FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Analize visokozmogljivostne tekočinske kromatografije (HPLC) vzorcev urina, zbranih do 48 ur po infuziji, so pokazale radiokemijsko čistoto lutecijevega (177Lu) oksodotreotida blizu 100 % v večini analiziranih vzorcev (z najnižjo radiokemijsko vrednostjo čistote, večjo od 92 %), kar kaže, da je spojina v glavnem izloči v urinu kot intaktna spojina.
English: However, since increased risk of presenting haematotoxicity has been described in elderly patients (≥ 70 years old), a close follow up allowing for prompt dose adaptation (DMT) in this population is advisable.
Slovenian: Je pa bilo pri starejših bolnikih (starih ≥ 70 let) opisano povečano tveganje pojava hematotoksičnosti, zato je pri tej populaciji priporočljivo skrbno spremljanje, ki bo omogočilo takojšnjo prilagoditev odmerka (DMT).
English: To continue Lutathera infusion, it is mandatory to use a new catheter possibly placing it in a contralateral venous access.
Slovenian: V nadaljevanju infuzije zdravila Lutathera je treba obvezno uporabiti novi kateter, ki ga je treba po možnosti vstaviti v kontralateralni venski dostop.
English: Store in the original package to protect from ionizing radiation (lead shielding).
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred ionizirajočim sevanjem (svinčena zaščita).
English: • Liver impairment with either total bilirubinemia > 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%;
Slovenian: • jetrna okvara s popolno bilirubinemijo > 3-kratne zgornje meje normalnih vrednosti ali albuminemija < 30 g/L z zmanjšanim deležem protrombina < 70 %;
English: CR = Complete response; PR = Partial response; SD = Stable disease; ORR = Objective response (CR+PR); DoR = Duration of response * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
Slovenian: CR = popolni odziv (Complete response); PR = delni odziv (Partial response); SD = stabilna bolezen (Stable disease); ORR - objektivni odziv (Objective response) (CR+PR); DoR (Duration of response) = trajanje odziva
English: The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion.
Slovenian: Zdravilo je treba infundirati po intravenskem katetru, ki je v veno vstavljen izključno za to infuzijo.
English: Lutathera side effects are mainly linked to radioactivity.
Slovenian: Neželeni učinki zdravila Lutathera so v glavnem povezani z radioaktivnostjo.
English: Absorbed dose estimates for lutetium (177Lu) oxodotreotide from NETTER-1 phase III study (Olinda output)
Slovenian: Preglednica 12: Ocene absorbiranega odmerka za lutecijev (177Lu) oksodotreotid iz študije NETTER-1 III. faze (izid Olinda)
English: Atrial fibrillation Palpitations Myocardial infarction Angina pectoris Cardiogenic shock
Slovenian: Atrijska fibrilacija Palpitacije Miokardni infarkt Angina pektoris Kardiogeni šok
English: Administration of the amino acid solution should be initiated 30 minutes before Lutathera infusion, with an infusion rate of 250 to 550 mL/h (depending on the solution type).
Slovenian: Apliciranje raztopine aminokislin je treba začeti 30 minut pred infundiranjem zdravila Lutathera z hitrostjo infundiranja od 250 do 550 ml/h (odvisno od vrste raztopine).
English: Gravity infusion method - tubing connection scheme
Slovenian: Slika 2: Metoda gravitacijske infuzije - shema priključitve cevke
English: To ensure complete administration, the Lutathera vial should be kept under even pressure.
Slovenian: Da se zagotovi celotna aplikacija je potrebno vialo zdravila Lutathera vzdrževati pod enakomernim tlakom.
English: See Table 5.
Slovenian: Glejte preglednico 5.
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”).
Slovenian: - Druge sestavine so: ocetna kislina, natrijev acetat, gentizinska kislina, askorbinska kislina, dietilen-triamin-pentaetanojska kislina (DTPA), natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje, voda za injekcije (glejte poglavje 2 z naslovom Zdravilo Lutathera vsebuje natrij).
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.
Slovenian: (177Hf), pri čemer ima najbogatejša β- (79,3 %) največjo energijo 0,497 MeV.
English: If you have been given more Lutathera than you should An overdose is unlikely because you will only receive a single dose of Lutathera precisely controlled by the nuclear medicine doctor supervising the administration procedure.
Slovenian: Preveliko odmerjanje ni verjetno, saj boste prejeli le en odmerek zdravila pod nadzorovanimi pogoji s strani zdravnika nuklearne medicine, ki bo nadzoroval postopek aplikacije.
English: • Hypersensitivity to the active substance, to any of the excipients listed in section 6.1.
Slovenian: Nosečnost Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: The MAH shall ensure that in each Member State where Lutathera is marketed, all patients/carers who are expected to be administered Lutathera have access to/are provided with a patient educational material containing:
Slovenian: Lutathera, zagotoviti, da vsi bolniki, ki bodo prejeli zdravilo Lutathera, in njihovi negovalci, prejmejo ali imajo dostop do gradiva za izobraževanje bolnikov, ki vsebuje:
English: In the case where the treatments previously provided for nausea and vomiting are insufficient, a single dose of corticosteroids can be used, as long as it is not given before initiating or within one hour after the end of Lutathera infusion.
Slovenian: V primeru, kadar predhodno zdravljenje proti navzei in bruhanju ne zadostuje, se lahko uporabi enkratni odmerek kortikosteroidov, če se že ni apliciral pred začetkom infundiranja zdravila
English: NETTER-1 phase III study was a multicentre stratified, open labelled, randomized, comparator-controlled, parallel-group study comparing treatment with Lutathera (4 doses of 7,400 MBq every 8 weeks) co-administered with amino acid solution plus best supportive care (BSC; octreotide long acting release [LAR] 30 mg every 4 weeks for symptoms control, replaced by short acting octreotide in the 4 weeks interval before Lutathera administration) to high dose octreotide LAR (60 mg every 4 weeks) in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours.
Slovenian: Študija NETTER-1 III. faze je bila multicentrična stratificirana, odprta, randomizirana, s primerjalnim zdravilom kontrolirana študija s vzporednimi študijskimi skupinami za primerjavo zdravljenja z zdravilom Lutathera (4 odmerki po 7.400 MBq vsakih 8 tednov) sočasno z raztopino aminokislin in najboljšo podporno oskrbo (NPO; 30 mg okreotida z dolgotrajnim sproščanjem [LAR] vsake 4 tedne za nadzor simptomov, nato okreotid s kratkotrajnim delovanjem v obdobju 4 tednov pred aplikacijo zdravila Lutathera) z visokim odmerkom oktreotida LAR (60 mg vsake 4 tedne) pri bolnikih z neoperabilnimi, progresivnimi, karcinoidnimi tumorji s pozitivnimi somatostatinskimi receptorji v srednjem črevesju.
English: Any haematological toxicity of grade 3 or superior (CTCAE)**, except lymphopenia.
Slovenian: Vsakršna hematološka toksičnost 3. ali višje stopnje (CTCAE)**, razen limfopenije.
English: It is strongly recommended to move your bowels every day and use a laxative if necessary.
Slovenian: Zelo priporočljivo je, da greste na blato vsak dan in po potrebi vzamete tudi odvajala.
English: Therefore, administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of this medicinal product.
Slovenian: Apliciranju dolgodelujočih somatostatinskih analogov se je treba zato izogibati v obdobju 30 dni pred aplikacijo tega zdravila.
English: Amount
Slovenian: Količina
English: Lutathera must not be used after the expiry date which is stated on the label after EXP. Store below 25 ºC.
Slovenian: Zdravila Lutathera se ne sme uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP.
English: Lutathera is a radiopharmaceutical medicine used for the treatment of certain tumours (gastroenteropancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and does not respond more to your current treatment.
Slovenian: (gastroenteropankreatskih nevroendokrinih tumorjev), ki jih iz telesa ni mogoče v celoti odstraniti z operacijo, so se razširili v telesu (metastatsko) in se ne odzivajo več na trenutno zdravljenje.
English: Visual controls of the solution levels should be repeated during the administration by direct visual control (when PMMA container is used) or using a pair of tongs to handle the vial when the lead shipping container is used.
Slovenian: Med aplikacijo je treba redno preverjati raven raztopine z neposredno vizualno kontrolo (pri uporabi vsebnika PMMA) ali s kleščami za prijemanje viale v primeru uporabe svinčenega vsebnika.
English: The overall safety profile of Lutathera is based on pooled data from patients from clinical trials (NETTER-1 phase III and Erasmus phase I/II Dutch patients) and from compassionate use programs.
Slovenian: Splošni varnostni profil zdravila Lutathera temelji na združenih podatkih bolnikov iz kliničnih preskušanj (NETTER-1, III. faza in Erasmus I./II.
English: You do not need to use bleach and do not need extra rinses.
Slovenian: Ni vam treba uporabljati belila ali dodanih ciklov izpiranja.
English: Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Slovenian: Aktivnost v času infundiranja: {Z} MBq - {DD/MM/LLLL uu:mm UTC}
English: It is considered unlikely that Lutathera will affect your ability to drive or to use machines; however, your general condition and the possible adverse reactions to treatment must be taken into account to assess this ability before driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bo zdravilo Lutathera vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev; vendar pa je treba pri oceni sposobnosti za vožnjo ali uporabo strojev upoštevati možne neželene učinke zdravljenja.
English: Store in the original package to protect from radiation.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred sevanjem.
English: Other medicines and Lutathera
Slovenian: Druga zdravila in zdravilo Lutathera
English: − Two (2) infusion poles
Slovenian: − dve (2) infuzijski stojali;
English: Anxiety Hallucination Disorientation
Slovenian: Anksioznost Halucinacije
English: The median PFS for Lutathera was 28.4 months whereas the one of octreotide LAR was 8.5 months.
Slovenian: Mediana PFS za zdravilo Lutathera je bila 28,4 meseca, za oktreotid LAR pa 8,5 meseca.
English: Take special care with Lutathera - if your kidney or urinary track are not correctly developed - if you are suffering from urinary incontinence
Slovenian: Bodite posebno pozorni pri zdravilu Lutathera: - če vaše ledvice ali urinarni trakt niso pravilno razviti;
English: In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or even discontinue the treatment (see Table 3 - Table 5 and Figure 1).
Slovenian: Prilagajanje odmerka V nekaterih okoliščinah bo morda treba začasno prekiniti zdravljenje z zdravilom Lutathera, po prvi aplikaciji prilagoditi odmerek ali celo dokončno ukiniti zdravljenje (glejte preglednico 3
English: • Hematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia;
Slovenian: • hematološka toksičnost, večja ali enaka 2. stopnji (CTCAE) pred zdravljenjem, razen limfopenije; • metastaze v kosti;
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).
Slovenian: Redko so opazili pojav hormonskih kriz, povezanih s sproščanjem bioaktivne snovi (verjetno zaradi lize celic nevroendokrinega tumorja), ki so izginile po ustreznem zdravljenju (glejte poglavje 4.4).
English: Storage of the vial
Slovenian: Zahteve Shranjevanje vial
English: • Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1., • ugotovljena nosečnost, sum nanjo ali primeri, kadar nosečnost ni izključena (glejte poglavje 4.6),
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Slovenian: Če ste v dvomih, je pomembno, da se posvetujte z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
English: Transchelation of lutetium from lutetium (175Lu) oxodotreotide into serum proteins has not been observed.
Slovenian: Transhelacije lutecija iz lutecijevega (175Lu) oksodotreotida v serumske proteine niso opazili.
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).
Slovenian: Infuzijo zdravila Lutathera je treba začeti 30 minut po začetku infuzije raztopine aminokislin pri hitrosti infundiranja približno 400 ml/h (to je referenčna hitrost infundiranja in jo je mogoče prilagoditi glede na bolnikovo stanje ven).
English: Abdominal distension Diarrhoea
Slovenian: Abdominalna distenzija Diareja
English: • Mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min;
Slovenian: • blaga do zmerna kronična bolezen ledvic s kreatininskim očistkom ≥ 50 ml/min;
English: This should be taken into consideration in patient on controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
English: Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion.
Slovenian: Zdravilo Lutathera je treba dajati s počasnim intravenskim infundiranjem v približno 30 minutah sočasno z raztopino aminokislin, aplicirano s kontralateralno intravensko infuzijo.
English: During the infusion, the radioactivity emission from the patient's thorax should steadily increase while the one from the Lutathera vial should decrease.
Slovenian: Med infuzijo se mora radioaktivno sevanje na bolnikovem prsnem košu enakomerno povečevati, medtem ko se mora sevanje iz viale zdravila Lutathera zmanjševati.
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).
Slovenian: Toksični učinek na kostni mozeg (mielo-/hematotoksičnost) se kaže s povratnim/prehodnim zmanjšanjem števila krvnih celic, ki vpliva na vse vrste celic (citopenije v vseh kombinacijah, tj. pancitopenija, bicitopenije, izolirane monocitopenije - anemija, nevtropenija, limfocitopenija in trombocitopenija).
English: The vial is enclosed within a plastic sealed, lead shielded container.
Slovenian: Viala je zaprta v zatesnjenem plastičnem vsebniku, zaščitenem s svincem.
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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Therefore, as a matter of cautiousness, repeated administration of high-doses of glucocorticosteroids should be avoided during Lutathera treatment.
Slovenian: Zato se je treba zaradi previdnosti izogniti večkratnemu apliciranju visokih odmerkov glukokortikoidov med zdravljenjem z zdravilom Lutathera.
English: The causality of nausea / vomiting is confounded by the emetic effect of the concomitant amino acids infusion administered for renal protection.
Slovenian: Vzročnost navzee/bruhanja je nejasna zaradi emetskega učinka sočasne infuzije aminokislin za zaščito ledvic.
English: No additional medicinal product can be administered to the same side where the extravasation occurred.
Slovenian: Na strani, kjer je prišlo do ekstravazacije, se ne aplicira nobenega dodatnega zdravila.
English: • The flow of the radiopharmaceutical solution should be regulated with the clamps.
Slovenian: • Pretok raztopine radiofarmaka je treba uravnavati s sponkami.
English: Patients with brain metastases
Slovenian: Bolniki z metastazami v možganih
English: In the Erasmus phase I/II study 188 patients (52%) received and 172 (48%) did not receive concomitant octreotide LAR during Lutathera treatment.
Slovenian: faze je med zdravljenjem z zdravilom Lutathera 188 bolnikov (52 %) sočasno prejemalo oktreotid LAR, 172 (48 %) pa jih tega ni prejemalo.
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.
Slovenian: 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.
English: The volume of sodium chloride 9 mg/mL (0.9%) solution for injection necessary to complete the infusion may vary.
Slovenian: Količina natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, potrebne za celotno infuzijo, je lahko različna.
English: This medicine contains 0.14 mmol (3.2 mg) of sodium per mL.
Slovenian: To zdravilo vsebuje 0,14 mmol (3,2 mg) natrija na ml.
English: Acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride 9 mg/mL injection, sodium hydroxide, water for injections.
Slovenian: Ocetna kislina, natrijev acetat, gentizinska kislina, askorbinska kislina, pentetinska kislina, natrijev klorid 9 mg/ml injekcija, natrijev hidroksid, voda za injekcije.
English: Urinary incontinence Glomerular filtration rate decreased Renal disorder
Slovenian: Urinarna inkontinenca Zmanjšana hitrost glomerularne filtracije
English: Instructions for dose modifications Adjust Lutathera dosing for the following severe adverse reactions: Severe adverse reactions
Slovenian: Odmerek zdravila Lutathera prilagodite v primeru naslednjih hudih neželenih učinkov:« Hudi neželeni učinki
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).
Slovenian: 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).
English: Antiemetic bolus
Slovenian: Antiemetik bolus
English: Electrocardiogram QT prolonged
Slovenian: Podaljšan interval QT elektrokardiograma
English: The visual inspection of the solution should be performed under a shielded screen for radioprotection purposes.
Slovenian: Pregled je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
English: Should you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure.
Slovenian: Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom nuklearne medicine, ki nadzoruje postopek.
English: p-value of Log-rank test Hazard ratio (95%-CI)
Slovenian: p-vrednost v testu Log rank Razmerje tveganja (95-% IZ)
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.
Slovenian: 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.
English: Lutathera has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Lutathera nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Slovenian: Radiofarmacevtska zdravila se bodo shranjevala v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
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.
Slovenian: 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.
English: • The short needle should be then connected to the pre-filled infusion set.
Slovenian: • Kratko iglo je treba nato priključiti na napolnjeni komplet za infuzijo.
English: Haematocrit decreased Protein urine
Slovenian: Proteini v urinu Zmanjšanje telesne mase
English: Specification of commercially available amino acid solutions Characteristic
Slovenian: Preglednica 2: Specifikacije komercialno dostopnih raztopin aminokislin Lastnosti
English: Administration of Lutathera and conduct of the procedure Lutathera is administered directly into a vein.
Slovenian: Apliciranje zdravila Lutathera in izvedba postopka Zdravilo Lutathera vam injicirajo neposredno v veno.
English: 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.
Slovenian: Odsotnost inhibicije ali znatne indukcije humanih encimov CYP450, odsotnost specifične interakcije s P-glikoproteinom (efluksnim transporterjem) in s transporterji OAT1, OAT3, OCT2, OATP1B1,
English: Individual benefit/risk justification
Slovenian: Presoja tveganja in koristi pri posameznem bolniku