natgillin/translations-raw huggingface dataset:
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Pri teh bolnikih je potrebno skrbno upoštevati razmerje med koristmi in tveganji, saj lahko pride do povečane izpostavljenosti sevanju.
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Če ste v dvomih, je pomembno, da se posvetujete z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Če obstaja dvom glede nosečnosti (če je ženski izostala menstruacija, če je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi nadomestne tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
Treatment with Lutetium (177Lu) radioligand therapy may lead to the following side effects - a reduced number of red blood cells (anaemia) - a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding - a reduced number of white blood cells (leukopenia, lymphopenia or neutropenia) which are important for protecting the body against infection
Zdravljenje z radioligandno terapijo z lutecijem (177Lu) lahko privede do naslednjih neželenih učinkov: - zmanjšanega števila rdečih krvnih celic (anemije); - zmanjšanega števila krvnih ploščic v krvi (trombocitopenija), ki so pomembne za zaustavitev krvavitve; - zmanjšanega števila belih krvnih celic (levkopenija, limfopenija ali nevtropenija), ki so pomembne za zaščito telesa pred okužbo.
Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Uporabljajo se lahko samo igle za brizge (na primer nekovinske) z dokazano odpornostjo proti razredčenim kislinam, da se zmanjša raven nečistot v obliki kovin v sledovih.
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.
Zaradi zmožnosti kelatnih ligandov (DTPA, EDTA), da tvorijo v vodi topne komplekse, se kompleksi in vezani lutecij (177Lu) hitro izločijo prek ledvic.
It is not known whether Lutetium (177Lu) chloride may interact with other medicines as specific studies have not been carried out.
Ni znano, ali lutecijev (177Lu) klorid medsebojno deluje z drugimi zdravili, saj posebne študije niso bile izvedene.
From a microbiological point of view, unless the method of withdrawal from the vial or any insertion into the vial preclude the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo porabiti takoj, razen če je način odvzetja iz viale ali kakršnega koli vstavljanja v vialo tak, da je tveganje onesnaženja z mikrobi preprečeno.
Myelodysplastic syndrome and acute myeloid leukaemia
Mielodisplastični sindrom in akutna mieloična levkemija
Side effects reported among patients treated for neuroendocrine tumors:
Neželeni učinki, o katerih so poročali pri bolnikih, pri katerih so zdravili nevroendokrine tumorje:
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).
1 g kelatorjev je treba dati s počasnim intravenskim injiciranjem v času od 3 do 4 minut ali infundiranjem (1 g na 100-250 ml glukoze ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje).
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.
Enak odmerek pri bolniku s polmerom trebuha 25 cm povzroči stopnjo odmerka sevanja, ki pri enem metru znaša 2,6 µSv/h.
If the integrity of this vial is compromised, the product should not be used.
Če je neoporečnost te viale ogrožena, zdravila ne smete uporabljati.
Since the medicine radiolabelled with EndolucinBeta is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose.
Ker z zdravilom, radioaktivno označenim z radionuklidnim predhodnikom EndolucinBeta, rokuje zdravnik nuklearne medicine v strogo nadzorovanih pogojih, je verjetnost prevelikega odmerjanja zelo majhna.
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.
Ta odmerek je približno sedemkrat manjši od intraperitonealne LD50 pri miših in več kot petkrat manjši od odmerka brez opaznega učinka (NOEL - no observed effect level), opaženega pri mačkah.
Renal impairment and haematological disorders
Okvara ledvic in hematološke motnje
Liver function should be monitored regularly during treatment.
Med zdravljenjem je treba redno spremljati delovanje jeter.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Izpostavljenost ionizirajočemu sevanju je povezana z nastankom raka in možnostjo razvoja dednih okvar.
In cats, no pharmacological effects on respiration and cardiovascular function were observed up to a cumulative intravenous dose of 10 mg/kg.
Pri mačkah do kumulativnega intravenskega odmerka 10 mg/kg niso bili opaženi nobeni farmakološki učinki na dihanje in delovanje kardiovaskularnega sistema.
The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Raztopino je treba odvzeti prek zamaška s pomočjo brizge za en odmerek, ki ima primeren varovalni ščit in sterilno iglo za enkratno uporabo, ali z odobrenim sistemom za samodejno dajanje.
The volume of one vial ranges from 0.075 - 3.75 mL solution (corresponding to 3 - 150 GBq at activity reference time).
Prostornina ene viale je od 0,075 do 3,75 ml raztopine (kar ustreza od 3 do 150 GBq v referenčnem času aktivnosti).
When taking the 3.5 µSv/h dose rate as an average, this would allow hospital staff to work approx. 300 hours/year in close vicinity of patients treated with EndolucinBeta labeled radiopharmaceuticals without wearing radiation protection.
Če za povprečje vzamemo stopnjo odmerka 3,5 µSv/h, bi to pomenilo, da lahko bolnišnično osebje v neposredni bližini bolnikov, zdravljenih z radiofarmaki, označenimi z radionuklidnim predhodnikom EndolucinBeta, brez nošenja zaščite pred sevanjem dela približno 300 ur/leto.
The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
V vsakem primeru je treba uporabiti čim manjšo aktivnost, ki še omogoča potrebni zdravilni učinek.
15 years old (56.8 kg)
Osebe, stare 15 let (56,8 kg)
Free non-bound Lutetium (177Lu) should be consequently minimised.
Zato je treba prosti nevezani lutecij (177Lu) minimizirati.
Lutetium (177Lu) chloride distributes mainly to the liver, spleen and bone.
Lutecijev (177Lu) klorid se porazdeli v glavnem v jetra, vranico in kosti.
If the administration is considered necessary, breastfeeding should be interrupted and the expressed feeds discarded.
Če je uporaba nujna, je treba dojenje začasno prekiniti, izločeno mleko pa zavreči.
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA 11.
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)
V medicinskih ustanovah, ki uporabljajo radionuklidni predhodnik EndolucinBeta za označevanje nosilnih molekul v terapevtske namene, morajo biti na voljo ti pripravki: - Ca-DTPA (trinatrijev kalcijev dietilentriamin pentaacetat) ali - Ca-EDTA (kalcijev dinatrijev etilendiamin tetraacetat)
…GBq/vial at ART ART: {DD/MM/YYYY 12:00 CET }
AKTIVNOST: … GBq/vialo v ART ART: {DD/MM/LLLL 12:00 CET}
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(-E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
For administration after in vitro radiolabelling.
Za dajanje po radioaktivnem označevanju in vitro.
Renal function should be assessed at baseline and during treatment and renal protection should be considered, in accordance with clinical guidance.
Ledvično funkcijo je treba oceniti na začetku in med zdravljenjem, razmisliti pa je treba o zaščiti ledvic v skladu s kliničnimi smernicami.
Renal function as well as electrolyte balance should be assessed at baseline and during treatment.
Delovanje ledvic in ravnovesje elektrolitov je treba oceniti na začetku zdravljenja in med njim.
EndolucinBeta is a type of product called a radiopharmaceutical precursor.
EndolucinBeta je vrsta izdelka, ki ga imenujemo radionuklidni predhodnik.
It contains the active substance Lutetium (177Lu) chloride which gives off beta-radiation, allowing a localised radiation effect.
Vsebuje zdravilno učinkovino lutecijev (177Lu) klorid, ki oddaja sevanje beta in tako omogoča učinek lokaliziranega sevanja.
1 year old (9.7 kg)
Osebe, stare 1 leto (9,7 kg)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT(-I) UPORABE
In a chromatographic process, the accumulated Lutetium (177Lu) is separated chemically from the original target material.
Pri kromatografskem postopku se zbrani lutecij (177Lu) kemično loči od izvirnega ciljnega materiala.
…GBq/mg at ART
… GBq/mg v ART
If at any time in the preparation of this product the integrity of this container is compromised it should not be used.
Če je kadar koli med pripravo tega radionuklidnega predhodnika ogrožena neoporečnost vsebnika,
Lutetium (177Lu) emits both medium-energy beta particles and imageable gamma photons, and has a half-life of 6.647 days.
Lutecij (177Lu) oddaja delce beta s srednjo energijo in gama fotone, ki jih je mogoče prikazati, njegova razpolovna doba pa znaša 6,647 dneva.
Very common (may affect more than 1 in 10 people): - Mild temporary hair loss
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - blaga, začasna izguba las
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.
Radioaktivno označevanje zdravil, kot so monoklonska protitelesa, peptidi, vitamini ali drugi substrati, z lutecijevim (177Lu) kloridom je zelo občutljivo za prisotnost nečistot v obliki kovin v sledovih.
On the basis of the scientific conclusions for Lutetium (177Lu) chloride the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing Lutetium (177Lu) chloride is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za lutecijev (177Lu) klorid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) lutecijev (177Lu) klorid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
ART: {DD/MM/YYYY 12:00 CET }
ART: {DD/MM/LLLL 12:00 CET}
Lutetium (177Lu) is a beta(-)/gamma emitter.
Lutecij (177Lu) je sevalec beta(-)/gama žarkov.
Free Lutetium (177Lu) is taken up and accumulates in the bones.
Prosti lutecij (177Lu) se privzame in kopiči v kosteh.
Should you have any further questions on the use of the medicine radiolabelled with EndolucinBeta, ask your nuclear medicine doctor who supervises the procedure.
Če imate dodatna vprašanja o uporabi zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, se posvetujte z zdravnikom nuklearne medicine, ki nadzoruje postopek.
The administration will depend on the type of the carrier medicine.
Dajanje bo odvisno od vrste nosilnega zdravila.
- If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
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
(≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
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.
Ti kelatorji pomagajo pri zaviranju radiotoksičnosti lutecija (177Lu) z izmenjavo med kalcijevim ionom v kompleksu in lutecijevim (177Lu) ionom.
10 years old (33.2 kg)
Osebe, stare 10 let (33,2 kg)
The primary radiation emissions of Lutetium (177Lu) are shown in Table 1.
Primarne emisije sevanja lutecija (177Lu) so prikazane v preglednici 1.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Postopke dajanja je treba izvajati tako, da se čim bolj zmanjša tveganje za kontaminacijo radionuklidnega predhodnika in obsevanje osebja.
…mL
PROSTORNINA: … ml
Therefore, in case of an inadvertent administration of EndolucinBeta, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like Ca-DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.
Če pride do nenamernega dajanja radionuklidnega predhodnika EndolucinBeta, je zato za hitrejše odstranjevanje radionuklida iz telesa treba zmanjšati radiotoksičnost za bolnika s takojšnjim (tj. v času ene ure) dajanjem pripravkov, ki vsebujejo kelatorje, kot je Ca-DTPA ali Ca-EDTA.
The dosimetry estimates were based on a rat biodistribution study performed according to MIRD pamphlet no.16, and the calculations were performed using the OLINDA 1.1 software package.
MIRD št. 16, izračuni pa so bili opravljeni s programsko opremo OLINDA 1.1.
Healthcare personnel are advised to limit the time of close contact with patients injected with Lutetium (177Lu)-labelled radiopharmaceuticals.
Zdravstvenemu osebju je treba svetovati, naj omeji čas tesnega stika z bolniki, ki so prejeli injekcije radiofarmakov, označenih z lutecijem (177Lu).
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.
Na voljo je v obliki bistre in brezbarvne raztopine v brezbarvni stekleni viali tipa I s prostornino 2 ml ali 10 ml, katere dno ima obliko črke V oziroma je plosko, z brombutilnim zamaškom in zaprti z aluminijastim tesnilom.
The following information is intended for healthcare professionals only: The complete SmPC of EndolucinBeta is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Celotni povzetek glavnih značilnosti zdravila za radionuklidni predhodnik EndolucinBeta je na voljo kot ločen dokument v pakiranju radionuklidnega predhodnika z namenom omogočiti zdravstvenemu osebju še druge, dodatne, znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
Adequate quality control of the radiochemical purity of ready to use radiopharmaceuticals gained after radiolabelling with EndolucinBeta should be assured.
Zagotoviti je treba ustrezen nadzor kakovosti radiokemijske čistote radiofarmakov, pripravljenih za uporabo, dosežene po radioaktivnem označevanju z radionuklidnim predhodnikom EndolucinBeta.
Medicines radiolabelled with EndolucinBeta will only be used in special controlled areas.
Zdravila, radioaktivno označena z radionuklidnim predhodnikom EndolucinBeta, bodo uporabljena le v posebnih, nadzorovanih okoljih.
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).
Uporaba z lutecijem (177Lu) označenih zdravil je zaradi tveganja ionizirajočega sevanja za plod kontraindicirana, če obstaja potrjena nosečnost, sum na nosečnost ali če nosečnost ni izključena (glejte poglavje 4.3).
EndolucinBeta is not a medicine and it is not intended to be used on its own.
EndolucinBeta ni zdravilo in se ne sme uporabljati samo.
Please read the package leaflet of that medicine carefully.
Natančno preberite navodilo za uporabo teh zdravil.
The volume depends on the quantity of medicine combined with EndolucinBeta required for administration by the nuclear medicine doctor.
Prostornina je odvisna od količine zdravila, kombiniranega z radionuklidnim predhodnikom EndolucinBeta, ki jo zdravnik nuklearne medicine potrebuje za dajanje.
The complexing agent and other reagents should be added to the vial with Lutetium (177Lu) chloride.
Kompleksirajoči reagent in druge reagente je treba dodati v vialo z lutecijevim (177Lu) kloridom.
Radiolabelled somatostatin analogues are excreted by the kidney.
Radioaktivno označeni analogi somatostatina se izločajo skozi ledvice.
No interaction studies of Lutetium (177Lu) chloride with other medicinal products have been performed.
Študij medsebojnega delovanja lutecijevega (177Lu) klorida z drugimi zdravili niso izvedli.
- if you are allergic to Lutetium (177Lu) chloride or any of the other ingredients of this medicine
- če ste alergični na lutecijev (177Lu) klorid ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
177Lu-chloride contains 2.4 µg Lutetium, corresponding to a human dose of 0.034 µg/kg.
Visok odmerek 10 GBq lutecijevega (177Lu) klorida vsebuje 2,4 µg lutecija, kar ustreza človeškemu odmerku 0,034 µg/kg.
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.
Zaščita pred sevanjem Približek s točkovnim virom kaže, da pri osebi na razdalji enega metra od središča telesa bolnika s polmerom trebuha 15 cm, ki je pred 20 urami prejel odmerek 7,3 GBq radiofarmaka, označenega z radionuklidnim predhodnikom EndolucinBeta (preostala radioaktivnost 1,5 GBq), povprečna stopnja odmerka sevanja znaša 3,5 µSv/h.
The vials are placed into a lead container for protective shielding and packed in a metallic can and an outer carton.
Viale so v svinčenem vsebniku, ki predstavlja varovalni ščit, in so pakirane v kovinski posodi in zunanji škatli.
However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator with reduced efficiency.Intravenous administration should not be protracted over more than 2 hours.
Vendar pa dajanje in učinkovito delovanje kelatorja z zmanjšano učinkovitostjo pri časovnem razmiku po izpostavljenosti, ki je > 1 ure, nista izključeni.
The produced Ytterbium (177Yb) with a half-life of 1.9 h decays to Lutetium (177Lu).
Pridobljeni iterbij (177Yb) z razpolovno dobo 1,9 ure razpade na lutecij (177Lu).
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.
Radionuklidni predhodnik EndolucinBeta se ne sme dajati neposredno bolniku, temveč ga je treba uporabiti za radioaktivno označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi,
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.
Brezbarvna steklena viala tipa I prostornine 2 ml ali 10 ml, katere dno ima obliko črke V oziroma je plosko, z brombutilnim zamaškom in zaprta z aluminijastim tesnilom.
The nuclear medicine doctor supervising the procedure will decide on the quantity of a medicine radiolabelled with EndolucinBeta to be used in your case.
Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, ki bo uporabljena pri vas.
Treatment with Lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells.
Zdravljenje z lutecijem (177Lu) lahko povzroči sindrom tumorske lize zaradi hitre razgradnje tumorskih celic.
Individual benefit/risk justification
Presoja razmerja med koristmi in tveganji pri posameznem bolniku
It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
Uporablja se samo za radioaktivno označevanje nosilnih molekul, posebej razvitih in odobrenih za radioaktivno označevanje z lutecijevim (177Lu) kloridom.
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJ ZA
You will not have to store this medicine.
Tega radionuklidnega predhodnika vam ne bo treba shranjevati.
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.
Informacije o dozimetriji sevanja vsakega različnega zdravila po dajanju radioaktivno označenega pripravka so na voljo v povzetku glavnih značilnosti zdravila/navodilu za uporabo posameznega radioaktivno označenega zdravila.
The effective dose to a 73.7 kg adult resulting from an inadvertently injected intravenous activity of 1 GBq would be 534 mSv.
Pri odraslem s telesno maso 73,7 kg znaša raven odmerka, pri katerem se pokaže učinek in ki izvira iz nenamerno intravensko injicirane aktivnosti 1 GBq, 534 mSv.
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.
Lutecijev (177Lu) klorid nastane z obsevanjem visoko obogatenega (> 99 %) iterbija (176Yb) v virih nevtronov s tokom termičnih nevtronov med 1013
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.
Pri podganjih samcih in samicah se lutecijev (177Lu) klorid po intravenskem dajanju hitro izloči iz krvi: 5 minut po injiciranju je v krvi najdene le 1,52 % injicirane aktivnosti (% ID) (kar ustreza
In all cases, the risk of the radiation is outweighed by the potential benefit of receiving the radiolabelled medicine.
V vsakem primeru možne koristi zaradi prejema radioaktivno označenega zdravila odtehtajo tveganje zaradi sevanja.
Each pack contains 1 vial placed into a lead container for protective shielding and packed in a metallic can and an outer carton.
Eno pakiranje vsebuje eno vialo v svinčenem vsebniku, ki predstavlja varovalni ščit, pakirano v kovinski posodi in zunanji škatli.
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 a Lutetium (177Lu)-labelled medicinal product or resulting from an accidental intravenous injection of EndolucinBeta.
Spodnja preglednica dozimetrije prikazuje ocenjeni prispevek nekonjugiranega lutecija (177Lu) k odmerku sevanja, ki sledi dajanju z lutecijem (177Lu) označenega zdravila ali je rezultat nenamernega intravenskega injiciranja radionuklidnega predhodnika EndolucinBeta.
The presence of free Lutetium (177Lu) chloride in the body after an inadvertent administration of EndolucinBeta will lead to increased bone marrow toxicity and haematopoietic stem cell damage.
Prisotnost prostega lutecijevega (177Lu) klorida v telesu po nenamernem dajanju radionuklidnega predhodnika EndolucinBeta povzroči povečano toksičnost za kostni mozeg in okvaro hematopoetskih matičnih celic.