FrancophonIA/ELRC3.0 huggingface dataset:
English: Lutetium (177Lu) chloride is produced by the irradiation of highly enriched (> 99 %) Ytterbium (176Yb) in neutron sources with a thermal neutron flux between 1013 and 1016 cm−2 s−1.
Maltese: Lutetium (177Lu) chloride huwa prodott mill irradjazzjoni ta' Ytterbium (176Yb) arrikit ħafna (> 99 %) f'sorsi tan-newtroni bi fluss tan-newtroni termali bejn 1013 u 1016 cm−2 s−1.
English: Adverse reactions are divided into groups according to the MedDRA convention frequencies: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: For administration after in vitro radiolabelling.
Maltese: Għal għoti wara radjutikkettar in vitro.
English: The intraperitoneal LD50 in mice was found to be approximately 315 mg/kg.
Maltese: L-LD50 intraperitoneali fil-ġrieden instab li hu bejn wieħed u ieħor 325 mg/kg.
English: ITG Isotope Technologies Garching GmbH D-85748 Garching/Germany
Maltese: ITG Isotope Technologies Garching GmbH D-85748 Garching/Il-Ġermanja
English: The volume is 0.075 - 2 mL.
Maltese: Il-volum huwa 0.075-2 mL.
English: Myelosuppression
Maltese: Mijelosuppressjoni
English: Table 2: Estimated organ absorbed radiation doses and effective doses (mSv/MBq) after inadvertent intravenous administration of 177LuCl3 for various human age classes, based on data collected in rats (n = 24)
Maltese: Tabella 2: Stima tad-dożi tar-radjazzjoni assorbiti fl-organi u dożi effettivi (mSv/MBq) wara għoti involontarju ġol-vina ta' 177LuCl3 għal diversi klassijiet tal-età tal-bniedem, abbażi tad data miġbura fil-firien (n = 24)
English: The volume is 0.2 - 3.75 mL.
Maltese: Il-volum huwa 0.2-3.75 mL.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps): common: Refractory cytopenia with multilineage dysplasia (Myelodysplastic syndrome) (see section 4.4) uncommon: Acute myeloid leukaemia (see section 4.4) Skin and subcutaneous tissue disorders: very common: Alopecia
Maltese: Komuni: Ċitopenja refrattorja b'displażja multilineari (Sindrome majelodisplastiku) (ara sezzjoni 4.4) Mhux komuni: Lewkimja mijelojdi akuta (ara sezzjoni 4.4)
English: The volume of one vial ranges from 0.075 - 3.75 mL solution (corresponding to 3 - 150 GBq at activity reference time).
Maltese: Il-volum ta' kunjett wieħed ivarja bejn 0.075 u 3.75 mL ta' soluzzjoni (li jikkorrispondi għal 3-150 GBq fil-ħin ta' referenza tal-attività).
English: 176Yb(n, γ) 177Yb → 177Lu
Maltese: 176Yb(n, γ)177Yb → 177Lu Il-Ytterbium prodott (177Yb) b'half-life ta' 1.9 sigħat jiddiżentegra għal Lutetium (177Lu).
English: The specific activity of the medicinal product at ART is indicated on the label and always greater than 3,000 GBq/mg.
Maltese: L-attività speċifika tal-prodott mediċinali fl-ART hija indikata fuq it-tikketta u hija dejjem aktar minn 3,000 GBq/mg.
English: In bone, the content increases from 0.01 %ID/g at 5 min to 0.23 %ID/g after 12 hours.
Maltese: Fl-għadam, il-kontenut jiżdied minn 0.01 %ID/g f'5 min għal 0.23 %ID/g wara 12
English: In cats, no pharmacological effects on respiration and cardiovascular function were observed up to a cumulative intravenous dose of 10 mg/kg.
Maltese: Fil-qtates, ma kinux osservati effetti farmakoloġiċi fuq ir-respirazzjoni u funzjoni kardjovaskulari sa doża ġol-vina kumulattiva ta' 10 mg/kg.
English: Doubling the distance to the patient to 2 meters reduces the dose rate by a factor of 4, to 0.9 µSv/h.
Maltese: L-irduppjar tad-distanza għallpazjent għal 2 metri tnaqqas ir-rata tad-doża b'fattur ta' 4, għal 0.9 µSv/h.
English: Myelodysplastic syndrome and acute myeloid leukaemia
Maltese: Sindrome majelodisplastiku u lewkimja mijelojdi akuta
English: After one hour, the amount in the liver is 9.56 % of the injected activity per gram (%ID/g) and in the spleen 5.26 %ID/g.
Maltese: Wara siegħa, l-ammont fil-fwied huwa ta' 9.56 % tal-attività injettata għal kull gramma (%ID/g) u filmilsa 5.26 %ID/g.
English: Each 2 mL vial contains an activity ranging from 3 - 80 GBq, corresponding to 0.73 - 19 micrograms of Lutetium (177Lu), at ART.
Maltese: Kull kunjett ta' 2 mL fih attività li tvarja minn 3-80 GBq, li tikkorrrispondi għal 0.73-19 mikrogramma ta' Lutetium (177Lu), fl-ART.
English: Taking into account the radioactive half-life of 177Lu of 6.647 days, the radioactivity remaining in the bone after 28 days is only about 0.06 %ID/g.
Maltese: Meta titqies il-half-life radjuattiva ta' 177Lu ta' 6.647 jiem, ir-radjuattività li tibqa' fl-għadam wara 28 jum hija biss madwar 0.06 %ID/g.
English: Blood and lymphatic system disorders: very common: Anaemia, thrombocytopenia, leukopenia and lymphopenia Endocrine disorders: not known: Carcinoid crisis
Maltese: Komuni ħafna: Anemija, trombiċitopenija, lewkopenija u limfopenija Disturbi fis-sistema endokrinarja:
English: EXP: {DD/MM/YYYY, hh:00 CET}
Maltese: JIS:{JJ/XX/SSSS, hh:00 CET}
English: This could potentially result in osteosarcomas.
Maltese: Dan jista' potenzjalment jirriżulta f'ostejosarkomi.
English: EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution
Maltese: EndolucinBeta 40 GBq/mL prekursur radjufarmaċewtiku, soluzzjoni
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkat fis-sezzjoni 6.1.
English: 177Lu-chloride contains 2.4 µg Lutetium, corresponding to a human dose of 0.034 µg/kg.
Maltese: Doża għolja ta' 10 GBq ta' 177Lu-chloride fiha 2.4 µg ta' Lutetium, li tikkorrispondi għal doża tal-bniedem ta' 0.034 µg/kg.
English: All cases recovered with treatment.
Maltese: Il-każijiet kollha rkupraw bi trattament.
English: In a chromatographic process, the accumulated Lutetium (177Lu) is separated chemically from the original target material.
Maltese: Fil-proċess kromatografiku, il-Lutetium akkumulat (177Lu) huwa separat b'mod kimiku mill-materjal fil-mira oriġinali.
English: VOLUME:
Maltese: VOLUM:
English: Radiolabelling of medicinal products, such as monoclonal antibodies, peptides, vitamins or other substrates, with Lutetium (177Lu) chloride is very sensitive to the presence of trace metal impurities.
Maltese: Ir-radjutikkettar tal-prodotti mediċinali, bħal antikorpi monoklonali, peptidi, vitamini jew sottostrati oħrajn, b'Lutetium (177Lu) chloride huwa sensittiv ħafna għall-preżenza ta' traċċi ta' impuritajiet tal metall.
English: 1 mL of solution contains 40 GBq of Lutetium (177Lu) chloride at activity reference time (ART).
Maltese: 1 mL ta' soluzzjoni fih 40 GBq ta' Lutetium (177Lu) chloride mill-ħin ta' referenza tal-attività (ART).
English: 1 mL of solution contains 40 GBq Lutetium (177Lu) chloride on activity reference time (ART), corresponding to 10 micrograms of Lutetium (177Lu) (as chloride).
Maltese: 1 mL ta' soluzzjoni fih 40 GBq Lutetium (177Lu) chloride fil-ħin ta' referenza tal-attività (activity reference time, ART), li jikkorrispondi għal 10 mikrogrammi ta' Lutetium (177Lu) (bħala chloride).
English: The same dose in a patient with an abdominal radius of 25 cm yields a dose rate at 1 meter of 2.6 µSv/h.
Maltese: L-istess doża ta' pazjent b'raġġ addominali ta' 25 cm tħalli rata ta' doża f'metru ta' 2.6 µSv/h.
English: Package leaflet: Information for the patient EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution
Maltese: Informazzjoni għall-pazjent EndolucinBeta 40 GBq/mL prekursur radjufarmaċewtiku, soluzzjoni
English: The following preparations must be available in medical institutions, which use EndolucinBeta for labelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Maltese: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL (2 mL, 10 mL)
Maltese: KUNJETT(2 mL, 10 mL)
English: The lower bound of the 95 % confidence interval of the reporting odds ratio for tumour lysis syndrome in EudraVigilance in association with Lu-177 is increased at 34.50, with 3 cases.
Maltese: Il-livell inferjuri tal-intervall ta' kunfidenza ta' 95 % tal-proporzjon tal-odds għar-rappurtaġġ tas sindromu ta' liżi tat-tumur f'EudraVigilance f'assoċjazzjoni ma' Lu-177 jiżdied f'34.50, bi 3 każijiet.
English: - Nausea - Vomiting
Maltese: - Dardir - Remettar
English: Anaemia, thrombocytopenia, leucopenia, lymphopenia, and less commonly neutropenia may occur during radioligand therapy with Lutetium (177Lu).
Maltese: Anemija, tromboċitopenija, lewkopenija, limfopenija u b'mod inqas komuni newtropenija jistgħu jseħħu waqt terapija b'radjuligand b'Lutetium (177Lu).
English: OTHER
Maltese: Sider
English: Extravasation
Maltese: Epatotossiċità
English: Radiopharmaceutical precursor, solution.
Maltese: U KONTENUT Prekursur radjufarmaċewtiku, soluzzjoni.
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10X
Maltese: Prodotti radjufarmaċewtiċi terapewtiċi oħrajn, Kodiċi ATC:
English: Renal function should be assessed at baseline and during treatment and renal protection should be considered, in accordance with clinical guidance.
Maltese: Il-funzjoni renali għandha tiġi valutata fil-linja bażi u waqt it-trattament u lprotezzjoni tal-kliewi għandha tiġi kkonsidrata, b'mod konformi mal-gwida klinika.
English: Other medicines and medicines radiolabelled with EndolucinBeta
Maltese: TAL-PRODOTT MEDIĊINALI EndolucinBeta 40
English: Each 10 mL vial contains an activity ranging from 8 - 150 GBq, corresponding to 1.936 micrograms of Lutetium (177Lu), at ART.
Maltese: Kull kunjett ta' 10 mL fih attività li tvarja bejn 8 u 150 GBq, li tikkorrispondi għal 1.9-36
English: EndolucinBeta is not to be administered directly to the patient, but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides, vitamins or other substrates.
Maltese: EndolucinBeta m'għandux jingħata direttament lill-pazjent iżda għandu jintuża għar-radjutikkettar ta' molekuli trasportaturi, bħal antikorpi monoklonali, peptidi, vitamini jew sottostrati oħrajn.
English: Lutetium (177Lu) emits β-particles of moderate maximum energy (0.498 MeV) with a maximum tissue penetration of approximately 2 mm. Lutetium (177Lu) also emits low-energy γ-rays which allow scintigraphic, biodistribution and dosimetry studies with the same Lutetium (177Lu)-labelled medicinal products.
Maltese: Lutetium (177Lu) jarmi wkoll raġġi-γ ta' enerġija baxxa li jippermettu studji xintigrafiċi, tal-bijodistribuzzjoni u tad-dożimetrija bl-istess prodotti mediċinali ttikkettati b'Lutetium (177Lu).
English: Lutetium (177Lu) emits both medium-energy beta particles and imageable gamma photons, and has a half-life of 6.647 days.
Maltese: Lutetium (177Lu) jarmi kemm partikuli beta ta' enerġija medja kif ukoll fotoni gamma li jistgħu jsiru immaġni, u għandu half-life ta' 6.647 jiem.
English: (see section 4.8).
Maltese: Prodott, sezzjoni 4.2).
English: Colourless type I glass 2 mL or 10 mL vial with a V-shaped and flat bottom, respectively, with a bromobutyl stopper, closed with an aluminium seal.
Maltese: Kunjett tal-ħġieġ tat-tip I mingħajr kulur ta' 2 mL jew 10 mL b'qiegħ forma ta' V u ċatt, rispettivament, b'tapp tal-bromobutyl, magħluq b'siġill tal-aluminju.
English: Five cases of tumour lysis syndrome (TLS) were identified in the scientific literature in association with Lu-177 based radioligand therapy (RLT).
Maltese: Ħames każijiet ta' sindrome ta' liżi tat-tumur (TLS, tumour lysis syndrome) kienu identifikati fil letteratura xjentifika u assoċjati ma' terapija b'radjoligand (RLT, radioligand therapy) abbażi ta' Lu177.
English: Therefore, Lutetium metal-ion toxicity of EndolucinBeta (177Lu)-labelled medicinal products can be excluded.
Maltese: Għaldaqstant, it-tossiċità tal-joni tal-metall ta' Lutetium ta' prodotti mediċinali ttikkettati b'EndolucinBeta (177Lu) ma tistax tiġi eskluża.
English: Treatment with Lutetium (177Lu) may cause disturbances of liver function.
Maltese: It-trattament b'Lutetium (177Lu) jista' jikkaġuna disturbi fil-funzjoni tal-fwied.
English: Brain
Maltese: Marrara
English: Liver
Maltese: Utru
English: - The active substance is Lutetium (177Lu) chloride.
Maltese: Lutetium (177Lu) chloride
English: In the male and female rat, following intravenous administration, Lutetium (177Lu) chloride is rapidly cleared from the blood: at 5 min post injection, only 1.52 % of the injected activity (%ID) is found in blood (corresponding to 0.08 %ID/g) and no activity above background levels remains 1 hour post dose.
Maltese: Distribuzzjoni wara għoti involontarju ġol-vina ta' Lutetium (177Lu) chloride Fil-firien irġiel u nisa, wara l-għoti ġol-vina, Lutetium (177Lu) chloride huwa mneħħi malajr mid demm: f'5 min wara l-injezzjoni, 1.52 % biss mill-attività injettata (%ID) hija misjuba fid-demm (li tikkorrispondi għal 0.08 %ID/g) u l-ebda attività 'l fuq mil-livelli tal-isfond ma tibqa' siegħa wara ddoża.
English: Point-source approximation shows that the average dose rate experienced 20 hours after administration of a dose of 7.3 GBq EndolucinBeta labelled radiopharmaceutical (residual radioactivity 1.5 GBq) by a person at 1 meter distance from the patient's body centre with an abdominal radius of 15 cm is 3.5 µSv/h.
Maltese: L-approssimazzjoni tas-sors punt (point-source approximation) turi li r-rata ta' doża medja esperjenzata 20 siegħa wara l-għoti ta' doża ta' 7.3 GBq ta' prodott farmaċewtiku ttikkettat b'EndolucinBeta (radjuattività residwa 1.5
English: Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) have been observed after treatment with Lutetium (177 Lu) peptide receptor radionuclide therapy for neuroendocrine tumours
Maltese: Kanċer tal-mudullun (sindrome majelodisplastiku u lewkimja mijelojdi akuta) kien irrapportat f'pazjenti diversi snin wara terapija radjonuklidi tar-riċettatur ta' peptide b'Lutetium (177Lu) għal tumuri newroendokrinali.
English: Dry mouth has been reported among patients with prostate cancer receiving treatment with Lutetium (177Lu) and has been temporary.
Maltese: Ħalq xott ġoe rapportat fost pazjenti b'kanċer tal-prostata li kienu qed jirċievu trattament b'Lutetium (177Lu) u dan kien temporanju.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: L-attività speċifika teoretika hija 4,110
English: Ovaries
Maltese: Pożoloġija
English: Absorbed dose per unit radioactivity administered (mSv/MBq) Adult (73.7 kg)
Maltese: Doża assorbita għal kull unità ta' radjuattività mogħtija (mSv/MBq)
English: This dose is approximately 7 orders of magnitude lower than the intraperitoneal LD50 in mice and more than 5 orders of magnitude lower than the NOEL observed in cats.
Maltese: Din id-doża hija bejn wieħed u ieħor 7 ordnijiet ta' kobor anqas mil-LD50 intraperitoneali fil-ġrieden u aktar minn 5 ordnijiet ta' kobor anqas mill-NOEL osservat fil-qtates.
English: DOSIMETRY
Maltese: U KWANTITATTIVA
English: Tumour lysis syndrome has been reported following Lutetium (177Lu) radioligand therapy.
Maltese: Sindrome tal-liżi tat-tumur Is-sindrome tal-liżi tat-tumur ġie rapportat wara terapija ta' radjoligand b'Lutetium (177Lu).
English: Heart Wall Kidneys
Maltese: Kriżi karċinojde
English: It is presented as a clear and colourless solution in a colourless type I glass 2 mL or 10 mL vial with a V-shaped and flat bottom, respectively, with a bromobutyl stopper, closed with an aluminium seal.
Maltese: Jiġi ppreżentat bħala soluzzjoni ċara u mingħajr kulur f'kunjett tal-ħġieġ tat-tip I mingħajr kulur ta' 2 mL jew 10 mL b'qiegħ forma ta' V u ċatt, rispettivament, b'tapp tal-bromobutyl, magħluq b'siġill tal-aluminju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal web Ewropew tal-mediċini.
English: The use of lutetium (177Lu)-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk of ionizing radiation to the foetus (see section 4.3).
Maltese: L-użu ta' prodotti mediċinali ttikkettati b'lutetium (177Lu) huwa kontroindikat waqt tqala stabbilita jew suspettata jew meta t-tqala ma ġietx eskluża minħabba r-riskju ta' radjazzjoni jonizzanti għall-fetu (ara sezzjoni 4.3).
English: The radiation dose received by various organs following intravenous administration of a Lutetium (177Lu)-labelled medicinal product is dependent on the specific molecule being radiolabelled.
Maltese: Id-doża ta' radjazzjoni riċevuta minn diversi organi wara l-għoti ġol-vina ta' prodott mediċinali tikkettat b'Lutetium (177Lu) ser tiddependi mill-molekula speċifika li tkun qiegħda tiġi radjutikkettata.
English: Skin and subcutaneous tissue disorders: Alopecia, described as mild and temporary, has been observed among patients receiving Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tumours.
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: Alopeċja, deskritta bħala ħafifa u temporanja, ġiet osservata fost pazjenti li kienu qegħdin jirċievu terapija radjonuklide tar-riċettur tal-peptide Lutetium (177Lu) għal tumuri newroendokrini.
English: Radiation nephropathy has been reported following peptide receptor radionuclide therapy for neuroendocrine tumours using other radioisotopes.
Maltese: Waqt it-terapija b'radjunuklide għar-riċettatur peptide għal tumuri newroendokrinali, analogi ta' somatostatin radjutikkettati jiġu eliminati mill-kliewi.
English: Adequate shielding is mandatory.
Maltese: Protezzjoni xierqa hija obbligatorja.
English: Urinary Bladder Wall Uterus
Maltese: Kliewi Fwied Pulmun Muskoli Ovarji Frixa
English: According to literature reports and taking a conservative approach (maximum patient dose of 10 GBq, average labeling yield and no additional measures), it may be considered that 177Lu-labelled medicinal products do not lead to reproductive toxicity including spermatogenetic damage in male testes or genetic damage in male testes or female ovaries.
Maltese: rendiment medju ta' tikkettar u ebda kejl addizzjonali), jista' jiġi kkunsidrat li prodotti mediċinali tikkettati b'177Lu ma jwasslux għal tossiċità riproduttiva inkluż ħsara spermatoġenika fit-testikoli tarraġel jew ħsara ġenetika fit-testikoli tar-raġel jew l-ovarji tal-mara.
English: The theoretical specific activity is 4,110 GBq/mg of Lutetium (177Lu).
Maltese: GBq/mg ta' Lutetium (177Lu).
English: What EndolucinBeta contains
Maltese: Kif taħżen EndolucinBeta
English: Cases of hepatotoxicity have been reported in the post-marketing setting and in the literature in patients with liver metastases undergoing treatment with Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tumours.
Maltese: Każijiet ta' espatotossiċità ġew rapportati fl-ambjent ta' wara t-tqegħid fis-suq u fil-letteratura f'pazjenti b'metastasi tal-fwied li jkunu għadejjin trattament b'terapija radjunuklidi tar-riċettatur ta' peptide b'Lutetium (177Lu) għal tumuri newroendokrinali.
English: The volume depends on the quantity of medicine combined with EndolucinBeta required for administration by the nuclear medicine doctor.
Maltese: Il-volum jiddependi mill-kwantità ta' mediċina kkombinata ma' EndolucinBeta meħtieġa għall-għoti mit-tabib tal-mediċina nukleari.
English: Because Lutetium (177Lu) can sometimes affect your blood cells, your doctor will do blood tests before you start and at regular intervals during treatment.
Maltese: Peress li Lutetium (177Lu) jista' xi kultant jaffetwa ċ-ċelluli tad-demm tiegħek, it-tabib tiegħek jista' jwettaq testijiet tad-demm qabel ma tibda u f'intervalli regolari waqt it-trattament.
English: Gallbladder Wall LLI Wall
Maltese: STRUZZJONIJIET DWAR L-UŻU
English: Testes
Maltese: LISTA
English: The primary radiation emissions of Lutetium (177Lu) are shown in Table 1.
Maltese: Lutetium (177Lu) huma murija f'Tabella 1.
English: Muscle
Maltese: Moħħ
English: Side effects reported among patients treated for neuroendocrine tumors:
Maltese: Rapportar ta' effett sekondarji fost pazjenti ttrattati għal tumuri newroendokrinali:
English: Limits for radiochemical impurities should be set recognising the radiotoxicological potential of Lutetium (177Lu).
Maltese: impuritajiet radjukimiċi għandhom ikunu stabbiliti għar-rikonoxximent tal-potenzjal radjutossikoloġiku ta' Lutetium (177Lu).
English: Treatment with Lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells.
Maltese: Trattament b'Lutetium (177Lu) jista' jikkawża sindrome tal-liżi tat-tumur, minħabba t-tkissir rapidu ta'
English: No interaction studies of Lutetium (177Lu) chloride with other medicinal products have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni ta' Lutetium (177Lu) chloride ma' prodotti mediċinali oħrajn.
English: 1 mL sterile solution contains 40 GBq Lutetium (177Lu) chloride on the activity reference time (corresponding to 10 micrograms of Lutetium (177Lu) as Lutetium (177Lu) chloride).
Maltese: (li jikkorrispondi għal 10 mikrogrammi ta' Lutetium (177Lu) bħala Lutetium (177Lu) chloride).
English: Please refer to the SmPC.
Maltese: Jekk jogħġbok ara l-SmPC.
English: Breasts
Maltese: DOŻIMETRIJA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LEAD POT
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: The administration will depend on the type of the carrier medicine.
Maltese: L-għoti ser jiddependi mit-tip ta' mediċina trasportatur.
English: Free non-bound Lutetium (177Lu) should be consequently minimised.
Maltese: Konsegwentement Lutetium (177Lu) ħieles mhux marbut għandu jkun minimizzat.
English: Lutetium (177Lu) chloride distributes mainly to the liver, spleen and bone.
Maltese: Lutetium (177Lu) chloride huwa distribwit prinċipalament lejn il-fwied, il-milsa u l-għadam.
English: Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6) For information on contraindications to particular Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with EndolucinBeta, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Maltese: Għal informazzjoni dwar l-interazzjonijiet assoċjati mal-użu ta' prodotti mediċinali ttikkettati b'Lutetium (177Lu), irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott/fuljett ta' tagħrif tal-prodott mediċinali li għandu jiġi radjutikkettat.
English: Tell your doctor if you feel faint or dizzy or experience flushing or diarrhoea following your treatment.
Maltese: Għandhom jiġu rispettati l-prekawzjonijiet tas-soltu rigward l-isterilità u r-radjuattività.
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation is available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Maltese: It-tossiċità ta' Lutetium chloride mhux radjuattiv ġiet studjata fi speċijiet ta' mammiferi differenti u blużu ta' rotot ta' għoti differenti.
English: Please read the package leaflet of that medicine carefully.
Maltese: F'xi pazjenti aktar minn linja waħda ta' ċelluli tista' tiġi affettwata.
English: The following nuclear reaction is ongoing in the irradiation:
Maltese: Ir-reazzjoni nukleari li ġejja hija dejjem għaddejja fl-irradjazzjoni:
English: Dry mouth has been reported among patients with metastatic castration resistant prostate cancer receiving PSMA-targeted Lutetium (177Lu)-labelled radioligands and has been transient.
Maltese: Il-ħalq xott ġie rapportat fost pazjenti b'kanċer tal-prostata metastatiku reżistenti għal kastrazzjoni li rċevew radjuligands tikkettati b'Lutetiun (177Lu) mmirati għal PSMA u dan kien temporanju.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Maltese: IL-PRODOTT MEDIĊINALI