natgillin/translations-raw huggingface dataset:
Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide. 
Nisu provedena ispitivanja reproduktivne funkcije na životinjama s lutecijevim (177Lu)
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. 
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.
Administration procedure of antiemetic amino acid solution and Lutathera 
Tablica 6. Postupak primjene antiemetika, otopine aminokiselina i lijeka Lutathera
Pancreatic enzymes decreased Hepatocellular injury Cholestasis 
Snižena razina enzima gušterače Hepatocelularno oštećenje Kolestaza
What you need to know before Lutathera is used Lutathera must not be used - if you are allergic to lutetium (177 
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
Acetic acid Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Water for injections 
Acetatna kiselina Natrijev acetat Gentizatna kiselina Askorbatna kiselina Pentetatna kiselina Natrijev klorid Natrijev hidroksid Voda za injekcije
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. 
Ako se u bilo koje vrijeme tijekom pripreme ovog lijeka spremnik ili bočica ošteti, lijek se ne smije koristiti.
Electrocardiogram QT prolonged 
Produžen QT interval na elektrokardiogramu
If at any time in the preparation of this medicinal product the integrity of this vial is compromised, it should not be used. 
Ako se u bilo koje vrijeme tijekom pripreme lijeka bočica ošteti, lijek se ne smije koristiti.
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). 
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,
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} 
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}
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). 
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).
Hypoglycaemia Hypernatremia Hypophosphatemia Tumor lysis syndrome Hypercalcaemia Hypocalcaemia Hypoalbuminaemia Metabolic acidosis 
Hipoglikemija Hipernatremija Hipofosfatemija Sindrom lize tumora Hiperkalcemija Hipokalcemija Hipoalbuminemija
Marketing Authorisation Holder Advanced Accelerator Applications 20 rue Diesel 
Nositelj odobrenja za stavljanje lijeka u promet Advanced Accelerator Applications 20 rue Diesel
The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 30 June 2016 is depicted in Figure 4. 
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.
• Haematology (Haemoglobin [Hb], white blood count, platelet count) 
• Hematologija (hemoglobin [Hb], broj leukocita, broj trombocita)
PFS and OS observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NET - (FAS, N=360) 
Tablica 11. PFS i OS zabilježeni u ispitivanju faze I/II Erasmus u nizozemskih bolesnika s GEP i bronhijalnim NET-ovima - (FAS, N=360)
Amino acid solution should be administered over 4 hour time span. 
Otopina aminokiselina primjenjuje se tijekom razdoblja od 4 sata.
Scheme of instructions for dose modifications 
Tablica 5. Upute za prilagodbu doze
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. 
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,
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. 
Postupci koji uključuju primjenu radionuklida provedeni na trudnicama uzrokuju i ozračivanje fetusa.
Pancreatitis acute Rectal haemorrhage Melaena 
Akutni pankreatitis Rektalno krvarenje Melena
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. 
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.
Weight decreased Blood creatine phosphokinase increased 
Smanjenje tjelesne težine Povišena kreatin fosfokinaza u krvi Povišena laktat dehidrogenaza u krvi
Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC} 
Volumen: {Y} mL Aktivnost u vrijeme infuzije: {Z} MBq - {DD/MM/GGGG hh:mm UTC}
Requirements 
Zahtjevi
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: 
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;
Hepatic encephalopathy Paraesthesia Parosmia 
Hepatička encefalopatija
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). 
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).
Excipient with known effect Each mL of solution contains 0.14 mmol (3.2 mg) of sodium. 
Svaki mL otopine sadržava 0,14 mmol (3,2 mg) natrija.
8 Includes Arthralgia, Pain in extremity, Back pain, Bone pain, Flank pain, Musculoskeletal chest pain and Neck pain 
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,
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. 
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
N Patients with events Censored patients 
Bolesnici s događajima
Bronchial 
Bronhijalni
The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion. 
Infuziju otopine aminokiselina potrebno je započeti 30 minuta prije početka infuzije Lutathere.
The vial is enclosed within a lead container for protective shielding. 
Bočica je zatvorena unutar zaštitnog olovnog spremnika.
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). 
Zbog potencijalnih nuspojava, krvnu sliku nužno je kontrolirati na početku liječenja i tijekom liječenja i do izlječenja bilo kakve toksičnosti (vidjeti dio 4.2).
How Lutathera is used 
Kako se Lutathera primjenjuje
• Previous external beam radiotherapy involving more than 25% of the bone marrow; 
- ako ste primili prethodnu vanjsku terapiju zračenjem na više od 25% koštane srži
Hyperglycaemia Dehydration Hypomagnesaemia Hyponatremia 
Hiperglikemija Dehidracija Hipomagnezemija Hiponatremija
• Patients with somatostatin receptor negative or mixed visceral lesions (tumour uptake score < 2) 
• Bolesnici s visceralnim lezijama negativnim ili istovremeno negativnim i pozitivnim na somatostatinske receptore (rezultat unosa u tumor < 2) prema oslikavanju somatostatinskih receptora.
Acute myeloid leukaemia Acute leukaemia Chronic myelomonocytic leukaemia 
Akutna mijeloidna leukemija Akutna leukemija
After administration of Lutathera 
Nakon primjene lijeka Lutathera
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. 
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),
Musculoskeletal pain8 Muscle spasms 
Bol u mišićima i kostima8 Spazam mišića
Non-clinical data on the cold compound (non-radioactive lutetium ( 
Postoje dokazi iz analize uzoraka urina 20 bolesnika iz podispitivanja dozimetrije, farmakokinetike i EKG-a u ispitivanju faze III NETTER-1, da se lutecijev (
If you get any side effects talk to your nuclear medicine doctor. 
Ako primijetite bilo koju nuspojavu, obratite se svojem liječniku specijalistu nuklearne medicine.
Blood potassium decreased Blood urea increased Glycosylated haemoglobin increased 
Snižen kalij u krvi Povišena urea u krvi Povišen glikirani hemoglobin Snižen hematokrit Proteini u urinu
Abdominal distension Diarrhoea 
Abdominalna distenzija Proljev
Major surgery. 
Veliki kirurški zahvat.
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. 
Predoziranje Predoziranje lijekom Lutathera nije vjerojatno jer se taj lijek isporučuje kao lijek u „jednokratnoj dozi”
Hypertension7 Flushing Hot flush Hypotension 
Hipertenzija7 Naleti crvenila Valunzi Hipotenzija
Conjunctivitis Respiratory tract infection Cystitis 
Konjunktivitis Infekcija dišnog sustava Cistitis
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. 
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.
Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney. 
Nefrotoksičnost Lutecijev (177Lu) oksodotreotid izlučuje se putem bubrega.
Temporarily discontinue treatment with Lutathera in the following conditions: 
Tabela 4. Kriteriji za privremeni prekid liječenja Lutatherom Privremeno prekinite liječenje Lutatherom u sljedećim situacijama: Kriterij
Lysine 
Lizin
Disposable waterproof gloves should be worn. 
Potrebno je nositi jednokratne vodootporne rukavice.
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) 
(limfopenija), nizak broj crvenih krvnih stanica (anemija), smanjenje apetita, smanjenje broja svih krvnih stanica (pancitopenija)
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. 
(lutecijev (175Lu) oksodotreotid) na proteine u plazmi pokazala je da je oko 50 % spoja vezano na proteine plazme.
NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion 
NAZIV LIJEKA Lutathera 370 MBq/mL otopina za infuziju
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. 
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.
oxodotreotide through the proximal tubules, resulting in a significant reduction in the kidney radiation dose (see section 4.2). 
Otopina aminokiselina smanjit će reapsorpciju lutecijeva (177Lu) oksodotreotida kroz proksimalne kanaliće, što rezultira značajnim smanjenjem doze zračenja bubrega (vidjeti dio 4.2).
Haematochezia Abdominal discomfort Intestinal obstruction Colitis 
Nelagoda u abdomenu Intestinalna opstrukcija Kolitis
Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide 
Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration. 
Jedan mL otopine za infuziju sadržava 370 MBq lutecijeva (177Lu) oksodotreotida na datum i vrijeme kalibracije.
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. 
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.
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) 
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)
Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion. 
Premedikaciju antiemeticima potrebno je injicirati 30 minuta prije početka infuzije otopine aminokiselina.
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. 
(AL) kasnog nastupa (vidjeti dio 4.8.), koji su se javili oko 28 mjeseci (9 - 41) za MDS i 55 mjeseci
− A pair of tongs (for Lutathera vial handling) 
− Hvataljka (za rukovanje bočicom lijeka Lutathera)
Leukocyturia 
Leukociturija
Includes Leukopenia and White blood cell count decreased 6 Includes Neutropenia and Neutrophil count decreased 
6 Uključuje neutropeniju i snižen broj neutrofila
How Lutathera is stored 
Kako se Lutathera čuva
PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumour - cutoff date 24 July 2015 (NETTER-1 phase III study; FAS, N=229) 
Slika 3. Kaplan Meierove krivulje za PFS u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 24. srpnja 2015 (Ispitivanje faze III NETTER-1;FAS, N=229)
If you are taking somatostatin analogues you might be asked to stop and/or adapt your treatment for a short period of time. 
možda ćete ih nakratko morati prestati primjenjivati i/ili prilagoditi liječenje.
Breast-feeding It is unknown whether lutetium (177Lu) oxodotreotide is excreted in breast milk. 
Nije poznato izlučuje li se lutecijev (177Lu) oksodotreotid u majčino mlijeko.
Unless your doctor has considered that the clinical benefit of the treatment overcomes the possible risks, you will not be given this medicine: - if you have received a previous external radiation therapy on more than 25% of your bone marrow - if you heart is seriously impaired - if you have seriously affected blood cell counts - if your liver is seriously impaired - if it appears that your tumour does not have sufficient somatostatin receptors 
- ako imate ozbiljno oštećenje srca - ako imate ozbiljno promijenjen broj krvnih stanica - ako imate ozbiljno oštećenje jetre - ako se čini da vaš tumor nema dovoljno somatostatinskih receptora
METHOD AND ROUTE(S) OF ADMINISTRATION Single-dose vial. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Ascities 
Ascites
Very common (may affect more than 1 in 10 people): 
Sažetak nuspojava prikazan je redoslijedom po učestalosti: Vrlo često (može se javiti u više od 1 na 10 osoba):
Tabulated list of adverse reactions The adverse reactions are listed in Table 7 according to the frequency and the MedDRA System Organ 
Nuspojave su navedene u Tablici 7 u skladu s učestalošću i MedDRA klasifikacijom organskih sustava (SOC).
PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumourcut-off date 30 June 2016 (NETTER-1 phase III study; FAS, N=231) 
Slika 4. Kaplan Meierove krivulje za PFS u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 30. lipnja 2016 (ispitivanje faze III NETTER-1; FAS, N=231)
The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe hepatic impairment has not been studied, 
Farmakokinetički profil lutecijeva (177Lu) oksodotreotida u bolesnika s teškim oštećenjem funkcije jetre nije proučavan, pa se ne preporučuje liječenje Lutatherom kod tih bolesnika.
Antiemetic premedication should be administered 30 minutes before start of amino acid solution infusion. 
Premedikaciju antiemeticima potrebno je primijeniti 30 minuta prije početka infuzije otopine aminokiselina.
The absence of inhibition or significant induction of the human CYP450 enzymes, the absence of specific interaction with P-glycoprotein (efflux transporter) as well as OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 and BCRP transporters in pre-clinical studies suggest that Lutathera has a low probability of causing significant other drug-drug interactions. 
P-glikoproteinom (efluksni transporter) kao i s OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 i
You can also report side effects directly via the national reporting system: 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
Any other CTCAE grade 3 or grade 4 toxicity** possibly related to Lutathera. 
Bilo koja druga toksičnosti CTCAE** stupnja 3.
Leukopenia5 Neutropenia6 
Neutropenija6
PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 30 June 2016 (full analyses set (FAS), N=231) 
Tablica 9. PFS zabilježen u ispitivanju faze III NETTER-1 u bolesnika s progresivnim karcinoidnim tumorom srednjeg crijeva - datum prestanka prikupljanja podataka 30. lipnja 2016. (potpuni skup podataka za analizu (FAS), N=231)
Ear and labyrinth 
Poremećaji uha i labirinta
Kidneys 
Vrtoglavica
Amino acid solution 
Metabolička acidoza
Gallbladder Wall Lower Large Intestine Wall Small Intestine Stomach Wall 
Stijenka donjeg dijela debelog crijeva
Biodistribution studies show that lutetium (177Lu) 
Farmakokinetički profil lutecijeva (177Lu)
− One vial of Lutathera 
Jedna bočica lijeka Lutathera
Vial No.: {X} 
Bočica br.: {X}
For information on the use in patients with hepatic impairment, see section 4.2. 
Informacije o uporabi u bolesnika s oštećenjem funkcije bubrega potražite u dijelu 4.2.
Pancreas 
Pankreatični
PFS = Progression free survival; OS = Overall survival * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic 
* Uključuje prednje, srednje i stražnje crijevo; **NET-ovi prednjeg crijeva osim bronhijalnih i pankreatičnih
Abdominal cavity drainage Dialysis 
Drenaža abdominalne šupljine Dijaliza
2 Includes Thrombocytopenia and Platelet count decreased Includes Lymphopenia and Lymphocyte count decreased 4 Includes Anaemia and Haemoglobin decreased 
Uključuje asteniju i umor 2 Uključuje trombocitopeniju i snižen broj trombocita
Arginine content 
Sadržaj arginina
EXPIRY DATE EXP: {DD MM YYYY hh:mm UTC} 
ROK VALJANOSTI Rok valjanosti: {DD MM GGGG hh:mm UTC}
• Kidney failure with creatinine clearance < 30 mL/min 
• Zatajenje bubrega s klirensom kreatinina < 30 mL/min 4.4.
STATEMENT OF ACTIVE SUBSTANCE(S) One mL contains 370 MBq of lutetium (177Lu) oxodotreotide at calibration time. 
Jedan mL sadrži 370 MBq lutecijeva (177Lu) oksodotreotida u vrijeme kalibracije.
Secondary hypothyroidism Hypothyroidism Diabetes mellitus 
Hipotireoza Dijabetes melitus Karcinoidna kriza Hiperparatiroidizam
NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide 
Uputa o lijeku: Informacije za korisnika Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
General warning 
Generalizirani pruritus
Orthostatic hypotension Phlebitis 
Ortostatska hipotenzija Flebitis
Oropharyngeal pain Pleural effusion Sputum increased Choecking sensation 
Povećanje količine sputuma Osjećaj gušenja
Solution for infusion 
Preporuke za otpad
Start time (min) 
Vrijeme početka
Lutetium-177 (177Lu) is a β- emitting radionuclide with a maximum penetration range in tissue of 
Lutecij (177Lu) se raspada β- emisijom u stabilni hafnij
Deaths 
Umor1
Injection site mass Chest discomfort Chest pain Pyrexia 
Masa na mjestu injekcije Nelagoda u prsištu Bol u prsištu Pireksija
Acute prerenal failure Renal impairment 
Akutno prerenalno zatajenje Oštećenje funkcije bubrega
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lutathera 370 MBq/mL solution for infusion 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lutathera 370 MBq/mL otopina za infuziju lutecijev (177Lu) oksodotreotid
Thrombocytopenia2 Lymphopenia3 
Trombocitopenija2 Limfopenija3