FrancophonIA/ELRC3.0 huggingface dataset:
English: The toxicity of free Lutetium (177Lu) due to in-vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.
Slovenian: Toksičnost prostega lutecija (177Lu) zaradi sprostitve in vivo iz označene biomolekule v telesu med zdravljenjem je mogoče zmanjšati z naknadnim dajanjem kelatorjev.
English: EndolucinBeta 40 GBq/mL Lutetium (177Lu) chloride
Slovenian: EndolucinBeta 40 GBq/ml lutecijev (177Lu) klorid
English: EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients.
Slovenian: EndolucinBeta je radionuklidni predhodnik in ni namenjen za neposredno uporabo pri bolnikih.
English: EndolucinBeta is intended for in vitro radiolabelling of medicinal products which are subsequently administered by the approved route.
Slovenian: Radionuklidni predhodnik EndolucinBeta je namenjen za radioaktivno označevanje zdravil in vitro, ki se nato dajejo v skladu z odobreno potjo uporabe.
English: Treatment with Lutetium (177Lu) may cause disturbances of liver function.
Slovenian: Zdravljenje z lutecijem (177Lu) lahko povzroči motnje delovanja jeter.
English: Tell your doctor if you feel faint or dizzy or experience flushing or diarrhoea following your treatment.
Slovenian: Obvestite zdravnika, če imate po zdravljenj občutek omedlevice ali omotice ali če imate vročinske oblive ali drisko.
English: EndolucinBeta is a radiopharmaceutical precursor, solution.
Slovenian: EndolucinBeta je radionuklidni predhodnik, raztopina.
English: Please read the package leaflet of that medicine.
Slovenian: Preberite navodilo za uporabo tega zdravila.
English: EndolucinBeta is only to be used by specialists experienced with in vitro radiolabelling.
Slovenian: Radionuklidni predhodnik EndolucinBeta smejo uporabljati le zdravniki specialisti, ki imajo izkušnje na področju radioaktivnega označevanja in vitro.
English: 5 years old (19.8 kg)
Slovenian: Osebe, stare 5 let (19,8 kg)
English: The European Medicines Agency has waived the obligation to submit the results of the studies with EndolucinBeta in all subsets of the paediatric population on grounds that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients.
Slovenian: Pediatrična populacija Ker zadevno zdravilo v primerjavi z obstoječimi zdravljenji za pediatrične bolnike ne pomeni pomembne terapevtske koristi, je Evropska agencija za zdravila odstopila od zahteve za predložitev rezultatov študij z radionuklidnim predhodnikom EndolucinBeta za vse podskupine pediatrične populacije.
English: The carrier medicine then takes the EndolucinBeta to the disease site in the body.
Slovenian: Nosilno zdravilo nato prenese radionuklidni predhodnik EndolucinBeta na obolelo mesto v telesu.
English: Distribution after inadvertent intravenous administration of Lutetium (177Lu) chloride
Slovenian: Porazdelitev po nenamernem intravenskem dajanju lutecijevega (177Lu) klorida
English: During peptide-receptor radionuclide therapy for neuroendocrine tumours, radiolabelled somatostatin analogues are excreted by the kidneys.
Slovenian: Med radionuklidno terapijo s peptidnimi receptorji za nevroendokrine tumorje ledvice izločajo radioaktivno označene somatostatinske analoge.
English: Other medicines and medicines radiolabelled with EndolucinBeta
Slovenian: Druga zdravila in zdravila, radioaktivno označena z radionuklidnim predhodnikom EndolucinBeta
English: The quantity of EndolucinBeta required for radiolabelling and the quantity of Lutetium (177Lu)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.
Slovenian: Količina radionuklidnega predhodnika EndolucinBeta, potrebna za radioaktivno označevanje, in količina z lutecijem (177Lu) označenega zdravila, ki je nato uporabljeno, sta odvisni od radioaktivno označenega zdravila in njegove predvidene uporabe.
English: There have been reports of carcinoid crisis and other syndromes associated with release of hormones from functional neuroendocrine tumours following Lutetium (177Lu) peptide receptor radionuclide therapy, which may be related to irradiation of tumour cells.
Slovenian: Sindromi sproščanja hormonov Obstajajo poročila o karcinoidni krizi in drugih sindromih, povezanih s sproščanjem hormonov iz funkcionalnih nevroendokrinih tumorjev po zdravljenju z radionuklidno terapijo s peptidnimi receptorji (PRRT) za lutecij (177Lu), ki so lahko povezani z obsevanjem tumorskih celic.
English: Renal irradiation
Slovenian: Sevanje v ledvicah
English: Your doctor will therefore take a blood test to measure your kidney function before you start and during treatment.
Slovenian: Zdravnik bo zato pred začetkom zdravljenja in med njim opravljal krvno preiskavo za merjenje delovanja vaših ledvic.
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.
Slovenian: Odmerki sevanja, ki jih prejmejo različni organi po intravenskem dajanju z lutecijem (177Lu) označenega zdravila, so odvisni od posamezne molekule, ki se radioaktivno označuje.
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Te informacije bodo navedene v povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki bo radioaktivno označevano.
English: A blood count should be taken at baseline and monitored regularly during treatment, in accordance with clinical guidance.
Slovenian: V skladu s kliničnimi smernicami je treba ob izhodišču napraviti krvno sliko in jo med zdravljenjem redno spremljati.
English: Your doctor will take a blood test to monitor your liver function during treatment.
Slovenian: Zdravnik vam bo med zdravljenjem opravil krvno preiskavo za spremljanje delovanja jeter.
English: The intraperitoneal LD50 in mice was found to be approximately 315 mg/kg.
Slovenian: Ugotovljeno je bilo, da je intraperitonealna LD50 pri miših približno
English: Read all of this leaflet carefully before you are given the medicine combined with EndolucinBeta because it contains important information for you.
Slovenian: EndolucinBeta, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Taking into account the PRAC Assessment Report on the PSUR(s) for Lutetium (177Lu) chloride, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za lutecijev (177Lu) klorid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: The use of a medicine radiolabelled with EndolucinBeta does involve exposure to radioactivity.
Slovenian: Pri uporabi zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, je prisotna izpostavljenost radioaktivnosti.
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
Slovenian: Pogosti: refraktarna citopenija z displazijo več celičnih linij (mielodisplastični sindrom) (glejte poglavje 4.4) Občasni: akutna mieloična levkemija (glejte poglavje 4.4)
English: Muscle
Slovenian: Mišice
English: EXP:{DD/MM/YYYY, hh:00 CET}
Slovenian: EXP:{DD/MM/LLLL, uu:00 CET}
English: EXP: {DD/MM/YYYY, hh:00 CET}
Slovenian: EXP: {DD/MM/LLLL, uu:00 CET}
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Slovenian: Radiofarmaki bodo shranjeni v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: - If you get any side effects, talk to your nuclear medicine doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine.
English: Urinary Bladder Wall Uterus
Slovenian: Ščitnica Stena sečnega mehurja
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Therefore, Lutetium metal-ion toxicity of EndolucinBeta (177Lu)-labelled medicinal products can be excluded.
Slovenian: Zato je mogoče toksičnost kovinskih ionov lutecija pri zdravilih, označenih z radionuklidnim predhodnikom EndolucinBeta (177Lu), izključiti.
English: EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution
Slovenian: EndolucinBeta 40 GBq/ml radionuklidni predhodnik, raztopina
English: After the medicine radiolablelled with EndolucinBeta is administered, it will deliver certain amounts of ionising radiation (radioactivity) which can induce a certain risk of cancer and development of hereditary defects.
Slovenian: boste prejeli določene količine ionizirajočega sevanja (radioaktivnosti), ki prinaša določeno tveganje za raka in razvoj dednih okvar.
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).
Slovenian: 1 ml sterilne raztopine vsebuje 40 GBq lutecijevega (177Lu) klorida v referenčnem času aktivnosti (kar ustreza 10 mikrogramom lutecija (177Lu) v obliki lutecijevega (177Lu) klorida).
English: Hydrochloric acid solution
Slovenian: Raztopina klorovodikove kisline
English: What EndolucinBeta is and what it is used for
Slovenian: Kaj je radionuklidni predhodnik EndolucinBeta in za kaj ga uporabljamo
English: Storage should be in accordance with local regulations for radioactive substances.
Slovenian: Shranjujte v skladu z lokalnimi predpisi o radioaktivnih snoveh.
English: Table 1: Lutetium (177Lu) principle radiation emission data
Slovenian: Preglednica 1: Podatki o glavnih emisijah sevanja lutecija (177Lu)
English: These carrier medicines have been specially developed for use with Lutetium (177Lu) chloride and may be substances that have been designed to recognise a particular type of cell in the body.
Slovenian: Ta nosilna zdravila so bila posebej razvita za uporabo z lutecijevim (177Lu) kloridom in so lahko snovi,
English: Blood and lymphatic system disorders: very common: Anaemia, thrombocytopenia, leukopenia and lymphopenia Endocrine disorders: not known: Carcinoid crisis
Slovenian: Zelo pogosti: anemija, trombocitopenija, levkopenija in limfopenija
English: - The active substance is Lutetium (177Lu) chloride.
Slovenian: - Zdravilna učinkovina je lutecijev (177Lu) klorid.
English: Each 2 mL vial contains an activity ranging from 3 - 80 GBq, corresponding to 0.73 - 19 micrograms of Lutetium (177Lu), at ART.
Slovenian: V eni 2-mililitrski viali je aktivnost v razponu od 3 do 80 GBq, kar ustreza 0,73-19 mikrogramom lutecija (177Lu) v času ART. Prostornina znaša 0,075-2 ml.
English: Effects on ability to drive and to use machines following treatment by Lutetium (177Lu)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Vplivi na sposobnost vožnje in upravljanja strojev po zdravljenju z zdravili, označenimi z lutecijem (177Lu), bodo podrobno navedeni v povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki bo radioaktivno označeno.
English: If you get any side effects, talk to your nuclear medicine doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom nuklearne medicine.
English: What EndolucinBeta is and what it is used for What you need to know before the medicine radiolabelled with EndolucinBeta is used How the medicine radiolabelled with EndolucinBeta is used Possible side effects
Slovenian: Kaj je radionuklidni predhodnik EndolucinBeta in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo, radioaktivno označeno z radionuklidnim predhodnikom EndolucinBeta
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with EndolucinBeta.
Slovenian: Zdravnik nuklearne medicine vas bo obvestil, ali morate po prejemu zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, upoštevati kakršne koli posebne previdnostne ukrepe.
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)
Slovenian: (mSv/MBq) po nenamernem intravenskem dajanju 177LuCl3 za različne starostne skupine ljudi, glede na podatke, zbrane pri podganah (n = 24)
English: Radiation nephropathy has been reported following peptide receptor radionuclide therapy for neuroendocrine tumours using other radioisotopes.
Slovenian: Po radionuklidni terapiji za nevroendokrine tumorje s peptidnimi receptorji so pri uporabi drugih radioaktivnih izotopov poročali o radiacijski nefropatiji.
English: Five cases of tumour lysis syndrome (TLS) were identified in the scientific literature in association with Lu-177 based radioligand therapy (RLT).
Slovenian: V znanstveni literaturi so v povezavi z radioligandno terapijo (RLT) z Lu-177 poročali o petih primerih sindroma tumorske lize (TLS).
English: EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution Lutetium (177Lu) chloride
Slovenian: EndolucinBeta 40 GBq/ml radionuklidni predhodnik, raztopina lutecijev (177Lu) klorid
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.
Slovenian: Lutecij (177Lu) oddaja tudi nizkoenergijske žarke γ, ki omogočajo scintigrafske, biodistribucijske in dozimetrične študije z istimi zdravili, označenimi z lutecijem (177Lu).
English: - The other ingredient is hydrochloric acid solution.
Slovenian: - Druga sestavina radionuklidnega predhodnika je raztopina klorovodikove kisline.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(-I) UPORABE ZDRAVILA
English: Gastrointestinal disorders: very common: Nausea, vomiting
Slovenian: Zelo pogosti: navzea, bruhanje
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Za več informacij glejte navodilo za uporabo zdravila, ki bo radioaktivno označeno.
English: Excipient: Hydrochloric acid solution
Slovenian: Pomožna snov: raztopina klorovodikove kisline
English: Small Intestine Stomach Wall ULI Wall
Slovenian: Stena žolčnega mehurja Stena spodnjega dela debelega črevesa Tanko črevo Želodčna stena
English: EndolucinBeta must be used only in combination with another medicine (carrier medicine) which has been specifically developed and authorised for being combined with Lutetium (177Lu) chloride.
Slovenian: Dajanje zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, in izvedba postopka EndolucinBeta se lahko uporablja le skupaj z drugim zdravilom (nosilnim zdravilom), ki je bilo posebej razvito in odobreno za kombiniranje z lutecijevim (177Lu) kloridom.
English: EndolucinBeta must not be used after the expiry date and time which is stated on the label after EXP. EndolucinBeta will be stored in the original package that provides protection from radiation.
Slovenian: Radionuklidnega predhodnika EndolucinBeta ne smete uporabljati po datumu in času izteka roka uporabnosti, ki sta navedena na nalepki poleg oznake EXP.
English: Gamma 208.3662 * mean energies are listed for beta particles Lutetium (177Lu) decays by emission of beta radiation to stable Hafnium (177Hf).
Slovenian: Lutecij (177Lu) z emisijo sevanja beta razpade na stabilni hafnij (177Hf).
English: What EndolucinBeta looks like and contents of the pack
Slovenian: Izgled radionuklidnega predhodnika EndolucinBeta in vsebina pakiranja
English: If you are breast-feeding
Slovenian: Če ste noseči
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.
Slovenian: Po prihodu zdravila na trg in v literaturi, pri bolnikih z metastazami jeter, ki prejemajo radionuklidno terapijo s peptidnimi receptorji (PRRT) za lutecij (177Lu) za zdravljenje nevroendokrinih tumorjev, so poročali o primerih hepatotoksičnosti.
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.
Slovenian: Lutecij (177Lu) lahko včasih vpliva na vaše krvne celice,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL (2 mL, 10 mL)
Slovenian: OVOJNINAH VIALA (2 ml, 10 ml)
English: VOLUME:
Slovenian: Številka serije:
English: For more information concerning paediatric use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Za več informacij v zvezi s pediatrično uporabo zdravil, označenih z lutecijem (177Lu), glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo zdravila, ki bo radioaktivno označeno.
English: Radiopharmaceutical precursor, solution.
Slovenian: Radionuklidni predhodnik, raztopina
English: The volume is 0.075 - 2 mL.
Slovenian: in 1016 cm−2 s−1.
English: How the medicine radiolabelled with EndolucinBeta is used
Slovenian: Kako se uporablja zdravilo, radioaktivno označeno z radionuklidnim predhodnikom EndolucinBeta
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo posameznega zdravila, ki bo radioaktivno označeno.
English: Red Marrow Osteogenic Cells Skin
Slovenian: Osteogene celice 2,1500 Koža
English: What EndolucinBeta contains
Slovenian: EndolucinBeta, kot bi smeli
English: It is recommended to add a binding agent such as DTPA prior to intravenous administration of Lutetium (177Lu)-labelled conjugates in order to form a complex with free Lutetium (177Lu), if present, leading to a rapid renal clearance of Lutetium (177Lu).
Slovenian: DTPA, z namenom tvorjenja kompleksa s prostim lutecijem (177Lu), če je ta prisoten, saj tako povzročimo hitro izločanje lutecija (177Lu) prek ledvic.
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
Slovenian: O raku kostnega mozga (mielodisplastičnem sindromu in akutni mieloični levkemiji) so pri bolnikih poročali več let po radionuklidni terapiji z lutecijem (177Lu) s peptidnimi receptorji za nevroendokrine tumorje.
English: Lungs
Slovenian: Pljuča
English: EndolucinBeta is not intended for direct use in patients.
Slovenian: Radionuklidni predhodnik EndolucinBeta ni namenjen za neposredno uporabo pri bolnikih.
English: Gamma 112.9498
Slovenian: Nadledvične žleze 0,2130
English: Ovaries
Slovenian: Vranica
English: Each 10 mL vial contains an activity ranging from 8 - 150 GBq, corresponding to 1.936 micrograms of Lutetium (177Lu), at ART.
Slovenian: V eni 10-mililitrski viali je aktivnost v razponu od 8 do 150 GBq, kar ustreza 1,9-36 mikrogramom lutecija (177Lu) v času ART. Prostornina znaša 0,2-3,75 ml. Teoretična specifična aktivnost je 4.110 GBq/mg lutecija (177Lu).
English: Dry mouth has been reported among patients with prostate cancer receiving treatment with Lutetium (177Lu) and has been temporary.
Slovenian: Pri bolnikih z rakom prostate, ki so bili zdravljeni z lutecijem (177Lu), so poročali o začasnem pojavu suhih ust.
English: There have been reports of extravasation of Lutetium (177Lu) labelled ligands in the post-marketing setting.
Slovenian: V obdobju trženja zdravila so poročali o ekstravazaciji ligandov, označenih z lutecijem (177Lu).
English: Thymus
Slovenian: Gama
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING METALLIC CAN AND OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI KOVINSKA POSODA IN ZUNANJA ŠKATLA
English: Specific activity: …GBq/mg at ART
Slovenian: PROSTORNINA: … ml AKTIVNOST: … GBq/vialo
English: After administration of the medicine radiolabelled with EndolucinBeta, you should
Slovenian: Po prejemu zdravila, radioaktivno označenega z radionuklidnim predhodnikom EndolucinBeta, morate narediti naslednje.
English: Please refer to the package leaflet of the medicine that is to be radiolabelled with EndolucinBeta.
Slovenian: Preberite navodilo za uporabo zdravila, ki bo radioaktivno označeno z radionuklidnim predhodnikom EndolucinBeta.
English: Myelosuppression
Slovenian: Mielosupresija
English: 1 mL of solution contains 40 GBq of Lutetium (177Lu) chloride at activity reference time (ART).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml raztopine vsebuje 40 GBq lutecijevega (177Lu) klorida v referenčnem času aktivnosti (ART
English: Gallbladder Wall LLI Wall
Slovenian: Stena zgornjega dela debelega črevesa Srčna stena
English: What you need to know before the medicine radiolabelled with EndolucinBeta is used The medicine radiolabelled with EndolucinBeta must not be used
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo, radioaktivno označeno z radionuklidnim predhodnikom EndolucinBeta
English: Tumour lysis syndrome has been reported following Lutetium (177Lu) radioligand therapy.
Slovenian: Po radioligandni terapiji z lutecijem (177Lu) so poročali o sindromu tumorske lize.
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.
Slovenian: Bolezni kože in podkožja: Pri bolnikih, ki so prejemali radionuklidno terapijo z lutecijem (177Lu) s peptidnimi receptorji za nevroendokrine tumorje so opazili alopecijo, ki so jo opisovali kot blago in začasno.
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.
Slovenian: Na osnovi 3 poročanih primerov v bazi EudraVigilance je spodnja meja 95-% intervala zaupanja razmerja obetov poročanja (reporting odds ratio - ROR) za sindrom tumorske lize v povezavi z Lu
English: OTHER
Slovenian: Priželjc
English: Limits for radiochemical impurities should be set recognising the radiotoxicological potential of Lutetium (177Lu).
Slovenian: upoštevanjem možne radiotoksičnosti lutecija (177Lu) je treba postaviti meje za radiokemijske nečistote.
English: B. PACKAGE LEAFLET
Slovenian: PRILOGA II
English: The pharmacokinetic properties of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with EndolucinBeta, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: Farmakokinetične lastnosti z lutecijem (177Lu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radionuklidnim predhodnikom EndolucinBeta pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označeno.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Slovenian: Zato je treba upoštevati nacionalne predpise glede previdnostnih ukrepov za zaščito pred ionizirajočimi sevanji.
English: EndolucinBeta should not be administered directly to the patient.
Slovenian: Radionuklidni predhodnik EndolucinBeta se ne sme dajati neposredno bolniku.