FrancophonIA/ELRC3.0 huggingface dataset:
English: In Cohort 2 (patients with surgically salvageable disease whose planned surgery was associated with severe morbidity), 209 of the 228 evaluable patients treated with XGEVA had not undergone surgery by month 6.
Maltese: F'Ko-orti 2 (pazjenti b'marda li tista' titneħħa permezz ta' kirurġija li l-kirurġija ppjanata tagħhom kienet assoċjata ma' morbidità severa), 209 mill-228 pazjent li setgħu jiġu evalwati ttrattati b'XGEVA m'għaddewx minn kirurġija sa 6 xhur wara.
English: In three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, hypocalcaemia was reported in 9.6% of patients treated with XGEVA and 5.0% of patients treated with zoledronic acid.
Maltese: III ikkontrollati bl-attiv f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, ipokalċimija kienet irrappurtata f'9.6% tal-pazjenti ttrattati b'XGEVA u f'5.0% tal-pazjenti ttrattati b'zoledronic acid.
English: Your healthcare professional will not administer XGEVA to you if you have unhealed wounds from dental or oral surgery.
Maltese: Il-professjonist tal-kura tas-saħħa tiegħek mhux se jagħtik XGEVA jekk għandek feriti li għadhom ma fiequx wara kirurġija dentali jew orali.
English: 71.6% (95% CI: 64.6, 77.9) of patients (table 4) assessed by any of the modalities, with the majority of responses defined by a reduction in fluorodeoxyglucose PET activity or increase in density measured in CT/HU, only 25.1% of the patients had a response per RECIST.
Maltese: B'mod globali, XGEVA kiseb rispons oġġettiv tat-tumur f'71.6% (CI ta' 95%: 64.6, 77.9) tal-pazjenti (tabella 4) evalwati permezz ta' kwalunkwe waħda millmodalitajiet, bil-maġġoranza tar-risponsi definiti minn tnaqqis fl-attività ta' Fluorodeoxyglucose f'PET jew żieda fid-densità mkejla f'CT/HU, u 25.
English: These measures will help to protect the environment.
Maltese: XGEVA ma kienx ittestjat f'nisa tqal.
English: Once removed from the refrigerator, XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Maltese: Ladarba jitneħħa mill-friġġ, XGEVA jista' jinħażen f'temperatura tal-kamra (sa 25°C) għal perjodu sa 30 ġurnata fil-kontenitur oriġinali.
English: New primary malignancy1
Maltese: Tumur malinn primarju ġdid1
English: In a clinical study in patients without advanced cancer, 19% of patients with severe renal impairment (creatinine clearance < 30 mL/min) and 63% of patients receiving dialysis developed hypocalcaemia despite calcium supplementation.
Maltese: < 30 mL/min) u 63% tal-pazjenti li jirċievu dijalisi żviluppaw ipokalċimija minkejja supplimentazzjoni tal-kalċju.
English: Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
Maltese: Eruzzjonijiet Lichenoid minħabba l-mediċina (eż. reazzjonijiet simili għal lichen planus), ġew irrappurtati f'pazjenti fl-ambjent ta' wara t-tqegħid fis-suq.
English: The patient-year adjusted overall incidence (number of events per 100 patient years) of confirmed ONJ was 1.1% during the first year of treatment, 3.7% in the second year and 4.6% per year thereafter.
Maltese: L-inċidenza globali aġġustata għal sena ta' pazjent (numru ta' avvenimenti għal kull 100 sena ta' pazjent) ta' ONJ ikkonfermata kienet ta' 1.1% matul l-ewwel sena ta' trattament, 3.7% fit-tieni sena u ta' 4.6% kull sena wara dan.
English: • While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Maltese: • Waqt it-trattament, għandek iżżomm iġjene orali tajba u tirċievi check-ups dentali b'mod regolari.
English: Monitoring of calcium levels should be conducted (i) prior to the initial dose of XGEVA, (ii) within two weeks after the initial dose, (iii) if suspected symptoms of hypocalcaemia occur (see section 4.8 for symptoms).
Maltese: Monitoraġġ tal-livelli talkalċju għandu jitwettaq (i) qabel id-doża inizjali ta' XGEVA, (ii) fi żmien ġimagħtejn wara d-doża inizjali, (iii) jekk iseħħu sintomi suspettati li huma kkawżati minn ipokalċimija (ara sezzjoni 4.8 għal sintomi).
English: Drug hypersensitivity1
Maltese: Sensittività eċċessiva għallmediċina1
English: • concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Maltese: • terapiji mogħtija fl-istess waqt: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija għar-ras u l-għonq.
English: Increased osteoclast activity, stimulated by RANKL, is a key mediator of bone destruction in metastatic bone disease and multiple myeloma.
Maltese: Żieda fl-attività tal-osteoklasti, stimulata minn RANKL, hija medjatur ewlieni tad-distruzzjoni tal-għadam fil-marda metastatika tal-għadam u f'mjeloma multipla.
English: Denosumab displayed non-linear pharmacokinetics with dose over a wide dose range, but approximately dose-proportional increases in exposure for doses of 60 mg (or 1 mg/kg) and higher.
Maltese: Denosumab wera farmakokinetika mhux lineari mad-doża fuq firxa wiesgħa ta' dożi, iżda żidiet ftit jew wisq proporzjonali mad-doża f'esponiment għal dożi ta' 60 mg (jew 1 mg/kg) u ogħla.
English: There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N-telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure.
Maltese: Ma kien hemm l-ebda tibdil klinikament rilevanti filkonċentrazzjoni l-aktar baxxa fis-serum u fil-farmakodinamiċi ta' denosumab (N-telopeptide fl-awrina aġġustata għall-krejatinina, uNTx/Cr) ikkawżat minn kimoterapija u/jew terapija bl-ormoni fl-istess waqt jew b'esponiment minn qabel għal bisphosphonate fil-vini.
English: In preclinical studies knockout mice lacking RANK or RANKL had an absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) and exhibited impairment of lymph node formation.
Maltese: Fi studji prekliniċi ġrieden knockout li m'għandhomx RANK jew RANKL kellhom nuqqas ta' treddigħ minħabba inibizzjoni ta' maturazzjoni tal-glandola mammarja (żvilupp tal-glandola lobuloalveolari waqt it-tqala) u wrew indeboliment fil-formazzjoni tal-glandola tal-limfa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with XGEVA in all subsets of the paediatric population in the prevention of skeletal related events in patients with bone metastases and subsets of the paediatric population below the age of 12 in the treatment of giant cell tumour of bone (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'XGEVA f'kull sett tal-popolazzjoni pedjatrika fil-prevenzjoni ta' avvenimenti relatati mal-għadam f'pazjenti b'metastasi fl-għadam u sottogruppi tal-popolazzjoni pedjatrika taħt l-età ta' 12-il sena fittrattament ta' tumur taċ-ċelluli ġganti tal-għadam (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw.
Maltese: Pazjenti li qed jirċievu kimoterapija u/jew radjuterapija, li qed jieħdu sterojdi jew mediċini antianġjoġeniċi (użati għat-trattament tal-kanċer), li qed jagħmlu kirurġija dentali, li ma jirċievux kura dentali b'mod regolari, li għandhom mard tal-ħanek, jew li jpejpu, jista' jkollhom riskju ogħla li jiżviluppaw osteonekrosi tax- xedaq.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab.
Maltese: Eżami dentali b'dentistrija preventiva u stima talbenefiċċju u r-riskju individwali huma rakkomandati qabel trattament b'denosumab.
English: A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid.
Maltese: Kien hemm tnaqqis ta' grad 3 fil-livelli tal-kalċju fis-serum f'1.4% talpazjenti ttrattati b'XGEVA u f'0.6% tal-pazjenti ttrattati b'zoledronic acid.
English: Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone MedDRA system organ class Frequency category
Maltese: Reazzjonijiet avversi rrappurtati f'pazjenti b'tumuri malinni avvanzati li jinvolvu l-għadam, mijeloma multipla, jew b'tumur taċ-ċelluli ġganti tal-għadam Klassi tas-sistemi u tal-organi
English: In Study 6, XGEVA has been evaluated in a subset of 18 adolescent patients (aged 13-17 years) with giant cell tumour of bone who had reached skeletal maturity defined by at least 1 mature long bone (e.g. closed epiphyseal growth plate of the humerus) and body weight ≥ 45 kg. An objective response was observed for four of six evaluable adolescents in an interim analysis of Study 6.
Maltese: Fi Studju 6, XGEVA ġie evalwat f'sottosett ta' 18-il pazjent adolexxenti (età ta' 13-17-il sena) b'tumur taċ-ċelluli ġganti tal-għadam li kienu laħqu maturità skeletrika definita b'mill-inqas għadma twila matura waħda (eż. saff tat-tkabbir tal-epifisi tal-omeru magħluq) u piż tal-ġisem ta' ≥ 45 kg.
English: In clinical trials, XGEVA has been administered in combination with standard anti-cancer treatment and in subjects previously receiving bisphosphonates.
Maltese: Fi provi kliniċi, XGEVA ingħata flimkien ma' trattament standard kontra l-kanċer u f'individwi li qabel kienu qed jirċievu bisphosphonates.
English: First radiation to bone Hazard ratio (95% CI)
Maltese: L-ewwel radjazzjoni għall-għadam Proporzjon ta' periklu (CI ta' 95%)
English: In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg XGEVA subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function).
Maltese: F'dan l-istudju, 1,718-il pazjent b'mijeloma multipla b'tal-anqas leżjoni waħda fl-għadam kienu randomised biex jirċievu 120 mg XGEVA taħt il-ġilda kull 4 ġimgħat (Q4W) jew 4 mg zoledronic acid fil-vini (IV - intravenously) kull 4 ġimgħat (aġġustati għad-doża għal funzjoni renali).
English: Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Maltese: Trattament ta' adulti u adolexxenti bi skeletru matur b'tumur taċ-ċelluli ġganti tal-għadam li ma jistax jitneħħa jew fejn tneħħija kirurġika x'aktarx twassal għal morbidità severa.
English: Supplementation with calcium and vitamin D is required in all patients unless hypercalcaemia is present (see section 4.2).
Maltese: Supplimentazzjoni b'kalċju u vitamina D huwa meħtieġ fil-pazjenti kollha sakemm ma tkunx preżenti iperkalċimija (ara sezzjoni 4.2).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Il-fatturi ta' riskju possibbli għal osteonekrosi tal-kanal estern tas-smigħ jinkludu l-użu ta' sterojdi u kimoterapija u/jew fatturi ta' riskju lokali bħal infezzjoni jew trawma.
English: • allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin).
Maltese: • reazzjonijiet allerġiċi (eż. tħarħir jew diffikultà biex tieħu n-nifs; nefħa fil-wiċċ, xufftejn, ilsien, griżmejn jew partijiet oħra tal-ġisem; raxx, ħakk jew ħorriqija fil-ġilda).
English: Superiority p-value
Maltese: Eċċipjent b'effetti magħruf
English: Unhealed lesions from dental or oral surgery.
Maltese: Leżjonijiet li ma jkunux fiequ wara kirurġija dentali jew fil-ħalq.
English: Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in paediatric patients (see section 4.4).
Maltese: Iperkalċimija klinikament sinifikanti wara twaqqif tat-trattament kienet irrappurtata fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti pedjatriċi (ara sezzjoni 4.4).
English: A post-hoc analysis in study 2 (patients with other solid tumours or multiple myeloma) examined overall survival for the 3 tumour types used for stratification (non-small cell lung cancer, multiple myeloma, and other).
Maltese: Analiżi post-hoc fi studju 2 (pazjenti b'tumuri solidi oħra jew mjeloma multipla) eżamina s-sopravivenza globali għat-3 tipi ta' tumuri użati għall-istratifikazzjoni (kanċer tal-pulmun taċ-ċellula mhux żgħira, mjeloma multipla, u oħrajn).
English: NR = not reached; NA = not available; HCM = hypercalcaemia of malignancy; SMR = skeletal morbidity rate; HR = Hazard Ratio; RRR = Relative Risk Reduction †Adjusted p-values are presented for Studies 1, 2 and 3 (first SRE and first and subsequent SRE endpoints); *Accounts for all skeletal events over time; only events occurring ≥ 21 days after the previous event are counted.
Maltese: HR = Proporzjon ta' Periklu; RRR = Tnaqqis Relattiv tar-Riskju †Valuri p aġġustati huma ppreżentati għall-Studji 1, 2 u 3 (l-ewwel SRE u punti finali tal-ewwel SRE u ta' dawk sussegwenti); *Jiġbor l-avvenimenti skeletriċi kollha maż-żmien; magħdudin biss avvenimenti li seħħew ≥ 21 ġurnata wara l-avveniment ta' qabel. ** Inkluż NSCLC, kanċer taċ-ċellula renali, kanċer tal-kolorektum, kanċer taċ-ċellula żgħira tal-pulmun, kanċer tal-bużżieqa tal-awrina, kanċer tar-ras u tal-għonq, kanċer tal-GI/apparat ġenitali u tal-awrina u oħrajn, esklużi kanċer tas-sider u tal-prostata.
English: Clinical efficacy in patients with multiple myeloma
Maltese: Effikaċja klinika f'pazjenti b'mijeloma multipla
English: A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid.
Maltese: Tnaqqis ta' grad 4 fillivelli tal-kalċju fis-serum kien esperjenzat f'0.4% tal-pazjenti ttrattati b'XGEVA u f'0.1% tal-pazjenti ttrattati b'zoledronic acid.
English: Consequently, osteolysis is reduced and proliferative tumour stroma is replaced with non-proliferative, differentiated, densely woven new bone.
Maltese: Konsegwentement, l-osteolisi jitnaqqas u stroma proliferattiva tat-tumur tinbidel ma' għadam ġdid, mhux proliferattiv, differenzjat, u minsuġ b'mod dens.
English: In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 2.7 to 15 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity.
Maltese: Fi studji dwar l-effett tossiku minn doża waħda u minn dożi ripetuti f'xadini cynomolgus, dożi ta' denosumab li jwasslu għall-esponiment sistemiku minn 2.7 drabi sa 15-il darba ogħla mid-doża rakkomandata fil-bniedem ma kellhom l-ebda effett fuq il-fiżjoloġija kardjovaskulari, fertilità maskili jew femminili, u ma wasslux għal tossiċità speċifika tal-organi mmirati.
English: The time to pain improvement (i.e. ≥ 2-point decrease from baseline in BPI-SF worst pain score) was similar for denosumab and zoledronic acid in each study and the integrated analyses.
Maltese: Iż-żmien biex jitjib l-uġigħ (jiġifieri tnaqqis ta' ≥ 2 punti mil-linja bażi fil-punteġġ tal-agħar uġigħ ta' BPI-SF) kien simili għal denosumab u zoledronic acid f'kull studju u fl-analiżi integrata.
English: First SRE
Maltese: L-ewwel SRE
English: An investigator assessment reported that all 18 adolescent patients had a best response of stable disease or better (complete response in 2 patients, partial response in 8 patients, and stable disease in 8 patients).
Maltese: Stima tal-investigatur irrappurtat li t-18-il pazjent adolexxenti kollha kellhom laħjar rispons ta' marda stabbli jew aħjar (rispons sħiħ f'2 pazjenti, rispons parzjali fi 8 pazjenti , u marda stabbli fi 8 pazjenti).
English: Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
Maltese: II li kellhom tneħħija kompluta ta' tumur taċ-ċelluli ġganti tal-għadam irċevew 6 xhur ta' trattament addizzjonali wara l-kirurġija skont il-protokoll tal-istudju.
English: Available clinical data does not suggest an increased risk of malignancy in giant cell tumour of bone patients treated with XGEVA.
Maltese: Data klinika disponibbli ma tissuġġerixxix riskju akbar ta' tumuri malinni f'pazjenti b'tumur taċ-ċelluli ġganti tal-għadam ittrattati b'XGEVA.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420).
Maltese: Jekk it-tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit-tabib tiegħek qabel tieħu din il-mediċina, peress li fiha sorbitol (E420).
English: • If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with XGEVA.
Maltese: • Jekk qed tirċievi trattament dentali jew se tagħmel kirurġija dentali (eż. qlugħ ta' snien), għarraf lit-tabib tiegħek dwar it-trattament dentali tiegħek u għid lid-dentist tiegħek li qed tiġi ttrattat b'XGEVA.
English: In subjects with advanced cancer, who received multiple doses of 120 mg every 4 weeks an approximate 2-fold accumulation in serum denosumab concentrations was observed and steady-state was achieved by 6 months, consistent with time-independent pharmacokinetics.
Maltese: F'individwi b'kanċer avvanzat, li rċevew dożi multipli ta' 120 mg kull 4 ġimgħat kienet osservata akkumulazzjoni ta' madwar id-doppju fil-konċentrazzjonijiet fis-serum ta' denosumab u stat fiss intlaħaq wara 6 xhur, konsistenti ma' farmakokinetika indipendenti mill-ħin.
English: The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year.
Maltese: L-inċidenza aġġustata għal sena ta' pazjent ta' ONJ kienet ta' 0.2% matul l-ewwel sena ta' trattament u 1.7% fit-tieni sena.
English: RANKL is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption.
Maltese: RANKL huwa essenzjali għallformazzjoni, funzjoni u sopravivenza tal-osteoklasti, it-tip ta' ċellula unika responsabbli għallassorbiment mill-ġdid tal-għadam.
English: Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Maltese: Studju 5 irreġistra 37 pazjent adulti b'tumur taċ-ċelluli ġganti tal-għadam ikkonfermat istoloġikament li ma jistax jitneħħa jew rikorrenti.
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Maltese: Testijiet standard biex jiġi investigat il-potenzjal ta' ġenotossiċità ta' denosumab ma kinux evalwati, peress li dawn it-testijiet mhumiex rilevanti għal din il-molekula.
English: Kaplan-Meier plots of time to first on-study SRE
Maltese: Kaplan-Meier plots ta' żmien sal-ewwel SRE waqt l-istudju
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to XGEVA administration.
Maltese: Waqt ittrattament, proċeduri dentali invażivi għandhom isiru biss wara konsiderazzjoni bir-reqqa u jiġu evitati qrib ta' għoti ta' XGEVA.
English: Lichenoid drug eruptions1
Maltese: Eruzzjonijiet Lichenoid minħabba l-mediċina1
English: In the post-marketing setting, musculoskeletal pain, including severe cases, has been reported in patients receiving XGEVA.
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq, uġigħ muskolu-skeletriku, inklużi każijiet severi, kien irrappurtat f'pazjenti li kienu qed jirċievu XGEVA.
English: Disease progression and overall survival with bone metastases from solid tumours
Maltese: Progressjoni tal-marda u sopravivenza globali b'metastasi fl-għadam minn tumuri solidi
English: • persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis).
Maltese: • Ikkuntattja lit-tabib u lid-dentist tiegħek minnufih jekk ikollok xi problemi fil-ħalq jew snien tiegħek bħal snien laxki, uġigħ jew nefħa, feriti li ma jfiqux jew tnixxija, peress li dawn jistgħu jkunu sinjali ta' osteonekrosi tax-xedaq.
English: An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
Maltese: SRE kien definit bħala wieħed minn dawn li ġejjin: ksur patoloġiku (vertebrali jew mhux vertebrali), terapija ta' radjazzjoni għall-għadam (inkluż l-użu ta' radjuisotopi), kirurġija fl-għadam, jew kompressjoni tan-nerv li jgħaddi mis-sinsla tad-dahar.
English: Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation.
Maltese: Iperkalċimija klinikament sinifikanti li tirrikjedi li l-pazjent jiġi rikoverat l-isptar u kkumplikata minn korriment renali akut kienet irrappurtata f'pazjenti trattati b'XGEVA b'tumur taċ-ċelluli ġganti talgħadam ġimgħat sa xhur wara t-twaqqif tat-trattament.
English: In a clinical study of patients without advanced cancer with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis, there was a greater risk of developing hypocalcaemia in the absence of calcium supplementation.
Maltese: Fi studju kliniku ta' pazjenti mingħajr kanċer avvanzat b'indeboliment sever tal-kliewi (tneħħija talkrejatinina ta' < 30 mL/min) jew li jirċievu d-dijalisi, kien hemm riskju akbar li tiżviluppa ipokalċimija fin-nuqqas ta' supplimentazzjoni tal-kalċju.
English: XGEVA is a solution for injection (injection).
Maltese: XGEVA huwa soluzzjoni għall-injezzjoni (injezzjoni).
English: The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.
Maltese: Il-farmakokinetika ta' denosumab mhux mistennija li tiġi affettwata minn indeboliment epatiku.
English: In Cohort 1 (patients with surgically unsalvageable disease), median time to disease progression was not reached, 21 of the 258 treated patients had disease progression.
Maltese: F'Ko-orti 1 (pazjenti b'marda li ma tistax titneħħa permezz ta' kirurġija), żmien medjan sa progressjoni tal-marda ma ntlaħaqx, 21 mill-258 pazjent ittrattati kellhom progressjoni tal-marda.
English: Elderly
Maltese: Amgen
English: How to store XGEVA
Maltese: X'fih XGEVA
English: The median time to ONJ was 19.4 months (range: 11 - 40).
Maltese: (firxa: 11 - 40).
English: In a post-hoc analysis of the combined dataset, the median time to worsening pain (> 4-point worst pain score) in patients with mild or no pain at baseline was delayed for XGEVA compared to zoledronic acid (198 versus 143 days) (p = 0.0002).
Maltese: F'analiżi post-hoc tad-dataset ikkombinata, iż-żmien medjan sakemm jaggrava l-uġigħ (punteġġ tal-agħar uġigħ ta' > 4 punti) f'pazjenti b'uġigħ ħafif jew bl-ebda uġigħ fil-linja bażi kien ittardjat għal XGEVA meta mqabbel ma' zoledronic acid (198 kontra 143 jum) (p = 0.0002).
English: HCM = hypercalcaemia of malignancy
Maltese: Eruzzjonijiet Lichenoid minħabba l-mediċina
English: Giant cell tumours of bone are characterised by neoplastic stromal cells expressing RANK ligand and osteoclast-like giant cells expressing RANK.
Maltese: Tumuri taċ-ċelluli ġganti tal-għadam huma kkaratterizzati minn ċelluli stromali neoplastiċi li jesprimu l-ligand RANK u ċelluli ġganti simili għall-osteoklasti li jesprimu RANK.
English: Number of patients who had SREs (%) Median time to SRE (months)
Maltese: Numru ta' pazjenti li kellhom SREs (%) Żmien medjan għal SRE (xhur)