FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactivation of hepatitis B has been reported rarely in patients receiving lenalidomide who have previously been infected with the hepatitis B virus (HBV).
Maltese: L-attivazzjoni mill-ġdid tal-epatite B ġiet irrappurtata b'mod rari f'pazjenti li kienu qed jirċievu lenalidomide li fil-passat kienu infettati bil-virus tal-epatite B (HBV).
English: Dose level- 4
Maltese: Livell tad-doża -4
English: • Rejection of solid organ transplant (such as kidney, heart).
Maltese: • Rifjut ta' trapjant ta' organu solidu (bħal kilwa, qalb).
English: Patients should be carefully assessed for their ability to tolerate lenalidomide in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min (see sections 4.2 and 4.8).
Maltese: Il-pazjenti għandhom JIGU evalwati b'attenzjoni għal ħila tagħhom li jittolleraw lenalidomide flimkien ma' mediċina oħra, u għandha tingħata konsiderazzjoni għall-età, ISS stadju III, ECOG PS≤2 jew CLcr<60 mL/min (ara sezzjoni 4.2 u 4.8).
English: This study investigated the use of combination therapy of MPR (melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles; prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles; and lenalidomide 10 mg/day orally on days 1 to 21 of repeated 28-day cycles) for induction therapy, up to 9 cycles.
Maltese: Dan l-istudju investiga l-użu ta' terapija kombinata ta' MPR (melphalan 0.18 mg/kg mill-ħalq f'jiem 1 sa 4 ta' ċikli ripetuti ta' 28 jum; prednisone 2 mg/kg mill-ħalq f'jiem 1 sa 4 ta' ċikli ripetuti ta' 28 jum; u lenalidomide mill-ħalq 10 mg/jum f'jiem 1 sa 21 ta' ċikli ripetuti ta' 28 jum) għal terapija ta' induzzjoni, għal sa 9 ċikli.
English: Starting dose
Maltese: Doża rakkomandata
English: Not Known Solid organ transplant rejection
Maltese: Mhux Magħrufa Rifjut ta' trapjant ta' organu solidu
English: Grade 4 febrile neutropenia was observed infrequently (0.6% in Rd and Rd18 compared with 0.7% in MPT).
Maltese: Newtropenija ta' grad 4 bid-deni ġiet osservata b'mod mhux frekwenti (0.6% f'Rd u Rd18 meta mqabbla ma' 0.7% f'MPT).
English: Endocrine Disorders
Maltese: Disturbi fis-Sistema Endokrinarja
English: Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b
Maltese: Rispons totali: CR, VGPR, jew PR Tul tar-rispons (xhur) Medjana (95% CI)h
English: ^See section 4.8 description of selected adverse reactions
Maltese: ^ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Acute hepatic failure^, Hepatitis toxic^, Cytolytic hepatitis^, Cholestatic hepatitis^, Mixed cytolytic/cholestatic hepatitis^
Maltese: Insuffiċjenza akuta tal-fwied^,@, Epatite tossika^, Epatite ċitolitika^, Epatite kolestatika^, Epatite ċitolitika mħallta/kolestatika^
English: Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Maltese: L-għoti fl-istess ħin b'10 mg darba kuljum ta' lenalidomide żied l-espożizzjoni tal-plażma ta' digoxin (0.5 mg, doża waħda) b'14% b'90% CI (intervall tal-kunfidenza) [0.52%-28.2%].
English: • Tubal sterilisation
Maltese: • Sterilizzazzjoni tat-tubi
English: Lenalidomide Accord 2.5 mg, Lenalidomide Accord 5 mg, Lenalidomide Accord 10 mg and Lenalidomide Accord 15 mg hard capsules
Maltese: Lenalidomide Accord 2.5 mg, Lenalidomide Accord 5 mg, Lenalidomide Accord 10 mg u Lenalidomide Accord 15 mg kapsuli ibsin
English: • That Lenalidomide Accord may cause venous and arterial thromboembolism
Maltese: • Li Lenalidomide Accord jista' jikkawża tromboemboliżmu venuż u arterjali
English: Prophylactic antithrombotic medicinal products should be recommended, especially in patients with additional thrombotic risk factors.
Maltese: Prodotti mediċinali antitrombotiċi profilattiċi, għandhom ikunu rakkomandati, b'mod speċjali f'pazjenti b'fatturi ta' riskju trombotiċi addizzjonali.
English: Odds ratio [95% CI], p-value b
Maltese: Proporzjon tal-odds [95% CI], valur p b
English: Lenalidomide has a potential for acute toxicity; minimum lethal doses after oral administration were > 2000 mg/kg/day in rodents.
Maltese: Lenalidomide għandu l-potenzjal għal tossiċità akuta; id-dożi minimi letali wara l-għoti mill-ħalq kienu ta' > 2000 mg/kg/kuljum f'annimali gerriema.
English: There is an increased risk of rhabdomyolysis when statins are administered with lenalidomide, which may be simply additive.
Maltese: Hemm żieda fir-riskju ta' rabdomijolożi meta statins jiġu mogħtija ma' lenalidomide, liema riskju jista' jkun sempliċiment addizzjonali.
English: Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Maltese: Lenalidomide hu strutturalment relatat ma' thalidomide li hu magħruf li jikkawża newropatija periferali severa.
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.
Maltese: Studju dwar il-fertilità fil-firien b'dożi ta' lenalidomide sa 500 mg/kg (madwar 200 u 500 darba taddożi umani ta' 25 mg u 10 mg, rispettivament, ibbażat fuq l-erja tas-superfiċje tal-ġisem) ma pproduċiet l-ebda effetti avversi fuq il-fertilità u l-ebda tossiċità lill-ġenituri.
English: Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
Maltese: Minħabba li lenalidomide għandu attività anti-neoplastika, il-kumplikazzjonijiet tas-sindromu tal-lisi tat-tumur (TLS) jistgħu jseħħu.
English: Pregnancy testing
Maltese: Testijiet u ċċekkjar
English: An absence of the intermediate lobe of the lung was observed at 10 and 20 mg/kg/day with dose dependence and displaced kidneys were observed at 20 mg/kg/day.
Maltese: L-assenza tal-lobu intermedju tal-pulmun kienet osservata f'dożi ta' 10 u 20 mg/kg/kuljum, b'dipendenza fuq id-doża, u kliewi li ma kienux f'posthom kienu osservati f'doża ta' 20 mg/kg/kuljum.
English: Lenalidomide Accord 10 mg and Lenalidomide Accord 20 mg hard capsules Gelatin
Maltese: Lenalidomide Accord 10 mg u Lenalidomide Accord 20 mg kapsuli ibsin Gelatin
English: Each capsule contains 20 mg of lenalidomide.
Maltese: Kull kapsula fiha 20 mg ta' lenalidomide.
English: The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance > 50 mL/min to more than 9 hours in subjects with reduced renal function < 50 mL/min.
Maltese: Il-half-life ta' lenalidomide żdidet minn madwar 3.5 sigħat f'pazjenti bi tneħħija tal-kreatinina ta' > 50 mL/min sa iktar minn 9 sigħat f'pazjenti b'funzjoni mnaqqsa renali ta' < 50 mL/min.
English: • Cloudy vision (cataract)
Maltese: • Vista mċajpra (katarretti)
English: Grade 4 febrile neutropenia episodes were consistent with the comparator arm (0.6 % in the Rd and Rd18 lenalidomide/dexamethasone-treated patients compared with 0.7% in the melphalan/prednisone/thalidomide arm, see section 4.8).
Maltese: Episodji ta' newtropenija bid-deni ta' grad 4 kienu konsistenti mal-parti tal-istudju dwar il-komparatur (0.6% f'pazjenti kkurati bl-Rd u Rd18 lenalidomide/dexamethasone meta mqabbla ma' 0.7% fil-parti tal-istudju dwar melphalan/prednisone/thalidomide, ara sezzjoni 4.8).
English: Patients in the placebo/dexamethasone (placebo/dex) group took 1 placebo capsule on days 1 to 28 of each 28-day cycle.
Maltese: Il-pazjenti fil-grupp tal-plaċebo/dexamethasone (plaċebo/dex) ħadu kapsula 1 tal-plaċebo f'jiem 1 sa 28 f'kull ċiklu ta' 28 jum.
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).
Maltese: g L-aħjar evalwazzjoni ta' rispons aġġudikat matul il-fażi ta' kura tal-studju (għad-definizzjonijiet ta' kull kategorija ta' rispons, Data tal għeluq għad-dejta = 24 ta' Mejju, 2013).
English: Lenalidomide Accord contains lactose.
Maltese: Lenalidomide Accord fih lactose.
English: The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles.
Maltese: Id-doża tal-bidu rakkomandata hija lenalidomide 10 mg darba kuljum mill-ħalq f'jiem 1 sa 21 ta' ċikli ripetuti ta' 28 jum għal sa 9 ċikli, melphalan 0.18 mg/kg mill-ħalq f'jiem 1 sa 4 ta' ċikli ripetuti ta' 28 jum, prednisone 2 mg/kg mill-ħalq f'jiem 1 sa 4 ta' ċikli ripetuti ta' 28 jum.
English: Specifically, lenalidomide inhibits proliferation of certain haematopoietic tumour cells (including MM plasma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells, inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of microvessels, augments foetal haemoglobin production by CD34+ haematopoietic stem cells, and inhibits production of pro-inflammatory cytokines (e.g., TNF-αand IL-6) by monocytes.
Maltese: Speċifikament, lenalidomide jinibixxi l-proliferazzjoni ta' ċerti ċelluli ematopojetiċi tat-tumur (li jinkludu celluli ta'tumur MM plażma u dawk bi tħassir fi kromosoma 5), itejjeb l-immunità medjata taċ-ċelluli T u Natural Killer (NK) u jżid in-numru ta' ċelluli NKT, jinibixxi l-anġjoġenesi billi jimblokka l-migrazzjoni u l-adeżjoni ta' ċelluli endoteljali u l-formazzjoni ta' microvessels, iżid il-produzzjoni ta' l-emoglobina tal-fetu miċ-ċelluli staminali ematopojetiċi CD34+, u jinibixxi l-produzzjoni ta' cytokines pro-infjammatorji (eż., TNF-α u IL-6) minn monocytes.
English: The serious adverse reactions observed more frequently (≥5%) with melphalan, prednisone and lenalidomide followed by lenalidomide maintenance (MPR+R) or melphalan, prednisone and lenalidomide followed by placebo (MPR+p) than melphalan, prednisone and placebo followed by placebo (MPp+p) were:
Maltese: Ir-reazzjonijiet avversi serji osservati b'mod aktar frekwenti (≥5%) b'melphalan prednisone, u lenalidomide segwiti minn manteniment b'lenalidomide (MPR+R) jew melphalan prednisone, u lenalidomide segwiti minn plaċebo (MPR+p) milli b'melphalan, prednisone u plaċebo segwiti minn plaċebo (MPp+p) kienu:
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (li jaffettwaw sa persuna 1 minn kull 1,000):
English: CI = confidence interval; CR = complete response; HR = Hazard Rate; M = melphalan; NE = not estimable; OS = overall survival; p = placebo; P = prednisone;
Maltese: HR = Proporzjoni ta' Periklu; M = melphalan; NE = mhux estimabbli; OS = sopravivenza globali; p = plaċebo; P = prednisone;
English: (95% CI 88.8, NE) in the lenalidomide arm versus 88.1 months (95% CI 80.7, 108.4) in the placebo arm.
Maltese: 8 NE) filparti tal-istudju dwar lenalidomide, kontra 88.1 xhur (95% CI 80.7, 108.4) fil-parti tal-istudju dwar ilplaċebo.
English: double-blind, placebo-controlled, parallel-group controlled studies (MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients with multiple myeloma.
Maltese: III, multi-centre, randomised, double-blind, ikkontrollati bil-plaċebo, ikkontrollati bil parallel-group (MM-009 u MM010) b'terapija ta' lenalidomide flimkien ma' dexamethasone kontra dexamethasone waħdu f'pazjenti b'majeloma multipla, li qabel kienu kkurati.
English: Therefore, lenalidomide is unlikely to cause any clinically relevant medicinal product interactions when co-administered with substrates of these enzymes.
Maltese: Għalhekk, lenalidomide mhux probabbli li se jikkawża kwalunkwe interazzjonijiet klinikament rilevanti meta jingħata flimkien ma' substrati ta' dawn l-enzimi.
English: Medianf (min, max), months: all surviving patients
Maltese: Medjan (min, max): il-pazjenti kollha
English: Lenalidomide Accord 7.5 mg, Lenalidomide Accord 20 mg and Lenalidomide Accord 25 mg hard capsules
Maltese: Lenalidomide Accord 7.5 mg, Lenalidomide Accord 20 mg u Lenalidomide Accord 25 mg kapsuli ibsin
English: 5 mg (days 1-21 every 28 days) Do not dose below 5 mg (days 1-21 every 28 days)
Maltese: 5 mg (jiem 1-21 kull 28 jum) Tagħtix doża inqas minn 5 mg (jiem 1-21 kull 28 jum)
English: In the IFM 2005-02 study, the adverse reactions observed more frequently with lenalidomide maintenance than placebo were neutropenia (60.8%), bronchitis (47.4%), diarrhoea (38.9%), nasopharyngitis (34.8%), muscle spasms (33.4%), leucopenia (31.7%), asthenia (29.7%), cough (27.3%), thrombocytopenia (23.5%), gastroenteritis (22.5%) and pyrexia (20.5%).
Maltese: Fl-istudju IFM 2005-02, ir-reazzjonijiet avversi osservati aktar ta' spiss bid-doża ta' manteniment ta' lenalidomide milli bi plaċebo kienu newtropenija (60.8%), bronkite (47.4%), dijarea (38.9%), nażofarinġite (34.8%), spażmi tal-muskoli (33.4%), lewkopenija (31.7%), astenija (29.7%), sogħla (27.3%), tromboċitopenija (23.5%), gastroenterite (22.5%) u deni (20.
English: The contribution of renal excretion to total clearance in subjects with normal renal function was 90%, with 4% of lenalidomide eliminated in faeces.
Maltese: Il-kontribut tal-eliminazzjoni renali għat-tneħħija totali f'pazjenti b'funzjoni renali normali kienet ta' 90%, b'4% ta' lenalidomide li jitneħħa fl-ippurgar.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (li jistgħu jaffettwaw sa 1 minn kull 100 persuna):
English: If dose increased (15 mg) a
Maltese: Jekk id-doża tiżdied (15-il mg) a
English: • Algorithm for implementation of PPP
Maltese: • Algorithm għall-implimentazzjoni tal-PPP
English: Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with medicinal products that inhibit cytochrome P450 enzymes is not likely to result in metabolic medicinal product interactions in humans.
Maltese: Riżultati minn studji dwar il-metaboliżmu uman in vitro jindikaw li lenalidomide ma jkunx metabolizzat mill-enzimi ta' ċitokrom P450 li tissuġġerixxi li l-għoti ta' lenalidomide ma' prodotti mediċinali li jinibixxu l-enzimi ta' ċitokrom P450 x'aktarx li mhux se tirriżulta f'interazzjonijiet metaboliċi tal-prodott mediċinali fil-bniedem.
English: • Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with melphalan and prednisone The combination of lenalidomide with melphalan and prednisone in clinical trials of newly diagnosed multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (34.1% in melphalan, prednisone and lenalidomide arm followed by lenalidomide [MPR+R] and melphalan, prednisone and lenalidomide followed by placebo [MPR+p] treated patients compared with 7.8% in MPp+p-treated patients; see section 4.8).
Maltese: • Majeloma multipla ddijanjostikata għall-ewwel darba: pazjenti li ma jkunux eliġibbli għal trapjanti kkurati b'lenalidomide flimkien ma' melphalan u prednisone Il-kombinazzjoni ta' lenalidomide ma' melphalan u prednisone fil-provi kliniċi ta' pazjenti ddijanjostikati għall-ewwel darba b'majeloma multipla, hi assoċjata ma' inċidenza ogħla ta' newtropenija ta' grad 4 (34.1% fil-parti tal-istudju dwar melphalan, prednisone u lenalidomide, segwita minn lenalidomide [MPR+R] u melphalan, prednisone u lenaldiomide, segwiti minn pazjenti kkurati bi plaċebo [MPR+p] meta mqabbla ma' 7.8% f'pazjenti kkurati b'MPp+p; ara sezzjoni 4.8).
English: A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Maltese: Reazzjoni inkroċjata possibbli bejn lenalidomide u thalidomide kienet irrappurtata fil-letteratura medika.
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:
Maltese: Ir-reazzjonijiet avversi serji osservati b'mod aktar frekwenti (≥5%) b'lenalidomide flimkien ma' doża baxxa ta' dexamethasone (Rd u Rd18) milli b'melphalan, prednisone u thalidomide (MPT) kienu:
English: • Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials
Maltese: • Deskrizzjoni u ġestjoni ta' newtropenja u tromboċitopenja inkluż rati ta' inċidenza minn provi kliniċi
English: The following information should also be provided in the appropriate brochure:
Maltese: L-informazzjoni li ġejja għandha tiġi pprovduta wkoll fil-pamflet adattat:
English: Multiple dosing does not cause marked medicinal product accumulation.
Maltese: Dożaġġ multiplu ma jikkawżax akkumulazzjoni notevoli talprodott mediċinali.
English: Multiple myeloma - in patients who have had treatment before Lenalidomide Accord is taken together with an anti-inflammatory medicine called ‘dexamethasone'.
Maltese: Majeloma multipla - f'pazjenti li rċivew kura fil-passat Lenalidomide Accord jittieħed flimkien ma' mediċina kontra l-infjammazzjoni msejħa ‘dexamethasone'.
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.
Maltese: Filgrupp li rċieva lenalidomide/doża baxxa ta' dexamethasone, 20 pazjent (9.1%) kellhom mill-inqas interruzzjoni waħda tad-doża meta mqabbla ma' 65 pazjent (29.3%) fil-parti tal-istudju li fih ilpazjenti rċivew lenalidomide/doża standard ta' dexamethasone.
English: A majority of lenalidomide is eliminated through urinary excretion.
Maltese: Il-maġġoranza ta' lenalidomide jiġi eliminat b'eliminazzjoni urinarja.
English: Mediana PFS2 time, months (95% CI) b HR [95% CI]c ; p-valued
Maltese: Żmien PFS2 medjana, xhur (95% CI)b HR [95% CI c; valur pd
English: Cases of allergic reaction/hypersensitivity reactions have been reported.
Maltese: Każijiet ta' reazzjonijiet allerġiċi/sensittività eċċessiva kienu rrappurtati.
English: The median age was 71 in the MPR+R and MPR+p arms and 72 in the MPp+p arm.
Maltese: Il-medjan tal-età kien ta' 71 sena fil-parti tal-istudju dwar MPR+R u MPR+p, u 72 sena fil-parti tal-istudju dwar MPp+p.
English: • Ringing in the ears (tinnitus)
Maltese: • Żanżin fil-widnejn (tinnitus)
English: The median duration of treatment was 44.0 weeks (min: 0.1, max: 254.9) for len/dex and 23.1 weeks (min: 0.3, max: 238.1) for placebo/dex.
Maltese: Il-medjan tat-tul ta' żmien tal-kura kien ta' 44.0 ġimgħa (minimu: 0.1, massimu: 254.9) għal len/dex u 23.1 ġimgħat (minimu: 0.3, massimu: 238.1) għal plaċebo/dex.
English: Patients between 18 and 70 years of age with active MM requiring treatment and without prior progression after initial therapy were eligible.
Maltese: Pazjenti bejn it-18 u s-70 sena b'MM attiva li kienu jeħtieġu kura u mingħajr progressjoni fil-passat wara t-terapija inizjali, kienu eliġibbli.
English: • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
Maltese: • Hi tifhem il-ħtieġa li tibda l-kura malli tingħata lenalidomide wara test tat-tqala negattiv
English: In patients with multiple myeloma, the combination of lenalidomide with dexamethasone is associated with an increased risk of arterial thromboembolism (predominantly myocardial infarction and cerebrovascular event) and was seen to a lesser extent with lenalidomide in combination with melphalan and prednisone.
Maltese: F'pazjenti b'majeloma multipla, il-kombinazzjoni ta' lenalidomide ma' dexamethasone hi assoċjata ma' żieda fir-riskju ta' tromboemboliżmu arterjali (l-aktar, infart mijokardijaku u avveniment ċerebrovasculari) u ġie osservat fi grad anqas b'lenalidomide flimkien ma' melphalan u prednisone.
English: Co-administration of multiple doses of the strong P-gp inhibitor quinidine (600 mg, twice daily) or the moderate P-gp inhibitor/substrate temsirolimus (25 mg) has no clinically relevant effect on the pharmacokinetics of lenalidomide (25 mg).
Maltese: L-għoti flimkien ta' dożi multipli mal-inibitur qawwi ta' P-gp quinidine (600 mg, darbtejn kuljum) jew l-inibitur/substrat moderat ta' P-gp temsirolimus (25 mg), m'għandu l-ebda effett klinikament rilevanti fuq ilfarmakokinetika ta' lenalidomide (25 mg).
English: Investigator-assessed PFS Mediana PFS time, months (95% CI)b HR [95% CI]c; p-valued PFS2e
Maltese: PFS evalwata mill-Investigatur Żmien PFS medjana, xhur (95% CI)b HR [95% CI]c; valur pd PFS2e
English: e Exploratory endpoint (PFS2) f The median is the univariate statistic without adjusting for censoring.
Maltese: e Punt aħħari esploratorju (PFS2) f Il-medjan hu l-istatistika univarjata mingħajr aġġustament għaċ-ċensura.
English: In clinical trials of newly diagnosed multiple myeloma patients not eligible for transplant, a 4.9-fold increase in incidence rate of hematologic SPM (cases of acute myeloid leukaemia [AML], myelodysplastic syndrome [MDS)]) has been observed in patients receiving lenalidomide in combination with melphalan and prednisone until progression (1.75 per 100 person-years) compared with melphalan in combination with prednisone (0.36 per 100 person-years).
Maltese: Fi provi kliniċi ta' majeloma multipla ddijanjostikata għall-ewwel darba f'pazjenti li mhumiex eliġibbli għal trapjant, ġiet osservata żieda ta' 4.9 darbiet fir-rata ta' inċidenza ta' SPM ematoloġika (każijiet ta' lewkimja majelojde akuta [AML], sindrome majelodisplastiku [MDS]) f'pazjenti li kienu qed jirċievu lenalidomide flimkien ma' melphalan u prednisone sal-progressjoni (1.75 għal kull 100 sena ta' persuna) meta mqabbel ma' melphalan flimkien ma' prednisone (0.36 għal kull 100 sena ta' persuna).
English: In patients, as well as in healthy volunteers, the maximum concentration (Cmax) and area-under-theconcentration time curve (AUC) increase proportionally with increases in dose.
Maltese: Fil-pazjenti, kif ukoll f'voluntiera b'saħħithom, il-konċentrazzjoni massima (Cmax) u ż-żona taħt il-kurva konċentrazzjoni-ħin (area under the concentration time curve - AUC) jiżdiedu proporzjonalment ma' żiedet fid-doża.
English: Population pharmacokinetic analyses included patients with mild hepatic impairment (N=16, total bilirubin >1 to ≤1.5 x ULN or AST > ULN) and indicate that mild hepatic impairment does not influence lenalidomide clearance (exposure in plasma).
Maltese: Analiżi farmakokinetika tal-popolazzjoni kienet tinkludi pazjenti b'indeboliment ħafif tal-fwied (N=16, bilirubina totali ta' >1 sa ≤1.5 x ULN jew AST > ULN) u tindika li indeboliment ħafif talfwied ma jinfluwenzax it-tneħħija ta' lenalidomide.
English: Lenalidomide Accord contains lactose
Maltese: Lenalidomide Accord fih lactose
English: How and when to take lenalidomide swallow the capsules whole, preferably with water.
Maltese: • Ibla' l-kapsuli lenalidomide sħaħ, preferibbilment ma' l-ilma.
English: • Dose is modified based upon clinical and laboratory findings (see section 4.4).
Maltese: • Id-doża tinbidel skont ir-riżultati kliniċi u tal-laboratorju (ara sezzjoni 4.4).
English: Severe renal impairment (CLcr < 30 mL/min, not requiring dialysis)
Maltese: Indeboliment sever renali (CLcr < 30 mL/min, li ma teħtieġx id-dijaliżi)
English: Dose level -1
Maltese: Livell tad-doża -1
English: Common Diarrhoea, Vomiting, Nausea
Maltese: Ipokalemija, Deidratazzjoni
English: Lenalidomide Accord 5 mg and Lenalidomide Accord 25 mg hard capsules Gelatin
Maltese: Lenalidomide Accord 5 mg u Lenalidomide Accord 25 mg kapsuli ibsin Gelatin
English: Gastrointestinal perforations have been reported during treatment with lenalidomide.
Maltese: Perforazzjonijiet gastrointestinali ġew irrappurtati matul il-kura b'lenalidomide.
English: Population pharmacokinetic analyses included patients with ages ranging from 39 to 85 years old and indicate that age does not influence lenalidomide clearance (exposure in plasma).
Maltese: Analiżi farmakokinetika tal-popolazzjoni kienet tinkludi pazjenti f'etajiet li kienu jvarjaw minn 39 sa 85 sena u jindikaw li l-età ma tinfluwenzax it-tneħħija ta' lenalidomide.