FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hematologic monitoring: white blood cells, platelets, and haemoglobin
Croatian: • Hematološke kontrole: leukociti, trombociti i hemoglobin
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku specijalistu nuklearne medicine koji će nadgledati postupak.
English: The patient should be encouraged to urinate as much as possible after Lutathera adminiastration.
Croatian: Bolesnika je potrebno poticati na što češće mokrenje nakon primjene lijeka Lutathera.
English: For instruction on preparation of the medicinal product before administration, see section 12.
Croatian: Za upute o pripremi lijeka prije primjene vidjeti dio 12.
English: Should you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure.
Croatian: Imate li kakvih dodatnih pitanja o primjeni ovog lijeka, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: OS median was 27.4 months in octreotide LAR arm and was not reached in Lutathera arm. An update conducted about one year after (30 June 2016) showed similar trend with 28 deaths in the Lutathera arm and 43 in octreotide LAR 60 mg arm, an HR of 0.536, and a median OS of 27.4 months in octreotide LAR arm and still not reached in Lutathera arm.
Croatian: Ažuriranje provedeno otprilike godinu dana poslije (30. lipnja 2016.) pokazalo je sličan trend s 28 smrti u skupini s lijekom Lutathera i 43 u skupini s oktreotidom LAR 60 mg, HR od 0,536 i medijan OS od 27,4 mjeseci u skupini s oktreotidom LAR i još uvijek nije postignut u skupini s lijekom Lutathera.
English: • The tubing line should be pre-filled with sodium chloride 9 mg/mL (0.9%) solution for injection and then connected with a venous catheter previously inserted to the patient's arm.
Croatian: • Cijev je potrebno prethodno napuniti otopinom natrijeva klorida 9 mg/mL (0,9 %) za injekciju i zatim spojiti na venski kateter koji je prethodno umetnut u bolesnikovu ruku.
English: Lutathera should be infused directly from its original container.
Croatian: Lijek Lutathera primjenjuje se infuzijom izravno iz originalnog spremnika.
English: For additional details about the treatment of patient with renal impairment see Table 5 in section 4.2 and section 4.4.
Croatian: Dodatne pojedinosti o liječenju bolesnika s oštećenjem funkcije bubrega potražite u Tablici 5 dijelu 4.2. i dijelu 4.4.
English: Dose-modifying toxicity (DMT) criteria
Croatian: Kriteriji toksičnosti koja modificira dozu
English: Factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors for MDS/AL.
Croatian: navode se dob > 70 godina, oštećenje funkcije bubrega, citopenija na početku terapije, prethodni broj terapija, prethodna izloženost kemoterapijskim sredstvima (posebno alkilirajućim sredstvima) i prethodna radioterapija.
English: Acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride 9 mg/mL injection, sodium hydroxide, water for injections.
Croatian: Acetatna kiselina, natrijev acetat, gentizatna kiselina, askorbatna kiselina, pentetatna kiselina, otopina natrijeva klorida 9 mg/mL za injekcije, natrijev hidroksid, voda za injekcije.
English: • Kidney failure with creatinine clearance < 50 mL/min;
Croatian: • Zatajenje bubrega s klirensom kreatinina < 50 mL/min;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LEAD SHIELDING CONTAINER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU ZAŠTITNI OLOVNI SPREMNIK
English: The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion.
Croatian: Lijek se primjenjuje infuzijom putem intravenskog katetera koji se postavlja u venu isključivo za tu infuziju.
English: Cryopreservation of sperm or eggs may be offered to you before the treatment.
Croatian: Prije liječenja može Vam se preporučiti zamrzavanje sperme ili jajnih stanica.
English: At the concentration used (about 10 μg/mL in total, for both free and radiolabeled forms), the peptide oxodotreotide does not exert any clinically relevant pharmacodynamic effect.
Croatian: Kod korištene koncentracije (ukupno oko 10 μg/mL, i za slobodni i za radioaktivno obilježeni oblik),
English: Formication
Croatian: Formikacija
English: Careful consideration of the activity to be administered to patients with hepatic impairment is required since an increased radiation exposure is possible in these patients.
Croatian: Potrebno je pažljivo procijeniti količinu aktivnosti koju se namjerava primijeniti bolesnicima s oštećenjem funkcije jetre jer je moguća povećana izloženost zračenju kod tih bolesnika.
English: For patient preparation, see section 4.4.
Croatian: Za upute o pripremi bolesnika vidjeti dio 4.4.
English: The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT) (see Table 5).
Croatian: 16 tjedana u slučaju toksičnosti koja modificira dozu (DMT) (vidi Tablicu 5).
English: Administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of Lutathera.
Croatian: Primjenu somatostatinskih analoga s dugotrajnim djelovanjem potrebno je izbjegavati unutar 30 dana prije primjene lijeka Lutathera.
English: Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide.
Croatian: Nisu provedena ispitivanja reproduktivne funkcije na životinjama s lutecijevim (177Lu)
English: An individual benefit-risk assessment is recommended prior to treatment with Lutathera in patients with mild and moderate renal impairment, for additional details see section 4.2 (Table 3) and section 4.4.
Croatian: Prije liječenja Lutatherom u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega preporučuje se individualna procjena omjera korist/rizik, za dodatne detalje vidjeti dio 4.2. (Tablica 3) i dio 4.4.
English: Administration procedure of antiemetic amino acid solution and Lutathera
Croatian: Tablica 6. Postupak primjene antiemetika, otopine aminokiselina i lijeka Lutathera
English: Pancreatic enzymes decreased Hepatocellular injury Cholestasis
Croatian: Snižena razina enzima gušterače Hepatocelularno oštećenje Kolestaza
English: What you need to know before Lutathera is used Lutathera must not be used - if you are allergic to lutetium (177
Croatian: Što morate znati prije primjene lijeka Lutathera Lutathera se ne smije primijeniti - ako ste alergični na lutecijev (177Lu) oksodotreotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste trudni
English: Acetic acid Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Water for injections
Croatian: Acetatna kiselina Natrijev acetat Gentizatna kiselina Askorbatna kiselina Pentetatna kiselina Natrijev klorid Natrijev hidroksid Voda za injekcije
English: If at any time in the preparation of this medicinal product the integrity of this container and vial is compromised it should not be used.
Croatian: Ako se u bilo koje vrijeme tijekom pripreme ovog lijeka spremnik ili bočica ošteti, lijek se ne smije koristiti.
English: Electrocardiogram QT prolonged
Croatian: Produžen QT interval na elektrokardiogramu
English: If at any time in the preparation of this medicinal product the integrity of this vial is compromised, it should not be used.
Croatian: Ako se u bilo koje vrijeme tijekom pripreme lijeka bočica ošteti, lijek se ne smije koristiti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lutathera in all subsets of the paediatric population in the treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Lutathera u svim podskupinama pedijatrijske populacije u liječenju GEP-NET-ova (ne uključujući neuroblastom,
English: Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC} Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Croatian: Volumetrijska aktivnost u vrijeme kalibracije: 370 MBq/mL - {DD/MM/GGGG hh:mm UTC} Aktivnost u vrijeme infuzije: {Z} MBq - {DD/MM/GGGG hh:mm UTC}
English: The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe renal impairment (creatinine clearance < 30 mL/min) has not been studied, therefore treatment with Lutathera in those patients is contraindicated (see section 4.3).
Croatian: oksodotreotida u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) nije ispitan, stoga je liječenje Lutatherom kod takvih bolesnika kontraindicirano (vidjeti dio 4.3).
English: Hypoglycaemia Hypernatremia Hypophosphatemia Tumor lysis syndrome Hypercalcaemia Hypocalcaemia Hypoalbuminaemia Metabolic acidosis
Croatian: Hipoglikemija Hipernatremija Hipofosfatemija Sindrom lize tumora Hiperkalcemija Hipokalcemija Hipoalbuminemija
English: Marketing Authorisation Holder Advanced Accelerator Applications 20 rue Diesel
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Advanced Accelerator Applications 20 rue Diesel
English: The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 30 June 2016 is depicted in Figure 4.
Croatian: Kaplan Meier grafikon za PFS za potpuni skup podataka za analizu (FAS) na datum prestanka prikupljanja podataka 30. lipnja 2016. prikazan je na Slici 4.
English: • Haematology (Haemoglobin [Hb], white blood count, platelet count)
Croatian: • Hematologija (hemoglobin [Hb], broj leukocita, broj trombocita)
English: PFS and OS observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NET - (FAS, N=360)
Croatian: Tablica 11. PFS i OS zabilježeni u ispitivanju faze I/II Erasmus u nizozemskih bolesnika s GEP i bronhijalnim NET-ovima - (FAS, N=360)
English: Amino acid solution should be administered over 4 hour time span.
Croatian: Otopina aminokiselina primjenjuje se tijekom razdoblja od 4 sata.
English: Scheme of instructions for dose modifications
Croatian: Tablica 5. Upute za prilagodbu doze
English: Additionally, due to the death and breakage of the malignant cells by the therapy, there is a possibility that you experience an excessive release of hormones from these cells increasing or triggering neuroendocrine tumour related symptoms such as diarrhoea, flushing and hot flushes, heartbeat disorder, shortness of breath, etc. Should you experience such symptoms: inform your doctor immediately, who may request that you stay at the hospital for observation and treatment if necessary.
Croatian: Pored toga, zbog smrti i raspadanja tumorskih stanica uslijed liječenja, postoji mogućnost da prekomjerno oslobađanje hormona iz ovih stanica pojača ili uzrokuje simptome povezane s neuroendokrinim tumorima kao što su proljev, naleti crvenila i valunzi, poremećaj srčanog ritma,
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Croatian: Postupci koji uključuju primjenu radionuklida provedeni na trudnicama uzrokuju i ozračivanje fetusa.
English: Pancreatitis acute Rectal haemorrhage Melaena
Croatian: Akutni pankreatitis Rektalno krvarenje Melena
English: Based on the data collected during the Erasmus phase I/II and NETTER-1 phase III studies, lutetium (177Lu) oxodotreotide is primarily eliminated by renal excretion: about 60% of the medicinal product is eliminated in the urine within 24 hours, and about 65% within 48 hours following the administration.
Croatian: lutecijev (177Lu) oksodotreotid se prvenstveno eliminira renalnim izlučivanjem: oko 60 % lijeka se eliminira mokraćom unutar 24 sata, i oko 65 % unutar 48 sati nakon primjene.
English: Weight decreased Blood creatine phosphokinase increased
Croatian: Smanjenje tjelesne težine Povišena kreatin fosfokinaza u krvi Povišena laktat dehidrogenaza u krvi
English: Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Croatian: Volumen: {Y} mL Aktivnost u vrijeme infuzije: {Z} MBq - {DD/MM/GGGG hh:mm UTC}
English: Requirements
Croatian: Zahtjevi
English: Given the mechanism of action and the tolerance profile of Lutathera (see section 4.8), it is not recommended to start treatment in the following cases:
Croatian: S obzirom na mehanizam djelovanja i profil podnošenja lijeka Lutathera (vidjeti dio 4.8.), ne preporučuje se započeti liječenje u sljedećim slučajevima: • Prethodna radioterapija vanjskim snopom koja uključuje više od 25 % koštane srži;
English: Hepatic encephalopathy Paraesthesia Parosmia
Croatian: Hepatička encefalopatija
English: At the time of final per-protocol PFS statistical analysis (cut-off date 24 July 2015), the number of centrally confirmed disease progressions or deaths was 21 events in the Lutathera arm and 70 events in the octreotide LAR arm (Table 8).
Croatian: srpnja 2015.), broj centralno potvrđenih progresija bolesti ili smrti bio je 21 događaj u skupini za lijek Lutathera i 70 događaja u skupini za oktreotid LAR (Tablica 8).
English: Excipient with known effect Each mL of solution contains 0.14 mmol (3.2 mg) of sodium.
Croatian: Svaki mL otopine sadržava 0,14 mmol (3,2 mg) natrija.
English: 8 Includes Arthralgia, Pain in extremity, Back pain, Bone pain, Flank pain, Musculoskeletal chest pain and Neck pain
Croatian: Uključuje hipertenziju i hipertenzivnu krizu 8 Uključuje artralgiju, bol u ekstremitetu, bol u leđima, bol u kostima, bol u slabinama, bol u mišićima i kostima,
English: This evidence confirms what has been previously observed in the Erasmus phase I/II study, in which HPLC analysis of a urine specimen collected 1 hour post administration of lutetium (177Lu) oxodotreotide from one patient receiving 1.85 MBq of lutetium (177Lu) oxodotreotide indicated that the main portion (91%) was excreted unchanged.
Croatian: HPLC analiza uzorka urina prikupljenog 1 sat nakon primjene lutecijeva (177Lu) oksodotreotida od jednog bolesnika koji je primio 1,85 MBq lutecijeva (177Lu) oksodotreotida pokazala da je veći dio
English: N Patients with events Censored patients
Croatian: Bolesnici s događajima
English: Bronchial
Croatian: Bronhijalni
English: The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion.
Croatian: Infuziju otopine aminokiselina potrebno je započeti 30 minuta prije početka infuzije Lutathere.
English: The vial is enclosed within a lead container for protective shielding.
Croatian: Bočica je zatvorena unutar zaštitnog olovnog spremnika.
English: Bone marrow function and/or blood count disorders Because of the potential for undesirable effects, blood counts must be monitored at baseline and during treatment, and until resolution of any eventual toxicity (see section 4.2).
Croatian: Zbog potencijalnih nuspojava, krvnu sliku nužno je kontrolirati na početku liječenja i tijekom liječenja i do izlječenja bilo kakve toksičnosti (vidjeti dio 4.2).
English: How Lutathera is used
Croatian: Kako se Lutathera primjenjuje
English: • Previous external beam radiotherapy involving more than 25% of the bone marrow;
Croatian: - ako ste primili prethodnu vanjsku terapiju zračenjem na više od 25% koštane srži
English: Hyperglycaemia Dehydration Hypomagnesaemia Hyponatremia
Croatian: Hiperglikemija Dehidracija Hipomagnezemija Hiponatremija
English: • Patients with somatostatin receptor negative or mixed visceral lesions (tumour uptake score < 2)
Croatian: • Bolesnici s visceralnim lezijama negativnim ili istovremeno negativnim i pozitivnim na somatostatinske receptore (rezultat unosa u tumor < 2) prema oslikavanju somatostatinskih receptora.
English: Acute myeloid leukaemia Acute leukaemia Chronic myelomonocytic leukaemia
Croatian: Akutna mijeloidna leukemija Akutna leukemija
English: After administration of Lutathera
Croatian: Nakon primjene lijeka Lutathera
English: Low white blood cell count (leukopenia or neutropenia), muscle pain, temporal partial hair loss (alopecia), abdominal distension (feeling bloated), diarrhoea, dizziness, injection site reaction or swelling, disturbed taste, pain in the site of injection, headache, high or low blood pressure, peripheral oedema, abnormal results of renal blood test (increased creatinine), abdominal pain (general and upper), constipation, abnormal results of liver blood test, flushing and hot flushes, increased sugar level in the blood, fainting, renal failure (including acute injury), dehydration, heartburn (dyspepsia), blood in urine, abnormal results of urine test (presence of serum proteins), decrease in function of thyroid, shortness of breath, inflammation of stomach (gastritis), abnormally high amounts of bile pigment (bilirubin) in the blood (Hyperbilirubinemia), abnormal results of blood test (Hypomagnesaemia and hyponatraemia), influenza like illness, chills, bone marrow cancer (myelodysplastic syndrome), blood transfusion.
Croatian: Nizak broj bijelih krvnih stanica (leukopenija ili neutropenija), bol u mišićima, privremeni djelomični gubitak kose (alopecija), rastezanje trbuha (osjećaj nadutosti), proljev, omaglica, reakcija na mjestu injekcije ili oticanje, promijenjeni osjet okusa, bol na mjestu injekcije, glavobolja, visoki ili niski krvni tlak, oticanje udova, abnormalni rezultati testa bubrežne funkcije (povišeni kreatinin), bolovi u trbuhu (općenito i u gornjem dijelu), zatvor, abnormalni rezultati testova jetrene funkcije, naleti crvenila i valunzi, povećana razina šećera u krvi, nesvjestica, zatajenje bubrega (uključujući akutnu ozljedu),
English: Musculoskeletal pain8 Muscle spasms
Croatian: Bol u mišićima i kostima8 Spazam mišića
English: Non-clinical data on the cold compound (non-radioactive lutetium (
Croatian: Postoje dokazi iz analize uzoraka urina 20 bolesnika iz podispitivanja dozimetrije, farmakokinetike i EKG-a u ispitivanju faze III NETTER-1, da se lutecijev (
English: If you get any side effects talk to your nuclear medicine doctor.
Croatian: Ako primijetite bilo koju nuspojavu, obratite se svojem liječniku specijalistu nuklearne medicine.
English: Blood potassium decreased Blood urea increased Glycosylated haemoglobin increased
Croatian: Snižen kalij u krvi Povišena urea u krvi Povišen glikirani hemoglobin Snižen hematokrit Proteini u urinu
English: Abdominal distension Diarrhoea
Croatian: Abdominalna distenzija Proljev
English: Major surgery.
Croatian: Veliki kirurški zahvat.
English: Overdose is unlikely with Lutathera as this medicinal product is supplied as a “single dose” and “ready to use” product containing a predefined amount of radioactivity.
Croatian: Predoziranje Predoziranje lijekom Lutathera nije vjerojatno jer se taj lijek isporučuje kao lijek u „jednokratnoj dozi”
English: Hypertension7 Flushing Hot flush Hypotension
Croatian: Hipertenzija7 Naleti crvenila Valunzi Hipotenzija
English: Conjunctivitis Respiratory tract infection Cystitis
Croatian: Konjunktivitis Infekcija dišnog sustava Cistitis
English: 2.2 mm (mean penetration range of 0.67 mm), which is sufficient to kill targeted tumour cells with a limited effect on neighbouring normal cells.
Croatian: Lutecij-177 (177Lu) je radionuklid s β- emisijom s maksimalnim rasponom penetracije u tkivu od 2,2 mm (srednji raspon penetracije od 0,67 mm) što je dostatno za ubijanje ciljanih tumorskih stanica s ograničenim učinkom na susjedne zdrave stanice.
English: Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney.
Croatian: Nefrotoksičnost Lutecijev (177Lu) oksodotreotid izlučuje se putem bubrega.
English: Temporarily discontinue treatment with Lutathera in the following conditions:
Croatian: Tabela 4. Kriteriji za privremeni prekid liječenja Lutatherom Privremeno prekinite liječenje Lutatherom u sljedećim situacijama: Kriterij
English: Lysine
Croatian: Lizin
English: Disposable waterproof gloves should be worn.
Croatian: Potrebno je nositi jednokratne vodootporne rukavice.
English: Nausea, vomiting, fatigue, low platelet count (thrombocytopenia), low white blood cell count (lymphopenia), low red cell count (anaemia), decreased appetite, decreased all blood cell count (pancytopenia)
Croatian: (limfopenija), nizak broj crvenih krvnih stanica (anemija), smanjenje apetita, smanjenje broja svih krvnih stanica (pancitopenija)
English: An analysis performed with human plasma to determine the extent of plasma protein binding of non-radioactive compound (lutetium (175Lu) oxodotreotide) showed that about 50% of the compound is bound to plasmatic proteins.
Croatian: (lutecijev (175Lu) oksodotreotid) na proteine u plazmi pokazala je da je oko 50 % spoja vezano na proteine plazme.
English: NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion
Croatian: NAZIV LIJEKA Lutathera 370 MBq/mL otopina za infuziju
English: The high performance liquid chromatography (HPLC) analyses performed on urine samples collected up to 48 hours post infusion showed lutetium (177Lu) oxodotreotide radiochemical purity close to 100% in most of the analysed samples (with lowest radiochemical purity value being greater than 92%), indicating that the compound is eliminated in urine mainly as intact compound.
Croatian: oksodotreotida blizu 100 % u većini analiziranih uzoraka (pri čemu je najniža radiokemijska čistoća veća od 92 %), što ukazuje na to da se spoj eliminira u mokraći uglavnom kao nepromijenjeni spoj.
English: oxodotreotide through the proximal tubules, resulting in a significant reduction in the kidney radiation dose (see section 4.2).
Croatian: Otopina aminokiselina smanjit će reapsorpciju lutecijeva (177Lu) oksodotreotida kroz proksimalne kanaliće, što rezultira značajnim smanjenjem doze zračenja bubrega (vidjeti dio 4.2).
English: Haematochezia Abdominal discomfort Intestinal obstruction Colitis
Croatian: Nelagoda u abdomenu Intestinalna opstrukcija Kolitis
English: Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Croatian: Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
English: One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
Croatian: Jedan mL otopine za infuziju sadržava 370 MBq lutecijeva (177Lu) oksodotreotida na datum i vrijeme kalibracije.
English: You will be requested to drink a sufficient amount of water (1 glass every hour) necessary to urinate every hour on the day of infusion and the day after, and try to defecate every day, in order to eliminate the medicine from your body.
Croatian: Od Vas će se tražiti da pijete dovoljnu količinu vode (1 čašu svakih sat vremena) što je potrebno kako biste mokrili svakog sata na dan infuzije i dan nakon toga, i pokušajte prazniti crijeva svaki dan kako biste uklonili lijek iz svojeg tijela.
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 24 July 2015 (full analyses set (FAS), N=229)
Croatian: PFS opažen u ispitivanju faze III NETTER-1 u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 24. srpnja 2015. (potpuni skup podataka za analizu, N=229)
English: Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion.
Croatian: Premedikaciju antiemeticima potrebno je injicirati 30 minuta prije početka infuzije otopine aminokiselina.
English: Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera (see section 4.8), occurring approximately 28 months (9 - 41) for MDS and 55 months (32 - 125) for AL after the end of treatment.
Croatian: (AL) kasnog nastupa (vidjeti dio 4.8.), koji su se javili oko 28 mjeseci (9 - 41) za MDS i 55 mjeseci
English: − A pair of tongs (for Lutathera vial handling)
Croatian: − Hvataljka (za rukovanje bočicom lijeka Lutathera)
English: Leukocyturia
Croatian: Leukociturija
English: Includes Leukopenia and White blood cell count decreased 6 Includes Neutropenia and Neutrophil count decreased
Croatian: 6 Uključuje neutropeniju i snižen broj neutrofila
English: How Lutathera is stored
Croatian: Kako se Lutathera čuva