FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 17 December 2009 (15.5 months follow up) showed a 62% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.38; 95% CI 0.27, 0.54; p <0.001).
Maltese: Ir-riżultati ta' PFS fl-unblinding, wara analiżi interim ppjanata minn qabel, bl-użu tad-data tal-għeluq tas-17 Diċembru, 2009 (15.5 xhur ta' follow-up) wera tnaqqis ta' 62% fir-riskju tal-progressjoni talmarda jew mewt favur lenalidomide (HR = 0.38; 95% CI 0.27, 0.54; p <0.
English: In total 460 patients were randomised: 231 patients to lenalidomide and 229 patients to placebo.
Maltese: B'kollox, 460 pazjent intgħażlu b'mod każwali: 213-il pazjent għal lenalidomide u 229 pazjent għall-plaċebo.
English: Repeated oral administration of 4 and 6 mg/kg/day to monkeys for up to 20 weeks produced mortality and significant toxicity (marked weight loss, reduced red and white blood cell and platelet counts, multiple organ haemorrhage, gastrointestinal tract inflammation, lymphoid, and bone marrow atrophy).
Maltese: L-għoti ripetut mill-ħalq ta' 4 u 6 mg/kg/kuljum lix-xadini sa 20 ġimgħa, ipproduċa mortalità u tossiċità sinifikanti (telf notevoli talpiż, tnaqqis fl-għadd taċ-ċelluli ħomor u bojod tad-demm u fl-għadd tal-plejtlits, emorraġiji multipli florgani, infjammazzjoni fl-apparat gastrointestinali, atrofija tal-limfi u tal-mudullun tal-għadam).
English: If PML is confirmed, lenalidomide must be permanently discontinued.
Maltese: Jekk tiġi kkonfermata PML, lenalidomide għandu jitwaqqaf b'mod permanenti.
English: In the presence of lenalidomide, cereblon binds substrate proteins Aiolos and Ikaros which are lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in cytotoxic and immunomodulatory effects.
Maltese: Fil-preżenza ta' lenalidomide, cereblon iwaħħal proteini substrati Aiolos u Ikaros li huma fatturi traskrizzjonali limfojdi, u dan iwassal għall-ubikwitinazzjoni u d-degradazzjoni sussegwenti tagħhom li tirriżulta f'effetti ċitossiċi u immunomodulatorji.
English: Lenalidomide Accord 2.5 mg hard capsules Lenalidomide Accord 5 mg hard capsules Lenalidomide Accord 7.5 mg hard capsules Lenalidomide Accord 10 mg hard capsules Lenalidomide Accord 15 mg hard capsules Lenalidomide Accord 20 mg hard capsules Lenalidomide Accord 25 mg hard capsules lenalidomide
Maltese: Lenalidomide Accord 2.5 mg kapsuli ibsin Lenalidomide Accord 5 mg kapsuli ibsin Lenalidomide Accord 7.5 mg kapsuli ibsin Lenalidomide Accord 10 mg kapsuli ibsin Lenalidomide Accord 15 mg kapsuli ibsin Lenalidomide Accord 20 mg kapsuli ibsin Lenalidomide Accord 25 mg kapsuli ibsin lenalidomide
English: 8-year survival rate, % (SE) HR [95% CI]c ; p-valued
Maltese: Rata ta' sopravivenza ta' 8 snin, % (SE) HR [95% CI]c; valur pd
English: Initial dose and regimen for Rd and Rd18 were adjusted according to age and renal function (see section 4.2).
Maltese: Id-doża tal-bidu u l-kors għal Rd u Rd18 ġew aġġustati skont l-età u l-funzjoni tal-kliewi (ara sezzjoni 4.2).
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.
Maltese: L-AUC żdiedet b'madwar 2.5, 4 u 5 darbiet f'individwi b'indeboliment moderat tal-kliewi, indeboliment sever tal-kliewi, u mard tal-kliewi fl-istadju tal-aħħar, rispettivament, meta mqabbla malgrupp li kien jikkombina individwi b'funzjoni normali tal-kliewi u individwi b'indeboliment ħafif talkliewi.
English: Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide monotherapy as follows: 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles given until disease progression.
Maltese: Pazjenti li jtemmu 9 ċikli jew li ma jkunux kapaċi jtemmu t-terapija kombinata minħabba intolleranza, jiġu kkurati b'monoterapija b'lenalidomide: 10 mg darba kuljum mill-ħalq f'jiem 1 sa 21 ta' ċikli ripetuti ta' 28 jum mogħti sal-progressjoni tal-marda.
English: In a post-hoc analysis, lower mortality was observed in the lenalidomide/low dose dexamethasone arm 6.8% (15/220) compared to the lenalidomide/standard dose dexamethasone arm 19.3% (43/223), in the newly diagnosed multiple myeloma patient population, with a median follow up of 72.3 weeks.
Maltese: F'analiżi post-hoc, ġiet osservata mortalità iktar baxxa fil-parti tal-istudju fejn il-pazjenti ngħataw lenalidomide/doża baxxa ta' dexamethasone, 6.8% (15/220), meta mqabbla mal-parti tal-istudju fejn il-pazjenti ngħataw lenalidomide/doża standard ta' dexamethasone, 19.3% (43/223), fil-popolazzjoni ta' pazjenti b'majeloma multipla ddijanjostikata għall-ewwel darba, b'follow-up medjan ta' sa 72.3 ġimgħa.
English: Lenalidomide Accord 15 mg hard capsules Gelatin
Maltese: Lenalidomide Accord 15 mg kapsuli ibsin Gelatin
English: Tumour flare reaction and tumour lysis syndrome
Maltese: Reazzjoni ta' aggravament tat-tumur u sindromu tal-lisi tat-tumur
English: The combination of lenalidomide with melphalan and prednisone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p treated patients, compared with 13.7% in MPp+p-treated patients; see section 4.8).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' melphalan u prednisone f'pazjenti b'majeloma multipla hi assoċjata ma' inċidenza ogħla ta' tromboċitopenija ta' grad 3 u grad 4 (40.4% f'pazjenti kkurati b'MPR+R/MPR+p, meta mqabbla ma' 13.7% f'pazjenti kkurati b'MPp+p; ara sezzjoni 4.8).
English: Return to ≥ 1 x 109/L when neutropenia is the only observed toxicity
Maltese: Imorru lura għal ≥ 1 x 109/L meta n-newtropenija tkun l-unika tossiċità li tiġi osservata
English: Return to ≥ 0.5 x 109/L when neutropenia is the only observed toxicity
Maltese: Imorru lura għal ≥ 0.5 x 109/L meta n-newtropenija hi l-unika tossiċità li tkun osservata
English: Lenalidomide Accord 2.5 mg hard capsules Lenalidomide Accord 5 mg hard capsules Lenalidomide Accord 7.5 mg hard capsules Lenalidomide Accord 10 mg hard capsules Lenalidomide Accord 15 mg hard capsules Lenalidomide Accord 20 mg hard capsules Lenalidomide Accord 25 mg hard capsules
Maltese: Lenalidomide Accord 2.5 mg kapsuli ibsin Lenalidomide Accord 5 mg kapsuli ibsin Lenalidomide Accord 7.5 mg kapsuli ibsin Lenalidomide Accord 10 mg kapsuli ibsin Lenalidomide Accord 15 mg kapsuli ibsin Lenalidomide Accord 20 mg kapsuli ibsin Lenalidomide Accord 25 mg kapsuli ibsin
English: • Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with low dose dexamethasone Grade 4 neutropenia was observed in the lenalidomide arms in combination with low dose dexamethasone to a lesser extent than in the comparator arm (8.5% in the Rd [continuous treatment] and Rd18 [treatment for 18 four-week cycles] compared with 15% in the melphalan/prednisone/thalidomide arm, see section 4.8).
Maltese: • Majeloma multipla ddijanjostikata għall-ewwel darba: pazjenti li ma jkunux eliġibbli għal trapjanti kkurati b'lenalidomide flimkien ma' doża baxxa ta' dexamethasone Newtropenija ta' grad 4 ġiet osservata fil-partijiet tal-istudju dwar lenalidomide flimkien ma' doża baxxa ta' dexamethasone fi grad inqas milli fil-parti tal-istudju dwar il-komparatur (8.5% fl-Rd [kura kontinwa] u b'Rd18 [kura għal 18-il ċiklu ta' erba' ġimgħat] meta mqabbla ma' 15% fil-parti talistudju dwar melphalan/prednisone/thalidomide, ara sezzjoni 4.8).
English: Patients randomised to the lenalidomide/standard dose dexamethasone arm received lenalidomide 25 mg/day, days 1 to 21 every 28 days plus dexamethasone 40 mg/day on days 1 to 4, 9 to 12, and 17 to 20 every 28 days for the first four cycles.
Maltese: Il-pazjenti li ntgħażlu b'mod każwali fil-parti talistudju biex jirċievu lenalidomide/doża standard ta' dexamethasone, irċivew lenalidomide 25 mg/jum, jiem 1 sa 21 kull 28 jum flimkien ma' dexamethasone 40 mg/jum f'jiem 1 sa 4, 9 sa 12, u 17 sa 20 kull 28 jum għall-ewwel erba' ċikli.
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)
Maltese: Rispons għal Majeloma Evalwat millInvestigatur n (%) CR PR Marda Stabbli (SD) Rispons Ma Setax Jiġi Evalwat (NE) Tul ta' Rispons Evalwat millInvestigatur (CR+PR) (xhur) Medjana (95% CI)
English: Each capsule contains 5 mg of lenalidomide.
Maltese: Kull kapsula fiha 5 mg ta' lenalidomide.
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).
Maltese: Manteniment b'lenalidomide wara ASCT hu assoċjat ma' frekwenza ogħla ta' tromboċitopenija ta' grad 3 jew 4 meta mqabbla mal-partijiet tal-istudju dwar il-manteniment bi plaċebo (37.5% vs 30.3% [17.9% kontra 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 2.5 mg hard capsules:
Maltese: Lenalidomide Accord 2.5 mg kapsuli ibsin:
English: A 2.12-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide (9 cycles) in combination with melphalan and prednisone (1.57 per 100 person-years) compared with melphalan in combination with prednisone (0.74 per 100 person-years).
Maltese: Ġiet osservata żieda ta' 2.12 darbiet fir-rata ta' inċidenza ta' tumur solidu SPM f'pazjenti li kienu qed jirċievu lenalidomide (9 ċikli) flimkien ma' melphalanin u prednisone (1.57 għal kull 100 sena ta' persuna) meta mqabbla ma' melphalan flimkien ma' prednisone (0.74 għal kull 100 sena ta' persuna).
English: Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Maltese: Varjazzjonijiet fit-tessut artab u skeletriċi fil-feti kienu wkoll osservati f'dożi ta' 10 u 20 mg/kg/kuljum.
English: The safety and efficacy of lenalidomide was assessed in a phase III multicenter, randomised double blind 3 arm study (MM-015) of patients who were 65 years or older and had a serum creatinine < 2.5 mg/dL.
Maltese: III, multiċentriku, li fih ilparteċipanti ntgħażlu b'mod każwali, double-blind, bi 3 partijiet (MM-015), ta' pazjenti li kellhom 65 sena jew aktar u kellhom krejatinina fis-serum ta' < 2.5 mg/dL.
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy
Maltese: • Operazzjoni salpingo-oophorectomy bilaterali, jew isterektomija li jkunu saru fil-passat
English: Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer.
Maltese: Lenalidomide ġeneralment jinħall iktar f'solventi organiċi, iżda juri l-ikbar solubilità f'soluzzjoni ta'0.1N HCl.
English: Lenalidomide Accord 20 mg hard capsules
Maltese: Lenalidomide Accord 20 mg kapsuli ibsin
English: • Educational Health Care Professional's kit
Maltese: • Pamflets edukattivi għall-Pazjenti
English: The median age was 73 in the 3 arms.
Maltese: Il-medjan tal-età kien 73 sena fit-3 partijiettal-istudju.
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 3 and 4 thrombocytopenia (8.1% in Rd and Rd18) compared with MPT (11%).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' doża baxxa ta' dexamethasone f'pazjenti b'majeloma multipla ddijanjostikata għall-ewwel darba hi assoċjata ma' frekwenza aktar baxxa ta' tromboċitopenija ta' grad 3 u 4 (8.1% f'Rd u Rd18) meta mqabbla ma' MPT (11%).
English: Lenalidomide Accord 20 mg hard capsules EU/1/18/1316/010
Maltese: Lenalidomide Accord 20 mg kapsuli ibsin EU/1/18/1316/010
English: Pregnancy, breast-feeding and contraception - information for women and men
Maltese: Tqala, treddigħ u kontraċezzjoni - informazzjoni għan-nisa u l-irġiel
English: d The p-value is based on the unstratified log-rank test of Kaplan-Meier curve differences between the indicated treatment arms.
Maltese: d Il-valur p hu bbażat fuq it-test log-rank mhux stratifikat tad-differenzai fil-kurva ta' Kaplan-Meier bejn il-partijiet tal-istudju indikati dwar il-kura.
English: The median progression free survival was 48.1 weeks (95% CI: 36.4, 62.1) in patients treated with len/dex versus 20.0 weeks (95% CI: 16.1, 20.1) in patients treated with placebo/dex.
Maltese: Il-medjan ta' sopravivenza mingħajr progressjoni kien ta' 48.1 ġimgħat (95% CI: 36.4, 62.1) f'pazjenti kkurati b'len/dex kontra 20.0 ġimgħa (95% CI: 16.1, 20.1) f'pazjenti kkurati bil-plaċebo/dex.
English: • Local country specific arrangements for a prescription for Lenalidomide Accord to be dispensed
Maltese: • Il-ħtieġa li twaqqaf Lenalidomide Accord immedjatament malli jkun hemm suspett ta' tqala
English: 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).
Maltese: Ġiet osservata żieda ta' 1.3 darbiet fir-rata ta' inċidenza ta' tumur solidu SPM f'pazjenti li kienu qed jirċievu lenalidomide flimkien ma' dexamethasone sal-progressjoni jew għal 18-il xahar (1.58 għal kull 100 sena ta' persuna) meta mqabbel ma' thalidomide flimkien ma' melphalan u prednisone (1.19 għal kull 100 sena ta' persuna).
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).
Maltese: Il-kumbinazzjoni ta' lenalidomide ma' dexamethasone f'pazjenti b'majeloma multipla hi marbuta ma' inċidenza ogħla ta' tromboċitopenija ta' grad 3 u grad 4 (9.9% u 1.4%, rispettivament, f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 2.3% u 0.0% f'pazjenti kkurati bilplaċebo/dexamethasone).
English: The median overall PFS2 was 69.9 months (95% CI 58.1, 80.0) in the lenalidomide arm versus 58.4 months (95% CI 51.1, 65.0) in the placebo arm. For OS, the observed HR was 0.90: (95% CI 0.72, 1.13; p = 0.355) for lenalidomide versus placebo.
Maltese: Għall-OS, l-HR osservata kienet ta' 0.90: (95% CI 0.72, 1.13; p = 0.355) għal lenalidomide kontra l-plaċebo.
English: Tabulated summary of post-marketing adverse reactions
Maltese: Sommarju tabulat ta' reazzjonijiet avversi wara t-tqegħid fis-suq
English: Lenalidomide Accord 25 mg hard capsules EU/1/18/1316/011
Maltese: Lenalidomide Accord 25 mg kapsuli ibsin EU/1/18/1316/011
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide maintenance than placebo were:
Maltese: Ir-reazzjonijiet avversi serji osservati aktar ta' spiss (≥5%) bil-manteniment b'lenalidomide milli bil-plaċebo kienu:
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.
Maltese: It-trattament b'lenalidomide m'għandux jinbeda jekk lGħadd Assolut tan-Newtrofili (Absolute Neutrophil Count, ANC)) ikun ta' < 1.0 x 109/L, u/jew lgħadd tal-plejtlits ikun ta' < 75 x 109/L.
English: Grade 4 febrile neutropenia episodes were observed infrequently (1.7% in MPR+R/MPR+p treated patients compared to 0.0 % in MPp+p treated patients; see section 4.8).
Maltese: Episodji ta' newtropenija bid-deni ta' grad 4 ġew osservati b'mod mhux frekwenti (1.7% f'pazjenti kkurati b'MPR+R/MPR+p meta mqabbla ma' 0.0% f'pazjenti kkurati b'MPp+p; ara sezzjoni 4.8).
English: HR [95% CI]c; p-valued Rd vs MPT
Maltese: HR [95% CI]c; p-valued
English: Lenalidomide Accord 15 mg hard capsules:
Maltese: Lenalidomide Accord 15 mg kapsuli ibsin:
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucosegalactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Common Febrile neutropenia^,◊, Pancytopenia◊
Maltese: Komuni Ħafna Newtropenija^,◊, Newtropenija
English: Lenalidomide Accord 10 mg hard capsules
Maltese: Lenalidomide Accord 10 mg kapsuli ibsin
English: The Cmax was similar between healthy subjects and patients with renal impairment.
Maltese: Is-Cmax kienet simili bejn pazjenti b'saħħithom u pazjenti b'indeboliment renali.
English: 7.5 mg once daily2 15 mg every other day
Maltese: 7.5 mg darba kuljum2 15 mg kull jumejn
English: Common Rash, Pruritus
Maltese: Komuni Ħafna Raxx, Ġilda xotta
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).
Maltese: Newtropenija bid-deni ta' grad 4 ġiet irrappurtata fi frekwenzi simili filpartijiet tal-istudju dwar il-manteniment b'lenalidomide meta mqabbla mal-partijiet tal-istudju dwar ilmanteniment bi plaċebo fiż-żewġ studji (0.4% vs 0.5% [0.4% vs 0.5% wara l-bidu tal-kura ta' manteniment] f'CALGB 100104 u 0.3% vs 0% f'IFM 2005-02, rispettivament).
English: • Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with lenalidomide maintenance
Maltese: • Majeloma multipla ddijanjostikata għall-ewwel darba: pazjenti li kellhom ASCT ikkurati b'manteniment b'lenalidomide
English: Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Maltese: Dexamethasone hu inducer minn dgħajjef sa moderat ta' l-enzymes u l-effett tiegħu fuq warfarin mhuwiex magħruf.
English: Lenalidomide is present in human semen (< 0.01% of the dose) after administration of 25 mg/day and the medicinal product is undetectable in semen of a healthy subject 3 days after stopping the substance (see section 4.4).
Maltese: Lenalidomide jinsab fis-semen uman (< 0.01% tad-doża) wara l-għoti ta' 25 mg/kuljum, u l-prodott mediċinali ma tkunx tista' tiġi osservata fis-semen ta' persuna b'saħħitha 3 ijiem wara li titwaqqaf issustanza (ara sezzjoni 4.4).
English: The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
Maltese: L-effikaċja ta' sterojdi kontraċettivi tista' titnaqqas matul il-kura flimkien ma' dexamethasone (ara sezzjoni 4.5).
English: • You must also use effective methods of contraception (see ‘Contraception' below).
Maltese: • Trid tuża wkoll metodi effettivi ta' kontraċezzjoni (ara ‘Kontraċezzjoni' hawn taħt).
English: • Description and management of cutaneous reactions
Maltese: • Deskrizzjoni u ġestjoni ta' reazzjonijiet kutanji
English: The recommended dose of dexamethasone is 40 mg 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 and then 40 mg once daily on days 1 to 4 every 28 days.
Maltese: Id-doża rakkomandata ta' dexamethasone hi ta' 40 mg mill-ħalq darba kuljum f'jiem 1 sa 4, 9 sa 12, u 17 sa 20 ta' kull ċiklu ta' 28 jum għall-ewwel 4 ċikli tat-terapija, u mbagħad 40 mg darba kuljum f'jiem 1 sa 4 kull 28 jum.
English: • Infections of all types
Maltese: • Infezzjonijiet ta' kull tip
English: Return to ≥ 25 x 109/L
Maltese: Imorru lura għal ≥ 25 x 109/L
English: For male patients taking lenalidomide, pharmacokinetic data has demonstrated that lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject (see section 5.2).
Maltese: Għal pazjenti rġiel li qed jieħdu lenalidomide, informazzjoni farmakokinetika wriet li lenalidomide jinsab fis-semen uman f'livelli estremament baxxi matul il-kura, u ma jkunx jista' jiġi osservat fissemen uman 3 ijiem wara li s-sustanza titwaqqaf fil-persuna b'saħħitha (ara sezzjoni 5.2).
English: The following post-marketing adverse reactions have been reported (frequency unknown): acute hepatic failure and cholestasis (both potentially fatal), toxic hepatitis, cytolytic hepatitis, mixed cytolytic/cholestatic hepatitis.
Maltese: Ir-reazzjonijiet avversi fil-fwied li ġejjin ta' wara t-tqegħid fis-suq ġew irrappurtati (frekwenza mhux magħrufa): insuffiċjenza akuta tal-fwied u kolestasi (it-tnejn potenzjalment fatali), epatite tossika, epatite ċitolitika, epatite mħallta ċitolitika/kolestatika.
English: Cases of viral reactivation have been reported in patients receiving lenalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation.
Maltese: Ġew irrappurtati każijiet ta' attivazzjoni mill-ġdid virali f'pazjenti li kienu qed jirċievu lenalidomide, li jinklużi każijiet serji ta' attivazzjoni mill-ġdid tal-virus ta' herpes zoster jew tal-epatite B (HBV).
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients).
Maltese: Il-kumbinazzjoni ta' lenalidomide ma' dexamethasone f'pazjenti b'majeloma multipla hi marbuta ma' inċidenza ogħla ta' newtropenija ta' grad 4 (5.1% f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 0.6% ta' pazjenti kkurati bil-plaċebo/dexamethasone).
English: In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Maltese: F'dawn l-istudji, il-fniek ngħataw 3, 10 u 20 mg/kg/kuljum oralment.
English: Lenalidomide Accord 7.5 mg hard capsules EU/1/18/1316/005
Maltese: Lenalidomide Accord 7.5 mg kapsuli ibsin EU/1/18/1316/005
English: What Lenalidomide Accord is
Maltese: Tiħux Lenalidomide Accord:
English: Return to ≥ 0.5 x 109/L
Maltese: Imorru lura għal ≥ 0.5 x 109/L
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 4 neutropenia (34.1% in MPR+R/MPR+p) compared with MPp+p (7.8%).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' melphalan u prednisone f'pazjenti b'majeloma multipla ddijanjostikata għall-ewwel darba hi assoċjata ma' frekwenza ogħla ta' newtropenija ta' grad 4 (34.1% f'MPR+R/MPR+p) meta mqabbla ma' MPp+p (7.8%).
English: • do not break, open or chew the capsules.
Maltese: • Taqsamx, tiftaħx u tomghodx il-kapsuli.
English: Dose level -3
Maltese: Livell tad-doża -3
English: Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
Maltese: Il-pazjenti jistgħu jkomplu t-terapija b'lenalidomide u dexamethasone sal-progressjoni tal-marda jew intolleranza.
English: Lenalidomide Accord 10 mg hard capsules EU/1/18/1316/006
Maltese: Lenalidomide Accord 10 mg kapsuli ibsin EU/1/18/1316/006
English: Both patient populations presented a median age of 63 years, with a comparable male to female ratio.
Maltese: Iż-żewġ popolazzjonijiet ta' pazjenti kellhom medjan ta' età ta' 63 sena, bi proporzjon komparabbli bejn l-irġiel u n-nisa.
English: Lenalidomide Accord 25 mg hard capsules
Maltese: Lenalidomide Accord 25 mg kapsuli ibsin
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.
Maltese: Lenalidomide Accord 20 mg huma 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 bliswed u “20 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Other medicines and Lenalidomide Accord
Maltese: Mediċini oħra u Lenalidomide Accord