FrancophonIA/ELRC3.0 huggingface dataset:
English: Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Disease include decrease of neutrophils, improved deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Maltese: Effetti farmakoloġiċi magħrufa oħra ta' hydroxycarbamide li jistgħu jikkontribwixxu għall-effetti benefiċjali tiegħu fil-Marda tas-Sickle Cell jinkludu t-tnaqqis ta' newtrofili, deformabilità mtejba taċ-ċelluli sickled, u l-adeżjoni mibdula taċċelluli ħomor tad-demm għall-endotelju.
English: Common: may affect up to 1 in 10 people - Nausea - Headache - Dizziness - Constipation - Darkening of the skin, nails and mouth - Dry skin - Hair loss
Maltese: Komuni: jistgħu jaffettwaw sa persuna 1 minn kull 10 persuni - Tbenġil mhux spjegat (akkumulazzjoni ta' demm taħt il-ġilda) jew fsada - Sensittività (infezzjoni tal-ġilda miftuħa) fuq il-ġilda tiegħek
English: Hepatobiliary disorders
Maltese: Disturbi gastro-intestinali
English: Destination:
Maltese: Destinazzjoni:
English: ICRP-30 data
Maltese: Dejta ta' ICRP-30
English: Holland B.V.
Maltese: I.D.B Holland B.V.
English: Activity (at ART): {Y} GBq
Maltese: Attività (f'ART): {Y} GBq
English: microgram of Lutetium.
Maltese: mikrogramma ta' Lutezju.
English: Dose / Injected Activity (mGy/MBq)
Maltese: Doża / Attività Injettata (mGy/MBq)
English: Also low gamma energy is emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Maltese: Enerġija gamma baxxa hija wkoll emessa, pereżempju f'113 keV (6.2%) u 208 keV (11%).
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000),
Maltese: (≥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: 5111 PV Baarle-Nassau The Netherlands
Maltese: 5111 PV Baarle-Nassau In-Netherlands
English: 8 days from the date of ART (= end of production).
Maltese: 8 ijiem mid-data tal-ART (= tmiem tal-produzzjoni).
English: EU/1/15/1013/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: EU/1/15/1013/001
English: The complexing agent and other reagents should be added to the vial with Lutetium (
Maltese: L-użu ta' mediċini tikkettati b'Lutezju (
English: Lutetium (177Lu) is a beta(-)/gamma emitter.
Maltese: Lutezju (177Lu) huwa emittent tal-beta(-)/gamma.
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3-4 minutes or by infusion (1 g in 100-250 mL of glucose, or sodium chloride 9 mg/mL (0,9%) solution for injection).
Maltese: 1 g tal-aġenti kelanti għandha tingħata permezz ta' injezzjoni bil-mod minn ġol-vina fi żmien 3 - 4 minuti jew permezz ta' infużjoni (1 g f'100 - 250 mL ta' glukożju, jew klorur tas-sodju 9 mg/mL (0,9 %) soluzzjoni għall-injezzjoni).
English: For administration after in vitro radiolabelling.
Maltese: Għal amministrazzjoni wara radjutikkettar in vitro.
English: Client code:
Maltese: Kodiċi tal-klijent:
English: Lutetium (177Lu) decays by β--emission to stable Hafnium (177Hf), with the most abundant β- (79.3%) having a maximum energy of 0.497 MeV.
Maltese: stabbli, bl-iktar β- abbundanti (79.3%) jkollu enerġija massima ta' 0.497 MeV.
English: • Bone marrow cancer (myelodysplastic syndrome)
Maltese: • Kanċer tal-mudullun (sindrome majelodisplastiku)
English: Pharmacokinetic data on Lumark related to free Lutetium:
Maltese: Dejta farmakokinetika dwar Lumark relatata ma' Lutezju liberu:
English: By intravenous route, the LD50 in rats and mice ranges between 30 and 60 mg/kg.
Maltese: B'rotta fil-vini, l-LD50 fil-firien u l-ġrieden tvarja bejn 30 u 60 mg/kg.
English: The toxicity of Lutetium (177Lu) chloride has been studied in different mammals and using different administration routes.
Maltese: It-tossiċità tal-klorur ta' Lutezju (177Lu) ġiet studjata f'mammali differenti u bl-użu ta' rotot ta' amministrazzjoni differenti.
English: Electrocardiograms showed no irregularities in cardiac rhythm or conduction.
Maltese: Elettrokardjogrammi ma wrew ebda irregolarità fir-ritmu jew konduzzjoni kardijaka.
English: Lumark is a radiopharmaceutical precursor.
Maltese: Lumark huwa prekursur radjufarmaċewtiku.
English: Effective Dose (mSv/MBq)
Maltese: Doża Effettiva [µSv/MBq]
English: • Carcinoid crisis
Maltese: • Kriżi karċinojde
English: Tumour lysis syndrome
Maltese: Sindrome tal-liżi tat-tumur
English: Blood and lymphatic system disorders very common: Anaemia, thrombocytopenia, leukopenia and lymphopenia
Maltese: Komuni ħafna: Anemija, trombiċitopenija, lewkopenija u limfopenija
English: One mL of solution contains 80 GBq Lutetium (177Lu) chloride at activity reference time (ART), corresponding to at most a maximum of 160 microgram of Lutetium.
Maltese: mL wieħed ta' soluzzjoni fih 80 GBq ta' klorur tal-Lutezju (177Lu) f'ħin ta' referenza tal-attività (ARTactivity reference time), li jikkorrispondi bħala massimu għal massimu ta' 160 mikrogramma ta' Lutezju.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, iddetentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista fl-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The distribution and mineral concentrations in the organs were investigated at low (9-10 mg/kg) and high (19-20 mg/kg) doses administered intravenously to rats.
Maltese: Id-distribuzzjoni u lkonċentrazzjoni tal-minerali fl-organi ġew investigati f'dożi baxxi (9-10 mg/kg) u għoljin (19-20 mg/kg) li ngħataw fil-vina lill-firien.
English: Absorbed dose per unit activity administered for various tissues
Maltese: Doża assorbita għal kull unità ta' attività mogħtija għal diversi tessuti
English: Liver function should be monitored regularly during treatment.
Maltese: Il-funzjoni tal-fwied għandu jiġi monitorat regolarment waqt ittrattament.
English: Intraperitoneal administration resulted in generalized peritonitis with adhesion and accumulation of some ascetic fluid.
Maltese: Amministrazzjoni intraperitonjali rriżultat f'peritonite ġeneralizzata b'adeżjoni u akkumulazzjoni ta' xi fluwidu asitiku.
English: Lu)-labeled conjugates in order to form a complex with free Lutetium (
Maltese: Ir-reazzjonijiet avversi wara l-għoti minn ġol-vini ta' prodotti mediċinali ttikkettati b'Lutezju (
English: By intraperitoneal route, the LD50 is approximately 300 mg/kg in mice and rats.
Maltese: B'rotta intraperitonjali, l-LD50 hija bejn wieħed u ieħor 300 mg/kg fil-firien u l-ġrieden.
English: 5111 PV Baarle-Nassau NETHERLANDS
Maltese: I.D.B Holland B.V. Weverstraat 17 5111 PV Baarle-Nassau In-Netherlands
English: Skin and subcutaneous tissue disorders: very common: Alopecia
Maltese: Komuni ħafna: Alopeċja
English: The ART is defined as the end of production.
Maltese: LART huwa definit bħala t-tmiem tal-produzzjoni.
English: Total Body
Maltese: Total Ġisem
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Maltese: protezzjoni mir-radjazzjoni f'konformità mar-regolazzjonijiet nazzjonali.
English: Administration of a high activity (7.400 MBq) of the Lutetium(177Lu)-labelled medicinal product results in an average radiation dose rate at 1 m distance from the patient of 4-11 µSv/h after 24 hours.
Maltese: MBq) tal-prodott mediċinali tikkettat b'Lutezju (177Lu) tirriżulta f'rata ta' doża medja ta' radjazzjoni f'distanza ta' 1 m mill-pazjent ta' 4-11 µSv/s wara 24 siegħa.
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 (see section 4.8).
Maltese: Sindrome majelodisplastiku u lewkimja mijelojdi akuta Sindrome majelodisplastiku (MDS) u lewkimja mijelojde akuta (AML) kienu osservati wara t-trattament b'terapija radjonuklidi tar-riċettatur ta' peptide b'Lutetium (177Lu) għal tumuri newroendokrinali (ara sezzjoni 4.8).
English: Pharmacokinetics of Lutetium (177Lu) was investigated in rats and mice.
Maltese: Il-farmakokinteiċi ta' Lutezju (177Lu) ġew investigati fil-firien u l-ġrieden.
English: In case of hormonal crises, treatments may include: intravenous high dose somatostatin analogues, intravenous fluids, corticosteroids, and correction of electrolyte disturbances in patients with diarrhoea and/or vomiting.
Maltese: F'każ ta' kriżi ormonali, it-trattamenti għandhom mnejn jinkludu: doża qawwija ġol-vina ta' analogi ta' somatostatin, fluwidi intravenużi, kortikosterojdi, u korrezzjoni tad-disturbi ta' elettroliti f'pazjenti b'dijarea u/jew remettar.
English: Hydrochloric acid
Maltese: Fih is-sustanza attiva klorur tal
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)
Maltese: Komuni: Ċitopenja refrattorja b'displażja multilineari (Sindrome majelodisplastiku) (ara sezzjoni 4.4)
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Aċidu idrokloriku
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: The following preparations must be available in medical institutions, which use Lumark for radiolabelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Maltese: - Ca-DTPA (Dietilenetriamminapentaaċetat tal-kalċju trisodiku) jew - Ca-EDTA (Etilendiamminatetraaċetat tal-kalċju disodiku)
English: Radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates, with Lutetium (177Lu) chloride is very sensitive to the presence of trace metal impurities.
Maltese: Radjutikkettar ta' molekuli trasportaturi, bħal antikorpi monoklonali, peptidi jew sottostrati oħrajn, bi Il-klorur tal-Lutezju (177Lu) huwa sensittiv ħafna għall-preżenza ta' impuritajiet ta' metalli ta' traċċar.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallmediċini: http://www.ema.europa.eu.
English: Due to the capacity of the chelating ligands (DTPA, EDTA) of forming water soluble complexes, the complexes and bound Lutetium(177Lu) are rapidly eliminated by the kidneys.
Maltese: Minħabba il-kapaċità tal-ligands kelanti (DTPA, EDTA) ta' kumplessi li jdubu fl-ilma li jiffurmaw, il-kumplessi u Lutezju (177Lu) marbut jiġu eliminati malajr mill-kliewi.
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Maltese: GĦAMLA FARMAĊEWTIKA Prekursur radjufarmaċewtiku, soluzzjoni.
English: Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq (at ART).
Maltese: Kull kunjett fih volum li jvarja minn 0.1 sa 5 mL li jikkorrespondi għal attività li tvarja minn 8 sa 400 GBq (f'ART).
English: Bone marrow cancer (myelodysplastic syndrome and acute myeloid leukaemia) has been reported in patients several years after treatment with Lutetium (177Lu) 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: • Mild temporary hair loss Common (may affect up to 1 in 10 people):
Maltese: • Telf ħafif u temporanju ta' xagħar Komuni (jistgħu jaffettwaw sa persuna 1 f'10):
English: Activity Reference Time (ART): {DD/MM/YYYY} {hh:mm} CET Specific activity (at ART): {YY} GBq/mg Lu mass:
Maltese: Attività speċifika (f'ART): {SS} GBq/mg
English: Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq at the ART.
Maltese: Kull kunjett fih volum li jvarja minn 0.1 sa 5 mL li jikkorrespondi għal attività li tvarja minn 8 sa 400 GBq fl-ART.
English: The dosimetry estimates are based on biodistribution data provided by ICRP-30, showing bone, liver and kidneys as the significant target organs for the biodistribution of lutetium.
Maltese: L-istimi tad-dożimetrija huma bbażati fuq dejta ta' bijodistribuzzjoni pprovduta minn ICRP-30, li turi l għadam, il-fwied u l-kliewi bħala l-organi fil-mira sinifikanti għall-biodistribuzzjoni ta' Lutezju.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Dejta rilevanti hija inkluża fis
English: The studies suggest that the intravenous toxicity of the ionic compounds of the rare earth elements would decrease with atomic weight resulting in Lutetium (177Lu) being the least toxic of the series.
Maltese: L-istudji jissuġġerixxu li t-tossiċità fil-vini tal-komposti joniċi ta' elementi terrestri rari tonqos mal-piż atomiku li jirriżulta f'li Lutezju (177Lu) ikun l-inqas tossiku mis-serje.
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' Lu-177.
English: Lutetium (177Lu) has a half-life of 6.647 days.
Maltese: Lutezju (177Lu) għandu semiħajja (half-life) ta' 6.647 jiem. Lutezju (177Lu) jiġi prodott minn irradjazzjoni ta'
English: EXPIRY DATE Expiry date: {DD/MM/YYYY} hh:mm CET
Maltese: Ħin ta' Referenza tal-Attività (ART): {JJ/XX/SSSS} hh:mm CET
English: Manufacturer I.D.B.
Maltese: Manifattur I.D.B Holland B.V.
English: A more detailed study of the biodistribution of Lutetium (177Lu) chloride in mice confirms the relatively high uptake in the liver, kidneys and bone marrow The results indicated that lutetium (177Lu) chloride is accumulated in the bone marrow and emphasizes the importance of all Lutetium (177Lu) to be peptide-bound at injection, as well as the in-vivo stability of the radionuclide-chelate-complex during therapy.
Maltese: Ir-riżultati wrew li l-klorur tal-Lutezju (177Lu) jakkumula fil-mudullun u jenfasizzaw l-importanza li kull Lutezju (177Lu) jkun marbut bil-peptidi flinjezzjoni, kif ukoll l-istabilità in-vivo tal-kumpless-radjonuklide-kelant waqt it-terapija.
English: Lumark 80 GBq/mL radiopharmaceutical precursor solution Lutetium (177Lu) chloride
Maltese: Lumark 80 GBq/mL prekursur radjufarmaċewtiku, soluzzjoni
English: Lumark is used for radiolabelling medicines, a technique in which medicines are tagged (radiolabelled) with a radioactive form of the element lutetium, known as lutetium (177Lu).
Maltese: Lumark jintuża għar-radjutikkettar ta' mediċini, teknika li biha mediċini jiġu mmarkati (radjutikkettati) b'forma radjuattiva tal-element Lutezju, magħruf bħala Lutezju (177Lu).
English: I.D.B.
Maltese: FIS-SUQ D.
English: What Lumark looks like and contents of the pack Lumark is presented as a sterile, clear, and colourless solution in a colourless type I glass vial of 10 mL, closed with a bromobutylrubber stopper and aluminium overseal
Maltese: Lumark huwa soluzzjoni sterili, ċara, u bla kulur f'kunjett tal-ħġieġ trasparenti tat-tip I ta' 10 mL, magħluq b'tapp tal-lastku bromobutil u b'siġill tal-aluminju
English: NAME OF THE MEDICINAL PRODUCT Lumark 80 GBq/mL radiopharmaceutical precursor, solution
Maltese: Informazzjoni għall-pazjent Lumark 80 GBq/mL soluzzjoni ta' prekursur radjufarmaċewtiku
English: Breasts
Maltese: KUNJETT
English: Renal function should be assessed at baseline and during treatment and renal protection should be considered, in accordance with clinical guidance.
Maltese: Ilfunzjoni renali għandha tiġi valutata fil-linja bażi u waqt it-trattament u l-protezzjoni tal-kliewi għandha tiġi kkonsidrata, b'mod konformi mal-gwida klinika.
English: Myelosuppression
Maltese: Epatotossiċità
English: Adequate shielding is mandatory.
Maltese: Protezzjoni ta' lqugħ xieraq hija obbligatorja.
English: An updated RMP should be submitted:
Maltese: Ir-RMP aġġornat għandu jiġi ppreżentat:
English: The minimal specific activity is 500 GBq/mg Lutetium (177Lu) at the ART.
Maltese: GBq/mg ta' Lutezju (177Lu) f'ART.
English: The radiation dose received by the various organs following administration of a Lutetium (177Lu)-labelled medicinal product will be dependent on the specific molecule being radiolabelled.
Maltese: Id-doża ta' radjazzjoni riċevuta mid-diversi organi wara l-għoti ta' prodott mediċinali tikkettat b'Lutezju (177Lu) se tiddependi mill-molekula speċifika li tkun qiegħda tiġi radjutikkettata.
English: • Tumour lysis syndrome (rapid breakdown of tumour cells)
Maltese: • Sindrome tal-liżi tat-tumur (tkissir rapidu taċ-ċelluli tat-tumur)
English: The possible use of chelating therapies could interfere with the use of Lutetium(177Lu)-labeled medicinal products.
Maltese: L-użu possibbli ta' terapiji kelanti jista' jfixkel l-użu ta' prodotti mediċinali ttikkettati b'Lutezju (177Lu).
English: Tumour lysis syndrome has been reported following Lutetium (177Lu) radioligand therapy.
Maltese: Is-sindrome tal-liżi tat-tumur ġie rapportat wara terapija ta' radjoligand b'Lutetium (177Lu).
English: These chelating agents help with the elimination of Lutetium (177Lu) radiotoxicity by an exchange between the calcium ion in the complex and the Lutetium (177Lu) ion.
Maltese: Dawn l-aġenti kelanti jgħinu bl-eliminazzjoni tar-radjutossiċità ta' Lutezju (177Lu) permezz ta' skambju bejn il-jon tal-kalċju fil-kumpless u l-jon tal-Lutezju (177Lu).
English: Lumark is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Maltese: Lumark m'għandux jingħata direttament lill-pazjent iżda għandu jintuża għar-radjutikkettar ta' molekuli trasportaturi, bħal antikorpi monoklonali, peptidi jew substrati oħrajn.
English: Renal impairment and haematological disorders
Maltese: Disturbi fis-sistema endokrinarja:
English: Adrenals Brain
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Lungs
Maltese: Pulmun
English: and has been temporary.
Maltese: u dan kien temporanju.
English: Fertility
Maltese: DOŻIMETRIJA
English: Myelodysplastic syndrome and acute myeloid leukaemia
Maltese: • Kanċer tal-mudullun (lewkimja mijelojdi akuta)
English: Relevant data is included in the Summary of Product Characteristics of the labeled medicinal products.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali ttikkettati.
English: For a person in the vicinity of the patient, assuming continuous exposure at 2 m and infinite biological half-life (no disposal by the patient after discharge from the hospital), this dose rate will result in an overall dose of approximately 0.6 mSv, which is approximately one half of the dose limit set for general public (1 mSv/year).
Maltese: Għal persuna fil-viċinanza talpazjent, jekk wieħed jassumi esponiment kontinwu f'distanza ta' 2 m u semiħajja bijoloġika infinita (ebda tneħħija mill-pazjent wara r-rilaxx mill-isptar), din ir-rata tad-doża sejra tirriżulta f'doża totali ta' madwar 0.6 mSv, li hija bejn wieħed u ieħor nofs il-limitu tad-doża stabbilit għall-pubbliku ġenerali (1 mSv/sena).
English: One mL of solution contains 80 GBq Lutetium (177Lu) chloride at Activity Reference Time (ART), corresponding to a maximum of 160
Maltese: Lutezju (177Lu) f'Ħin ta' Referenza tal-Attività (ART) li jikkorrespondi għal massimu ta' 160
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 tar-raġel jew ħsara ġenetika fit-testikoli tar-raġel jew l-ovarji tal-mara.
English: No interaction studies of Lutetium (177Lu) with other medicinal products have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni ta' Lutezju (177Lu) ma' prodotti mediċinali oħrajn.
English: For instruction on extemporary preparation of the medicinal product before administration, see section 12.
Maltese: Għal struzzjonijiet dwar it-tħejjija improvizzata tal-prodott mediċinali qabel l-amministrazzjoni, ara s sezzjoni 12.
English: Gallbladder Wall LLI Wall Small Intestine Stomach Wall ULI Wall Heart Wall Kidneys
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Lutetium (177Lu) chloride is produced by irradiation of 176Lu with neutrons.
Maltese: Mhux assenjat Il-klorur tal-Lutezju (177Lu) huwa prodott b'irradjazzjoni ta' 176Lu b'newtroni.
English: Hepatotoxicity:
Maltese: Disturbi gastro-intestinali:
English: leading to a rapid renal clearance of Lutetium (177Lu).
Maltese: Klorur tal-Lutezju (177Lu)
English: For Lutetium (177Lu) the different dose levels did not result in significantly different uptake with 65% appearing in the liver, 5.3% in the spleen and 13% in the bones at one day after administration.
Maltese: Għal Lutezju (177Lu) il-livelli differenti ta' dożi ma rriżultawx f'teħid differenti b'mod sinifikanti b'65%
English: Lumark is only used to radiolabel medicines that have been specifically developed for use with the active substance lutetium (177Lu)chloride.
Maltese: Lumark jintuża biss biex jiġu radjutikkettati mediċini li ġew żviluppati speċifikament għall-użu mas-sustanza attiva klorur tal-Lutezju (177Lu).
English: Pharmacotherapeutic group: Not yet assigned, ATC code: Not yet assigned
Maltese: Mhux assenjat, Kodiċi ATC:
English: Pregnancy The use of Lutetium (177Lu)-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Maltese: L-użu ta' prodotti mediċinali ttikkettati b'Lutezju (177Lu) huwa kontraindikat matul tqala stabbilita jew suspettata jew meta t-tqala ma ġietx eskluża (ara s-sezzjoni 4.3).
English: Other sources of information
Maltese: Sorsi oħrajn ta' informazzjoni
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Lutetium(177Lu) to the radiation dose following the administration of Lutetium (177Lu)-labelled medicinal product or resulting from an accidental intravenous injection of Lumark.
Maltese: It-tabella ta' dożimetrija hawn isfel ġiet ippreżentata sabiex tiġi evalwata l-kontribuzzjoni ta' Lutezju (177Lu) mhux konjugat għad-doża ta' radjazzjoni wara l-amministrazzjoni ta' prodott mediċinali tikkettati b'Lutezju (177Lu)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lumark 80 GBq/mL radiopharmaceutical precursor, solution Lutetium (177Lu) chloride
Maltese: It-tagħrif farmakokinetiku ta' prodotti mediċinali ttikkettati b'Lutezju (177Lu) imħejjija permezz tarradjutikkettar b'Lumark, qabel l-għoti, jiddependi mit-tip ta' prodott mediċinali li għandu jiġi radjutikkettat.