomide Accord 20 mg hard capsules
Lenalidomid Accord 20 mg tvrde kapsule
Each capsule contains 7.5 mg of lenalidomide.
Jedna kapsula sadrži 7,5 mg lenalidomida.
Dose level -2
2. razina doze
How to store Lenalidomide Accord
Kako čuvati Lenalidomid Accord
Dose level -5
5. razina doze
Return to ≥ 25 x 109/L
Vrati se na ≥ 25 x 109/L
• Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
• Sažetak opisa svojstava lijeka, uputu o lijeku i označivanje.
Return to ≥ 0.5 x 109/L
Povrat na ≥ 0,5 x 109/L
Eye Disorders
Poremećaji oka
Co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Potreban je oprez kod istodobne primjene lenalidomida s drugim mijelosupresivnim lijekovima.
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.
Korist u smislu preživljenja bez progresije bolesti opažena je u podskupini bolesnika s potpunim odgovorom i u podskupini bolesnika koji nisu postigli potpuni odgovor.
Brochure for women patients with childbearing potential
Knjižica za bolesnice u reproduktivnoj dobi
Excipient with known effect Each hard capsule contains 36 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 36 mg laktoze.
ADRs reported in clinical studies in patients with multiple myeloma treated with lenalidomide in combination with dexamethasone, or with melphalan and prednisone System Organ
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
Lenalidomide Accord 10 mg hard capsules
Lenalidomid Accord 10 mg tvrde kapsule
Common Hypothyroidism
Često hipotireoidizam
Lenalidomide Accord 5 mg hard capsules Each hard capsule contains 5 mg of lenalidomide.
Lenalidomid Accord 5 mg tvrde kapsule Jedna tvrda kapsula sadrži 5 mg lenalidomida.
Return to ≥ 30 x 109/L
Povrat na ≥30 x 109/L
Each capsule contains 25 mg of lenalidomide.
Jedna kapsula sadrži 25 mg lenalidomida.
Progression free survival Median [95% CI], weeks
Preživljenje bez napredovanja bolesti Medijan [95 % CI], tjedni p < 0,001
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.
40 mg peroralno jednom dnevno od 1. do 4. dana svakog 28-dnevnog ciklusa liječenja.
First fall to < 0.5 x 109/Lª
Prvi put padne na < 0,5 x 109/Lª
Lenalidomide Accord 15 mg hard capsules Each hard capsule contains 15 mg of lenalidomide.
Lenalidomid Accord 15 mg tvrde kapsule Jedna kapsula sadrži 15 mg lenalidomida.
Lenalidomide Accord 2.5 mg hard capsules
Lenalidomid Accord 2,5 mg tvrde kapsule
Lenalidomide Accord 2.5 mg hard capsules:
Lenalidomid Accord 2,5 mg tvrde kapsule:
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.
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.
Lenalidomide Accord 25 mg hard capsules EU/1/18/1316/011
Lenalidomid Accord 25 mg tvrde kapsule EU/1/18/1316/011
Lenalidomide Accord 20 mg hard capsules EU/1/18/1316/010
Lenalidomid Accord 20 mg tvrde kapsule EU/1/18/1316/010
Excipient with known effect Each hard capsule contains134 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 134 mg laktoze.
Tabulated summary of post-marketing adverse reactions
Sažeti tablični prikaz nuspojava zabilježenih nakon stavljanja lijeka u promet
Lenalidomide treatment must not be started if the ANC is < 1.5 x 109/L, and/or platelet counts are < 75 x 109/L.
Liječenje lenalidomidom ne smije se započeti ako je ABN < 1,5 x 109/L i/ili broj trombocita < 75 x 109/L.
Lenalidomide Accord 25 mg hard capsules
Lenalidomid Accord 25 mg tvrde kapsule
Each capsule contains 10 mg of lenalidomide.
Jedna kapsula sadrži 10 mg lenalidomida.
Common Abnormal liver function tests
Često abnormalni testovi jetrene funkcije
Each capsule contains 15 mg of lenalidomide.
Jedna kapsula sadrži 15 mg lenalidomida.
Each capsule contains 5 mg of lenalidomide.
Jedna kapsula sadrži 5 mg lenalidomida.
Lenalidomide Accord 10 mg hard capsules:
Lenalidomid Accord 10 mg tvrde kapsule:
Lenalidomide Accord 7.5 mg hard capsules
Lenalidomid Accord 7,5 mg tvrde kapsule
Lenalidomide treatment must not be started if the ANC is < 1.0 x 109/L, and/or platelet counts are < 50 x 109/L.
Liječenje lenalidomidom ne smije se započeti ako je ABN < 1,0 x 109/L i/ili broj trombocita < 50 x 109/L.
Dose level -3
3. razina doze
WARNING: Risk of severe birth defects.
• opis rizika od pojave druge primarne zloćudne bolesti.
How Lenalidomide Accord works
Kako Lenalidomid Accord djeluje
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.
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.
Resume lenalidomide at starting dose once daily
Nastaviti s lenalidomidom pri početnoj dozi jednom dnevno
How to take Lenalidomide Accord 4.
Kako uzimati Lenalidomid Accord 4. Moguće nuspojave
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)
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)
First fall to < 0.5 x 109/L
Prvi put padne na < 0,5 x 109/L
How and when to take lenalidomide swallow the capsules whole, preferably with water.
• Kapsule progutajte cijele, po mogućnosti s vodom.
Lenalidomide Accord 15 mg hard capsules
Lenalidomid Accord 15 mg tvrde kapsule
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.
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.
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.
Nakon otkrivanja slijepe šifre ispitivanja, bolesnici u skupini placeba mogli su preći u skupinu lenalidomida prije napredovanja bolesti.
Lenalidomide Accord 10 mg hard capsules EU/1/18/1316/006
Lenalidomid Accord 10 mg tvrde kapsule EU/1/18/1316/006
Lenalidomide Accord 5 mg hard capsules
Lenalidomid Accord 5 mg tvrde kapsule
Lenalidomide Accord 7.5 mg hard capsules:
Lenalidomid Accord 7,5 mg tvrde kapsule:
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.
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.
Return to ≥ 50 x 109/L
Vrati se na ≥ 50 x 109/L
Resume lenalidomide at next lower dose level (dose level -1, -2 or -3) once daily.
Nastaviti s lenalidomidom pri sljedećoj nižoj razini doze (1., 2. ili 3. razina doze) jednom dnevno; ne primjenjivati doze ispod 5 mg jednom dnevno
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless,
• 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)
Lenalidomide Accord 15 mg hard capsules:
Lenalidomid Accord 15 mg tvrde kapsule:
Excipient with known effect Each hard capsule contains50 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 50 mg laktoze.
Excipient with known effect Each hard capsule contains100 mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 100 mg laktoze.
• Stroke, fainting
• moždani udar, nesvjestica
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.
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.
Lenalidomide Accord 2.5 mg hard capsules EU/1/18/1316/001
Lenalidomid Accord 2,5 mg tvrde kapsule EU/1/18/1316/001
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.
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.
Lenalidomide Accord 7.5 mg hard capsules EU/1/18/1316/005
Lenalidomid Accord 7,5 mg tvrde kapsule EU/1/18/1316/005
Dose level- 4
4. razina doze
For men taking lenalidomide
Za muškarce koji uzimaju lenalidomid
• Posology
• žgaravica
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.
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.
There have been rare reports of TLS in patients with MM treated with lenalidomide.
Sindrom lize tumora rijetko je zabilježen u bolesnika s multiplim mijelomom liječenih lenalidomidom.
A 1.3-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months (1.58 per 100 person-years) compared to thalidomide in combination with melphalan and prednisone (1.19 per 100 person-years).
U bolesnika koji su primali lenalidomid u kombinaciji s deksametazonom do napredovanja bolesti ili tijekom 18 mjeseci (1,58 na 100 osoba-godina), opažen je porast stope incidencije solidnih tumora kao drugih primarnih zloćudnih bolesti od 1,3 puta u usporedbi s talidomidom u kombinaciji s melfalanom i prednizonom (1,19 na 100 osoba-godina).
Excipientwith known effect Each hard capsule contains 67mg of lactose.
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 67 mg laktoze.
Resume lenalidomide at dose level -1 once daily
Nastaviti s lenalidomidom pri 1. razini doze jednom dnevno
Dose level -1
1. razina doze
Lenalidomide Accord 15 mg hard capsules EU/1/18/1316/008
Lenalidomid Accord 15 mg tvrde kapsule EU/1/18/1316/008
Lenalidomide Accord 15 mg are gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Lenalidomid Accord 15 mg su želatinske tvrde kapsule veličine „2“ dugačke približno 17,4 mm do 18,2 mm, s neprozirnom narančastom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „15 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
• Patient cards
• kartice za bolesnike
Lenalidomide Accord 2.5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Lenalidomid Accord 2,5 mg su želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, sa sivom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „2.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
Lenalidomide Accord 5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, opaque white cap and body with “LENALIDOMIDE” printed on cap in black and “5 mg” printed on body in green, containing white to off white coloured powder.
Lenalidomid Accord 5 mg su želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
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.
Želatinske tvrde kapsule veličine „1“ dugačke približno 19,0 mm 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.
HR [95% CI]c; p-valued Rd vs MPT
HR [95 % CI]c; p-vrijednostd
Gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Želatinske tvrde kapsule veličine „2“ dugačke približno 17,4 mm do 18,2 mm, s neprozirnom narančastom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „15 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
Patients in the Rd and Rd18 arms took lenalidomide 25 mg once daily on days 1 to 21 of 28-day cycles according to protocol arm. Dexamethasone 40 mg was dosed once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Bolesnici u skupinama Rd i Rd18 uzimali su lenalidomid 25 mg jednom dnevno od 1. do 21. dana 28-dnevnih ciklusa prema planu ispitivanja.
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.
Želatinske tvrde kapsule veličine „3“ dugačke približno 15,4 mm 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.
• The need to use condoms if sexual partner is pregnant or a WCBP not using effective contraceptions (even if man has had a vasectomy)
• potreba za uporabom prezervativa ako je partnerica trudna ili u reproduktivnoj dobi a ne primjenjuje djelotvornu metodu kontracepcije (čak i ako se muški partner podvrgnuo vazektomiji) o tijekom liječenja lijekom Lenalidomid Accord o tjedan dana nakon zadnje doze
Lenalidomide Accord 5 mg hard capsules EU/1/18/1316/003
Lenalidomid Accord 5 mg tvrde kapsule EU/1/18/1316/003
NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 10 mg hard capsules lenalidomide
Lenalidomid Accord 10 mg tvrde kapsule lenalidomid
NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 7.5 mg hard capsules lenalidomide
Lenalidomid Accord 7,5 mg tvrde kapsule lenalidomid
This may lead to very serious infection.
• oštećenje stijenke želuca ili crijeva, što može dovesti do vrlo ozbiljne infekcije.
Resume lenalidomide at next lower dose level
U sljedećem ciklusu liječenje nastaviti pri sljedećoj nižoj razini doze
Leucopenias
Trombocitopenija
Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, sa sivom kapicom i neprozirnim bijelim tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „2.5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, opaque white cap and body with “LENALIDOMIDE” printed on cap in black and “5 mg” printed on body in green, containing white to off white coloured powder.
Želatinske tvrde kapsule veličine „5“ dugačke približno 11,0 mm do 11,8 mm, s neprozirnom bijelom kapicom i tijelom, s crnim natpisom „LENALIDOMIDE“ na kapici i zelenim natpisom „5 mg“ na tijelu, koje sadrže bijeli do bjelkasti prašak.
Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171)
Lenalidomid Accord 15 mg tvrde kapsule želatina željezov oksid, crveni (E172) željezov oksid, žuti (E172) titanijev dioksid (E171)
Tumour flare reaction
Reakcija razbuktavanja tumora
capsule shell: gelatin, titanium dioxide (E171) printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
- tinta za označavanje: crna i zelena tinta (koja sadrži šelak, propilenglikol, željezov oksid, crni (E172), željezov oksid, žuti (E172), titanijev dioksid (E171), indigo karmin (E132) i kalijev hidroksid)
Overall survival (months) Mediana OS time, months (95% CI)b
PFS prema procjeni ispitivača (mjeseci) Medijana trajanja PFS-a, mjeseci (95 % CI)b
NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 25 mg hard capsules lenalidomide
Lenalidomid Accord 25 mg tvrde kapsule lenalidomid
Grade 3−4 ADRs/Frequency
Nuspojave lijeka 3. do 4. stupnja / učestalost
EU/1/18/1316/008 7x1 hard capsules EU/1/18/1316/009 21x1 hard capsules
EU/1/18/1316/008 7x1 tvrda kapsula EU/1/18/1316/009 21x1 tvrda kapsula
• if you have any signs of an infection, such as a cough or fever
• ako imate bilo kakve znakove infekcije kao što je kašalj ili vrućica
The median overall PFS was 44.4 months (39.6, 52.0) in the lenalidomide arm versus 23.8 months (95% CI 21.2, 27.3) in the placebo arm. For PFS2, the observed HR was 0.80 (95% CI 0.66, 0.98; p = 0.026) for lenalidomide versus placebo.
Medijan ukupnog PFS-a bio je 44,4 mjeseci (39,6; 52,0) u skupini lenalidomida naspram 23,8 mjeseci (95 % CI 21,2; 27,3) u skupini placeba.
NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 2.5 mg hard capsules lenalidomide
Lenalidomid Accord 2,5 mg tvrde kapsule lenalidomid
Iron oxide black (E172) Titanium dioxide (E171)
Lenalidomid Accord 2,5 mg tvrde kapsule želatina željezov oksid, crni (E172) titanijev dioksid (E171)
EU/1/18/1316/006 7x1 hard capsules EU/1/18/1316/007 21x1 hard capsules
EU/1/18/1316/006 7x1 tvrda kapsula EU/1/18/1316/007 21x1 tvrda kapsula
Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 4 neutropenia compared to placebo maintenance (32.1% vs 26.7% [16.1% vs 1.8% after the start of maintenance treatment] in CALGB 100104 and 16.4% vs 0.7% in IFM 2005-02, respectively).
naspram 26,7 % [16,1 % naspram 1,8 % nakon početka terapije održavanja] u ispitivanju CALGB 100104 i 16,4 % naspram 0,7 % u ispitivanju IFM 2005-02).
• Circulatory problems
• problemi s krvotokom
EU/1/18/1316/003 7x1 hard capsules EU/1/18/1316/004 21x1 hard capsules
EU/1/18/1316/003 7x1 tvrda kapsula EU/1/18/1316/004 21x1 tvrda kapsula
Lenalidomide Accord 5 mg and Lenalidomide Accord 25 mg hard capsules Gelatin
Lenalidomid Accord 5 mg i Lenalidomid Accord 25 mg tvrde kapsule želatina titanijev dioksid (E171)
• Muscle weakness
• slabost u mišićima
EU/1/18/1316/001 7x1 hard capsules EU/1/18/1316/002 21x1 hard capsules
EU/1/18/1316/001 7x1 tvrda kapsula EU/1/18/1316/002 21x1 tvrda kapsula
Renal impairment
Često vaskulitis