FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Maltese: Mill-153 pazjent ikkurati b'zoledronic acid u 115 pazjenti kkurati b'risedronate li ddaħħlu fl-istudju estiż ta' osservazzjoni, wara perjodu medju ta' 3.8 snin minn meta ngħataw id-dożaggi, il-proporzjon ta' pazjenti li temmu l-Perjodu Estiż ta' Osservazzjoni minħabba l-ħtieġa għal trattament mill-ġdid (ġudizzju kliniku) kien ogħla għal risedronate (48 pazjent, jew 41.7%) meta mqabbel ma' zoledronic acid (11-il pazjent, jew 7.2%).
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Maltese: prodotti mediċinali nefrotossiċi konkomitanti, terapija djuretika konkomitanti jew deidrazzjoni fil-perjodu ta' wara l-infużjoni (ara l-effetti skont ilklassi f'sezzjonijiet 4.4 u 4.8)
English: How to prepare and administer Zoledronic acid Teva Generics
Maltese: Mediċini oħra u Zoledronic acid Teva Generics
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' zoledronic acid fit-tfal u l-adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
Maltese: pazjenti li rċevew glukokortikojdi għal aktar minn 3 xhur qabel randomisation, zoledronic acid żied il-BMD tas-sinsla lumbari b'4.06% versus 2.71% għal risedronate (differenza medja: 1.36%;
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda f'kull 100)
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell.
Maltese: Uġigħ ta' ras, sturdament, dardir, rimettar, dijarea, uġigħ fil-muskoli, uġigħ fl-għadam u/jew fil-ġogi, uġigħ fid-dahar, fid-dirgħajn jew fir-riġlejn, sintomi bħal tal-influwenza (eż. għeja, tkexkix ta' bard, uġigħ fil-ġogi u fil-muskoli) tkexkix ta' bard, tħoss għeja u nuqqas ta' interess, dgħufija, uġigħ u tħossok ma tiflaħx.
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Maltese: Madwar 42% tal-pazjenti kellhom punteġġ-T BMD għall-għonq tal-femori taħt -2.5 u madwar 45% tal-pazjenti kellhom punteġġ-T BMD għall-għonq tal-femori 'l fuq minn -2.5.
English: Effect on all clinical fractures
Maltese: U KONTENUT Soluzzjoni għall-infużjoni
English: For osteoporosis, Zoledronic acid Teva Generics works for one year.
Maltese: Għall-osteoporożi, Zoledronic acid Teva Generics jaħdem għal sena.
English: Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Maltese: Ħafna minn dawn il-pazjenti kellhom sinjali ta' infezzjoni lokali inkluża osteomajlajtis, u l-parti l-kbira tar-rapporti jirreferu għallpazjenti b'kanċer wara li qalgħu sinna jew għamlu xi kirurġiji dentali.
English: Talk to your doctor before you are given Zoledronic acid Teva Generics: - if you are being treated with any other bisphosphonate medicine, since the combined effects of these medicines taken together with Zoledronic acid Teva Generics are unknown.
Maltese: - jekk qed tingħata kura b'xi mediċina bisfosfonata oħra, billi l-effetti kombinati ta' dawn ilmediċini meħudin flimkien ma' Zoledronic acid Teva Generics mhumiex magħrufa.
English: 1 bottle of 100 ml.
Maltese: Flixkun ta' 100 ml.
English: You must not be given Zoledronic acid Teva Generics:
Maltese: M'għandekx tingħata Zoledronic acid Teva Generics:
English: No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.
Maltese: M'hemmx bżonn tibdil fid-doża f'pazjenti bi tneħħija tal-kreatinina ≥ 35 ml/min.
English: There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Maltese: Ma kienx hemm akkumulazzjoni tas-sustanza attiva fil-plażma wara dożi multipli li ngħataw kull 28 ġurnata.
English: Absolute reduction in fracture event rate % (CI)
Maltese: Tnaqqis assolut flinċidenza tal-fratturi % (CI)
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables
Maltese: Tabella 4 Tqabbil bejn kura u oħra tal-varjabbli kliniċi tal-fratturi ewlenin Riżultat
English: Relative reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv firriskju tal-inċidenzi ta' frattura % (CI)
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Maltese: Mhux magħruf il-mekkaniżmu taż żieda fil-fibrillazzjoni atrijali.
English: ATC code: L04AX04.
Maltese: L04AX04.
English: 08039 Barcelona, Spain
Maltese: 08039 Barcelona,
English: • Anaemia (5.3%)
Maltese: • Anemija (5.3%)
English: Renal function (CLcr)
Maltese: Funzjoni renali (CLcr)
English: • an immunosuppressant medicine called ‘prednisone'.
Maltese: • mediċina immunosoppressanti msejħa ‘prednisone'.
English: Stevens-Johnson Syndrome^, Toxic epidermal necrolysis^
Maltese: Sindrome ta' StevensJohnson^, Nekrolisi epidermali tossika^
English: System Organ Class/Preferred Term
Maltese: Klassi tas-sistemi u talorgani/Terminu Ppreferut
English: • Pneumonia (9.8%)
Maltese: • Pnewmonja (9.8%)
English: Common Pulmonary embolism◊,*
Maltese: Komuni Emboliżmu pulmonari◊,*
English: Data cut-off dates: 17 Dec 2009 and 01 Feb 2016
Maltese: Dati tal-għeluq tad-data: 17 Diċ 2009 u 01 Frar 2016
English: • Implant
Maltese: • Impjant
English: • The active substance is lenalidomide.
Maltese: • Is-sustanza attiva hi lenalidomide.
English: • Confusion
Maltese: • Konfuzjoni
English: • Description of the PPP
Maltese: • Deskrizzjoni tal-PPP
English: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
Maltese: • Tromboemboliżmu venuż (trombożi fonda tal-vini, emboliżmu pulmonari (ara sezzjoni 4.4))
English: A conservative approach was applied to determine the adverse reactions from CALGB 100104.
Maltese: Ġie applikat approċċ konservattiv biex jiddetermina r-reazzjonijiet avversi minn CALGB 100104.
English: • an anti-inflammatory medicine called ‘dexamethasone'
Maltese: • mediċina kontra l-infjammazzjoni msejħa ‘dexamethasone'
English: 5 mg (days 1-21 every 28 days)
Maltese: 5 mg (jiem 1-21 kull 28 jum)
English: Moderate renal impairment (30  CLcr < 50 mL/min)
Maltese: Indeboliment moderat renali (30 ≤ CLcr < 50 mL/min)
English: • Renal failure (including acute) (6.3%)
Maltese: • Insuffiċjenza tal-kliewi (li tinkludi dik akuta) (6.3%)
English: Date of first authorisation: 20th September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta 'Settembru 2018
English: Placebo (N = 229)
Maltese: Plaċebo (N = 229)
English: Common Deep vein thrombosis^,◊,d
Maltese: Komuni Trombożi tal-vini profondi^,◊,d
English: • Circulatory problems
Maltese: • Problemi ċirkolatorji
English: • Lung infection (9.4% [9.4% after the start of maintenance treatment]) from CALGB 100104
Maltese: • Infezzjoni fil-pulmun (9.4% [9.4% wara l-bidu tal-kura ta' manteniment]) minn CALGB
English: Pack size of 21x1 capsules.
Maltese: Daqs tal-pakkett ta' 21x1 kapsuli.
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Maltese: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Qoxra tal-kapsula
English: Myalgia, Musculoskeletal pain
Maltese: Mijalġja, Uġigħ muskoloskeletriku
English: Common Myelodysplastic syndrome◊,*
Maltese: Komuni Sindrome majelodisplastiku◊,*
English: • Pneumonias (10.6%; combined term) from IFM 2005-02
Maltese: • Pnewmonji (10.6%; terminu kombinat) minn
English: Lenalidomide Accord contains the active substance ‘lenalidomide'.
Maltese: Lenalidomide Accord fih is-sustanza attiva ‘lenalidomide'.
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Maltese: Ġew irrapurtati każijiet ta' iewkoenċefalopatija multifokali progressiva (PML), inkluż każijiet fatali, b'lenalidomide.
English: Hydroxylenalidomide and N-acetyl-lenalidomide represent 4.59% and 1.83% of the excreted dose, respectively.
Maltese: Hydroxy-lenalidomide u N-acetyl-lenalidomide jirrappreżentaw 4.59% u 1.83% tad-doża mneħħija, rispettivament.
English: The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.
Maltese: Il-mekkaniżmu ta' l-azzjoni ta' lenalidomide jinkludi proprjetajiet anti-neoplastiċi, anti-anġjoġeniċi, pro-eritropojetiċi, u immunomodulatorji.
English: Endpoint len/dex (N=353)
Maltese: Aħħari len/dex (N=353)
English: In vitro studies indicate that lenalidomide is not a substrate of human breast cancer resistance protein (BCRP), multidrug resistance protein (MRP) transporters MRP1, MRP2, or MRP3, organic anion transporters (OAT) OAT1 and OAT3, organic anion transporting polypeptide 1B1 (OATP1B1), organic cation transporters (OCT) OCT1 and OCT2, multidrug and toxin extrusion protein (MATE) MATE1, and organic cation transporters novel (OCTN) OCTN1 and OCTN2.
Maltese: Studji in vitro jindikaw li lenalidomide mhuwiex substrat tal-proteina tar-reżistenza tal-kanċer tassider (BCRP - breast cancer resistance protein), transportaturi ta' proteina reżistenti kontra ħafna mediċini (MRP) MRP1, MRP2, jew MRP3, trasportaturi enajoniċi organiċi (OAT) OAT1 u OAT3, polypeptide tat-trasport ta' enajoni organiċi 1B1 (OATP1B1), trasportaturi ta' ketajoni organiċi (OCT) OCT1 u OCT2, multidrug u toxin extrusion protein (MATE) MATE1, u organic cation transporters novel (OCTN) OCTN1 u OCTN2.
English: Of the 704 patients evaluated in the MM-009 and MM-010 studies, 44.6% were aged 65 or over.
Maltese: Mis-704 pazjent evalwati flistudji MM-009 u MM-010, 44.6% kellhom 65 sena jew iżjed.
English: Common Pancytopenia◊
Maltese: Panċitopenija◊
English: 319 Pinner Road
Maltese: 319 Pinner Road North Harrow Middlesex
English: • if you have any signs of an infection, such as a cough or fever
Maltese: • imbagħad mill-inqas kull xahar wara dak il-perijodu.
English: Overall response [n, %] Complete response [n, %]
Maltese: Rispons totali [n, %] Rispons sħiħ [n, %]
English: Rd vs MPT Rd vs Rd18 Rd18 vs MPT PFS2e (months) Mediana PFS2 time, months (95% CI)b HR [95% CI]c; p-valued
Maltese: Rd vs MPT Rd vs Rd18 Rd18 vs MPT Sopravivenza globali (xhur) Medjana żmien OS, xhur (95% CI)b HR [95% CI]c; p-valued
English: Grade 3−4 ADRs/Frequency
Maltese: ADRs ta' Grad 3−4/Frekwenza
English: Lenalidomide is structurally related to thalidomide.
Maltese: Lenalidomide hu strutturalment relatat ma' thalidomide.
English: Pack size of 7x1 or 21x1 capsules.
Maltese: Daqs tal-pakkett ta' 7x1 jew 21x1 kapsuli.
English: • Febrile neutropenia (6.0%)
Maltese: • Newtropenija bid-deni (6.0%)
English: Gastrointestinal Disorders
Maltese: Disturbi Gastrointestinali
English: • XY genotype, Turner syndrome, uterine agenesis.
Maltese: • Ġenotip XY, sindromu ta' Turner, aġenesi ta' l-utru.
English: Summary of results of efficacy analyses as of cut-off date for extended follow-uppooled studies MM-009 and MM-010 (cut-offs 23 July 2008 and 2 March 2008, respectively)
Maltese: Sommarju tar-riżultati tal-analiżi ta' l-effikaċja sad-data ta' skadenza għal follow-up estiża - studji miġbura MM-009 u MM-010 (dati ta' skadenza 23 ta' Lulju 2008, u 2 ta' Marzu 2008, rispettivament)
English: Starting dose (10 mg)
Maltese: Doża tal-bidu (10 mg)
English: Multiple myeloma
Maltese: Majeloma multipla
English: • Grade 4 neutropenia (see section 4.4).
Maltese: • Newtropenija ta' grad 4 (ara sezzjoni 4.4)
English: In IFM 2005-02, the adverse reactions were from the maintenance treatment period only.
Maltese: F'IFM 2005-02, ir-reazzjonijiet avversi kienu mill-perjodu ta' manteniment biss.
English: • Description and management of hypersensitivity and angioedema
Maltese: • Deskrizzjoni u ġestjoni ta' sensittività eċċessiva u anġjoedema
English: HR [95% CI], p-value a
Maltese: HR [95% CI], valur p a
English: • Levonorgestrel-releasing intrauterine system (IUS)
Maltese: • Sistema ta' ġo l-utru li terħi levonorgestrel (intrauterine system - IUS)
English: In an in vitro study with human hepatocytes, lenalidomide, at various concentrations tested did not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4/5.
Maltese: Fi studju in vitro b'epatoċiti umani, lenalidomide, f'diversi konċentrazzjonijiet li kienu ttestjati, ma stimulax CYP1A2, CYP2B6, CYP2C9, CYP2C19 u CYP3A4/5.
English: • Loss of sex drive (libido)
Maltese: • Telf ta' aptit sesswali (libido)
English: • if you have or have ever had previous viral infection, particularly hepatitis B infection, varicella zona, HIV.
Maltese: • jekk għandek jew qatt kellek infezzjoni virali fil-passat, partikularment infezzjoni tal-epatite B, varicella zona, HIV.
English: AMT = antimyeloma therapy; CI = confidence interval; CR = complete response; d = low-dose dexamethasone; HR = hazard ratio; IMWG = International Myeloma Working Group; IRAC = Independent Response Adjudication Committee; M = melphalan; max = maximum; min = minimum; NE = not estimable; OS = overall survival; P = prednisone; PFS = progression-free survival; PR = partial response; R = lenalidomide; Rd = Rd given until documentation of progressive disease; Rd18 = Rd given for 18 cycles; SE = standard error; T = thalidomide; VGPR = very good partial response; vs = versus.
Maltese: IMWG = International Myeloma Working Group; IRAC (Independent Response Adjudication Committee) = Kumitat ta' Aġġudikazzjoni Indipendenti dwar ir-Rispons; M = melphalan; max = massimu; min = minimu; NE = mhux estimabbli; OS = sopravivenza globali; P = prednisone; PFS = sopravivenza mingħajr progressjoni; PR = rispons parzjali; R = lenalidomide; Rd = Rd mog]ti sad-dokumentazzjoni ta' marda progressiva;
English: In total, 353 patients were evaluated in the MM-009 study; 177 in the len/dex group and 176 in the placebo/dex group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the len/dex group and 175 in the placebo/dex group.
Maltese: B'kollox, 353 pazjenti kienu evalwati fl-istudju MM-009; 177 fil-grupp ta' len/dex u 176 fil-grupp tal-plaċebo/dex, u b'kollox, 351 pazjent kienu evalwati fi studju MM-010; 176 fil-grupp ta' len/dex u 175 fil-grupp tal-plaċebo/dex.
English: • She should be capable of complying with effective contraceptive measures
Maltese: • Hi għandha tkun kapaċi li tkun konformi b'miżuri ta' kontraċezzjoni effettiva
English: The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Maltese: Ir-riskju ta' tromboemboliżmu venuż jibqa' sejjer għal 4−6 ġimgħat wara t-twaqqif tal-kontraċezzjoni kombinata orali.
English: Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
Maltese: Minn 353 pazjent fl-istudji MM-009 u MM-010 li rċievew lenalidomide/dexamethasone, 45.6% kellhom 65 sena jew iżjed.
English: Tabulated summary for monotherapy in MM
Maltese: Sommarju tabulat għal monoterapija f'MM
English: Common Sepsis◊,b, Bacteraemia, Lung infection◊, Lower respiratory tract infection bacterial, Bronchitis◊, Influenza◊, Gastroenteritis◊, Herpes zoster◊, Infection◊
Maltese: Komuni Sepsis◊,b, Batteremija, Infezzjoni fil-pulmun◊, Infezzjoni batterjali fin-naħa t'isfel tal-passaġġ respiratorju, Bronkite◊, Influwenza◊, Gastroenterite◊, Herpes zoster◊, Infezzjoni◊
English: - capsule contents: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Maltese: - kontenut tal-kapsula: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
English: • a chemotherapy medicine called ‘melphalan' and
Maltese: • mediċina tal-kimoterapija msejħa ‘melphalan' u
English: Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4
Maltese: Lenalidomide jeħel direttament ma' cereblon, komponent ta' kumpless tal-enzimi cullin ring E3 ubiquitin ligase li jinkludi proteina li teħel mal-ħsara f'deoxyribonucleic acid (DNA) 1(DDB1), cullin 4 (CUL4), u regulatur ta' cullins 1 (Roc1).
English: MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p PFS2 (months) ¤ Mediana PFS2 time, months (95% CI)
Maltese: MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p PFS2 (xhur)
English: • Thrombocytopenia
Maltese: • Tromboċitopenija
English: HR [95% CI]; p-value MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p Overall survival (months) Mediana OS time, months (95% CI)
Maltese: HR [95% CI]; valur p MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p
English: • Need for adequate contraception and definition of adequate contraception
Maltese: • Il-ħtieġa għal kontraċezzjoni adegwata u definizzjoni ta' kontraċezzjoni adegwata
English: The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jimplimenta programm talprevenzjoni tat-tqala (PPP, Pregnancy Prevention Programme) f'kull Stat Membru.
English: In two phase III placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
Maltese: III, ikkontrollati bil-plaċebo, 353 pazjent b'majeloma multipla kienu esposti għall-kumbinazzjoni lenalidomide/dexamethasone u 351 għall-kumbinazzjoni plaċebo/dexamethasone.
English: In plasma, the relative exposures of the S- and Renantiomers of lenalidomide are approximately 56% and 44%, respectively.
Maltese: Fil-plażma, l-espożizzjonijiet ta'l-enantiomers S- u R- ta'lenalidomide huma madwar 56% u 44%, rispettivament.
English: In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or UGT1A1.
Maltese: Studji in vitro jindikaw li lenalidomide m'għandu l-ebda effett inibitorju fuq CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A jew UGT1A1.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil-Metaboliżmu u nNutrizzjoni
English: Dose adjustment (days 1 to 21 of repeated 28-day cycles)
Maltese: Aġġustament fid-doża (jiem 1-21 ta' ċikli ripetuti ta' 28 jum)
English: Rare Tumour lysis syndrome
Maltese: Rari Sindrome tal-lisi tat-tumur
English: In vitro studies indicate that lenalidomide has no inhibitory effect on human bile salt export pump (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, and OCT2.
Maltese: Studji in vitro jindikaw li lenalidomide m'għandu l-ebda effett inibitorju fuq il-human bile salt export pump (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, u OCT2.
English: The adverse reactions from CALGB 100104 included events reported post-high dose melphalan and ASCT (HDM/ASCT) as well as events from the maintenance treatment period.
Maltese: Ir-reazzjonijiet avversi minn CALGB 100104 kienu jinkludu avvenimenti rrappurtati wara doża għolja ta' melphalan u ASCT (HDM/ASCT) kif ukoll avvenimenti mill-perjodu ta' kura ta' manteniment.
English: PD = progressive disease; PR = partial response; R = lenalidomide; SD = stable disease; VGPR = very good partial response.
Maltese: PD = marda progressiva; PR = rispons parzjali; R = lenalidomide;
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi Muskoluskeletriċi u tat-Tessuti Konnettivi
English: All ADRs/Frequency
Maltese: L-ADRs kollha/Frekwenza
English: Lenalidomide Accord hard capsules are available in OPA-AL-PVC/Aluminium foil perforated unit dose blister.
Maltese: Lenalidomide Accord kapsuli ibsin jiġu f'folja tal-folj tal- OPA AL PVC/Aluminju mtaqqba ta' unità tad-doża.
English: Patients were stratified at randomisation by age ( 75 vs. > 75 years) and stage (ISS; Stages I and II vs. stage III).
Maltese: Ilpazjenti ġew stratifikati fl-għażla b'mod każwali skont l-età ( 75 vs. > 75 sena) u l-istadju (Stadji I u II vs. stadju III).
English: Lenalidomide has been used in clinical trials in multiple myeloma patients up to 91 years of age (see section 5.1).
Maltese: .2. Lenalidomide intuża fi studji kliniċi f'pazjenti b'majeloma multipla li kellhom sa 91 sena (ara sezzjoni 5.1).
English: In total 614 patients were randomised: 307 patients to lenalidomide and 307 patients to placebo.
Maltese: 307 pazjenti għallenalidomide u 307 pazjenti għall-plaċebo.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Acute myeloid leukaemia Multiple myeloma
Maltese: Lewkimja majelojde akuta Majeloma multipla
English: Haemorrhagic disorders are listed under several system organ classes: Blood and lymphatic system disorders; nervous system disorders (intracranial haemorrhage); respiratory, thoracic and mediastinal disorders (epistaxis); gastrointestinal disorders (gingival bleeding, haemorrhoidal haemorrhage, rectal haemorrhage); renal and urinary disorders (haematuria); injury, poisoning and procedural complications (contusion) and vascular disorders (ecchymosis).
Maltese: Disturbi tad-demm u tas-sistema limfatika; disturbi fis-sistema nervuża (emorraġija intrakranjali); disturbi respiratorji, toraċiċi u medjastinali (tinfaraġ); disturbi gastro-intestinali (emorraġija ġinġivali, emorraġija talmurliti, emorraġija tar-rektum, disturbi fil-kliewi u fis-sistema urinarja (ematurja); korriment u avvelenament u komplikazzjonijiet ta' xi proċedura (kontużjoni) u disturbi vaskulari (ekkimożi).
English: Lactose intolerance
Maltese: Intollerenza għal lactose
English: Table 7 summarises the results of the follow-up efficacy analyses - pooled studies MM-009 and MM-010.
Maltese: Tabella 7 turi fil-qosor ir-riżultati tal-analiżi dwar l-effikaċja tal-follow-up - studji miġbura MM-009 u MM-010.
English: Very Common Pneumonias◊,a, Neutropenic infection
Maltese: Komuni Ħafna Pnewmonji◊,a, Infezzjoni newtropenika
English: End Stage Renal Disease (ESRD) (CLcr < 30 mL/min, requiring dialysis)
Maltese: Stadju (ESRD - End Stage Renal Disease) (CLcr < 30 mL/min, li jeħtieġ id-dijalisi).
English: An increase of second primary malignancies (SPM) has been observed in clinical trials in previously treated myeloma patients receiving lenalidomide/dexamethasone (3.98 per 100 person-years) compared to controls (1.38 per 100 person-years).
Maltese: Ġiet osservata żieda ta' tieni tumuri malinni primarji (SPM) fil-provi kliniċi f'pazjenti b'majeloma li ġew ikkurati fil-passat li kienu qed jirċievu lenalidomide/dexamethasone (3.98 għal kull 100 sena ta' persuna) meta mqabbla mal-kontrolli (1.38 għal kull 100 sena ta' persuna).
English: Not Known Acute hepatic failure^, Hepatitis toxic^
Maltese: Mhux Magħrufa Indeboliment akut tal-fwied^,@, Epatite tossika^
English: Uncommon Angioedema
Maltese: Mhux komuni Anġjoedema