FrancophonIA/ELRC3.0 huggingface dataset:
English: Absorption The medicinal product is administered intravenously and is immediately and completely bioavailable.
Croatian: Apsorpcija Lijek se primjenjuje intravenski i odmah je i u potpunosti bioraspoloživ.
English: If in any doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Croatian: Ako postoji sumnja na trudnoću (ako je u žene izostala mjesečnica, ako je mjesečnica vrlo neredovita, itd.), bolesnici je potrebno ponuditi druge metode koje ne uključuju primjenu ionizirajućeg zračenja (ako su dostupne).
English: 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.
Croatian: Rezultati ukazuju na poboljšanje ukupne kvalitete života povezane sa zdravljem do 84. tjedna u bolesnika liječenih lijekom Lutathera u odnosu na bolesnike liječene oktreotidom LAR.
English: 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)*.
Croatian: Ako se promatrana toksičnost razriješi unutar 16 tjedana nakon posljednje infuzije, moguće je nastaviti liječenje lijekom Lutathera tako da se primjenjuje infuzija pola doze (3700 MBq)*.
English: The catheters should be connected to the infusion sets (one for Lutathera, one for amino acid solution).
Croatian: Kateteri bi trebali biti povezani s kompletima za infuziju (jednim za lijek Lutathera, drugim za otopinu aminokiselina).
English: Other very common adverse reactions reported include fatigue (27.7%) and decreased appetite
Croatian: Ostale vrlo česte nuspojave uključuju umor (27,7 %) i smanjeni apetit (13,4 %).
English: • Kidney function (creatinine and creatinine clearance)
Croatian: • Funkcija bubrega (kreatinin i klirens kreatinina)
English: Concomitant use of cold somatostatin analogues may be needed for disease symptoms control.
Croatian: Možda će biti potrebna istovremena uporaba „hladnih“ (neradioaktivnih) somatostatinskih analoga radi kontrole simptoma bolesti.
English: Treatment can be resumed after resolution or stabilisation.
Croatian: Liječenje se može nastaviti kada se problem riješi ili se stanje stabilizira.
English: − Two (2) gravity intravenous infusion sets with a clamp to regulate or stop the flow (one for Lutathera, one for amino acid solution administration)
Croatian: − Dva (2) kompleta za gravitacijsku intravensku infuziju sa stezaljkom za regulaciju ili zaustavljanje protoka (jedan za primjenu Lutathere, jedan za primjenu otopine aminokiselina)
English: Feeling abnormal
Croatian: Smrt Abnormalni osjećaj
English: The posology can be adapted according to the patient's status at the discretion of the physician.
Croatian: Doziranje se može prilagoditi bolesnikovom stanju prema odluci liječnika.
English: Therefore, as a matter of cautiousness, repeated administration of high-doses of glucocorticosteroids should be avoided during Lutathera treatment.
Croatian: Stoga je, kao mjera opreza, potrebno izbjegavati ponovnu primjenu visokih doza glukokortikosteroida tijekom terapije lijekom Lutathera.
English: The patient treated with Lutathera should be kept away from others during the administration and up to reaching the radiation emission limits stipulated by applicable laws, usually within the 4-5 hours following medicinal product administration.
Croatian: Bolesnika koji je liječen lijekom Lutathera potrebno je odvojiti od drugih osoba tijekom primjene lijeka i do postizanja graničnih vrijednosti emisije zračenja propisanih važećim zakonima, obično unutar 4-5 sati nakon primjene lijeka.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Zato je potrebno poduzeti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: Gastrointestinal pain Stomatitis
Croatian: Gastrointestinalna bol Stomatitis
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.
Croatian: U slučaju da su prethodno primijenjene terapije protiv mučnine i povraćanja nedostatne, može se koristiti pojedinačna doza kortikosteroida, sve dok se ne daje prije početka ili unutar sat vremena po završetku infuzije lijeka Lutathera.
English: It is necessary to wear waterproof gloves and suitable aseptic techniques when handling the medicinal product.
Croatian: Za rukovanje lijekom potrebno je nositi vodonepropusne rukavice i služiti se odgovarajućim aseptičkim tehnikama.
English: Two intravenous plastic catheters should be inserted into patient's peripheral veins, one on each arm.
Croatian: U periferne vene bolesnika potrebno je umetnuti dva intravenska plastična katetera, po jedan na svaku ruku.
English: Meldola (FC) Italy
Croatian: Meldola (FC) Italija
English: The flow of Lutathera from the vial to the patient should be monitored during the entire infusion.
Croatian: Protok lijeka Lutathera od bočice do bolesnika potrebno je pratiti tijekom cijele infuzije.
English: Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake (tumour uptake score ≥ 2).
Croatian: Prije započinjanja liječenja Lutatherom oslikavanje somatostatinskih receptora (scintigrafijom ili pozitronskom emisijskom tomografijom [PET]) mora potvrditi prekomjernu ekspresiju tih receptora u tumorskom tkivu s unosom u tumor koji je najmanje jednak normalnom unosu u jetru (rezultat unosa u tumor ≥ 2).
English: The use of Lutathera is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk associated with the ionizing radiation (see section 4.3).
Croatian: Uporaba lijeka Lutathera je kontraindicirana tijekom potvrđene trudnoće ili sumnje na trudnoću ili kada trudnoća nije isključena, zbog rizika vezanih uz ionizirajuće zračenje (vidjeti dio
English: Clear, colourless to slightly yellow solution.
Croatian: Bistra, bezbojna do blijedo žuta otopina.
English: A patient presenting with any of the conditions below is more prone to develop adverse reactions.
Croatian: Bolesnik koji ima bilo koje od dolje navedenih stanja skloniji je nuspojavama.
English: Men and women of child-bearing potential must refrain from procreation by using effective contraceptive methods during the treatment and for 6 months after.
Croatian: Muškarci i žene reproduktivne dobi moraju se suzdržati od začeća upotrebom djelotvorne metode zaštite od trudnoće tijekom liječenja i 6 mjeseci nakon završetka liječenja.
English: Store in the original package to protect from radiation.
Croatian: Čuvati u originalnom pakiranju radi zaštite od zračenja.
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.
Croatian: Predoziranje nije vjerojatno jer ćete primiti samo jednu dozu lijeka Lutathera koju precizno kontrolira liječnik specijalist nuklearne medicine koji nadgleda postupak primjene.
English: Items that cannot be flushed down the toilet, such as menstrual pads and bandages, must be placed in specific trash plastic bags (according to the recommendation stated in section "Trash recommendations" below).
Croatian: Predmeti koji se ne mogu bacati u zahod, kao što su menstrualni ulošci i zavoji, moraju se odložiti u posebne plastične vrećice (prema preporuci navedenoj u dijelu
English: Overall, the results of the dosimetric analysis performed in the NETTER-1 phase III dosimetry substudy and in the Erasmus phase I/II study are in agreement and indicate that Lutathera dose regimen (4 administrations of 7,400 MBq) is safe.
Croatian: Ukupno gledajući, rezultati dozimetrijske analize provedene u dozimetrijskom podispitivanju u ispitivanju faze III NETTER-1. i u ispitivanju faze I/II Erasmus su usklađeni i pokazuju da je režim doziranja lijeka Lutathera (4 primjene od 7400 MBq) siguran.
English: Use of toilets
Croatian: Posuđe i pribor za kupaonicu
English: Secondary malignant neoplasms
Croatian: Sekundarne maligne neoplazme
English: − Two (2) infusion poles
Croatian: − Dva (2) stalka za infuziju
English: These finding are supported by in vitro metabolism data in human hepatocytes, in which no metabolic degradation of lutetium (175Lu) oxodotreotide was observed.
Croatian: Te nalaze podupiru podaci o in vitro metabolizmu u ljudskim hepatocitima, u kojima nije zabilježena nikakva metabolička razgradnja lutecijeva (175Lu) oksodotreotida.
English: It is strongly recommended to move your bowels every day and use a laxative if necessary.
Croatian: Izrazito se preporuča svakodnevno prazniti crijeva i po potrebi koristiti laksativ.
English: Urine and faeces should be disposed according to the national regulations.
Croatian: Urin i feces potrebno je odlagati u skladu s državnim propisima.
English: It is a ready to use radiopharmaceutical medicinal product for single use only.
Croatian: To je radiofarmaceutik spreman za primjenu, namijenjen samo za jednokratnu uporabu.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6).
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima (vidjeti dio 6.6).
English: In the case of overdose, an increase in the frequency of the adverse reactions related to radiotoxicity is expected.
Croatian: U slučaju predoziranja očekuje se povećanje učestalosti nuspojava povezanih s radiotoksičnosti.
English: In the event of administration of a radiation overdose with Lutathera, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding during the first 48 hours after infusion.
Croatian: U slučaju primjene prevelike doze zračenja lijekom Lutathera, dozu koju je bolesnik apsorbirao potrebno je smanjiti, kad je to moguće, ubrzavanjem eliminacije radionuklida iz tijela čestim mokrenjem ili prisilnom diurezom i čestim pražnjenjem mokraćnog mjehura tijekom prvih 48 sati nakon infuzije.
English: The median PFS for Lutathera was not reached at the time of analysis whereas the one of octreotide LAR was 8.5 months.
Croatian: Medijan PFS-a za lijek Lutathera nije postignut u vrijeme analize, dok je za oktreotid LAR iznosio 8,5 mjeseci.
English: In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered.
Croatian: U slučaju jake mučnine ili povraćanja tijekom infuzije otopine aminokiselina može se primijeniti antiemetik iz druge farmakološke grupe.
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Croatian: Kada se planira primjena radiofarmaceutika u žena reproduktivne dobi, važno je isključiti moguću trudnoću.
English: The ORR (including complete response (CR) and partial response (PR) according to RECIST criteria) and duration of response (DoR) for the FAS Dutch population with gastroenteropancreatic (GEP) and bronchial NETs (360 patients) as well as per tumour type are presented in Table 10.
Croatian: ORR (uključujući kompletan odgovor (CR) i djelomični odgovor (PR) u skladu s kriterijima RECIST) i trajanje odgovora (DoR) za nizozemsku FAS populaciju s gastroenteropankreatičnim (GEP) i bronhijalnim NET-ovima (360 bolesnika), kao i po vrsti tumora, prikazani su u Tablici 10.
English: Staphylococcal infections Streptococcal bacteraemia
Croatian: Stafilokokne infekcije Streptokokna bakterijemija
English: Cases of irreversible hematological pathologies, i.e., premalignant and malignant blood neoplasms (i.e., myelodysplastic syndrome and acute myeloid leukemia, respectively) have been reported following Lutathera treatment.
Croatian: Slučajevi ireverzibilnih hematoloških patologija, tj. premaligne i maligne neoplazme krvi (tj. mijelodisplastični sindrom odnosno akutna mijeloidna leukemija), zabilježeni su nakon liječenja lijekom Lutathera.
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.
Croatian: Ukupni sigurnosni profil lijeka Lutathera temelji se na prikupljenim podacima bolesnika iz kliničkih ispitivanja (ispitivanje faze III NETTER-1 i ispitivanje faze I/II Erasmus, nizozemski bolesnici) i iz programa milosrdnog davanja lijeka („compassionate use“).
English: Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death.
Croatian: Lutathera se veže na te receptore i emitira radioaktivnost izravno u tumorske stanice,
English: Occurrence of an intercurrent disease (e.g. urinary tract infection), which according to the physician could increase the risks associated to Lutathera administration.
Croatian: Pojava interkurentne bolesti (npr. infekcije mokraćnog sustava) koja bi prema liječniku mogla povećati rizike povezane s primjenom
English: • Information on the precautions the patient should take before, during and after the administration procedure, at the hospital and at home, to limit unnecessary exposure to radiations of themselves and their entourage.
Croatian: • Kratki uvod o liječenju i postupku primjene lijeka • Informacije o mjerama opreza koje bolesnik mora poduzeti prije, tijekom i nakon postupka primjene, u bolnici i kod kuće kako bi se ograničila nepotrebna izloženost zračenjima njih samim i osoba u njihovoj pratnji.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2017
Croatian: Datum prvog odobrenja: 26. rujan 2017.
English: The causality of nausea / vomiting is confounded by the emetic effect of the concomitant amino acids infusion administered for renal protection.
Croatian: Uzrok mučnine/povraćanja može se pripisati i emetičkom učinkom istodobne infuzije aminokiselina koja se primjenjuje za renalnu zaštitu.
English: • Information that PPRT can cause serious side effects during or after treatment and that any side effect should be reported to the physician.
Croatian: • Informacije da PRRT (radionuklidna terapija usmjerena na peptidne receptore) može uzrokovati ozbiljne nuspojave tijekom ili po završetku liječenja i da se svaka nuspojava mora prijaviti liječniku.
English: It binds to malignant cells which overexpress sst2 receptors.
Croatian: Veže se na zloćudne stanice koje imaju prekomjernu ekspresiju sst2 receptora.
English: There is no relevant use of Lutathera in the paediatric population in the indication of treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Croatian: Nema relevantne primjene Lutathere u pedijatrijskoj populaciji u indikaciji liječenja GEP-NET-ova (isključujući neuroblastom, neuroganglioblastom, feokromocitom).
English: Constant intra-vial pressure should be maintained during the entire infusion.
Croatian: Potrebno je održavati stalni tlak u bočici tijekom cijele infuzije.
English: Due to the bone marrow toxicity of Lutathera, the most expected adverse reactions were related to haematological toxicity: thrombocytopenia (25%), lymphopenia (22.3%), anaemia (13.4%), pancytopenia (10.2%).
Croatian: Zbog toksičnog učinka lijeka Lutathera na koštanu srž, najvjerojatnije nuspojave bile su povezane s hematološkom toksičnošću: trombocitopenija (25 %), limfopenija (22,3 %), anemija (13,4 %),
English: 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.
Croatian: Budući da je poznato da se ovaj lijek u velikoj mjeri izlučuje putem bubrega, bolesnike s blago ili umjereno oštećenom funkcijom bubrega potrebno je češće pratiti tijekom liječenja.
English: The visual inspection of the solution should be performed under a shielded screen for radioprotection purposes.
Croatian: Vizualni pregled otopine potrebno je izvesti sa zaštitnom maskom radi zaštite od zračenja.
English: a. If the observed toxicity continues beyond 16 weeks after the last infusion, treatment with Lutathera must be definitively stopped.
Croatian: Ako se zabilježena toksičnost nastavi nakon 16 tjedana nakon posljednje infuzije, liječenje lijekom Lutathera mora se trajno obustaviti.
English: Soon after the start of the infusion, the radioactivity emission over the patient's thorax should be measured using Geiger counter to verify the presence of Lutathera in the bloodstream.
Croatian: Ubrzo nakon početka infuzije potrebno je mjeriti emisiju radioaktivnosti u području bolesnikovog prsnog koša pomoću Geigerovog brojača radi potvrde prisutnost lijeka Lutathera u krvotoku.
English: * The concomitant amino acids infusion is always administered at full dose (see section 4.4).
Croatian: * Istovremena infuzija aminokiselina uvijek se primjenjuje u punoj dozi (vidjeti dio 4.4.). ** CTCAE (engl.
English: Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
Croatian: Radioaktivnost u bočici s lijekom Lutathera potrebno je izmjeriti neposredno prije infuzije pomoću kalibriranog sustava za mjerenje radioaktivnosti.
English: The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion.
Croatian: Ukupna količina radioaktivnosti po jednodoznoj bočici iznosi 7400 MBq na datum i vrijeme infuzije.
English: The use of Lutathera is contraindicated in patients with severe kidney failure (see section 4.3).
Croatian: Uporaba lijeka Lutathera je kontraindicirana kod bolesnika s teškim zatajenjem bubrega (vidjeti dio 4.3).
English: Each vial contains a volume varying from 20.5 to 25.0 mL of solution corresponding to an activity of 7,400 MBq at date and time of infusion.
Croatian: Svaka bočica sadržava volumen koji varira od 20,5 do 25,0 mL otopine koja odgovara aktivnosti od 7400 MBq na datum i vrijeme infuzije.
English: 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.
Croatian: Lutathera, a za djecu i trudnice trebao bi biti ograničen na manje od 15 minuta svaki dan, uz zadržavanje udaljenosti od najmanje 1 metar.
English: Criteria for permanent discontinuation of treatment with Lutathera
Croatian: Tablica 3. Kriteriji za trajni prekid liječenja Lutatherom
English: This should be taken into consideration in patient on controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika bit će u skladu s nacionalnim propisima o radioaktivnim materijalima.
English: If you get any side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu obratite se svojem liječniku.
English: People who are confined to the bed or have reduced mobility will preferably receive assistance by a care provider.
Croatian: Poželjno je da nepokretni bolesnici ili bolesnici koji imaju smanjenu pokretljivost dobiju pomoć od pružatelja usluga skrbi.
English: The use of Lutathera does involve exposure to amounts of radioactivity.
Croatian: Uporaba lijeka Lutathera uključuje izloženost određenim dozama radioaktivnosti.
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.
Croatian: Ispitivanje faze III NETTER-1 bilo je multicentrično, stratificirano, otvoreno, randomizirano ispitivanje, kontrolirano usporednim lijekom, i s paralelnim skupinama koje je uspoređivalo liječenje lijekom Lutathera (4 doze od 7400 MBq svakih 8 tjedana) istodobno primijenjenom uz otopinu aminokiselina i uz najbolju potpornu skrb (oktreotid dugotrajnog oslobađanja [LAR, engl. long acting release] 30 mg svaka 4 tjedna za kontrolu simptoma, zamijenjen oktreotidom kratkotrajnog djelovanja u intervalu od 4 tjedna prije primjene lijeka Lutathera) s oktreotidom LAR visoke doze (60 mg svaka 4 tjedna) u bolesnika s inoperabilnim, progresivnim, karcinoidnim tumorima srednjeg crijeva (engl. midgut) koji su pozitivni na somatostatinske receptore.
English: Lutathera side effects are mainly linked to radioactivity.
Croatian: Nuspojave lijeka Lutathera uglavnom su povezane s radioaktivnošću.
English: • Care supplies and equipment:
Croatian: • Pomagala i oprema za njegu:
English: Since many patients referred for Lutathera therapy have hepatic metastasis, it may be common to observe patients with altered baseline liver function.
Croatian: Budući da mnogi bolesnici koji su upućeni na terapiju lijekom Lutathera imaju jetrene metastaze, nije neuobičajeno da bolesnici imaju izmijenjenu početnu funkciju jetre.
English: • Blood chemistry monitoring: serum creatinine and glycaemia.
Croatian: • Praćenje biokemijskih parametara krvi: serumski kreatinin i glikemija.
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).
Croatian: Primjenu otopine aminokiselina potrebno je započeti 30 minuta prije infuzije lijeka Lutathera, s brzinom infuzije od 250 do 550 mL/h (ovisno o vrsti otopine).
English: • Liver impairment with either total bilirubinemia > 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%;
Croatian: • Oštećenje funkcije jetre s ili ukupnom bilirubinemijom koja je ˃ 3 puta veća od gornje granice normalne vrijednosti ili albuminemijom < 30 g/L uz protrombinski omjer smanjen na < 70 %;
English: Antiemetic bolus
Croatian: Antiemetik bolus
English: Sleep disorders
Croatian: Poremećaji spavanja
English: All the administration device materials should be kept in order to measure the residual radioactivity and the activity actually administered and eventually the absorbed dose should be determined.
Croatian: Sve dijelove uređaja za primjenu potrebno je zadržati kako bi se izmjerila preostala radioaktivnost i aktivnost koja se stvarno primijenila te na kraju utvrdila apsorbirana doza.
English: 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).
Croatian: Nije zabilježena statistički značajna razlika u PFS između podskupine bolesnika koji nisu primali oktreotid LAR (25,4 mjeseci [95% CI 22,8 - 30,6]) u odnosu na podskupinu koja je primila istodobnu terapiju oktreotidom LAR (30,9 mjeseci [95% CI 25,6 - 34,8]) (p=0,747).
English: Store in the original package to protect from ionizing radiation (lead shielding).
Croatian: Čuvati u originalnom pakiranju radi zaštite od ionizirajućeg zračenja (olovni spremnik).