FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall median PFS and OS for the FAS Dutch population with GEP and bronchial NETs (360 patients) as well as per tumour type are presented in Table 11.
Croatian: Ukupni medijan za PFS i OS za FAS nizozemsku populaciju s GEP i bronhijalnim NET-ovima (360 bolesnika), kao i po vrsti tumora, prikazani su u Tablici 11.
English: Absorbed dose estimates for lutetium (177Lu) oxodotreotide from NETTER-1 phase III study (Olinda output)
Croatian: Tablica 12. Procjene apsorbirane doze za lutecijev (177Lu) oksodotreotid iz ispitivanja faze III NETTER-1 (rezultat Olinda)
English: - The other ingredients are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, diethylene triamine pentaacetic acid (DTPA), sodium chloride 9 mg/mL (0.9%) solution for injection, water for injections (see section 2 “Lutathera contains sodium”).
Croatian: Drugi sastojci su: acetatna kiselina, natrijev acetat, gentizatna kiselina, askorbatna kiselina, dietilen triamin pentaoctena kiselina (DTPA), otopina natrijevog klorida 9 mg/mL (0,9 %) za injekciju, voda za injekcije (vidjeti dio 2. „Lutathera sadržava natrij”).
English: Thrombocytopenia of grade 2 or superior (CTCAE)**.
Croatian: Trombocitopenija stupnja 2. ili višeg stupnja (CTCAE) ** .
English: See Table 5.
Croatian: Vidjeti Tablicu 5.
English: Myelodisplastic syndrome and acute leukaemia
Croatian: Mijelodisplastični sindrom i akutna leukemija
English: The patient should also be encouraged to defecate every day and to use laxative if needed.
Croatian: Bolesnika je potrebno poticati na svakodnevno pražnjenje crijeva i uporabu laksativa ako je to potrebno.
English: This can lead to the decrease of the different types of blood cells, most importantly, red blood cells (responsible for transporting the oxygen from the lungs to the different organs), platelets (a special cell which helps the blood to clot), and other blood cells such as white blood cells (helps to fight infection).
Croatian: (odgovornih za transport kisika iz pluća u različite organe), trombocita (posebna vrsta stanica koja pomaže kod zgrušavanja krvi) i drugih krvnih stanica kao što su bijele krvne stanice (pomažu u borbi protiv infekcije).
English: Cryopreservation of sperm or eggs can be discussed as an option to patients before the treatment.
Croatian: Prije liječenja se može raspraviti o zamrzavanju sperme ili jajnih stanica kao mogućnosti za bolesnike.
English: To continue Lutathera infusion, it is mandatory to use a new catheter possibly placing it in a contralateral venous access.
Croatian: Za nastavak infuzije lijeka Lutathera, obavezno se mora upotrijebiti novi kateter koji se po mogućnosti postavlja na mjesto kontralateralnog venskog pristupa.
English: 9 Includes Blood bilirubin increased and Hyperbilirubinaemia
Croatian: Uključuje povišeni bilirubin u krvi i hiperbilirubinemiju
English: Therefore, administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of this medicinal product.
Croatian: Stoga je primjenu somatostatinskih analoga s dugotrajnim djelovanjem potrebno izbjegavati unutar 30 dana prije primjene ovog lijeka.
English: Gravity infusion method - tubing connection scheme
Croatian: Slika 2. Gravitacijska metoda infuzije - shema povezivanja cijevi
English: The following table summarises the required procedures during a treatment course with Lutathera using the gravity method:
Croatian: Sljedeća tablica navodi potrebne postupke tijekom liječenja lijekom Lutathera primjenom gravitacijske metode:
English: The median PFS for Lutathera was 28.4 months whereas the one of octreotide LAR was 8.5 months.
Croatian: Medijan PFS-a za lijek Lutathera iznosio je 28,4 mjeseci, dok je za oktreotid LAR iznosio 8,5 mjeseci.
English: Lutathera infusion should start 30 minutes after the beginning of the amino acid solution infusion, with the infusion rate of approximately 400 mL/h (this infusion rate is the reference rate and can be adapted depending on the patient's venous status).
Croatian: Infuziju lijeka Lutathera potrebno je započeti 30 minuta nakon početka infuzije otopine aminokiselina, s brzinom infuzije od približno 400 mL/h (ova brzina infuzije je referentna brzina i može se prilagoditi ovisno o statusu vena bolesnika).
English: Organ uptake At 4 hours after administration, the distribution pattern of lutetium (177Lu) oxodotreotide shows a rapid uptake in kidneys, tumour lesions, liver and spleen, and in some patients in the pituitary gland and in the thyroid.
Croatian: Četiri sata nakon primjene, uzorak raspodjele lutecijeva (177Lu) oksodotreotida pokazuje brzi unos u bubrege, tumorske lezije, jetru i slezenu te kod nekih bolesnika u hipofizu i štitnjaču.
English: During the administration only disposable materials should be used.
Croatian: Tijekom primjene potrebno je koristiti samo materijal za jednokratnu upotrebu.
English: • Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Croatian: • Preosjetljivost na djelatnu tvar ili ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Potvrđena ili suspektna trudnoća ili kada trudnoća nije isključena (vidjeti dio 4.6).
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.
Croatian: (177Hf), pri čemu najviše β- čestica (79,3%) ima maksimalnu energiju 0,497 MeV.
English: Lutathera must not be used after the expiry date which is stated on the label after EXP. Store below 25 ºC.
Croatian: Lutathera se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na označavanju iza „Rok valjanosti“.
English: The level of solution in the vial should remain constant during the entire infusion.
Croatian: Razina otopine u bočici trebala bi ostati stalna tijekom cijele infuzije.
English: However, it is recommended that when conducting standard care or exams with medical devices or other instruments which contact the skin (e.g. electrocardiogram (ECG)), basic protection measures should be observed such as wearing gloves, installing the material/electrode before the start of radiopharmaceutical infusion, changing the material/electrode after measurement, and eventually monitoring the radioactivity of equipment after use.
Croatian: obrati pozornost na osnovne mjere zaštite poput nošenja rukavica, postavljanja materijala/elektrode prije početka infuzije radiofarmaceutika, mijenjanje materijala/elektrode nakon mjerenja i na kraju praćenje radioaktivnosti opreme nakon uporabe.
English: Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.
Croatian: Prozirna, bezbojna, staklena bočica tipa I, zatvorena čepom od bromobutilne gume i aluminijskim zatvaračem.
English: 25 g Sodium chloride 9 mg/mL (0.9%) solution for injection 1 L Alternatively, some commercially available amino acid solutions can be used if compliant with the specification described in Table 2.
Croatian: 25 g Otopina natrijeva klorida 9 mg/mL (0,9 %) za injekciju 1 L Umjesto toga mogu se upotrijebiti neke komercijalno dostupne otopine aminokiselina ako su u skladu sa specifikacijom opisanom u Tablici 2. Tablica 2. Specifikacija komercijalno dostupnih otopina aminokiselina Karakteristika
English: Atrial fibrillation Palpitations Myocardial infarction Angina pectoris Cardiogenic shock
Croatian: Fibrilacija atrija Palpitacije Infarkt miokarda Angina pektoris Kardiogeni šok
English: • The long needle should be connected to the pre-filled tubing line and then inserted into the Lutathera vial, so that it touches the bottom of the vial.
Croatian: • Dugu iglu potrebno je spojiti na prethodno napunjenu cijev, a zatim umetnuti u bočicu s lijekom Lutathera tako da dotakne dno bočice.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Croatian: Potrebno je pažljivo procijeniti količinu aktivnosti koju se namjerava primijeniti jer je moguća povećana izloženost zračenju kod tih bolesnika.
English: This medicine contains 0.14 mmol (3.2 mg) of sodium per mL.
Croatian: Ovaj lijek sadržava 0,14 mmol (3,2 mg) natrija po mL.
English: • Bone metastasis;
Croatian: • Koštane metastaze;
English: If necessary, patients may be treated with short acting somatostatin analogues during the 4 weeks until 24 hours preceding Lutathera administration.
Croatian: Ako je potrebno, bolesnike je moguće liječiti somatostatinskim analozima kratkog djelovanja tijekom 4 tjedna do 24 sata prije primjene lijeka Lutathera.
English: OS Time (months)
Croatian: OS Vrijeme (mjeseci)
English: Transchelation of lutetium from lutetium (175Lu) oxodotreotide into serum proteins has not been observed.
Croatian: Nije zabilježeno transkeliranje lutecija iz lutecijeva (175Lu) oksodotreotida u serumske proteine.
English: Mechanism of action Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (sst2).
Croatian: Lutecijev (177Lu) oksodotreotid ima visok afinitet za somatostatinske receptore podtipa 2 (sst2).
English: Best response, ORR and DoR observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NETs - (FAS, N=360)
Croatian: Najbolji odgovor, ORR i DoR zabilježeni u ispitivanju faze I/II Erasmus u nizozemskih bolesnika s GEP i bronhijalnim NET-ovima - (FAS, N=360)
English: • Medicinal products to be administered:
Croatian: • Lijekovi za primjenu:
English: For renal protection purpose, an amino acid solution must be administered intravenously during 4 hours.
Croatian: U svrhu zaštite bubrega mora se primijeniti otopinu aminokiselina intravenski tijekom 4 sata.
English: The volume of sodium chloride 9 mg/mL (0.9%) solution for injection necessary to complete the infusion may vary.
Croatian: Volumen otopine natrijevog klorida 9 mg/mL (0,9 %) za injekciju koji je potreban za dovršetak infuzije može varirati.
English: For instructions on the medicinal product before administration, see section 12.
Croatian: Za upute o lijeku prije primjene vidjeti dio 12.
English: Lutathera administration should be initiated by opening first the tubing line connected to the patient's peripheral vein, and then, by opening the infusion set connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Primjena lijeka Lutathera započinje prvo otvaranjem cijevi povezane s bolesnikovom perifernom venom, a zatim otvaranjem kompleta za infuziju koji je spojen na vrećicu s otopinom natrijeva klorida 9 mg/mL (0,9 %) za injekciju.
English: In spite of an observed significant selective B-cell depletion, no increase in the rate of infectious complications occurs after PRRT.
Croatian: Unatoč zabilježenom značajnom selektivnom smanjenju broja B-stanica, nakon radionuklidne terapije usmjerene na peptidne receptore (PRRT, engl. peptide receptor radionuclide therapy) ne dolazi do povećanje stopa komplikacija povezanih s infekcijama.
English: Lutathera is for intravenous use.
Croatian: Lutathera je namijenjena za intravensku primjenu.
English: Blood creatinine increased GGT* increased ALAT** increased ASAT*** increased Blood ALP**** increased
Croatian: Povišen kreatinin u krvi Povišen GGT* Povišen ALT** Povišen AST*** Povišen ALP**** u krvi
English: The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow.
Croatian: Najčešća nuspojava kod bolesnika koji su liječeni lijekom Lutathera je utjecaj na koštanu srž.
English: Hypersensitivity to the active substance or to any of the excipients of this medicinal product When specific adverse reactions to this medicinal product persist or reoccur, such as delayed grade 3-4 (G3-G4) hematotoxicity (see Table 5).
Croatian: Kada su specifične nuspojave na ovaj lijek ustrajne ili se ponovno javljaju, kao što je npr. odgođena hematotoksičnost stupnja 3-4 (G3-G4) (vidjeti Tablicu 5).
English: Amount
Croatian: Količina
English: Lutathera should always be infused through an intravenous catheter placed exclusively for its infusion.
Croatian: Lijek Lutathera primjenjuje se uvijek putem intravenskog katetera postavljenog isključivo za njegovu infuziju.
English: Anxiety Hallucination Disorientation
Croatian: Anksioznost Halucinacije
English: Lu) oxodotreotide) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity.
Croatian: Neklinički podaci o „hladnom“ spoju (neradioaktivni lutecijev (175Lu) oksodotreotid) ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti.
English: Patients with brain metastases
Croatian: Bolesnici s metastazama na mozgu
English: Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion.
Croatian: Lutathera se mora davati sporom intravenskom infuzijom tijekom približno 30 minuta, istodobno s otopinom aminokiselina koja se primjenjuje putem kontralateralne intravenske infuzije.
English: What Lutathera looks like and contents of the pack Lutathera is a clear and colourless solution for infusion, supplied in a colourless glass vial closed with a rubber stopper and sealed with an aluminium capsule.
Croatian: Lutathera je bistra i bezbojna otopina za infuziju, isporučena u bezbojnoj staklenoj bočici koja je zatvorena gumenim čepom i zapečaćena aluminijskom kapicom.
English: Frequency of adverse reactions reported from clinical trials and from post-marketing surveillance
Croatian: Učestalost nuspojava koje su prijavljene u kliničkim ispitivanjima i tijekom praćenja nakon stavljanja lijeka u promet
English: Instructions for dose modifications Adjust Lutathera dosing for the following severe adverse reactions: Severe adverse reactions
Croatian: Prilagodite doziranje lijeka Lutathera pri sljedećim teškim nuspojavama: Teške nuspojave
English: Lysine content
Croatian: Sadržaj lizina
English: Any haematological toxicity of grade 3 or superior (CTCAE)**, except lymphopenia.
Croatian: Svaka hematološka toksičnost stupnja 3 ili višeg stupnja (CTCAE)**, osim limfopenije.
English: Hormonal crises related to bioactive substances release (probably due to lysis of the neuroendocrine tumour cells) have rarely been observed and resolved after appropriate medical treatment (section 4.4).
Croatian: Hormonske krize Rijetko su zabilježene hormonske krize povezane s otpuštanjem bioaktivnih tvari (vjerojatno zbog lize neuroendokrinih tumorskih stanica) i one se rješavaju odgovarajućim medicinskim liječenjem (vidjeti dio 4.4).
English: Renal protection and renal impairment Because lutetium (177Lu) oxodotreotide is almost exclusively eliminated through the renal system, it is mandatory to concomitantly administer an amino acid solution containing the amino acids L-lysine and L-arginine.
Croatian: Budući da se lutecijev (177Lu) oksodotreotid gotovo isključivo eliminira kroz bubrežni sustav, obvezno je istodobno primjenjivati otopinu aminokiselina koja sadržava aminokiseline L-lizin i L-arginin.
English: What you need to know before Lutathera is used 3.
Croatian: Što morate znati prije primjene lijeka Lutathera
English: During the infusion, the flow of sodium chloride 9 mg/mL (0.9%) solution for injection increases the pressure in the Lutathera vial, facilitating the flow of Lutathera into the catheter inserted in the patient's peripheral vein.
Croatian: Tijekom infuzije protok otopine natrijevog klorida 9 mg/mL (0,9 %) za injekciju povećava tlak u bočici s lijekom Lutathera, što olakšava dotok lijeka Lutathera u kateter koji je umetnut u perifernu venu bolesnika.
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Croatian: U slučaju bilo kakve sumnje, važno je savjetovati se s liječnikom specijalistom nuklearne medicine koji će nadgledati postupak.
English: Patients should be encouraged to empty their bladder as frequently as possible during the administration of amino acids and the hours after administration.
Croatian: Bolesnike je potrebno poticati da isprazne mjehur što je češće moguće tijekom primjene aminokiselina i tijekom prvih nekoliko sati nakon primjene.
English: It is also recommended to perform these tests every 4 weeks for at least 3 months after the last infusion of Lutathera and every 6 months thereof, in order to be able to detect possible delayed adverse reactions (see section 4.8).
Croatian: 3 mjeseca nakon posljednje infuzije Lutathere i zatim nakon svakih 6 mjeseci kako bi se mogle otkriti moguće zakašnjele nuspojave (vidjeti dio 4.8.).
English: No animal studies have been performed to determine the effects of lutetium (177Lu) oxodotreotide on the fertility of either gender.
Croatian: Nisu provedena nikakva ispitivanja na životinjama radi utvrđivanja učinaka lutecijeva (177Lu) oksodotreotida na plodnost bilo kojeg spola.
English: Depending on the case, aspiration of extravasation fluid, sodium chloride 9 mg/mL (0.9%) solution for injection flush injection, or applying warm compresses or a heating pad to the infusion site to accelerate vasodilation should be considered.
Croatian: Ovisno o slučaju, potrebno je razmotriti aspiraciju ekstravazirane tekućine, ispiranje s injekcijom otopine natrijevog klorida 9 mg/mL (0,9 %) za injekcije ili primjenu toplog obloga ili grijaćeg obloga na mjesto infuzije radi ubrzanja vazodilatacije.
English: Precautions with respect to environmental hazard see section 6.6.
Croatian: Za mjere opreza s obzirom na opasnosti za okoliš vidjeti dio 6.6.
English: Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC}
Croatian: Volumetrijska aktivnost u vrijeme kalibracije: 370 MBq/mL - {DD/MM/GGGG hh:mm UTC}
English: Urinary incontinence Glomerular filtration rate decreased Renal disorder
Croatian: Urinarna inkontinencija Smanjena brzina glomerularne filtracije
English: Lutathera contains sodium
Croatian: Lutathera sadržava natrij
English: The hazard ratio for Lutathera was 0.18 (95% CI: 0.11 - 0.29), indicating 82% reduction in the risk for a patient to progress or die under Lutathera compared to octreotide LAR.
Croatian: Omjer hazarda za lijek Lutathera iznosio je 0,18 (95 % CI: 0,11 - 0,29), što ukazuje na 82 %-tno smanjenje rizika da bolesnik doživi progresiju ili umre tijekom primjene lijeka Lutathera u usporedbi s oktreotidom LAR.
English: Lutathera with sodium chloride 9 mg/mL (0.9%) solution for injection
Croatian: Lutathera s otopinom natrijeva klorida 9 mg/mL (0,9%) za injekciju
English: Bone marrow toxicity (myelo-/hematotoxicity) manifested with reversible / transient reductions in blood counts affecting all lineages (cytopenias in all combinations, i.e., pancytopenia, bicytopenias, isolated monocytopenias - anemia, neutropenia, lymphocytopenia, and thrombocytopenia).
Croatian: Toksičnost za koštanu srž (mijelo-/hematoksičnost) očituje se s reverzibilnim/prolaznim smanjenjem broja krvnih stanica koje obuhvaća sve krvne loze (citopenije u svim kombinacijama, tj. pancitopenija, bicitopenija, izolirana monocitopenija - anemija, neutropenija, limfocitopenija i trombocitopenija).
English: To avoid treatment-related nausea and vomiting, an intravenous bolus of an antiemetic medicinal product should be injected 30 minutes before the start of amino acid solution infusion (see section
Croatian: Kako bi se izbjegli mučnina i povraćanje povezani s liječenjem, potrebno je primijeniti intravenski bolus antiemetičkog lijeka 30 minuta prije početka infuzije otopine aminokiselina (vidjeti dio 4.2).
English: If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.
Croatian: Ako je potrebno liječenje lijekom Lutathera tijekom dojenja, dijete se mora prestati dojiti.
English: Erasmus phase I/II study was a monocentric single arm open-label study to evaluate the efficacy of Lutathera (7,400 MBq administered for 4 times every 8 weeks) co-administered with amino acid solution in patients with somatostatin receptor positive tumours.
Croatian: Ispitivanje faze I/II Erasmus bilo je monocentrično, otvoreno ispitivanje s jednom skupinom bolesnika kako bi se procijenila djelotvornost lijeka Lutathera (7400 MBq primijenjena 4 puta svakih 8 tjedana) istodobno primijenjenog uz otopinu aminokiselina u bolesnika s tumorima pozitivnim na somatostatinske receptore.
English: • Mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min;
Croatian: • Blaga do umjerena kronična bolest bubrega s klirensom kreatinina ≥ 50 mL/min;
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
Croatian: Od zdravstvenih radnika traži se da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: During the infusion, the radioactivity emission from the patient's thorax should steadily increase while the one from the Lutathera vial should decrease.
Croatian: Tijekom infuzije emisija radioaktivnosti iz bolesnikovog prsnog koša trebala bi se jednolično povećavati, dok bi se ona iz bočice s lijekom Lutathera trebala smanjivati.
English: 11 Includes injection site reaction, injection site hypersensibility, injection site induration, injection site swelling * Gamma-glutamyltransferase increased **Alanine amino transferase *** Aspartate amino transferase **** Alkaline phosphatase
Croatian: oticanje mjesta injekcije * Povišena gama-glutamiltransferaza ** Alanin aminotransferaza *** Aspartat aminotransferaza **** Alkalna fosfataza
English: The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each.
Croatian: Preporučeni režim liječenja Lutatherom u odraslih sastoji se od 4 infuzije, gdje je aktivnost svake
English: The hazard ratio for Lutathera was 0.21 (95% CI: 0.14 - 0.33), indicating 79% reduction in the risk for a patient to progress or die under Lutathera compared to octreotide LAR.
Croatian: Omjer hazarda za lijek Lutathera iznosio je 0,21 (95 % CI: 0,14 - 0,33), što ukazuje na 79 %-tno smanjenje rizika da bolesnik doživi progresiju ili umre tijekom primjene lijeka Lutathera u usporedbi s oktreotidom LAR.
English: The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 24 July 2015 is depicted in Figure 3.
Croatian: Kaplan-Meier grafikon za PFS za potpuni skup podataka za analizu (FAS, engl. full analysis set) na datum prestanka prikupljanja podataka 24. srpnja 2015. prikazan je na Slici 3.
English: To ensure complete administration, the Lutathera vial should be kept under even pressure.
Croatian: Kako bi se osigurala potpuna primjena, bočicu s lijekom Lutathera potrebno je držati pod stalnim tlakom.
English: • Renal or urinary tract morphological abnormalities;
Croatian: • Morfološke abnormalnosti bubrega ili mokraćnog sustava;
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (može se javiti u do 1 na 100 osoba)
English: At the cut-off date for post-hoc statistical analysis (30 June 2016), the number of centrally confirmed disease progressions or deaths was 30 events in the Lutathera arm and 78 events in the octreotide LAR arm (Table 9).
Croatian: Na datum prestanka prikupljanja podataka za post-hoc statističku analizu (30. lipnja 2016) broj centralno potvrđenih progresija bolesti ili smrti bio je 30 događaja u skupini s lijekom Lutathera te 78
English: The co-administration of amino acid solution decreases the kidney uptake, enhancing the elimination of radioactivity (see section 4.4).
Croatian: Istodobna primjena otopine aminokiselina smanjuje unos u bubrege, što ubrzava eliminaciju radioaktivnosti (vidjeti dio 4.4).
English: Composition of the standard amino acid solution
Croatian: Sastav standardne otopine aminokiselina
English: − One bag of sodium chloride 9 mg/mL (0.9%) solution for injection (500 mL)
Croatian: − Jedna vrećica otopine natrijeva klorida 9 mg/mL (0,9%) za injekciju (500 mL)
English: The vial is enclosed within a plastic sealed, lead shielded container.
Croatian: Bočica je zatvorena unutar plastikom zatvorenog, zaštitnog olovnog spremnika.
English: Lutathera vial tubing connections procedure (see Figure 2):
Croatian: Postupak spajanja bočice lijeka Lutathera na cijev (vidjeti Sliku 2):