FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 6 mL of solution (6600 kBq radium-223 dichloride at the reference date).
Maltese: Kull kunjett fih 6 mL ta' soluzzjoni (6600 kBq ta' radium-223 dichloride fid-data ta' referenza).
English: Main secondary endpoints included time to symptomatic skeletal events (SSE), time to progression of total alkaline phosphatase (ALP), time to progression of prostate specific antigen (PSA), response of total ALP and normalisation of total ALP.
Maltese: Punti aħħarin sekondarji ewlenin kienu jinkludu iż-żmien sa avvenimenti skeletriċi sintomatiċi (SSE - symptomatic skeletal events), iż-żmien għallprogressjoni ta' alkaline phosphatase (ALP) totali, iż-żmien għall-progressjoni ta' antiġen speċifiku għallprostata (PSA - prostate specific antigen), rispons għal ALP totali u normalizzazzjoni ta' ALP totali.
English: No significant effects were seen on vital organ systems, i.e. cardiovascular (dog), respiratory or central nervous systems (rat), after single dose administration of activities from 497 to 1100 kBq per kg body weight (9 [dog] to 20 [rat] times the clinically recommended activity).
Maltese: Ma ġew osservati l-ebda effetti sinifikanti fuq is-sistemi tal-organi vitali, i.e. sistema kardjovaskulari (klieb), respiratorja jew nervuża ċentrali (firien), wara l-għoti ta' doża waħda ta' attivitajiet minn 497 sa 1100 kBq għal kull kg ta' piż tal-ġisem (9 [klieb] sa 20 [firien] darba l-attività rrakkomandata klinikament).
English: Alpha1 emission (Gy/MBq)
Maltese: Emissjoni alpha1 (Gy/MBq)
English: The high linear energy transfer of alpha emitters (80 keV/µm) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect.
Maltese: It-trasferiment ta' enerġija lineari qawwija ta' emittenti alpha (80 keV/µm) iwassal għal frekwenza għolja ta' qtugħ tad-double strand tad-DNA f'ċelluli ta' biswit it-tumur, u dan jirriżulta f'effett ċitotossiku qawwi.
English: Adverse reactions from clinical trials are classified according to their frequencies.
Maltese: Reazzjonijiet avversi minn provi kliniċi huma kklassifikati skont il-frekwenzi tagħhom.
English: A minimal number of abnormal spermatocytes were seen in a few seminiferous tubules in the testes of male rats after a single administration of ≥ 2270 kBq/kg body weight radium-223 dichloride (≥ 41 times the clinically recommended activity).
Maltese: Ġie osservat numru żgħir ta' spermatoċiti mhux normali fi ftit tubi seminiferużi fit-testikoli ta' firien irġiel wara għoti ta' darba ta' ≥ 2270 kBq/kg ta' piż tal-ġisem ta' radium-223 dichloride (≥ 41 darba l-attività rrakkomandata klinikament).
English: Gamma emission (Gy/MBq)
Maltese: Emissjoni gamma (Gy/MBq)
English: The intravenous access line or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo.
Maltese: Il-linja ta' aċċess fil-vini jew kannula trid titlaħlaħ b'soluzzjoni għall-injezzjoni isotonika ta' sodium chloride 9 mg/mL (0.9%) qabel u wara l-injezzjoni ta' Xofigo.
English: In single and repeated dose toxicity studies in rats, the main findings were reduced body weight gain, haematological changes, reduced serum alkaline phosphatase and microscopic findings in the bone marrow (depletion of haematopoietic cells, fibrosis), spleen (secondary extra-medullary haematopoiesis) and bone (depletion of osteocytes, osteoblasts, osteoclasts, fibro-osseous lesions, disruption/disorganisation of the physis/growth line).
Maltese: Fi studji dwar l-effett tossiku minn dożi waħedhom u minn dożi ripetuti fil-firien, is-sejbiet ewlenin kienu tnaqqis fiż-żieda tal-piż tal-ġisem, tibdil ematoloġiku, tnaqqis fil-livell ta' alkaline phosphatase fis-serum u sejbiet mikroskopiċi fil-mudullun (tnaqqis ta' ċelluli ematopoetiċi, fibrożi), fil-milsa (ematopojesi extramedullari sekondarja) u fl-għadam (tnaqqis ta' osteoċiti, osteoblasts, osteoklasts, leżjonijiet fibroosseużi, tfixkil/diżorganizazzjoni tal-fisi/linja ta' tkabbir).
English: The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01 - 1.27 MeV).
Maltese: Il-porzjon li joħroġ bħala partiċelli beta hu ta' 3.6% (enerġiji medji huma 0.445 MeV u 0.492 MeV), u l-porzjon li joħroġ bħala radjazzjoni gamma hu ta' 1.1% (firxa ta' enerġija ta' 0.01 - 1.27 MeV).
English: Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI)
Maltese: Numru (%) ta' mwiet Sopravivenza globali medjana (xhur) (CI ta' 95%)
English: Its active moiety radium-223 (as radium-223 dichloride) mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.
Maltese: Il-parti attiva radium-223 (bħala radium-223 dichloride) timita l-calcium u timmira b'mod selettiv l-għadam, speċifikament żoni ta' metastasi fl-għadam, billi tifforma kumplessi mal-minerali tal-għadam hydroxyapatite.
English: Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
Maltese: Kull mL ta' soluzzjoni fih 1100 kBq ta' radium Ra 223 dichloride (radium-223 dichloride), li jikkorrispondu għal 0.58 ng radium-223 fid-data ta' referenza.
English: The limited available data indicates that patients receiving chemotherapy after Xofigo had a similar haematological profile compared to patients receiving chemotherapy after placebo (see also section 5.1).
Maltese: Id-dejta limitata disponibbli tindika li pazjenti li jirċievu kimoterapija wara Xofigo kellhom profil ematoloġiku simili meta mqabbel ma' pazjenti li jirċievu kimoterapija wara plaċebo (ara wkoll sezzjoni 5.1).
English: Before subsequent administrations, the ANC should be ≥ 1.0 x 109/l and the platelet count ≥ 50 x 109/l.
Maltese: Qabel għoti sussegwenti, l-ANC għandu jkun ta' ≥ 1.0 x 109/L u l-għadd tal-plejtlits ta' ≥ 50 x 109/L.
English: The six-stage-decay of radium-223 to lead-207 occurs via short-lived daughters, and is accompanied by a number of alpha, beta and gamma emissions with different energies and emission probabilities.
Maltese: It-tnaqqis fil-potenza (decay) f'sitt stadji ta' radium-223 għal lead-207 iseħħ permezz ta' emissjonijiet ta' ħajja qasira (short-lived daughters), u huwa akkompanjat minn numru ta' emissjonijiet alpha, beta u gamma b'enerġiji u probabbiltajiet ta' emissjoni differenti.
English: Table 3: Secondary efficacy endpoints from the phase III ALSYMPCA study (interim analysis)
Maltese: III ALSYMPCA (analiżi interim) Inċidenza
English: Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, 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 (see section 4.4).
Maltese: Xofigo bħala monoterapija jew flimkien ma' analogu tal-ormon li jerħi l-ormon luteinising (LHRHluteinising hormone releasing hormone) hu indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku talprostata reżistenti għall-kastrazzjoni (mCRPC - metastatic castration-resistant prostate cancer), metastasi flgħadam bis-sintomi u bl-ebda metastasi magħrufa fil-vixxri, waqt progressjoni wara mill-inqas żewġ linji preċedenti ta' terapija sistemika għal mCRPC (minbarra analogi ta' LHRH), jew ineliġibbli għal kwalunkwe trattament sistemiku għal mCRPC disponibbli (ara sezzjoni 4.4).
English: Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI) p-valuea (2-sided)
Maltese: Proporzjon ta' periklub (CI ta' 95%) valur pa (2 naħat)
English: Grade 3 and 4 neutropenia was observed in 2.2% of patients treated with Xofigo and in 0.7% of patients receiving placebo.
Maltese: Newtropenija ta' grad 3 u 4 ġiet osservata fi 2.2% tal-pazjenti kkurati b'Xofigo u f'0.7% talpazjenti li rċivew plaċebo.
English: The volume of distribution was higher than the blood volume indicating distribution to peripheral compartments.
Maltese: Il-volum ta' distribuzzjoni kien ogħla mill-volum tad-demm u dan jindika distribuzzjoni f'kompartimenti periferali.
English: The clinical safety and efficacy of Xofigo have been evaluated in a double-blind, randomised, multiple dose, phase III, multicentre study (ALSYMPCA; EudraCT 2007-006195-1)) in castration-resistant prostate cancer patients with symptomatic bone metastases.
Maltese: III, li fih il-parteċipanti ntgħażlu b'mod każwali, b'dożi multipli u multiċentriku (ALSYMPCA; EudraCT 2007-006195-1) f'pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni b'metastasi fl-għadam bis-sintomi.
English: It is important to avoid dehydration by drinking plenty of fluids.
Maltese: Huwa importanti li tiġi evitata d-deidratazzjoni billi tixrob ħafna fluwidi.
English: Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
Maltese: Tromboċitopenija ta' grad 3 u 4 kienet osservata f'5.9% tal-pazjenti kkurati b'Xofigo u f'6.7% tal-pazjenti li rċivew plaċebo (ara sezzjoni 4.4).
English: Table 4: Calculated absorbed radiation doses to organs Target Organ
Maltese: Tabella 4: Dożi ta' radjazzjoni assorbita kkalkulati għall-organi Organu fil-Mira
English: Beta emission (Gy/MBq)
Maltese: Emissjoni beta (Gy/MBq)
English: Health Related Quality of Life (HRQOL) was assessed in the phase III ALSYMPCA study using specific questionnaires: the EQ-5D (generic instrument) and the FACT-P (prostate cancer specific instrument).
Maltese: III ALSYMPCA billi ntużaw kwestjonarji speċifiċi: il-EQ-5D (strument ġeneriku) u l-FACT-P (strument speċifiku tal-kanċer tal-prostata).
English: Before the first administration, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/l, the platelet count ≥ 100 x 109/l and haemoglobin ≥ 10.0 g/dl.
Maltese: Qabel lewwel għoti, l-għadd assolut tan-newtrofili (ANC - absolute neutrophil count) għandu jkun ta' ≥ 1.5 x 109/L, l-għadd tal-plejtlits ta' ≥ 100 x 109/L u l-emoglobina ≥ 10.
English: The recommended dose of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram body weight.
Maltese: Id-doża rrakkomandata ta' Xofigo hi ta' 55 kBq (Becquerel, l-unità li tintuża biex tesprimi r-radjuattività) għal kull kilogramma ta' piż tal-ġisem.
English: In the course of the 2:1 randomised ALSYMPCA study, 93 (15.5%) patients in the Xofigo group and 54 (17.9%) patients in the placebo group received cytotoxic chemotherapy at varying times after the last treatment.
Maltese: 5%) pazjent fil-grupp ta' Xofigo u 54 (17.9%) pazjent fil-grupp tal-plaċebo rċivew kimoterapija ċitotossika f'ħinijiet differenti wara l-aħħar kura.
English: In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded.
Maltese: F'pazjenti li jieħdu bisphosphonates u Xofigo, żieda fir-riskju ta' żvilupp ta' osteonekrosi tax-xedaq (ONJosteonecrosis of the jaw) ma tistax tiġi eskluża.
English: An interim analysis from a clinical trial in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer and progressive disease with bone metastases showed an increased risk of fractures and a trend for increased mortality among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone (see section 5.1).
Maltese: Analiżi interim minn prova klinika f'pazjenti li qatt ma ħadu trattament ta' kimoterapija b'kanċer tal-prostata mhux sintomatiku jew kemmxejn sintomatiku reżistenti għall-kastrazzjoni u marda progressiva b'metastasi fl-għadam wera riskju akbar ta' ksur u tendenza għal żieda fil-mortalità fost pazjenti li kienu qed jirċievu Xofigo flimkien ma' abiraterone acetate u prednisone/prednisolone meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo flimkien ma' abiraterone acetate u prednisone/prednisolone (ara sezzjoni 5.1).Għalhekk Xofigo huwa kontraindikat flimkien ma' abiraterone acetate u prednisone/prednisolone (ara sezzjoni 4.3).
English: The MAH shall conduct and submit the results of a phase IV randomised double-blind multicentre study according to an agreed protocol in order to further characterise the efficacy and safety, in particular the risk of fractures, the risk of formation of visceral and nodal metastases of radium-223 in the authorized indication.
Maltese: IV randomised, doubleblind, u b'aktar minn ċentru wieħed, skont protokoll miftiehem sabiex jiġu kkaratterizzati aktar l-effikaċja u s-sigurtà, b'mod partikolari r-riskju ta' ksur, ir-riskju ta' formazzjoni ta' metastasi fil-vixxri u nodali ta' radium-223 fl-indikazzjoni awtorizzata.
English: This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.7% tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum mad-dieta minn adult.
English: - Decay correction (DK) factor to correct for physical decay of radium-223.
Maltese: - Fattur ta' korrezzjoni għat-tnaqqis fil-potenza (DK - decay correction) li jikkoreġi t-tnaqqis fil-potenza fiżika ta' radium-223.
English: Neutropenia Pancytopenia Leukopenia
Maltese: Newtropenija Panċitopenija Lewkopenija
English: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported in patients treated with Xofigo (see section 4.8).
Maltese: Trażżin tal-mudullun, b'mod speċjali tromboċitopenija, newtropenija, lewkopenija u panċitopenija, ġie rrappurtat f'pazjenti kkurati b'Xofigo (ara sezzjoni 4.8).
English: In a clinical study, the addition of Xofigo to abiraterone acetate and prednisone/prednisolone, increased the incidence of fractures approximately three-fold in the Xofigo arm (see sections 4.8 and 5.1).
Maltese: Fi studju kliniku, iż-żieda ta' Xofigo ma' abiraterone acetate u prednisone/prednisolone żiedet l-inċidenza ta' ksur b'madwar tliet darbiet fil-grupp ta' Xofigo (ara sezzjonijiet 4.8 u 5.1).
English: Retinal detachment was seen in dogs after a single injection of activities of 166 and 497 kBq per kg body weight (3 and 9 times the clinically recommended dose), but not after repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months.
Maltese: Ġie osservat distakk tar-retina fil-klieb wara injezzjoni waħda ta' attivitajiet ta' 166 u 497 kBq għal kull kg ta' piż tal-ġisem (3 u 9 darbiet id-doża rrakkomandata klinikament), iżda mhux wara għoti ripetut tal-attività rrakkomandata klinikament ta' 55 kBq għal kull kg ta' piż tal-ġisem darba kull 4 ġimgħat għal 6 xhur.
English: Grade 3 and 4 thrombocytopenia was observed in 6.3% of patients treated with Xofigo and in 2% of patients receiving placebo (see section 4.4).
Maltese: Tromboċitopenija ta' grad 3 u 4 ġiet osservata f'6.3% tal-pazjenti kkurati b'Xofigo u fi 2% tal-pazjenti li rċivew plaċebo (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: Therapeutic radiopharmaceuticals, other therapeutic radiopharmaceuticals, various therapeutic radiopharmaceuticals, ATC code: V10XX03
Maltese: Radjufarmaċewtiċi terapewtiċi, radjufarmaċewtiċi terapewtiċi oħrajn, radjufarmaċewtiċi terapewtiċi varji, Kodiċi ATC:
English: Safety and effectiveness of Xofigo have not been studied in children and adolescents below 18 years of age.
Maltese: Is-sigurtà u l-effettività ta' Xofigo ma ġewx studjati fi tfal u f'adolexxenti b'età inqas minn 18-il sena.
English: Osteosarcomas, a known effect of bone-seeking radionuclides, were observed at clinically relevant doses in rats 7 - 12 months after start of treatment.
Maltese: Osteosarkomi, effett magħruf ta' radjunuklidi li jiġu depożitati fl-għadam, ġew osservati b'dożi klinikament rilevanti fil-firien 7 - 12-xahar wara l-bidu tal-kura.
English: Since radium-223 is neither metabolised by the liver nor eliminated via the bile, hepatic impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Maltese: Peress li radium-223 mhux metabolizzat mill-fwied u lanqas ma jiġi eliminati permezz tal-bili mill-marrara, indeboliment tal-fwied mhux mistenni li jaffettwa l-farmakokinetika ta' radium-223 dichloride.
English: In the phase III clinical study, no relevant differences in safety or efficacy were observed between patients with mild renal impairment (creatinine clearance [CLCR]: 50 to 80 mL/min) and normal renal function.
Maltese: III, ma ġew osservati l-ebda differenzi rilevanti fis-sigurtà jew l-effikaċja bejn pazjenti b'indeboliment ħafif tal-kliewi (tneħħija tal-krejatinina [CLCR - creatinine clearance]: 50 sa 80 mL/min) u funzjoni normali tal-kliewi.
English: SSE components
Maltese: Komponenti ta' SSE
English: Although radium-223 is predominantly an alpha emitter, gamma and beta radiation is associated with the decay of radium-223 and its radioactive daughter isotopes.
Maltese: Għalkemm radium-223 fil-biċċa l-kbira jerħi radjazzjoni alpha, radjazzjoni gamma u beta hija assoċjata mat-tnaqqis fil-potenza ta' radium-223 u l-isotopi radjuattivi tiegħu.
English: Demographic and baseline disease characteristics (interim analysis population) were similar between the Xofigo and placebo groups and are shown below for Xofigo:
Maltese: Karatteristiċi demografiċi u fil-linja bażi tal-marda (popolazzjoni tal-analiżi interim) kienu simili bejn ilgruppi ta' Xofigo u l-gruppi tal-plaċebo u qed jintwerew hawn taħt għal Xofigo:
English: The volume to be administered to a given patient should be calculated using the: - Patient's body weight (kg) - Dosage level (55 kBq/kg body weight) - Radioactivity concentration of the product (1100 kBq/mL) at reference date.
Maltese: - Piż tal-ġisem tal-pazjent (kg) - Livell ta' dożaġġ (55 kBq/kg ta' piż tal-ġisem) - Konċentrazzjoni ta' radjuattività tal-prodott (1100 kBq/mL) fid-data ta' referenza.
English: In dogs, haematological changes were observed starting at the lowest activity of 55 kBq/kg, the clinically recommended dose.
Maltese: Fil-klieb, ġie osservat tibdil ematoloġiku li beda bl-iktar attività baxxa ta' 55 kBq/kg, id-doża rrakkomandata klinikament.
English: Overall, the frequency of grade 3 and 4 thrombocytopenia was lower in patients that did not previously receive docetaxel (2.8% in patients treated with Xofigo versus 0.8% in patients receiving placebo) compared to patients that previously received docetaxel (8.9% in patients treated with Xofigo versus 2.9% in patients receiving placebo).
Maltese: B'mod ġenerali, il-frekwenza ta' tromboċitopenija ta' grad 3 u 4 kienet aktar baxxa f'pazjenti li fil-passat ma rċivewx docetaxel (2.8% f'pazjenti kkurati b'Xofigo kontra 0.8% f'pazjenti li rċivew plaċebo) meta mqabbla ma' pazjenti li fil-passat irċivew docetaxel (8.9% f'pazjenti kkurati b'Xofigo kontra 2.9% f'pazjenti li rċivew plaċebo).
English: In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm.
Maltese: III, każijiet ta' ONJ kienu rrappurtati f'0.67% tal-pazjenti (4/600) fil-grupp ta' Xofigo meta mqabbel ma' 0.33% tal-pazjenti (1/301) fil-grupp talplaċebo.
English: Dose-limiting myelotoxicity was seen in dogs after single administration of 497 kBq radium-223 dichloride per kg body weight (9 times the clinically recommended activity).
Maltese: Ġiet osservata majelotossiċità li tillimita d-doża fil-klieb wara għoti ta' doża waħda ta' 497 kBq radium-223 dichloride għal kull kg ta' piż tal-ġisem (9 darbiet l-attività rrakkomandata klinikament).
English: The combination of radium-223 with other systemic cancer therapies other than LHRH analogues is therefore not recommended.
Maltese: Għalhekk il-kombinazzjoni ta' radium-223 ma' terapiji sistemiċi oħra għall-kanċer minbarra analogi ta' LHRH mhix rakkomandata.
English: At the cut-off date of the pre-planned interim analysis (confirmatory analysis), a total of 809 patients were randomised 2:1 to receive Xofigo 55 kBq/kg intravenously every 4 weeks for 6 cycles (N=541) plus best standard of care, or matching placebo plus best standard of care (N=268).
Maltese: Fid-data ta' skadenza tal-analiżi interim ippjanata minn qabel (analiżi konfermatorja), total ta' 809 pazjent intgħażlu b'mod każwali fi proporzjon ta' 2:1 biex jirċievu Xofigo 55 kBq/kg fil-vini kull 4 ġimgħat għal 6 ċikli (N = 541) flimkien mal-aħjar standard ta' kura, jew plaċebo li jaqbel flimkien mal-aħjar standard ta' kura (N=268).
English: At 4 hours, about 4% of the injected activity remained in the blood, decreasing to less than 1% at 24 hours after the injection.
Maltese: Wara 4 sigħat, madwar 4% tal-attività injettata baqgħet fid-demm, u naqset għal inqas minn 1% 24 siegħa wara l-injezzjoni.
English: - The other ingredients are: water for injections, sodium citrate, sodium chloride and hydrochloric acid (see end of Section 2 for further information on sodium).
Maltese: - Is-sustanzi l-oħra huma: ilma għall-injezzjonijiet, sodium citrate, sodium chloride u hydrochloric acid (ara t-tmiem ta' Sezzjoni 2 għal informazzjoni addizzjonali dwar sodium).
English: The adverse reactions observed with Xofigo are represented in the table below (see Table 1).
Maltese: Ir-reazzjonijiet avversi li ġew osservati b'Xofigo huma rrappreżentati fit-tabella hawn taħt (ara Tabella 1).
English: • in combination with abiraterone and prednisone/prednisolone (which are used together to treat prostate cancer).
Maltese: • flimkien ma' abiraterone u prednisone/prednisolone (li huma wżati flimkien biex jittrattaw kanċer tal prostata).
English: Concomitant chemotherapy with Xofigo may have additive effects on bone marrow suppression (see section 4.4).
Maltese: Kimoterapija flimkien ma' Xofigo jista' jkollha effetti addittivi fuq it-trażżin tal-mudullun (ara sezzjoni 4.4).
English: • 46% of patients had no pain or WHO scale 1 (asymptomatic or mildly symptomatic) and 54% had pain WHO scale 2-3.
Maltese: • 46% tal-pazjenti ma kellhom l-ebda wġigħ jew uġigħ ta' skala 1 tal-WHO (mingħajr sintomi jew b'sintomi ħfief) u 54% kellhom uġigħ ta' skala 2-3 tal-WHO.
English: Total dose (Gy/MBq)
Maltese: Doża totali (Gy/MBq)
English: They are classified according to System Organ Class.
Maltese: Huma kklassifikati skont il-Klassi tas-Sistemi u tal-Organi.
English: The MAH shall conduct and submit the results of a non-interventional post-authorisation safety study (PASS) based on the data from the Prostate Cancer Data Base Sweden (PCBaSe) and other relevant Scandinavian cancer registers or other suitable data sources, in order to further characterise the safety of radium-223 in the authorized indication.
Maltese: ibbażat fuq data minn Prostate Cancer Data Base Sweden (PCBaSe) u reġistri tal-kanċer Skandinavi relevanti oħra jew sorsi oħra adattati ta' data xierqa, sabiex tiġi kkaratterizzata aktar is-sigurtà ta' radium-223 fl-indikazzjoni awtorizzata.
English: Patients with evidence of compromised bone marrow reserve e.g. following prior cytotoxic chemotherapy and/or radiation treatment (EBRT) or prostate cancer patients with advanced diffuse infiltration of the bone (EOD4; “superscan”) should be treated with caution.
Maltese: Pazjenti b'evidenza ta' riserva kompromessa tal-mudullun, eż. wara kura b'kimoterapija ċitotossika u/jew radjazzjoni fil-passat (EBRT - external beam radiation treatment) jew pazjenti b'kanċer tal-prostata b'infiltrazzjoni avanzata mifruxa fl-għadam (EOD4; “superskan”), għandhom jiġu kkurati b'kawtela.
English: 6 mL 6.6 MBq/vial at 12 h (CET) ref. date: [DD/MM/YYYY]
Maltese: MBq/kunjett wara 12 h (CET) data ta' ref [JJ/XX/SSSS]
English: • 16% of patients had <6 bone metastases, 44% of patients had between 6 and 20 bone metastases,
Maltese: • 16% tal-pazjenti kellhom <6 metastasi fl-għadam, 44% tal-pazjenti kellhom bejn 6 u 20 metastasi fl għadam, 40% tal-pazjenti kellhom aktar minn 20 metastasi fl-għadam jew superscan.