FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexamethasone 8 mg once a day
Maltese: Dexamethasone 8 mg darba kuljum
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara ‘JIS'.
English: Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia
Maltese: Imblokk tal-bundle branch tax-xellug
English: How to take Akynzeo
Maltese: X'inhu Akynzeo
English: Serotonergic medicinal products (e.g. SSRIs and SNRIs)
Maltese: Prodotti mediċinali serotoninerġiċi (eż.
English: The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5HT3 receptor antagonist) blocks certain receptors for serotonin.
Maltese: Il-mediċini f'Akynzeo jeħlu mar-riċetturi fis-sistema nervuża li permezz tagħha serotonin u sustanza P jaħdmu: netupitant (antagonist tar-riċetturi NK1) jimblokka r-riċetturi għal sustanza P, u palonosetron (antagonist tar-riċetturi 5-HT3) jimblokka ċerti riċetturi għal serotonin.
English: Common: (may affect up to 1 in 10 people)
Maltese: Komuni: (jistgħu jaffettwaw sa 1 minn kull 10 persuni)
English: Pack size of one hard capsule or 4 x 1 hard capsules in perforated unit dose blisters.
Maltese: Daqs tal-pakkett ta' kapsula waħda iebsa jew 4 x 1 kapsuli ibsin f'folji perforati ta' doża waħda.
English: Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase
Maltese: Tabella 3: Proporzjon ta' pazjenti li kienu qed jirċievu kimoterapija b'cisplatin li rrispondew skont il-grupp ta' kura u l-fażi
English: Upper 95% confidence limit of the point estimates of placebo and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration.
Maltese: Upper 95% confidence limit tal-point estimates tal-plaċebo u QTcI ikkoreġut fil-linja bażi kien il-ħin kollu fil-medda ta' 10 ms fil-punti kollha ta' ħin fuq perjodu ta' jumejn wara l-għoti tas-sustanza tal-istudju.
English: When netupitant was administered on Day 8 of a 12-day regimen of digoxin, no changes in digoxin pharmacokinetics were observed.
Maltese: Netupitant mhuwiex substrat għal P-gp. Meta netupitant ingħata f'Jum 8 ta' kors ta' 12-il jum ta' digoxin, ma ġie osservat l-ebda tibdil fil-farmakokinetika ta' digoxin.
English: Uncommon: (may affect up to 1 in 100 people)
Maltese: Mhux komuni: (jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: • problems with the muscles in your heart (cardiomyopathy)
Maltese: • problemi fil-muskoli tal-qalb tiegħek (kardjomijopatija)
English: What Akynzeo looks like and contents of the pack
Maltese: Kif jidher Akynzeo u l-kontenut tal-pakkett
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Maltese: Filwaqt li l-half-life tal-eliminazzjoni terminali u l-medja tal-esponiment sistemiku ta' palonosetron jiżdiedu f'individwi b'indeboliment sever tal-fwied, dan ma jiġġustifikax tnaqqis fid-doża.
English: Mild to moderate renal impairment does not significantly affect palonosetron PK parameters.
Maltese: Indeboliment minn ħafif sa moderat tal-kliewi ma jaffettwax b'mod sinifikanti l-parametri PK ta' palonosetron.
English: Table1: Adverse reactions System organ class
Maltese: Tabella 1 Reazzjonijiet avversi
English: • high levels of creatinine - which measures kidney function (shown in blood tests)
Maltese: • livelli għolja ta' kreatinina - li tkejjel il-funzjoni tal-kliewi (li jidhru fit-testijiet tad-demm)
English: Delayed phase: 25 to 120 hours post-cisplatin treatment.
Maltese: Fażi li tittardja: 25 sa 120 siegħa wara l-kura b'cisplatin.
English: Absolute netupitant bioavailability data are not available in humans; based on data from two studies with intravenous netupitant, the bioavailability in humans is estimated to be greater than 60%.
Maltese: Dejta dwar il-bijodisponibilità assoluta ta' netupitant mhijiex disponibbli fil-bnedmin; ibbażat fuq dejta minn żewġ studji dwar netupitant ġol-vini, il-bijodisponibilità fil-bnedmin hi stmata li hi ta' aktar minn 60%.
English: Approximately half the radioactivity administered orally as [14C]-netupitant was recovered from urine and faeces within 120 h of dosing.
Maltese: Madwar nofs ir-radjuattività li ngħatat mill-ħalq bħala [14C] netupitant, ġiet irkuprata mill-awrina u l-ippurgar fi żmien 120 siegħa wara d-dożaġġ.
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Maltese: Ma ġie osservat l-ebda tibdil rilevanti fil-farmakokinetika ta' netupitant u palonosetron.
English: Non-clinical studies indicate that netupitant and its metabolites and the combination with palonosetron only at very high concentrations may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Maltese: Studji mhux kliniċi jindikaw li netupitant u l-metaboliti tiegħu u l-kombinazzjoni ma' palonosetron f'konċentrazzjonijiet qawwija ħafna biss, jistgħu jimblukkaw il-kanali tal-joni involuti fiddepolarizzazzjoni u fir-repolarizzazzjoni ventrikulari u jtawwal kemm iddum l-azzjoni potenzjali.
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these active substances with netupitant/palonosetron capsules.
Maltese: L-effetti potenzjali ta' żieda tal-konċentrazzjonijiet filplażma ta' midazolam jew benzodiazepines oħrajn metabolizzati permezz ta' CYP3A4 (alprazolam, triazolam) għandhom jiġu kkunsidrati meta dawn is-sustanzi attivi jingħataw flimkien ma' kapsuli ta' netupitant/palonosetron.
English: Eructation
Maltese: Ġelatina
English: An increased incidence of positional foetal abnormalities of the limbs and paws, fused sternebrae and agenesis of accessory lung lobe were observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher during the period of organogenesis.
Maltese: Żieda fl-inċidenza ta' anormalitajiet pożizzjonali tal-fetu ta' dirgħajn u riġlejn, sternebrae mwaħħlin ma' xulxin u agenesi tal-lobu aċċessorju tal-pulmun, ġew osservati wara l-għoti kuljum ta' netupitant fil-fniek f'doża ta' 10 mg/kg/jum u ogħla matul il-perjodu ta' organoġenesi.
English: The AUC was 30% higher in cancer patients than in healthy subjects.
Maltese: L-AUC kienet 30% ogħla f'pazjenti bil-kanċer milli f'individwi b'saħħithom.
English: • high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases
Maltese: • livelli għoljin ta' ċerti enzimi, li jinkludu alkaline phosphatase tad-demm u transaminases tal fwied (li jidhru fit-testijiet tad-demm)
English: In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron.
Maltese: Studji dwar il-metaboliżmu in vitro wrew li CYP2D6 u, fi grad inqas, l-isoenzimi ta' CYP3A4 u CYP1A2, huma involuti fil-metaboliżmu ta' palonosetron.
English: This medicine contains 7 mg of sorbitol in each hard capsule.
Maltese: Dan il-prodott mediċinali fih 7 mg sorbitol f'kull kapsula iebsa.
English: It may also contain a trace of lecithin derived from soya.
Maltese: Jista' jkun fih ukoll traċċa ta' lecithin li jiġi mis-sojja.
English: Following administration of a single dose of Akynzeo, netupitant is eliminated from the body in a multi-exponential fashion, with an apparent mean elimination half-life of 88 hours in cancer patients.
Maltese: Wara l-għoti ta' doża waħda ta' Akynzeo, netupitant jiġi eliminat mill-ġisem b'mod multiesponenzjali, b'half-life tal-eliminazzjoni medja apparenti ta' 88 siegħa f'pazjenti bil-kanċer.
English: • you have any other heart problems • you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.
Maltese: • qalulek li għandek żbilanċ ta' minerali fid-demm tiegħek, bħal potassium u magnesium, li ma ġiex ikkoreġut.
English: The primary efficacy endpoint was the CR rate in the delayed phase, 25-120 hours after the start of the chemotherapy administration.
Maltese: Il-punti aħħari tal-effikaċja primarja kienet ir-rata ta' CR fil-fażi li tittardja, 25-120 siegħa wara l-bidu tal-għoti tal-kimoterapija.
English: Adverse reactions are listed below by MedDRA body system organ class and frequency.
Maltese: Il-konvenzjoni li ġejja ntużat għall-klassifikazzjoni tal-frekwenza:
English: • low levels of ‘neutrophils' - a kind of white blood cell which fight infections (shown in blood tests)
Maltese: • livelli baxxi ta' ‘newtrofili' - tip ta' ċellula bajda tad-demm li tiġġieled l-infezzjonijiet (li jidhru fit-testijiet tad-demm)
English: These metabolites each have less than 1% of the 5-HT3 receptor antagonist activity of palonosetron.
Maltese: Kull wieħed minn dawn ilmetaboliti għandu inqas minn 1% tal-attività tal-antagonist ta' riċettur 5-HT3 ta' palonosetron.
English: In humans, netupitant is eliminated mainly by hepatic metabolism mediated by CYP3A4 with a marginal renal excretion.
Maltese: Fil-bnedmin, netupitant jiġi eliminat primarjament permezz ta' metaboliżmu fil-fwied medjat minn CYP3A4 bi tneħħija marġinali mill-kliewi.
English: High doses of palonosetron (each dose causing at least 15 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumors, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumors in rats but not in mice.
Maltese: Dożi qawwija ta' palonosetron (kull doża li tikkawża mill-inqas 15-il darba l-esponiment terapewtiku fil-bnedmin) li ngħatat kuljum għal sentejn, ikkawżaw żieda fir-rata ta' tumuri tal-fwied, neoplażmi endokrinali (fit-tirojde, fil-pitwitarja, filpankreas, fil-medulla adrenali) u tumuri tal-ġilda fil-firien, iżda mhux fil-ġrieden.
English: Netupitant AUC0-∞ and Cmax increased by 1.1 fold and 1.2 fold, respectively, after a high fat meal.
Maltese: L-AUC0-∞ u s-Cmax ta' netupitant żdiedu b'1.1 darbiet u 1.2 darbiet, rispettivament, wara ikla b'ammont għoli ta' xaħam.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Akynzeo in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Akynzeo f'kull sett tal-popolazzjoni pedjatrika fil-prevenzjoni ta' dardir u rimettar akut u li jseħħ wara ċertu żmien, assoċjati ma' kimoterapija kontra l-kanċer emetoġenika ħafna (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Dizziness
Maltese: Limfoċitosi
English: The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Maltese: L-impatt tad-dardir u rimettar fuq il-ħajja ta' kuljum tal-pazjenti ġie evalwat bl-użu tal-Functional Living Index-Emesis (FLIE).
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 mcg/kg in healthy subjects.
Maltese: Wara l-għoti ta' dożi waħidhom bl-użu ta' soluzzjoni buffered, il-medja tal-konċentrazzjonijiet massimi ta' palonosetron (Cmax) u l-erja taħt il-kurva konċentrazzjoni-ħin (AUC0-∞) kienu proporzjonali għad-doża fuq il-medda tad-doża ta' 3.0 sa 80 mcg/kg f'individwi b'saħħithom.
English: Flatulence
Maltese: Disfaġija
English: Co-administration of a single dose of 300 mg netupitant with a dexamethasone regimen (20 mg on Day 1, followed by 8 mg twice daily from Day 2 to Day 4) significantly increased the exposure to dexamethasone in a time and dose dependent manner.
Maltese: L-għoti flimkien ta' doża waħda ta' 300 mg ta' netupitant ma' kors ta' dexamethasone (20 mg f'Jum 1, segwit minn 8 mg darbtejn kuljum minn Jum 2 sa Jum 4) żiedu b'mod sinifikanti l-esponiment għal dexamethasone b'mod li jiddependi miż-żmien u d-doża.
English: • high levels of myoglobin - which indicates muscle injury (shown in blood tests)
Maltese: • livelli għolja ta' myoglobin - li jindikaw ħsara fil-muskoli (li jidhru fit-testijiet tad-demm)
English: In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established.
Maltese: Dejta in vitro tissuġġerixxi li netupitant jinibixxi UGT2B7; il-qawwa ta' dan l-effett fi sfond kliniku ma ġietx stabbilita.
English: Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Maltese: Serotonin imbagħad jattiva r-riċetturi ta' 5-HT3 li jinsabu fuq afferenti vagali biex jibda l-proċess tar-rimettar.
English: Polyglyceryl oleate Purified water
Maltese: • pressjoni tad-demm għolja
English: After a single oral 300 mg dose administration in cancer patients, netupitant disposition was characterised by a two compartment model with an estimated median systemic clearance of 20.5 L/h and a large distribution volume in the central compartment (486 L).
Maltese: Wara l-għoti ta' doża orali waħda ta' 300 mg f'pazjenti bil-kanċer, id-dispożizzjoni ta' netupitant kienet ikkaratterizzata minn mudell b'żewġ kompartimenti bi tneħħija sistemika medjana stmata ta' 20.5
English: • midazolam - a sedative used to treat anxiety
Maltese: • midazolam - sedattiv li jintuża biex jikkura l-ansjetà
English: Netupitant and Palonosetron Combinate Capsule:
Maltese: N-oxide-palonosetron u 6-Shydroxy-palonosetron.
English: • medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine,
Maltese: • mediċini li jistgħu jikkawżaw taħbit mhux normali tal-qalb bħal amiodarone, nicardipine,
English: The primary efficacy endpoint was complete response (CR) rate (defined as no emetic episodes, no rescue medication) within 120 hours (overall phase) after the start of the highly emetogenic chemotherapy administration.
Maltese: Il-punt aħħari tal-effikaċja primarju kienet ir-rata ta' rispons komplet (CR) (definita bħala l-ebda episodju emetiku, l-ebda medikazzjoni ta' salvataġġ) wara 120 siegħa (fażi globali) wara l-bidu talgħoti tal-kimoterapija emetoġenika b'mod qawwi.
English: • feeling drowsy
Maltese: • għandek problemi tal-fwied
English: • high levels of troponin - which indicates heart muscle dysfunction (shown in blood tests)
Maltese: • livelli għolja ta' troponin - li jindikaw disfunzjoni fil-muskolu tal-qalb (li jidhru fit-testijiet tad demm)
English: In a multicenter, randomized, parallel, double-blind, active-controlled, superiority study, the efficacy and safety of a single oral dose of Akynzeo was compared with a single oral dose of palonosetron 0.5 mg in cancer patients scheduled to receive the first cycle of an anthracycline and cyclophosphamide regimen for the treatment of a solid malignant tumor.
Maltese: Fi studju dwar is-superjorità, multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, parallel, double-blind, ikkontrollat b'mod attiv, l-effikaċja u s-sigurtà ta' doża waħda orali ta' Akynzeo tqabblet ma' doża orali waħda ta' palonosetron 0.5 mg f'pazjenti bil-kanċer li kienu skedati biex jirċievu l-ewwel ċiklu ta' kors ta' anthracycline u cyclophosphamide għall-kura ta' tumur malinn solidu.
English: • medicines for depression or anxiety called SNRIs (serotonin noradrenaline re-uptake inhibitors)
Maltese: • infezzjoni u infjammazzjoni fil-bużżieqa tal-awrina (ċistite)
English: Renal excretion for netupitant is negligible.
Maltese: Polyglyceryl oleate Ilma ppurifikat
English: This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
Maltese: Dan il-prodott mediċinali jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali mogħtija fl-istess ħin li jiġu metabolizzati permezz ta' CYP3A4.
English: Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1
Maltese: Proporzjon ta' pazjenti li kienu qed jirċievu kimoterapija b'anthracycline u cyclophosphamide li rrispondew skont il-grupp ta' kura u l-fażi - ċiklu 1
English: The pharmacokinetics of palonosetron or netupitant has not been studied in subjects with end-stage renal disease requiring hemodialysis and no data on the effectiveness or safety of netupitant/palonosetron capsules in these patients are available.
Maltese: Il-farmakokinetika ta' palonosetron jew netupitant ma ġietx studjata f'pazjenti b'mard tal-kliewi fl-aħħar stadju li jeħtieġu emodijalisi, u m'hemm l-ebda dejta disponibbli dwar l-effikaċja jew is-sigurtà ta' kapsuli ta' netupitant/palonosetron f'dawn ilpazjenti.
English: • high levels of blood urea - which indicates kidney dysfunction (shown in blood tests)
Maltese: • livelli għoljin ta' bilirubina tal-pigment - li jindikaw disfunzjoni tal-fwied (li jidhru fit-testijiet tad-demm)
English: No antiemetic treatment
Maltese: L-ebda kura antiemetika
English: • low level of potassium (shown in blood tests)
Maltese: • livell baxx ta' potassium (li jidher fit-testijiet tad-demm)
English: Primary endpoint Complete response Overall phase Major secondary endpoints Complete response Acute phase Delayed phase No emesis Acute phase Delayed phase Overall phase No significant nausea Acute phase Delayed phase Overall phase Acute phase: 0 to 24 hours post-cisplatin treatment.
Maltese: Fi studji li mhumiex kliniċi bbażati fuq sigurtà farmakoloġika u effett tossiku minn dożi waħidhom u dożi ripetuti, l-effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: These effects were not considered clinically important.
Maltese: Dawn l-effetti ma ġewx ikkunsidrati li kienu klinikament rilevanti.
English: The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Maltese: Is-sinjali jistgħu jinkludu rogħda, aġitazzjoni, għaraq, movimenti mijokloniċi, ipertonija u deni.
English: How much to take
Maltese: Ilsien miksi
English: Tel: +34 902 121 111
Maltese: Vifor Pharma España, S.L. Tel: +34 902 121 111
English: More information on Xofigo is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
Maltese: Aktar informazzjoni dwar Xofigo hija disponibbli fuq is-sit elettroniku tal-EMA: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018 EMA/500948/2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 ta' Settembru 2018
English: Monitoring should continue for at least 24 months.
Maltese: Il-monitoraġġ għandu jkompli għal tal-inqas 24 xahar.
English: The Agency's recommendations are based on the assessment of data from a randomised, double blind, placebo controlled phase III trial (ERA-223), which showed that there was an increased incidence of fractures (28.6% vs 11.4%), a possible reduction in median overall survival (30.7 months vs 33.3 months, HR 1.195, 95% confidence interval (CI) 0.950 - 1.505, p=0.13) and an increased risk of radiological non-bone progression (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) among patients receiving Xofigo in combination with abiraterone acetate plus prednisone/prednisolone (n=401) compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone (n=405).
Maltese: III (ERA-223), li wriet li kien hemm żieda fl-inċidenza ta' ksur (28.6% vs 11.4%), tnaqqis possibbli fis-sopravivenza globali medjana (30.7 xhur vs 33.3 xhur, HR 1.195, intervall ta' kunfidenza (CI) ta' 95% 0.950 - 1.505, p=0.13) u riskju miżjud ta' progressjoni radjoloġika mhux tal-għadam (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) fost pazjenti li rċivew Xofigo flimkien ma' abiraterone acetate u prednisone/prednisolone (n=401) meta mqabbel ma' pazjenti li rċivew plaċebo flimkien ma' abiraterone acetate u prednisone/prednisolone (n=405).
English: EMA restricts use of prostate cancer medicine Xofigo
Maltese: L-EMA tillimita l-użu tal-mediċina kontra l-kanċer tal prostata Xofigo
English: In another randomised, double blind, placebo controlled phase III trial (ALSYMPCA), a statistically significant overall survival benefit of treatment with Xofigo could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.5531.466], p=0.674) or a baseline total alkaline phosphatase (ALP) <220 U/L (HR 0.823 95% CI 0.6331.068, p=0.142), indicating that efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Maltese: III (ALSYMPCA), ma setax jintwera benefiċċju ta' soprarivenza globali statistikament sinifikanti tal-kura b'Xofigo fis-sottogruppi ta' pazjenti b'inqas minn 6 metastasi (HR għal radium-223 għal plaċebo 0.901; 95% CI [0.553 - 1.466], p=0.674) jew fosfatażi alkalina (ALP) totali fil-linja bażi <220 U/L (HR 0.823 95% CI 0.
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Maltese: Lanqas ma huwa rakkomandat flimkien ma' terapiji kontra l-kanċer sistemiċi minbarra analogi ta' LHRH.
English: In March 2018, the
Maltese: EMA/680161/2018
English: Xofigo must also not be used with the medicines Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone.
Maltese: Xofigo m'għandux jintuża wkoll mal-mediċini Zytiga (abiraterone acetate) u l-kortikosterojd prednisone jew prednisolone.
English: • Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
Maltese: • Xofigo għandu jintuża biss bħala monoterapija jew flimkien ma' analogu ta' LHRH għall-kura ta' pazjenti adulti b'kanċer tal-prostata reżistenti għall-kastrazzjoni metastatiku (mCRPC), metastasi fl-għadam sintomatika u l-ebda metastasi vixxerali magħrufa, fi progressjoni wara tal-inqas żewġ linji preċedenti ta' terapija sistemika għall-mCRPC (minbarra analogi ta' LHRH), jew ineliġibbli għal kwalunkwe kura sistemika disponibbli ta' mCRPC.
English: Xofigo is currently used to treat adult men with cancer of the prostate (a gland of the male reproductive system).
Maltese: Xofigo attwalment jintuża biex jikkura adulti rġiel bil-kanċer tal-prostata (glandola tas-sistema riproduttiva tar-raġel).
English: Depending on the results of these tests, Xofigo may be interrupted or stopped, and you may be given an alternative treatment.
Maltese: Skont ir-riżultati ta' dawn it-testijiet, Xofigo jista' jiġi interrott jew jitwaqqaf, u tista' tingħata kura alternattiva.
English: In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination.
Maltese: Barra minn hekk, 29 % tal-pazjenti li rċivew il-kombinazzjoni ta' Xofigo kellhom ksur, meta mqabbel ma' 11 % tal-pazjenti li ngħataw il-kombinazzjoni ta' plaċebo.