natgillin/translations-raw huggingface dataset:
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). 
Na datum, določen za naknadno statistično analizo (30. junij 2016) je bilo število centralno potrjenih napredovanj bolezni ali smrti 30 pri skupini, ki je prejemala zdravilo Lutathera, in 78 dogodkov pri skupini, ki je prejemala oktreotid LAR (preglednica 9).
There is evidence , from the analysis of urine samples of 20 patients included in the NETTER-1 phase III Dosimetry, pharmacokinetic and ECG substudy, that lutetium (177Lu) oxodotreotide is poorly metabolized and is excreted mainly as intact compound by renal route. 
Na podlagi analize vzorcev urina 20 bolnikov, vključenih v podštudijo o odmerjanju, farmakokinetiki in EKG študije NETTER-1 III. faze, obstajajo dokazi, da se lutecijev (177Lu) oksodotreotid slabo presnavlja in se v glavnem izloča skozi ledvice kot intaktna spojina.
Therefore, as a matter of cautiousness, repeated administration of high-doses of glucocorticosteroids should be avoided during Lutathera treatment. 
Zato se je treba zaradi previdnosti izogniti večkratnemu apliciranju visokih odmerkov glukokortikoidov med zdravljenjem z zdravilom Lutathera.
The causality of nausea / vomiting is confounded by the emetic effect of the concomitant amino acids infusion administered for renal protection. 
Vzročnost navzee/bruhanja je nejasna zaradi emetskega učinka sočasne infuzije aminokislin za zaščito ledvic.
No additional medicinal product can be administered to the same side where the extravasation occurred. 
Na strani, kjer je prišlo do ekstravazacije, se ne aplicira nobenega dodatnega zdravila.
• The flow of the radiopharmaceutical solution should be regulated with the clamps. 
• Pretok raztopine radiofarmaka je treba uravnavati s sponkami.
Patients with brain metastases 
Bolniki z metastazami v možganih
In the Erasmus phase I/II study 188 patients (52%) received and 172 (48%) did not receive concomitant octreotide LAR during Lutathera treatment. 
faze je med zdravljenjem z zdravilom Lutathera 188 bolnikov (52 %) sočasno prejemalo oktreotid LAR, 172 (48 %) pa jih tega ni prejemalo.
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. 
Podatki za skupno mediano vrednost PFS in OS za FAS nizozemske populacije z GEP in bronhialnimi NET (360 bolnikov) in po vrstah tumorjev so predstavljeni v preglednici 11.
The volume of sodium chloride 9 mg/mL (0.9%) solution for injection necessary to complete the infusion may vary. 
Količina natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, potrebne za celotno infuzijo, je lahko različna.
This medicine contains 0.14 mmol (3.2 mg) of sodium per mL. 
To zdravilo vsebuje 0,14 mmol (3,2 mg) natrija na ml.
Acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride 9 mg/mL injection, sodium hydroxide, water for injections. 
Ocetna kislina, natrijev acetat, gentizinska kislina, askorbinska kislina, pentetinska kislina, natrijev klorid 9 mg/ml injekcija, natrijev hidroksid, voda za injekcije.
Urinary incontinence Glomerular filtration rate decreased Renal disorder 
Urinarna inkontinenca Zmanjšana hitrost glomerularne filtracije
Instructions for dose modifications Adjust Lutathera dosing for the following severe adverse reactions: Severe adverse reactions 
Odmerek zdravila Lutathera prilagodite v primeru naslednjih hudih neželenih učinkov:« Hudi neželeni učinki
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). 
Ob času, določenem za končno statistično analizo po protokolu PFS (končni datum, določen za analizo je bil 24 julij 2015), je število centralno potrjenih napredovanj bolezni ali smrti znašalo 21 dogodkov pri skupini, ki je prejemala zdravilo Lutathera, in 70 dogodkov pri skupini, ki je prejemala oktreotid LAR (preglednica 8).
Electrocardiogram QT prolonged 
Podaljšan interval QT elektrokardiograma
The visual inspection of the solution should be performed under a shielded screen for radioprotection purposes. 
Pregled je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
Should you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure. 
Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom nuklearne medicine, ki nadzoruje postopek.
p-value of Log-rank test Hazard ratio (95%-CI) 
p-vrednost v testu Log rank Razmerje tveganja (95-% IZ)
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. 
Apliciranje zdravila Lutathera je potrebno začeti, tako da se najprej odpre vod cevke, priključen na bolnikovo periferno veno, nato pa odpre komplet za infuzijo, priključen na vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopino za injiciranje.
Lutathera has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Lutathera nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials. 
Radiofarmacevtska zdravila se bodo shranjevala v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
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. 
faze je bila monocentrična, odprta študija z eno skupino za preverjanje učinkovitosti zdravila Lutathera (7.400 MBq aplicirano 4-krat vsakih 8 tednov) sočasno z raztopino aminokislin pri bolnikih s tumorji s pozitivnimi somatostatinskimi receptorji.
• The short needle should be then connected to the pre-filled infusion set. 
• Kratko iglo je treba nato priključiti na napolnjeni komplet za infuzijo.
Haematocrit decreased Protein urine 
Proteini v urinu Zmanjšanje telesne mase
Specification of commercially available amino acid solutions Characteristic 
Preglednica 2: Specifikacije komercialno dostopnih raztopin aminokislin Lastnosti
Administration of Lutathera and conduct of the procedure Lutathera is administered directly into a vein. 
Apliciranje zdravila Lutathera in izvedba postopka Zdravilo Lutathera vam injicirajo neposredno v veno.
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. 
Odsotnost inhibicije ali znatne indukcije humanih encimov CYP450, odsotnost specifične interakcije s P-glikoproteinom (efluksnim transporterjem) in s transporterji OAT1, OAT3, OCT2, OATP1B1,
Individual benefit/risk justification 
Presoja tveganja in koristi pri posameznem bolniku
No statistically significant difference in PFS was observed between the subgroup of patients who did not receive octreotide LAR (25.4 months [95% CI 22.8-30.6]) versus the subgroup who did receive concomitant treatment with octreotide LAR (30.9 months [95% CI 25.6-34.8]) (p= 0.747). 
Pri PFS ni bilo statistično pomembnih razlik med podskupino bolnikov, ki ni prejemala oktreotida LAR (25,4 meseca [95-% IZ, 22,8-30,6]),
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. 
Razmerje tveganja za zdravilo Lutathera je bilo 0,18 (95-% IZ: 0,11-0,29), kar kaže na 82-% zmanjšanje tveganja za bolnika za napredovanje bolezni ali smrt pri zdravilu Lutathera v primerjavi z oktreotidom LAR.
As this medicinal product is known to be substantially excreted by the kidneys, patients with mild to moderate impaired renal function should be more frequently monitored during the treatment. 
Znano je, da so to zdravilo v glavnem izloča preko ledvic, zato je treba bolnike z blago do zmerno ledvično okvaro med zdravljenjem pogosteje spremljati.
Lysine content 
Vsebnost lizina
If necessary, patients may be treated with short acting somatostatin analogues during the 4 weeks preceding Lutathera administration, until 24 hours before the administration of Lutathera. 
Če je potrebno se bolnike lahko zdravi s kratkodelujočimi somatostatinskimi analogi v obdobju 4 tednov pred aplikacijo zdravila Lutathera do 24 ur pred aplikacijo zdravila Lutathera.
No animal studies have been performed to determine the effects of lutetium (177Lu) oxodotreotide on the fertility of either gender. 
Izvedena ni bila nobena študija na živalih za ugotavljanje učinkov lutecijevega (177Lu) oksodotreotida na plodnost katerega koli spola.
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. 
Razmerje tveganja za zdravilo Lutathera je bilo 0,21 (95-% IZ: 0,140,33), kar kaže na 79-% zmanjšanje tveganja za bolnika za napredovanje bolezni ali smrt pri zdravilu Lutathera v primerjavi z oktreotidom LAR.
Temporarily discontinue treatment with Lutathera in the following conditions: 
Preglednica 4: Merila za začasno prekinitev zdravljenja z zdravilom Lutathera Zdravljenje z zdravilom Lutathera začasno prekinite v naslednjih pogojih:
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. 
Postopek aplikacije (gravitacijska metoda) Pretok raztopine natrijevega klorida 9 mg/ml (0,9 %) raztopne za injiciranje med infuzijo poveča tlak v viali zdravila Lutathera in omogoči pretok zdravila Lutathera v kateter, vstavljen v bolnikovo periferno veno.
What you need to know before Lutathera is used Lutathera must not be used - if you are allergic to lutetium (177 
Kaj morate vedeti, preden boste prejeli zdravilo Lutathera Zdravila Lutathera ne smete prejeti: - če ste alergični na lutecijev (177Lu) oksodotreotid ali katero koli sestavino tega zdravila
Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6). 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi (glejte poglavje
Major or some specific adverse reactions to Lutathera. 
Pomembni ali nekateri določeni neželeni učinki zdravila Lutathera.
Talk to your nuclear medicine doctor if you are under 18 years old. 
Če ste mlajši od 18 let, se pogovorite z zdravnikom nuklearne medicine, preden prejmete to zdravilo.
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. 
Lutecijev (177Lu) oksodotreotid se izloča skoraj izključno preko ledvičnega sistema, zato je treba obvezno sočasno aplicirati raztopino aminokislin, ki vsebuje aminokislini L-lizin in L-arginin.
Cryopreservation of sperm or eggs can be discussed as an option to patients before the treatment. 
Z bolniki se je mogoče pred zdravljenjem pogovoriti o možnosti krioprezervacije sperme ali jajčec.
Since many patients referred for Lutathera therapy have hepatic metastasis, it may be common to observe patients with altered baseline liver function. 
Veliko bolnikov, ki so napoteni na zdravljenje z zdravilom Lutathera ima metastaze v jetrih, zato so ugotovitve bolnikov s spremenjeno izhodiščno jetrno funkcijo lahko pogoste.
Close contact with other people should be restricted during 7 days following an administration of Lutathera, and for children and pregnant women it should be limited to less than 15 minutes for each day while keeping a distance of at least 1 meter. 
stike z otroci in nosečnicami pa morajo omejiti na manj kot 15 minut vsak dan, pri tem pa vzdrževati razdaljo vsaj 1 metra.
Pancreatic enzymes decreased Hepatocellular injury Cholestasis 
Znižana raven encimov trebušne slinavke Hepatocelularna poškodba Holestaza
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Viala št .
b. If the observed toxicity resolves within 16 weeks after the last infusion, it is possible to continue the treatment with Lutathera by infusing a half dose (3,700 MBq)*. 
b. Če opažena toksičnost izgine v 16 tednih po zadnji infuziji, je mogoče zdravljenje z zdravilom Lutathera nadaljevati z infundiranjem polovičnega odmerka
• Hematologic monitoring: white blood cells, platelets, and haemoglobin 
• hematološko spremljanje: levkocite, trombocite in hemoglobin;
Hypoglycaemia Hypernatremia Hypophosphatemia Tumor lysis syndrome Hypercalcaemia Hypocalcaemia Hypoalbuminaemia Metabolic acidosis 
Hipoglikemija Hipernatriemija Hipofosfatemija Sindrom tumorske lize Hiperkalcemija Hipokalcemija Hipoalbuminemija Metabolna acidoza
Deaths 
Smrt
It is a ready to use radiopharmaceutical medicinal product for single use only. 
Je radiofarmak, pripravljen na uporabo, in je samo za enkratno uporabo.
Swelling face Hyperhidrosis Pruritus generalized 
Oteklost obraza Hiperhidroza Generalizirani pruritus
The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each. 
Priporočeni režim zdravljenja z zdravilom Lutathera pri odraslih sestavljajo 4 infuzije, vsaka s
Constant intra-vial pressure should be maintained during the entire infusion. 
V celotnem času infundiranja je treba vzdrževati stalen tlak v viali.
The results indicate an improvement in the overall global health-related quality of life up to week 84, for patients on Lutathera treatment as compared to patients on Octreotide LAR arm. 
Pri bolnikih, ki so prejemali zdravilo Lutathera, rezultati kažejo na splošno izboljšanje kakovosti življenja, povezane z zdravjem, do 84. tedna, v primerjavi z bolniki v skupini, ki je prejemala Octreotide LAR.
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. 
Zaradi smrti in razpada malignih celic po zdravljenju obstaja tudi možnost, da bo pri vas prišlo do prekomernega izločanja hormonov iz teh celic, povečanja ali sprožanja simptomov, povezanih z nevroendokrinim tumorjem, kot so driska, zardevanje in vročinski oblivi, motnja bitja srca, zasoplost itd.
The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 24 July 2015 is depicted in Figure 3. 
Diagram Kaplan-Meier PFS za celotno skupino bolnikov (FAS) na datum za končno analizo 24. julija 2015 je prikazan v sliki 3.
How Lutathera is stored 6. 
Shranjevanje zdravila Lutathera 6.
Gallbladder Wall Lower Large Intestine Wall Small Intestine Stomach Wall 
Stena spodnjega debelega črevesa Tanko črevo
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) 
občutek siljenja na bruhanje, utrujenost, zmanjšano število trombocitov (trombocitopenija), zmanjšano število belih krvnih celic (limfopenija), zmanjšano število rdečih krvnih celic (anemija), zmanjšanje apetita, zmanjšano število vseh krvnih celic (pancitopenija).
Weight decreased Blood creatine phosphokinase increased 
Zvečanje vrednosti kreatin fosfokinaze v krvi
Gastrointestinal pain Stomatitis 
Vstavitev gastrointestinalne cevke
• The infusion set should be connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection and pre-filled by opening the clamp. 
• Komplet za infuzijo je treba priključiti na vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje in predhodno napolniti z odprtjem sponke.
(not < 320 mL/h for commercial solutions) 
(za komercialno dostopne raztopine ne manj kot 320 ml/h)
The vial is enclosed within a lead container for protective shielding. 
Viala je zaprta v zaščitnem svinčenem vsebniku.
• Kidney failure with creatinine clearance < 50 mL/min; 
• ledvična odpoved s kreatininskim očistkom < 50 ml/min;
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). 
Zaradi možnosti neželenih učinkov je treba krvno sliko nadzirati v izhodišču, med zdravljenjem in do izboljšanja katere koli morebitne toksičnosti (glejte poglavje 4.2).
If necessary, patients may be treated with short acting somatostatin analogues during the 4 weeks until 24 hours preceding Lutathera administration. 
Bolnike se po potrebi lahko zdravi s kratkodelujočimi somatostatinskimi analogi v obdobju 4 tednov in do 24 ur pred aplikacijo zdravila Lutathera.
- if you have mild to moderate chronic kidney disease - if you previously received anti-cancer treatment (chemotherapy) - if you have mildly altered blood cell counts - if you have bone metastasis - if you have previously received any radionuclide therapy - if you had other type of cancer within last 5 years 
- če trpite za urinarno inkontinenco (nehoteno uhajanje urina); - če imate blago do zmerno kronično bolezen ledvic; - če ste predhodno že prejemali terapijo za zdravljenje raka (kemoterapijo); - če imate blago spremenjeno število krvnih celic;
The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 30 June 2016 is depicted in Figure 4. 
Diagram Kaplan Meier PFS za celotno skupino bolnikov (FAS) na končni datum 30. junija 2016 je prikazan na sliki 4.
Haematochezia Abdominal discomfort Intestinal obstruction Colitis 
Hematohezija Nelagodje v trebuhu Intestinalna obstrukcija Kolitis
For instruction on preparation of the medicinal product before administration, see section 12. 
Za navodila glede priprave zdravila pred aplikacijo glejte poglavje 12.
− One bag of sodium chloride 9 mg/mL (0.9%) solution for injection (500 mL) 
− ena vrečka natrijevega klorida 9 mg/ml (0,9 %) raztopina za injiciranje (500 ml);
• Patients with somatostatin receptor negative or mixed visceral lesions (tumour uptake score < 2) 
• bolniki z negativnim izvidom za somatostatinske receptorje ali ali mešanimi visceralnimi lezijami (z oceno privzema v tumorju < 2) po slikanju somatostatinskih receptorjev.
Ovaries** 
Jajčniki**
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. 
Pred zdravljenjem bolnikov z blago in zmerno ledvično okvaro z zdravilom Lutathera je priporočljivo oceniti koristi in tveganja pri posamezniku; za dodatne podrobnosti glejte poglavje 4.2 (preglednica 3) in 4.4.
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). 
Farmakokinetični profil lutecijevega (177Lu) oksodotreotida pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) ni bil raziskan, zato zdravljenje z zdravilom
METHOD AND ROUTE(S) OF ADMINISTRATION Single-dose vial. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Viala z enim odmerkom.
Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC} 
Volumetrična aktivnost v času umerjanja: 370 MBq/ml - {DD/MM/LLLL uu:mm UTC}
Renal toxicity defined as an estimated creatinine clearance < 40 mL/min, or a 40% increase compare to the baseline serum creatinine level with a decrease of over 40% compared to the baseline creatinine clearance. 
povečanje v primerjavi s izhodiščno ravnjo serumske koncentracije kreatinina z več kot 40% zmanjšanjem v primerjavi z izhodiščnim kreatininskim očistkom.
Amino acid solution should be administered over 4 hour time span. 
Raztopino aminokislin je treba aplicirati v 4-urnem časovnem obdobju.
Administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of Lutathera. 
Apliciranju dolgodelujočih somatostatinskih analogov se je treba izogibati v obdobju 30 dni pred aplikacijo zdravila Lutathera.
METHOD OF ADMINISTRATION Single-dose vial. 
POSTOPEK UPORABE Viala z enim odmerkom.
For renal protection purpose, an amino acid solution must be administered intravenously during 4 hours. 
Za zaščito ledvic je treba v trajanju 4 ur intravensko infundirati raztopino aminokislin.
Breast-feeding It is unknown whether lutetium (177Lu) oxodotreotide is excreted in breast milk. 
Dojenje Ni znano ali se lutecijev (177Lu) oksodotreotid izloča v materino mleko.
Herpes zoster Ophthalmic herpes zoster Influenza 
Oftalmični herpes zoster
With respect to overall survival OS, at the time of interim analysis (24 July 2015), there were 17 deaths in the Lutathera arm and 31 in octreotide LAR 60 mg arm and the hazard ratio was 0.459 in favour of Lutathera, but did not reach the level of significance for interim analysis (HR 99.9915% CI: 0.140, 1.506). 
Razmerje tveganja (HR - hazard ratio) je bilo 0,459 v korist zdravila Lutathera, vendar raven pomembnosti pri vmesni analizi ni bila dosežena (HR 99,9915 % IZ: 0,140, 1,506).
Health Related Quality of Life (HRQOL) was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (generic instrument) and its neuroendocrine tumour module (EORTC QLQ-GI.NET-21). 
Kakovost življenja, povezano z zdravjem (Health Related Quality of Life - HRQOL) so ocenili z vprašalnikom za kakovost življenja Evropske organizacije za raziskave in zdravljenje raka (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - EORTC QLQ
• Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL), platelets < 75 G/L 
• oslabljena hematološka funkcija z vrednostmi Hb < 4,9 mmol/l (8 g/dl), trombocitov < 75 g/l (75x103/mm3) ali levkocitov < 2 g/l (2.000/mm3) (razen limfopenije);
BATCH NUMBER Batch: 
ŠTEVILKA SERIJE Številka serije:
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. 
Posodobitev čez približno leto dni (30. junija 2016) je pokazala podoben trend s 28 smrtmi pri skupini z zdravilom Lutathera in 43 smrtmi pri skupini z oktreotidom LAR 60 mg, razmerjem tveganja 0,536, mediana OS pri oktreotidu LAR je bila 27,4 meseca, pri zdravilu Lutathera pa še vedno ni bila dosežena.
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). 
Če določeni neželeni učinki tega zdravila, kot je na primer hematotoksičnost razreda 3-4 (G3-G4), vztrajajo ali se ponovno pojavijo (glejte preglednico 5)
The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies: 
Na podlagi kliničnih študij z ocenami sevalne dozimetrije so bili za zdravljenje z zdravilom Lutathera določeni naslednji sklepi: