FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 RECIST 1.1: Modified Response Evaluation Criteria in Solid Tumours to evaluate tumour burden based on computed tomography (CT)/magnetic resonance imaging (MRI) 3 EORTC: Modified European Organisation for Research and Treatment of Cancer criteria to evaluate metabolic response using fluorodeoxyglucose positron emission tomography (FDG-PET) 4 Density/Size: Modified Inverse Choi criteria to evaluate tumour size and density using Hounsfield units based on CT/MRI
Maltese: Kriterji Modifikati tal-Organizzazzjoni Ewropea għar-Riċerka u t-Trattament tal-Kanċer biex jiġi evalwat ir-rispons metaboliku bl-użu ta' tomografija ta' emissjoni ta' pożitron bl-użu ta' Fluorodeoxyglucose (FDG-PET - fluorodeoxyglucose positron emission tomography) 4 Densità/Daqs: Kriterji Choi Inversi Modifikati biex jiġi evalwat id-daqs u d-densità tat-tumur bl-użu ta' unitajiet Hounsfield ibbażat fuq CT/MRI
English: Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Maltese: Denosumab huwa antikorp IgG2 monoklonali uman magħmul f'linja ta' ċelluli mammiferi (ċelluli tal-ovarju tal-ħamster Ċiniż) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: In a combined pre-specified analysis from studies 1, 2 and 3, overall survival was similar between XGEVA and zoledronic acid (hazard ratio and 95% CI 0.99 [0.91, 1.07]).
Maltese: F'analiżi kkombinata speċifikata minn qabel mill-istudji 1, 2 u 3, is-sopravivenza globali kienet simili bejn XGEVA u zoledronic acid (proporzjon ta' periklu u CI ta' 95% ta' 0.99 [0.91, 1.07]).
English: • another medicine containing denosumab
Maltese: • mediċina oħra li fiha denosumab
English: Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
Maltese: Effikaċja klinika u sigurtà f'adulti u adolexxenti bi skeletru matur b'tumur taċ-ċelluli ġganti talgħadam
English: XGEVA was evaluated in an international, randomised (1:1), double-blind, active-controlled study comparing XGEVA with zoledronic acid in patients with newly diagnosed multiple myeloma, study 4.
Maltese: XGEVA kien evalwat fi studju internazzjonali, randomised (1:1), double-blind, ikkontrollat bl-attiv li qabbel XGEVA ma' zoledronic acid f'pazjenti b'mijeloma multipla ddijanjostikata reċentement, studju 4.
English: ONJ has been reported commonly in patients receiving XGEVA (see section 4.8).
Maltese: ONJ kien irrappurtat b'mod komuni f'pazjenti li jirċievu XGEVA (ara sezzjoni 4.8).
English: RANKL exists as a transmembrane or soluble protein.
Maltese: RANKL jeżisti bħala proteina transmembranika jew li tinħall.
English: XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone (see section 4.4).
Maltese: XGEVA mhux rakkomandat f'pazjenti pedjatriċi (età ta' < 18) minbarra adolexxenti bi skeletru matur b'tumur taċ-ċelluli ġganti tal-għadam (ara sezzjoni 4.4).
English: Study 6 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
Maltese: Studju 6 irreġistra 507 adulti jew adolexxenti bi skeletru matur b'tumur taċ-ċelluli ġganti tal-għadam u evidenza ta' marda attiva li tista' titkejjel.
English: In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]).
Maltese: Fi studji 1, 2 u 3, is-sopravivenza globali kienet bilanċjata bejn XGEVA u zoledronic acid f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam: pazjenti b'kanċer tas-sider (proporzjon ta' periklu u CI ta' 95% kienu 0.95 [0.81, 1.11]), pazjenti b'kanċer tal-prostata (proporzjon ta' periklu u CI ta' 95% kienu 1.03 [0.91, 1.17]), u pazjenti b'tumuri solidi oħra jew mjeloma multipla (proporzjon ta' periklu u CI ta' 95% kienu 0.95 [0.83, 1.08]).
English: XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Maltese: XGEVA kien studjat fi prova open label li rreġistrat 18-il adolexxent bi skeletru matur b'tumur taċ-ċelluli ġganti tal-għadam.
English: In two phase II single-arm clinical trials in patients with giant cell tumour of bone, ONJ occurred in 2.3% (12 of 523) of patients treated with XGEVA (median overall exposure of 20.3 months; range: 0 - 83.4).
Maltese: II bi grupp wieħed f'pazjenti b'tumur taċ-ċelluli ġganti tal-għadam, ONJ seħħet fi 2.3% (12 minn 523) tal-pazjenti ttrattati b'XGEVA (esponiment globali medjan ta' 20.3 xhur; firxa: 0 - 83.4).
English: In the primary double blind treatment phases of four phase III active-controlled clinical trials in patients with advanced malignancies involving bone, new primary malignancy was reported in 54/3691 (1.5%) of patients treated with XGEVA (median exposure of 13.8 months; range: 1.0-51.7) and 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; range:
Maltese: III ikkontrollati bl-attiv f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, tumur malinn primarju ġdid ġie rrapportat f'54/3691 (1.5%) tal-pazjenti ttrattati b'XGEVA (esponiment medjan ta' 13.8-il xahar; firxa: 1.0-51.7) u 33/3688 (0.9%) ta' pazjenti ttrattati b'zoledronic acid (esponiment medjan ta' 12.9-il xahar; firxa:
English: In subjects who discontinued 120 mg every 4 weeks, the mean half-life was 28 days (range 14 to 55 days).
Maltese: F'individwi li waqqfu 120 mg kull 4 ġimgħat, il-half-life medja kienet ta' 28 jum (firxa 14 sa 55 jum).
English: This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull 120 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Following subcutaneous administration, bioavailability was 62%.
Maltese: Wara għoti taħt il-ġilda, il-bijodisponibilità kienet ta' 62%.
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures (e.g. tooth extractions).
Maltese: • iġene orali fqira, mard paradentali, dentaturi li ma jeħlux sew, mard dentali eżistenti minn qabel, proċeduri dentali invażivi (eż. qlugħ ta' sinna).
English: Atypical femoral fractures have also been reported in patients with certain co-morbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors).
Maltese: Ksur mhux tipiku tal-wirk kien irrappurtat ukoll f'pazjenti li kellhom ċertu mard komorbuż ieħor (eż. nuqqas ta' vitamina D, artrite rewmatika, ipofosfatasja) u bl-użu ta' ċertu sustanzi farmaċewtiċi (eż. bisphosphonates, glucocorticoids, inibituri tal-proton pump).
English: The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs).
Maltese: Il-punti finali primarji u sekondarji evalwaw l-okkorrenza ta' avveniment skeletriku relatat (SREs - skeletal related events) wieħed jew aktar.
English: In the double-blind treatment phase of this trial, ONJ was confirmed in 5.9% of patients treated with XGEVA (median exposure of 19.4 months; range 1 52) and in 3.2% of patients treated with zoledronic acid.
Maltese: Fil-fażi ta' trattament double-blind ta' din il-prova, ONJ kienet ikkonfermata f'5.9% tal-pazjenti ttrattati b'XGEVA (esponiment medjan ta' 19.4 xhur; firxa 1 - 52) u fi 3.2% tal-pazjenti ttrattati b'zoledronic acid.
English: A grade 4 decrease in serum calcium levels was experienced in 0.6% of patients treated with XGEVA and 0.2% of patients treated with zoledronic acid (see section 4.4).
Maltese: Kien hemm tnaqqis ta' grad 4 fil-livelli tal-kalċju fis-serum f'0.6% tal-pazjenti ttrattati b'XGEVA u f'0.2% tal-pazjenti ttrattati b'zoledronic acid (ara sezzjoni 4.4).
English: 1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
Maltese: Soluzzjoni ta' 1.7 mL f'kunjett għall-użu ta' darba (ħġieġ tat-tip I) b'tapp (elastomer miksi b'fluoropolymer) u siġill (aluminju) b'għatu ‘flip-off'.
English: All 20 patients (100%) with histology assessments responded.
Maltese: L-20 pazjent kollha (100%) b'valutazzjonijiet istoloġiċi rrispondew.
English: Upon enrolment of 282 patients, in Study 6 cohorts 1 and 2 combined, a clinically meaningful reduction in worst pain (i.e. ≥ 2-point decrease from baseline) was reported for 31.4% of patients at risk (i.e. those who had a worst pain score of ≥ 2 at baseline) within 1 week of treatment, and ≥ 50% at week 5.
Maltese: Mar-reġistrazzjoni ta' 282 pazjent, f'ko-orti 1 u 2 ikkombinati ta' Studju 6, tnaqqis klinikament sinifikanti fl-agħar uġigħ (jiġifieri tnaqqis ta' ≥ 2 punti mil-linja bażi) kien irrappurtat għal 31.4% tal-pazjenti f'riskju (jiġifieri dawk li kellhom punteġġ tal-agħar uġigħ ta' ≥ 2 fil-linja bażi) fi żmien ġimgħa ta' trattament, u għal ≥ 50% f'ġimgħa 5.
English: A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid.
Maltese: Kien hemm tnaqqis ta' grad 3 fil-livelli tal-kalċju fis-serum fi 2.5% tal-pazjenti ttrattati b'XGEVA u f'1.2% tal-pazjenti ttrattati b'zoledronic acid.
English: In phase III clinical trials of patients with advanced malignancies involving bone, median uNTx/Cr reductions of approximately 80% were maintained through 49 weeks of XGEVA treatment (120 mg every Q4W).
Maltese: III ta' pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, kien miżmum tnaqqis uNTx/Cr medjan ta' madwar 80% matul 49 ġimgħa ta' trattament b'XGEVA (120 mg kull Q4W).
English: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).
Maltese: Prevenzjoni ta' avvenimenti relatati mal-għadam (ksur patoloġiku, radjazzjoni fl-għadam, kompressjoni tas-sinsla tad-dahar jew kirurġija fl-għadam) f'adulti b'tumuri malinni avvanzati li jinvolvu l-għadam (ara sezzjoni 5.1).
English: Non-inferiority / Superiority p-values
Maltese: GĦAMLA KWALITATTIVA
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see section 5.3).
Maltese: Inibizzjoni ta' RANK/ligand RANK (RANKL - RANK ligand) fi studji fuq l-annimali kien konness ma' inibizzjoni tat-tkabbir tal-għadam u man-nuqqas ta' ħruġ tas-snien, u dawn il-bidliet kienu parzjalment riversibbli mal-waqfien tal-inibizzjoni ta' RANKL (ara sezzjoni 5.3).
English: Overall of 225 patients for whom giant cell tumours of bone surgery (excluding lung metastases only) was planned, 109 had no surgery performed and 84 underwent a less morbid procedure than planned at baseline.
Maltese: B'mod globali minn 225 pazjent li kellhom ippjanata kirurġija ta' tumuri taċ-ċelluli ġganti tal-għadam (eskluż metastasi fil-pulmun biss), 109 ma kellhom l-ebda kirurġija u 84 għaddew minn proċedura inqas morbida milli kien ippjanat fil-linja bażi.
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 3 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Maltese: Permezz ta' immunoassay sensittiv < 1% tal-pazjenti ttrattati b'denosumab għal perjodu sa 3 snin ittestjaw pożittivi għall-antikorpi mhux newtralizzanti li jeħlu bl-ebda evidenza ta' bidla fil-farmakokinetika, fit-tossiċità, jew rispons kliniku.
English: HR (95% CI) / RRR (%) Superiority p-value
Maltese: RRR (%) Valuri p Mhux ta' inferjorità / Superjorità Proporzjon ta' individwi (%)
English: Cases of osteonecrosis of the jaw (see sections 4.4 and section 4.8 - description of selected adverse reactions) have been commonly observed in patients taking XGEVA.
Maltese: Każijiet ta' osteonekrosi tax-xedaq (ara sezzjoni 4.4 u sezzjoni 4.8 - deskrizzjoni ta' reazzjonijiet avversi magħżula) kienu osservati b'mod komuni f'pazjenti li kienu qed jieħdu XGEVA.
English: In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at systemic exposures 12-fold higher than the human dose, there were increased stillbirths and postnatal mortality; abnormal bone growth resulting in reduced bone strength, reduced haematopoiesis, and tooth malalignment; absence of peripheral lymph nodes; and decreased neonatal growth.
Maltese: Fi studju ieħor fuq xadini cynomolgus li ngħataw denosumab matul it-tqala kollha f'esponimenti sistemiċi 12-il darba ogħla mid-doża fil-bniedem, kien hemm żieda fil-frieħ imwielda mejta u filmortalità wara t-twelid; tkabbir mhux normali tal-għadam li rriżulta f'għadam aktar debboli, ematopoesi mnaqqsa, u allinjament ħażin tas-snien; nuqqas ta' glandoli tal-limfa periferali, u tnaqqis fit-tkabbir ta' wara t-twelid.
English: Baseline pre-treatment analgesic use in cohort 1 and cohort 2 was graded on a seven point scale, where 74.8% of patients reported no or mild analgesic use (i.e. analgesic score ≤ 2) and 25.2% of patients used strong opioids (i.e. analgesic score 3 to 7).
Maltese: Użu ta' analġeżiċi qabel it-trattament fil-linja bażi f'ko-orti 1 u ko-orti 2 kien gradat fuq skala ta' seba' punti, fejn 74.8% tal-pazjenti ma rrappurtaw l-ebda użu jew użu ħafif ta' analġeżiċi (jiġifieri punteġġ analġeżiku ta' ≤ 2) u 25.2% tal-pazjenti użaw opjojdi qawwija (jiġifieri punteġġ analġeżiku ta' 3 sa 7).
English: Symptoms of hypocalcaemia in clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Maltese: Sintomi ta' ipokalċimija fi studji kliniċi inkludew parasteżija jew ebusija fil-muskoli, kontrazzjonijiet, spażmi u bugħawwieġ fil-muskoli.
English: Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4).
Maltese: Supplimentazzjoni ta' mill-inqas 500 mg ta' kalċju u 400 IU ta' vitamina D kuljum huwa meħtieġ fil-pazjenti kollha, sakemm ma tkunx preżenti iperkalċimija (ara sezzjoni 4.4).
English: Efficacy results from study 4 are presented in figure 2 and table 3.
Maltese: Ir-riżultati tal-effikaċja minn studju 4 huma ppreżentati fil-figura 2 u fit-tabella 3.
English: Each vial contains 120 mg of denosumab in 1.7 mL of solution (corresponding to 70 mg/mL).
Maltese: Kull kunjett fih 120 mg ta' denosumab f'1.7 mL ta' soluzzjoni (jikkorrispondu għal 70 mg/mL).
English: No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali (ara sezzjoni 4.4 għal rakkomandazzjonijiet dwar il-monitoraġġ tal-kalċju, 4.8 u 5.2).
English: In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, ONJ was confirmed in 1.8% of patients treated with XGEVA (median exposure of 12.0 months; range: 0.1 - 40.5) and 1.3% of patients treated with zoledronic acid.
Maltese: III ikkontrollati bl-attiv f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, ONJ ġiet ikkonfermata f'1.8% tal-pazjenti ttrattati b'XGEVA (esponiment medjan ta' 12.0-il xahar; firxa: 0.1 - 40.5) u f'1.3% tal-pazjenti ttrattati b'zoledronic acid.
English: Anaphylactic reaction1
Maltese: Reazzjoni anafilattika1
English: Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.
Maltese: Denosumab huwa antikorp monoklonali uman (IgG2) li jimmira u jeħel b'affinità u speċifiċità għolja ma' RANKL, u b'hekk jipprevjeni l-interazzjoni ta' RANKL/RANK milli sseħħ u jwassal għal tnaqqis fil-kwantità u fil-funzjoni tal-osteoklasti, b'hekk inaqqas l-assorbiment millġdid tal-għadam u d-distruzzjoni tal-għadam indotta mill-kanċer.
English: In mouse bone metastasis models of oestrogen receptor positive and negative human breast cancer, prostate cancer and non-small cell lung cancer, OPG-Fc reduced osteolytic, osteoblastic, and osteolytic/osteoblastic lesions, delayed formation of de novo bone metastases, and reduced skeletal tumour growth.
Maltese: F'mudelli ta' metastasi fl-għadam fil-ġrieden ta' kanċer tas-sider uman pożittiv u negattivi għarriċettur tal-estroġenu, kanċer tal-prostata u kanċer tal-pulmun taċ-ċellula mhux żgħira, OPG-Fc naqqas il-leżjonijiet osteolitiċi, osteoblastiċi, u osteolitiċi/osteoblastiċi, ittardja l-formazzjoni ta' metastasi de novo fl-għadam, u naqqas it-tkabbir tat-tumur fl-għadam. Meta OPG-Fc kien ikkombinat ma' terapija ta' ormoni (tamoxifen) jew kimoterapija (docetaxel) f'dawn il-mudelli, kien hemm inibizzjoni addizzjonali tat-tkabbir tat-tumur skeletriku f'kanċer tas-sider, u tal-prostata jew tal-pulmun rispettivament.
English: The safety and efficacy of XGEVA was studied in two phase II open-label, single-arm trials (studies 5 and 6) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity.
Maltese: II open-label, bi grupp wieħed (studji 5 u 6) li rreġistraw 529 pazjent b'tumur taċ-ċelluli ġganti tal-għadam li ma setax jitneħħa jew li għalihom kirurġija tkun assoċjata ma' morbidità severa.
English: One hundred and ninety had at least 1 evaluable time point response and were included in the analysis (table 4).
Maltese: Mija u disgħin kellhom mill-inqas rispons 1 li jista' jiġi evalwat f'punt ta' żmien u kienu inklużi fl-analiżi (tabella 4).
English: The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone.
Maltese: Is-sigurtà u l-effikaċja ta' XGEVA għadhom ma ġewx determinati f'pazjenti pedjatriċi (età ta' < 18) minbarra adolexxenti bi skeletru matur b'tumur taċ-ċelluli ġganti tal-għadam.
English: Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure were excluded from the clinical trials.
Maltese: Pazjenti bi storja preċedenti ta' ONJ jew osteomjelite tax-xedaq, kondizzjoni attiva dentali jew tax-xedaq li teħtieġ kirurġija orali, kirurġija dentali/orali mhux imfejqa, jew kwalunkwe proċedura dentali invażiva ppjanata kienu esklużi mill-provi kliniċi.
English: Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion.
Maltese: Mill-15il -pazjent li fadal, 10 (67%) kejl radjugrafiku ma wera l-ebda progressjoni tal-leżjoni mmirata.
English: Monitoring of calcium levels and adequate intake of calcium and vitamin D is especially important in patients with renal impairment (see section 4.4).
Maltese: Monitoraġġ tal-livelli tal-kalċju u teħid adegwat ta' kalċju u vitamina D huma importanti ħafna f'pazjenti b'indeboliment renali (ara sezzjoni 4.4).
English: Response criteria included elimination of giant cells based on histopathology or lack of progression by radiography.
Maltese: Kriterji tar-rispons inkludew eliminazzjoni ta' ċelluli ġganti bbażata fuq istopatoloġija jew nuqqas ta' progressjoni skont radjugrafija.
English: At the completion of the double-blind treatment phase of this trial, the patient-year adjusted incidence (number of events per 100 patient years) of confirmed ONJ in the XGEVA group (median exposure of 19.4 months; range 1 - 52), was 2.0% during the first year of treatment, 5.0% in the second year, and 4.5% per year thereafter.
Maltese: Mat-tlestija tal-fażi ta' trattament double-blind ta' din il-prova, l-inċidenza aġġustata għas-sena tal-pazjent (numru ta' avvenimenti għal kull 100 sena ta' pazjent) ta' ONJ ikkonfermata fil-grupp ta' XGEVA (esponiment medjan ta' 19.4 xhur; firxa 1 - 52) kienet 2.0% matul l-ewwel sena ta' trattament, 5.0% fit-tieni sena, u 4.5% kull sena wara dan.
English: Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models.
Maltese: Peress li l-attività bijoloġika ta' denosumab fl-annimali hija speċifika għall-primati mhux umani, intużaw evalwazzjoni ta' ġrieden maħluqa permezz ta' inġinerija ġenetika (knockout) jew l-użu ta' inibituri bijoloġiċi oħra tar-rotta RANK/RANKL, bħal OPG-Fc u RANK-Fc, biex jiġu evalwati lkwalitajiet farmakodinamiċi ta' denosumab f'mudelli gerriema.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).
Maltese: Kull kunjett fih 120 mg ta' denosumab f'1.7 mL ta' soluzzjoni (70 mg/mL).
English: • shortness of breath,
Maltese: • għaraq eċċessiv,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/703/001
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Maltese: Denosumab huwa magħmul biss minn aċidi amminiċi u karboidrati bħala immunoglobulina indiġena u mhux probabbli li jiġi eliminat permezz ta' mekkaniżmi metaboliċi tal-fwied.
English: Atypical femoral fractures have been reported in patients receiving denosumab (see section 4.8).
Maltese: Ksur mhux tipiku tal-wirk kien irrappurtat f'pazjenti li kienu qed jirċievu denosumab (ara sezzjoni 4.8).
English: In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level.
Maltese: II f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, dożaġġ taħt ilġilda (SC - subcutaneous) ta' XGEVA mogħti kull 4 ġimgħat (Q4W) jew kull 12-il ġimgħa wassal għal tnaqqis rapidu fil-markaturi tal-assorbiment mill-ġdid tal-għadam (uNTx/Cr, CTx tas-serum), bi tnaqqis medjan ta' madwar 80% għal uNTx/Cr li jseħħ fi żmien ġimgħa irrispettivament mit-terapija ta' bisphosphonate li ngħatat qabel jew mil-livell ta' uNTx/Cr fil-linja bażi.
English: The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Maltese: Id-doża rakkomandata ta' XGEVA hija 120 mg mogħtija bħala injezzjoni waħda taħt il-ġilda darba kull 4 ġimgħat fil-koxxa, fl-addome jew fil-parti ta' fuq tad-driegħ b'dożi addizzjonali ta' 120 mg f'jiem 8 u 15 tat-trattament tal-ewwel xahar ta' terapija.
English: XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
Maltese: XGEVA fih denosumab, proteina (antikorp monoklonali) li taħdem biex tittardja t-tifrik tal-għadam ikkawżat minn kanċer li jinfirex għall-għadam (metastasi fl-għadam) jew minn tumur taċ-ċelluli ġganti tal-għadam.