FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Tromboċitopenija ta' grad 3 u 4 ġiet osservata fi frekwenza ogħla fil-partijiet tal-istudju dwar ilmanteniment b'lenalidomide meta mqabbla mal-partijiet tal-istudju dwar il-manteniment bi plaċebo fi studji li evalwaw il-manteniment b'lenalidomide f'pazjenti b'NDMM li kellhom ASCT (37.5% vs 30.3% [17.9% vs 4.1% wara l-bidu tal-kura ta' manteniment] f'CALGB 100104 u 13.0% vs 2.9% f'IFM 2005-02, rispettivament).
English: Lenalidomide Accord 7.5 mg hard capsules
Maltese: Lenalidomide Accord 7.5 mg kapsuli ibsin
English: 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.
Maltese: Għall-PFS2, l-HR osservata kienet ta' 0.80 (95% CI 0.66, 0.98; p = 0.026) għal lenalidomide kontra l-plaċebo.
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Maltese: • Pilloli li jkun fihom il-progesterone biss li jinibixxu l-ovulazzjoni (i.e. desogestrel)
English: Lenalidomide Accord 5 mg hard capsules
Maltese: Lenalidomide Accord 5 mg kapsuli ibsin
English: Patients >75 years received a dexamethasone dose of 20 mg once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Maltese: Pazjenti li kellhom >75 sena rċivew doża ta' dexamethasone 20 mg darba kuljum f'jiem 1, 8, 15, u 22 ta' kull ċiklu ta' 28 jum.
English: 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.
Maltese: Lenalidomide Accord 15 mg huma kapsuli ibsin tal-gelatin daqs “2” ta' madwar tul ta' 17.4 mm sa 18.2mm, b'kappa oranġjo opaka u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bliswed u “15 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Lenalidomide Accord 2.5 mg hard capsules EU/1/18/1316/001
Maltese: Lenalidomide Accord 2.5 mg kapsuli ibsin EU/1/18/1316/001
English: EU/1/18/1316/005 21x1 hard capsules
Maltese: EU/1/18/1316/002 21x1 kapsuli ibsin
English: Fall to < 25 x 109/L
Maltese: Jaqgħu għal < 25 x 109/L
English: Return to ≥ 50 x 109/L
Maltese: Imorru lura għal ≥ 50 x 109/L
English: Counselling
Maltese: Accord
English: Lenalidomide Accord 2.5 mg hard capsules
Maltese: Lenalidomide Accord 2.5 mg kapsuli ibsin
English: • Certain types of skin tumour
Maltese: • Ċerti tipi ta' tumur tal-ġilda
English: Investigator-assessed PFS (months) Mediana PFS time, months (95% CI)b HR [95% CI]c; p-valued
Maltese: PFS evalwat mill-Investigatur - (xhur) Medjana żmien PFS, xhur (95% CI)b HR [95% CI]ċ; valur pd
English: • Brochure for male patients
Maltese: • Tnaqqis fil-piż
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.
Maltese: Lenalidomide Accord 25 mg huma kapsuli ibsin tal-gelatin daqs “0” ta' madwar tul ta' 21.0 mm sa 21.8 mm, b'kappa u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “25 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: 0.833 [0.687, 1.009], p = 0.045
Maltese: HR = 0.57 (95% CI 0.47, 0.68; p < 0.001).
English: In total 459 patients were enrolled into the study, with 152 patients randomised to MPR+R, 153 patients randomised to MPR+p and 154 patients randomised to MPp+p.
Maltese: B'kollox, 459 pazjent ġew irreġistrati fl-istudju, b'152 pazjent li ntgħażlu b'mod każwali għal MPR+R, 153 pazjent li ntgħażlu b'mod każwali għal MPR+p u 154 pazjent li ntgħażlu b'mod każwali għal MPp+p.
English: In both studies, patients in the lenalidomide/dexamethasone (len/dex) group took 25 mg of lenalidomide orally once daily on days 1 to 21 and a matching placebo capsule once daily on days 22 to 28 of each 28-day cycle.
Maltese: Fiż-żewġ studji, il-pazjenti fil-grupp ta' lenalidomide/dexamethasone (len/dex) ħadu 25 mg ta' lenalidomide mill-ħalq darba kuljum f'jiem 1 sa 21, u kapsula li taqbel tal-plaċebo darba kuljum f'jiem 22 sa 28 f'kull ċiklu ta' 28 jum.
English: • if you are pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men').
Maltese: • jekk int tqila, taħseb li int tqila, jew qed tippjana li toħroġ tqila, għax lenalidomide hu mistenni li jkun ta' ħsara lit-tarbija mhix imwielda (ara sezzjoni 2, ‘Tqala. treddigħ u kontraċezzjoniinformazzjoni għan-nisa u l-irġiel').
English: In patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months, the hematologic SPM incidence rate (0.16 per 100 person-years) was not increased as compared to thalidomide in combination with melphalan and prednisone (0.79 per 100 person-years).
Maltese: F'pazjenti li kienu qed jirċievu lenalidomide flimkien ma' dexamethasone sal-progressjoni jew għal 18-il xahar, ir-rata ta' inċidenza ta' SPM ematoloġika (0.16 għal kull 100 sena ta' persuna) ma żdiditx meta mqabbla ma' thalidomide flimkien ma' melphalan u prednisone (0.79 għal kull 100 sena ta' persuna).
English: Lenalidomide is poorly metabolized as 82% of the dose is excreted unchanged in urine.
Maltese: Lenalidomide ma tantx jiġi mmetabolizzat għax 82% tad-doza titneħħa mill-ġisem mal-awrina bħala mediċina mhux mibdula.
English: In total 1623 patients were enrolled into the study, with 535 patients randomised to Rd, 541 patients randomised to Rd18 and 547 patients randomised to MPT.
Maltese: B'kollox, 1623 pazjent ġew irreġistrati fl-istudju, b'535 pazjent li ntgħażlu b'mod każwali għal Rd, 541 pazjent li ntgħażlu b'mod każwali għal Rd18 u 547 pazjenti li ntgħażlu b'mod każwali għal MPT.
English: The median overall PFS was 40.1 months (95% CI 35.7, 42.4) in the lenalidomide arm versus 22.8 months (95% CI 20.7, 27.4) in the placebo arm.
Maltese: 001). Il-PFS medjan globali tas-sopravivenza kien ta' 40.1 xhur (95% CI 35.7, 42.4) fil-parti tal-istudju dwar lenalidomide, kontra 22.8 xhur (95% CI 20.7, 27.4) fil-parti tal-istudju dwar il-plaċebo.
English: Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Maltese: Lenalidomide Accord flimkien ma' dexamethasone hu indikat għall-kura ta' pazjenti adulti b'majeloma multipla li rċievew mill-inqas terapija waħda fil-passat.
English: The lenalidomide arm was discontinued, as a proactive safety measure, after observing an imbalance of SPMs (see section 4.4).
Maltese: Il-parti tal-istudju dwar lenalidomide ma tkomplietx, bħala miżura ta' sigurtà proattiva, wara li ġie osservat żbilanċ tal-SPMs (ara sezzjoni 4.4).
English: Return to ≥ 30 x 109/L
Maltese: Imorru lura għal ≥ 30 x 109/L
English: Overall, grade 4 neutropenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in the 2 studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (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).
Maltese: B'mod ġenerali, newtropenija ta' grad 4 ġiet osservata fi frekwenza ogħla fil-partijiet tal-istudju dwar il-manteniment b'lenalidomide meta mqabbla mal-partijiet tal-istudju dwar il-manteniment bi plaċebo fiż-2 studji li evalwaw il-manteniment b'lenalidomide f'pazjenti b'NDMM li kellhom ASCT (32.1% vs 26.7% [16.1% vs 1.8% wara l-bidu tal-kura ta' manteniment] f'CALGB 100104 u 16.4% vs 0.7% f'IFM 2005-02, rispettivament).
English: Dyspnoea◊, Rhinorrhoea
Maltese: FULJETT TA' TAGĦRIF
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.
Maltese: Kapsuli ibsin tal-gelatin daqs “4” ta' madwar tul ta' 14.0 mm sa 14.8mm, b'kappa vjola opaka u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “7.5 mg” stampata fuq il-korp blaħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: The recommended dose of dexamethasone is 40 mg orally once daily on days 1, 8, 15 and 22 of repeated 28-day cycles.
Maltese: Dexamethasone 40 mg ġie ddożat darba kuljum f'jiem 1, 8, 15, u 22 ta' kull ċiklu ta' 28 jum.
English: The major dose limiting toxicities (DLT )of lenalidomide include neutropenia and thrombocytopenia.
Maltese: It-tossiċitajiet maġġuri li jillimitaw id-doża (DLT) ta' lenalidomide jinkludu n-newtropenija u ttromboċitopenija.
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.
Maltese: Lenalidomide Accord 7.5 mg huma kapsuli ibsin tal-gelatin daqs “4” ta' madwar tul ta' 14.0 mm sa 14.8mm, b'kappa vjola opaka u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bliswed u “7.5 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Repeated oral administration of 75, 150 and 300 mg/kg/day to rats for up to 26 weeks produced a reversible treatment-related increase in kidney pelvis mineralisation in all 3 doses, most notably in females.
Maltese: L-għoti ripetut mill-ħalq ta' 75, 150 u 300 mg/kg/kuljum lil firien sa 26 ġimgħa, ipproduċa żieda riversibbli marbuta mal-kura filmineralizzazzjoni tal-pelvi u renali fit-3 dożi kollha, l-aktar fin-nisa.
English: Patients who completed 9 cycles or who were unable to complete 9 cycles due to intolerance proceeded to maintenance therapy starting with lenalidomide 10 mg orally on days 1 to 21 of repeated 28-day cycles until disease progression.
Maltese: Pazjenti li temmew 9 ċikli, jew li ma setgħux itemmu 9 ċikli minħabba intolleranza, komplew bit-terapija ta' manteniment u bdew b'lenalidomide 10 mg mill-ħalq f'jiem 1 sa 21 ta' ċikli ripetuti ta' 28 jum sal-progressjoni tal-marda.
English: 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.
Maltese: Lenalidomide Accord 2.5 mg huma kapsuli ibsin tal-gelatin daqs “5” ta' madwar tul ta' 11.0 mm sa 11.8mm, b'kappa griża u korp opak abjad b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “2.5 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: When neutrophils
Maltese: Meta n-newtrofili
English: Co-administration of single or multiple doses of dexamethasone (40 mg once daily) has no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide (25 mg once daily).
Maltese: L-għoti flimkien ta' dożi waħidhom jew multipli ta' dexamethasone (40 mg darba kuljum) m'għandu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' dożi multipli ta' lenalidomide (25 mg darba kuljum).
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.
Maltese: Lenalidomide Accord 10 mg huma kapsuli ibsin tal-gelatin daqs “3” ta' madwar tul ta' 15.4 mm sa 16.2mm, b'kappa ħadra kulur il-werqa u korp abjad opak b'“LENALIDOMIDE” stampata fuq ilkappa bl-iswed u “10 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Maltese: Thalidomide hu sustanza attiva teratoġenika umana magħrufa li tikkawża difetti tat-twelid severi li huma ta' periklu għall-ħajja.
English: • When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant.
Maltese: • Meta lenalidomide jintuża għall-kura ta' majeloma multipla f'pazjenti li kellhom trapjant talmudullun.
English: 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.
Maltese: Kapsuli ibsin tal-gelatin daqs “2” ta' madwar tul ta' 17.4 mm sa 18.2mm, b'kappa oranġjo opaka u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “15 mg” stampata fuq ilkorp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Neutropenia^,◊, Febrile neutropenia^,◊,
Maltese: Infezzjoni◊, Infezzjoni flpassaġġ tal-awrina◊,*,
English: Lenalidomide Accord 5 mg hard capsules EU/1/18/1316/003
Maltese: Lenalidomide Accord 5 mg kapsuli ibsin EU/1/18/1316/003
English: Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Maltese: Neoplażmi Beninni, Malinni u dawk Mhux Speċifikati (inklużi ċesti u polipi)
English: Lenalidomide treatment must not be started if the ANC < 1.0 x 109/L, and/or platelet counts < 75 x 109/L or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/L.
Maltese: ANC ≥ 1.5 x 109/L b'għadd tal-plejtlits ta' ≥ 100 x 109/L fil-bidu ta' ċiklu ġdid).
English: Lenalidomide Accord 15 mg hard capsules EU/1/18/1316/008
Maltese: Lenalidomide Accord 15 mg kapsuli ibsin EU/1/18/1316/008
English: Findings from this study indicate that lenalidomide produced external malformations including non-patent anus and malformations of upper and lower extremities (bent, shortened, malformed, malrotated and/or absent part of the extremities, oligo and/or polydactyly) in the offspring of female monkeys who received the active substance during pregnancy.
Maltese: Ir-riżultati ta' dan l-istudju jindikaw li lenalidomide ipproduċa malformazzjonijiet esterni, li jinkludu non-patent anus u malformazzjonijiet tal-estremitajiet ta' fuq u t'isfel (estremitajiet milwija, qosra, malformati, imdawra ħażin u/jew parti minnhom nieqsa, oligo u/jew polydactyly) filfrieħ ta' xadini nisa li rċivew is-sustanza attiva matul it-tqala.
English: ◊ Adverse reactions reported as serious in clinical trials in patients with NDMM who had undergone ASCT * Applies to serious adverse drug reactions only ^ See section 4.8 description of selected adverse reactions a “Pneumonias” combined AE term includes the following PTs: Bronchopneumonia, Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis b “Sepsis” combined AE term includes the following PTs: Bacterial sepsis, Pneumococcal sepsis, Septic shock, Staphylococcal sepsis c “Peripheral neuropathy” combined AE term includes the following preferred terms (PTs): Neuropathy peripheral, Peripheral sensory neuropathy, Polyneuropathy d “Deep vein thrombosis” combined AE term includes the following PTs: Deep vein thrombosis, Thrombosis, Venous thrombosis
Maltese: • jekk fil-passat kellek kombinazzjoni ta' kwalunkwe mis-sintomi li ġejjin: raxx fuq il-wiċċ jew raxx estiż, ġilda ħamra, deni qawwi, sintomi bħal tal-influwenza, għoqod tal-limfa mkabbra (sinjali ta' reazzjoni severa tal-ġilda msejħa Reazzjoni tal-Mediċina b'Eosinofilja u sintomi sistemiċi (DRESS), ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”).
English: Common Respiratory distress◊, Dyspnoea◊
Maltese: Disturbi Respiratorji, Toraċiċi u
English: T-cell type acute leukaemia◊, Basal cell carcinoma^,◊, Tumour lysis syndrome
Maltese: • Ħalq infjammat u misluħ, ħalq xott, diffikultà biex tibla'
English: Patients randomised to the lenalidomide/low dose dexamethasone arm received lenalidomide 25 mg/day, days 1 to 21 every 28 days plus low dose dexamethasone - 40 mg/day on days 1, 8, 15, and 22 every 28 days.
Maltese: Il-pazjenti li ntgħażlu b'mod każwali fil-parti tal-istudju biex jirċievu lenalidomide/doża baxxa ta' dexamethasone, irċivew lenalidomide 25 mg/jum, jiem 1 sa 21 kull 28 jum flimkien ma' doża baxxa ta' dexamethasone 40 mg/jum f'jiem 1, 8, 15, u 22 kull 28 jum.
English: Patients in both treatment groups took 40 mg of dexamethasone orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy.
Maltese: Il-pazjenti fiż-żewġ gruppi tal-kura ħadu 40 mg ta' dexamethasone mill-ħalq darba kuljum f'jiem 1 sa 4, 9 sa 12, u 17 sa 20 f'kull ċiklu ta' 28 jum għall-ewwel 4 ċikli tat-terapija.
English: • Breathlessness
Maltese: • Newtropenija
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.
Maltese: Il-kura b'Lenalidomide m'għandhiex tinbeda jekk l-ANC ikun ta' < 1.5 x 109/L, u/jew l-għadd talplejtlits ikun ta' < 75 x 109/L.
English: Lenalidomide Accord 15 mg hard capsules
Maltese: Lenalidomide Accord 15 mg kapsuli ibsin
English: Other intrinsic factors
Maltese: Fatturi intrinsiċi oħra
English: • Toothache
Maltese: • Vista mċajpra
English: Lenalidomide Accord
Maltese: X'inhu Lenalidomide Accord
English: • Abnormal liver test results
Maltese: • Dati li fihom sar it-test tat-tqala u riżultati
English: 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)
Maltese: - qoxra tal-kapsula: gelatin, titanium dioxide (E171) linka tal-istampar: linka sewda u ħadra (li tinkludi shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) u potassium hydroxide)
English: • Each 28 - day cycle is called a ‘treatment cycle'.
Maltese: • Kull ċiklu ta' 28 jum jissejjaħ ‘ċiklu ta' kura'.
English: Common Chest pain, Lethargy
Maltese: Komuni Dijarea, Rimettar, Dardir
English: Return to ≥ 0.5 x 109/L when dose-dependent haematological toxicities other than neutropenia are observed
Maltese: Imorru lura għal ≥ 0.5 x 109/L meta n-newtropenija tkun l-unika tossiċità li tiġi osservata
English: Renal impairment
Maltese: Disturbi Vaskulari
English: ADRs reported in clinical trials in patients with multiple myeloma treated with lenalidomide maintenance therapy
Maltese: Tabella 1: ADRs irrappurtati fi provi kliniċi f'pazjenti b'majeloma multipla kkurati b'terapija ta' manteniment b'lenalidomide
English: However, it is not known whether there is an interaction during clinical use (concomitant treatment with dexamethasone).
Maltese: Madankollu, mhuwiex magħruf jekk hemmx interazzjoni waqt l-użu kliniku (kura fl-istess ħin b'dexamethasone).
English: 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.
Maltese: Kapsuli ibsin tal-gelatin daqs “1” ta' madwar tul ta' 19.0 mm sa 19.8 mm, b'kappa ħadra opaka u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “20 mg” stampata fuq il-korp blaħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day.
Maltese: Sar studju dwar l-iżvilupp embrijofetali fuq xadini li ngħataw lenalidomide f'dożi minn 0.5 u sa 4 mg/kg/kuljum.
English: • Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Maltese: • Definizzjoni ta' nisa li jista' jkollhom tfal (WCBP, Women of ChildBearing Potential) u azzjonijiet li t-tabib għandu jieħu jekk ma jkunx ċert Pariri dwar is-sigurtà għal nisa ta' li jista' jkollhom it-tfal
English: Co-administration of multiple 10 mg doses of lenalidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Maltese: PML ġiet irrappurtata diversi xhur għal diversi snin wara l-bidu tal-kura b'lenalidomide.
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Common Rashes
Maltese: Kors rakkomandat
English: Peripheral neuropathies (excluding motor neuropathy), Dizziness, Tremor, Dysgeusia, Headache
Maltese: Newropatija periferali, Newropatija periferali tal-moviment, Newropatija sensorjali periferali, Polinewropatija.
English: 5 mg once daily.
Maltese: 5 mg darba kuljum.
English: • Muscle weakness
Maltese: • Tħossok bla nifs
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.
Maltese: Kapsuli ibsin tal-gelatin daqs “0” ta' madwar tul ta' 21.0 mm sa 21.8 mm, b'kappa u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “25 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju/r-riskju tal-prodott mediċinali.
English: Pregnancy
Maltese: Rabdomijolożi
English: • Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience
Maltese: • Deskrizzjoni u ġestjoni ta' riskju tromboemboliku inkluż rati ta' inċidenza minn provi kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq
English: Co-administration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of lenalidomide.
Maltese: L-għoti flimkien ta' dożi waħidhom ta' 25 mg ta' warfarin ma kellu l-ebda effett fuq il-farmakokinetiċi ta' lenalidomide.
English: A negative JCV PCR does not exclude PML.
Maltese: HBc iżda negattivi għal HBsAg.
English: Resume lenalidomide and melphalan at dose level -1
Maltese: Kompli lenalidomide fil-livell tad-doża -1
English: Repeated oral administration of 1 and 2 mg/kg/day to monkeys for up to 1 year produced reversible changes in bone marrow cellularity, a slight decrease in myeloid/erythroid cell ratio and thymic atrophy.
Maltese: Lgħoti ripetut mill-ħalq ta' 1 u 2 mg/kg/kuljum lix-xadini sa sena, ipproduċa tibdil riversibbli fiċċellularità tal-mudullun tal-għadam, tnaqqis żgħir fil-proporzjon taċ-ċelluli majelodi/eritrojdi u thymic atrophy.
English: 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.
Maltese: Lenalidomide Accord 5 mg huma kapsuli ibsin tal-gelatin daqs “5” ta' madwar tul ta' 11.0 mm sa 11.8mm, b'kappa u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “5 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.