FrancophonIA/ELRC3.0 huggingface dataset:
English: Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed.
Croatian: Toksikološka ispitivanja provedena na štakorima pokazala su da se jedna intravenska injekcija do 4550 MBq/kg dobro podnosi i nisu zabilježeni smrtni slučajevi.
English: Secondary endpoints included objective response rate (ORR), overall survival (OS), time to tumour progression (TTP), safety and tolerability of the medicinal product and quality of life (QoL).
Croatian: Mjere sekundarnog ishoda obuhvaćale su stopu objektivnog odgovora (ORR), ukupno preživljenje (OS), vrijeme do progresije tumora (TTP), sigurnost i podnošljivost lijeka i kvalitetu života (QoL).
English: Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
Croatian: Lutatheru smiju primjenjivati samo osobe ovlaštene za rukovanje radiofarmaceuticima u namjenskom kliničkom okruženju (vidjeti dio 6.6) te nakon što kvalificirani liječnik pregleda bolesnika.
English: Therefore, it is recommended to monitor ALAT, ASAT, bilirubin and albumin serum during treatment (see section 4.2).
Croatian: Stoga je preporučljivo pratiti serumski ALT, AST, bilirubin i albumin tijekom liječenja (vidjeti dio 4.2).
English: General rule
Croatian: Opće pravilo
English: Healthcare personnel are advised to limit the time of close contact with patients injected with Lutathera.
Croatian: Savjetuje se da medicinsko osoblje ograniči vrijeme bliskog kontakta s bolesnicima koji su primili lijek Lutathera.
English: Wait 12 weeks after the date of surgery to administer Lutathera.
Croatian: Pričekajte 12 tjedana od datuma kirurškog zahvata s primjenom lijeka Lutathera.
English: The frequencies are categorized as follows: very common (≥1/10), common (≥1/100 to
Croatian: Učestalosti su kategorizirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10),
English: Patients with risk factors
Croatian: Bolesnici s rizičnim čimbenicima
English: Testes*
Croatian: Testisi*
English: • Severe heart failure defined as class III or IV in the NYHA classifications;
Croatian: • Teško zatajenje srca definirano kao klasa III ili IV prema NYHA klasifikaciji;
English: Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Croatian: 113 keV (6,2%) i 208 keV (11%).
English: • Administration room:
Croatian: • Prostorija za primjenu:
English: Not reached p-value of Log-rank test Hazard ratio (95%-CI)
Croatian: Nije postignuto p-vrijednost log-rang testa Omjer hazarda (95%-CI)
English: Considering the high quantity of amino acids and the significant volume that commercially available solutions may require to meet the above specifications, the compounded solution is considered the medicinal product of choice, due to its lower total volume to be infused and lower osmolarity.
Croatian: Uzimajući u obzir visoku količinu aminokiselina i značajni volumen koji može biti nužan pri uporabi komercijalno dostupnih otopina radi zadovoljavanja prethodno navedenih specifikacija, magistralni pripravak otopine prvi je izbor zbog manjeg ukupnog volumena za infuziju i manje osmolarnosti.
English: − One (1) Short needle
Croatian: − Jedna (1) kratka igla
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:
Croatian: MAH će osigurati da se u svakoj državi članici u kojoj se lijek Lutathera stavlja na tržište, svi bolesnici/njegovatelji za koje se očekuje da će primiti lijek Lutathera imaju pristup / dobiju edukacijske materijale za bolesnike koji sadrže: • Uputu o lijeku
English: The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used.
Croatian: Otopinu je potrebno vizualno pregledati radi otkrivanja oštećenja i kontaminacije prije uporabe, a smiju se upotrebljavati samo bistre otopine bez vidljivih čestica.
English: • Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL), platelets < 75 G/L
Croatian: • Narušena hematološka funkcija s ili Hb < 4,9 mmol/L (8 g/dL), trombocitima < 75 G/L
English: ** CTCAE: Common Terminology Criteria for Adverse Events, National Cancer Institute
Croatian: Common Terminology Criteria for Adverse Events, National Cancer Institute): Zajednički terminološki kriteriji za nuspojave Nacionalnog instituta za rak
English: Subsequent checks of the radioactivity emission should be performed approximately every 5 minutes at the level of the patient's thorax and vial.
Croatian: Naknadne provjere emisije radioaktivnosti obavljaju se približno svakih 5 minuta u području prsnog koša bolesnika i kod bočice.
English: • The flow of the radiopharmaceutical solution should be regulated with the clamps.
Croatian: • Protok radiofarmaceutske otopine potrebno je regulirati uz pomoć stezaljki.
English: Discontinue Lutathera administrations in patients who have experienced or are at risk of any of the following conditions during treatment:
Croatian: Prekinite primjenu Lutathere u bolesnika koji su tijekom liječenja imali ili su izloženi riziku od bilo kojeg od sljedećih stanja:
English: This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovaj lijek primjenjuju i njime rukuju samo osobe obučene i kvalificirane za njegovu sigurnu primjenu.
English: In case of hormonal crises, recommended treatments are: intravenous high dose somatostatin analogues, intravenous fluids, corticosteroids, and correction of electrolyte disturbances in patients with diarrhoea and/or vomiting.
Croatian: U slučaju hormonskih kriza, preporučene terapije su: intravenski somatostatinski analozi visokih doza, intravenske tekućine, kortikosteroidi i korekcija poremećaja elektrolita u bolesnika s proljevom i/ili povraćanjem.
English: The most common adverse reactions in patients receiving Lutathera treatment were nausea and vomiting which occurred at the beginning of the infusion in 58.9% and 45.5% of patients, respectively.
Croatian: Najčešće nuspojave kod bolesnika koji su primali lijek Lutathera bili su mučnina i povraćanje koji su se pojavili na početku infuzije u 58,9 %, odnosno 45,5 % bolesnika.
English: Anaemia4
Croatian: Anemija4
English: Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion.
Croatian: S obzirom na fiksnu volumetrijsku aktivnost od 370 MBq/mL na datum i vrijeme kalibracije, volumen otopine prilagođava se između 20,5 mL i 25,0 mL radi pružanja potrebne količine radioaktivnosti na datum i vrijeme infuzije.
English: • Hematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia;
Croatian: • Hematološka toksičnost veća ili jednaka stupnju 2 (CTCAE) prije liječenja, osim limfopenije;
English: Talk to your doctor before you are given Lutathera as it may cause: - secondary blood cancer (myelodisplastic syndrome or acute leukaemia) which can rarely occur several years after you have completed Lutathera treatment.
Croatian: Razgovarajte sa svojim liječnikom prije nego što počnete s primjenom lijeka Lutathera jer ona može uzrokovati: - sekundarni rak krvi (mijelodisplastični sindrom ili akutnu leukemiju) koji se rijetko može pojaviti nekoliko godina nakon što ste završili liječenje lijekom Lutathera.
English: Lutathera should be administered over 20 to 30 minute time span.
Croatian: Lijek Lutathera primjenjuje se tijekom razdoblja od 20 do 30 minuta.
English: • Either in a container made of polymethyl methacrylate (PMMA), a transparent radioprotection container that allows a direct visual inspection of the vial,
Croatian: • Ili u spremniku od polimetil metakrilata (PMMA), prozirnom spremniku sa zaštitom od radioaktivnosti koji omogućuje izravno vizualno pregledavanje bočice,
English: Ionizing radiations of lutetium (177Lu) oxodotreotide may potentially have temporary toxic effects on female and male gonads.
Croatian: Ionizirajuće zračenje lutecijeva (177Lu) oksodotreotida može potencijalno imati privremene toksične učinke na ženske i muške gonade.
English: The educational programme is aimed at increasing patients' awareness on the risk of radiotoxicity by occupational exposure and inadvertent exposure to peptide receptor radionuclide therapy, and at providing information concerning the necessary precautions to take to limit unnecessary exposure to themselves and the people around them.
Croatian: Edukacijski program teži ka povećanju osviještenosti bolesnika o riziku od radiotoksičnosti putem izloženosti na radnom mjestu te nenamjernoj izloženosti radionuklidnoj terapiji usmjerenoj na peptidne receptore, te davanju informacija u vezi potrebnih mjera opreza koje treba poduzeti kako bi se ograničila nepotrebna izloženost njih samih i osoba u njihovoj blizini.
English: There is some evidence that corticosteroids can induce down-regulation of SST2 receptors.
Croatian: Postoje određeni dokazi da kortikosteroidi mogu izazvati smanjenje ekspresije SST2 receptora.
English: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Croatian: Lutathera je indicirana za liječenje neresektabilnih ili metastatskih, progresivnih, dobro diferenciranih (G1 i G2), gastroenteropankreatičnih neuroendokrinih tumora pozitivnih na somatostatinske receptore (GEP-NETs) u odraslih bolesnika.
English: Before the patient is released, the nuclear physician should explain the necessary radioprotection rules of interacting with family members and third parties, and the general precautions the patient must follow during daily activities after treatment (as given in next paragraph and the package leaflet) to minimize radiation exposure to others.
Croatian: Prije otpuštanja bolesnika, liječnik specijalist nuklearne medicine treba objasniti nužna pravila za zaštitu od zračenja pri interakciji s članovima obitelji i trećim osobama, te opće mjere opreza koje bolesnik mora slijediti tijekom svakodnevnih aktivnosti nakon terapije (kako je navedeno u sljedećem odlomku i uputi o lijeku) kako bi se smanjila izloženost zračenju drugih osoba.
English: Two hundred thirty-one (231) patients have been randomized to receive either Lutathera (n=117) or octreotide LAR (n=114).
Croatian: Dvjesto trideset i jedan (231) bolesnik randomiziran je za primanje ili lijeka Lutathera (n=117) ili oktreotida LAR (n=114).
English: The nuclear medicine physician should determine when the patient can leave the controlled area of the hospital, i.e. when the radiation exposure to third parties does not exceed regulatory thresholds.
Croatian: Liječnik specijalist nuklearne medicine određuje i kada bolesnik može napustiti bolničku izolaciju, tj. kada izloženost zračenju trećih osoba ne prelazi propisane granice.
English: Specification
Croatian: Specifikacija
English: Blood catecholamines c-reactive protein increased
Croatian: Katekolamini u krvi Povišeni C-reaktivni protein
English: Etiology of this therapy related secondary myeloid neoplasms (t-MNs) is unclear.
Croatian: Etiologija ovih sekundarnih mijeloidnih neoplazmi povezanih s liječenjem nije jasna.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Croatian: Primjena radiofarmaceutika rizična je za druge osobe jer može doći do vanjskog zračenja ili kontaminacije uslijed prolijevanja mokraće, povraćanja itd.
English: There is no efficacy data in patients with known brain metastases therefore individual benefit-risk must be assessed in these patients.
Croatian: Za bolesnike s poznatim metastazama u mozgu nema podataka o djelotvornosti, pa se kod tih bolesnika mora individualno procijeniti omjer koristi i rizika.
English: If anyone helps you clean up vomit, blood, urine, or stool they should wear plastic gloves; the gloves should then be disposed of in a specific trash plastic bag (according to the recommendation stated in section "Trash recommendations" below).
Croatian: Ako Vam itko pomaže očistiti povraćeni sadržaj, krv, urin ili stolicu, ta bi osoba trebala nositi plastične rukavice; rukavice potom treba odložiti u posebnu plastičnu vrećicu (prema preporuci navedenoj u dijelu „Preporuke za otpad” u nastavku).
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.
Croatian: Vizualne preglede razina otopine potrebno je ponavljati tijekom primjene direktnom vizualnom kontrolom (kada se upotrebljava PMMA spremnik) ili upotrebom hvataljke za držanje bočice kada se upotrebljava olovni spremnik za transport.
English: Administered agents
Croatian: Primijenjeni agensi
English: Total activity administered is equal to the activity in the vial before infusion minus the activity remaining in the vial after the infusion.
Croatian: Ukupna primijenjena aktivnost jednaka je aktivnosti u bočici prije infuzije umanjene za aktivnost koja ostane u bočici nakon infuzije.
English: If the half dose is well tolerated (i.e. no DMT reoccurrence), the next remaining treatment administration(s) should continue with full dose (i.e. 7,400 MBq); but, if DMT recurs after treatment with a half dose, treatment with Lutathera must be definitively stopped.
Croatian: Ako se pola doze dobro podnosi (tj. nema ponovnog pojavljivanja DMT-a), sljedeće preostale primjene potrebno je nastaviti punom dozom (tj. 7400 MBq); ali ako se DMT ponovi nakon primjene pola doze, liječenje lijekom Lutathera mora se trajno obustaviti.
English: In the Erasmus phase I/II study 188 patients (52%) received and 172 (48%) did not receive concomitant octreotide LAR during Lutathera treatment.
Croatian: U ispitivanju faze I/II Erasmus 188 bolesnika (52 %) je primilo, a 172 (48 %) nije primilo istodobno oktreotid LAR tijekom terapije Lutatherom.
English: For recommendations in case of extravasation, see section 4.4.
Croatian: Za preporuke u slučaju ekstravazacije vidjeti dio 4.4.
English: Breast-feeding should be avoided during treatment with this medicinal product.
Croatian: Dojenje treba izbjegavati tijekom liječenja ovim lijekom.
English: This leaflet was last revised in
Croatian: Ova je uputa zadnji puta revidirana u Ostali izvori informacija
English: Treatment with Lutathera can have an impact on blood cells, liver and kidneys (see section 4).
Croatian: Liječenje lijekom Lutathera može imati utjecaj na krvne stanice, jetru i bubrege (pogledajte dio 4).
English: The amount of radioactivity in the vial must be measured prior to infusion using a suitable radioactivity calibration system in order to confirm that the actual amount of radioactivity to be administered is equal to the planned amount at the infusion time.
Croatian: Količina radioaktivnosti u bočici mora se izmjeriti prije infuzije korištenjem odgovarajućeg sustava kalibracije radioaktivnosti kako bi se potvrdilo da je stvarna količina radioaktivnosti koja će se primijeniti jednaka planiranoj količini u vrijeme infuzije.
English: Crises due to excessive release of hormones or bioactive substances may occur following treatment with Lutathera, therefore observation of patients by overnight hospitalisation should be considered in some cases (e.g. patients with poor pharmacologic control of symptoms).
Croatian: Krizne situacije koje su posljedica pretjeranog oslobađanja hormona ili bioaktivnih tvari mogu se pojaviti nakon liječenja lijekom Lutathera, pa je u nekim slučajevima potrebno razmotriti j hospitalizaciju bolesnika preko noći (npr. kod bolesnika s lošom farmakološkom kontrolom simptoma).
English: When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed.
Croatian: Kod testiranja „hladnog“ spoja (neradioaktivni lutecijev (175Lu) oksodotreotid) kao jednokratne intravenske injekcije kod štakora i pasa pri dozama do 20 000 μg/kg (štakori) i 3200 μg/kg (psi), spoj se dobro podnio u obje vrste i nije zabilježena niti jedna smrt.
English: − Calibrated radioactivity measurement system and Geiger counter to monitor the radioactivity of Lutathera
Croatian: − Kalibrirani sustav za mjerenje radioaktivnosti i Geigerov brojač za praćenje radioaktivnosti lijeka Lutathera
English: Ovaries**
Croatian: Jajnici**
English: Herpes zoster Ophthalmic herpes zoster Influenza
Croatian: Herpes zoster Oftalmički herpes zoster Gripa
English: 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).
Croatian: S obzirom na ukupno preživljenje OS (engl. overall survival), u vrijeme interim analize (24. srpnja 2015.), bilo je 17 smrti u skupini s lijekom Lutathera i 31 u skupini s oktreotidom LAR 60 mg, a omjer hazarda bio je 0,459 u korist lijeka Lutathera, ali nije dostigao razinu značajnosti za interim analizu (HR 99,9915% CI: 0,140, 1,506).
English: • The short needle should be then connected to the pre-filled infusion set.
Croatian: • Kratku iglu potom je potrebno spojiti na prethodno napunjeni komplet za infuziju.
English: Radioprotection rules
Croatian: Pravila zaštite od zračenja
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
Croatian: CR = potpuni odgovor; PR = djelomični odgovor; SD = stabilna bolest; ORR = objektivni odgovor (CR + PR); DoR = Trajanje odgovora * Uključuje prednje, srednje i stražnje crijevo; **NET-ovi prednjeg crijeva osim bronhijalnih i pankreatičnih
English: This medicinal product contains up to 3.5 mmol (81.1 mg) sodium per dose.
Croatian: Ovaj lijek sadržava do 3,5 mmol (81,1 mg) natrija po dozi.
English: The recommended infusion method for administration of Lutathera is the gravity method.
Croatian: Preporučena metoda infuzije za primjenu lijeka Lutathera je gravitacijska metoda.
English: You must inform the nuclear medicine doctor before the administration of Lutathera if there is a possibility you might be pregnant or if you have missed your period or if you are breast-feeding.
Croatian: Morate obavijestiti liječnika specijalista nuklearne medicine prije primjene lijeka Lutathera ako postoji mogućnost da ste trudni, ako Vam je izostala mjesečnica ili ako dojite.
English: Influenza like illness
Croatian: Bolest slična gripi
English: 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).
Croatian: Health Related Quality of Life - HRQOL) bila je ocijenjena pomoću upitnika o kvaliteti života Europske organizacije za istraživanje i liječenje raka (EORTC QLQ-C30) (generički instrument) i njegovog modula za neuroendokrine tumore (EORTC
English: N Patients with events Censored patients Median months (95%-CI)
Croatian: Cenzurirani bolesnici Medijan mjeseci (95%-CI)
English: When the recommended concomitant amino acids infusion is delivered over a 4 hour time span, a mean reduction in kidney radiation exposure of about 47% has been reported.
Croatian: Kada se preporučena istodobna infuzija aminokiselina primjenjuje tijekom 4 sata, zabilježeno je prosječno smanjenje izloženosti bubrega zračenju od oko 47 %.
English: Patients should sleep in a separate bedroom for 7 days, what should be extended to 15 days in case of pregnant partners or children.
Croatian: dana, što bi trebalo produljiti na 15 dana u slučaju trudnih partnerica ili djece.
English: - 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
Croatian: - ako ste prethodno liječeni zbog raka (kemoterapija) - ako imate blago promijenjen broj krvnih stanica - ako imate metastaze u kostima - ako ste prethodno primili terapiju radionuklidima - ako ste imali drugu vrstu raka unutar zadnjih 5 godina
English: • The critical organ is the bone marrow, however, with the recommended Lutathera cumulative dose of 29,600 MBq (4 administrations of 7,400 MBq), no correlation between hematologic toxicity and the total radioactivity administered or bone marrow absorbed dose has been observed either in Erasmus phase I/II or in NETTER-1 phase III study.
Croatian: • Kritični organ je koštana srž, međutim, s preporučenom kumulativnom dozom lijeka Lutathera od 29 600 MBq (4 primjene od 7400 MBq) nije primijećena korelacija između hematološke toksičnosti i ukupne primijenjene radioaktivnosti ili apsorbirane doze u koštanoj srži, bilo u ispitivanju faze I/II Erasmus ili ispitivanju faze III NETTER-1.
English: 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.
Croatian: Renalna toksičnost definirana kao procijenjeni klirens kreatinina < 40 mL/min ili porast vrijednosti kreatinina u serumu za 40 % u usporedbi s početnom razinom s padom vrijednosti klirensa kreatinina za više od 40 % u usporedbi s početnom vrijednosti.
English: • Or hypoalbuminemia < 30 g/L with a decreased prothrombin ratio < 70%.
Croatian: • Ili hipoalbuminemija < 30 g/L uz smanjeni protrombinski omjer < 70 %.
English: It is not known if there is of interaction between glucocorticosteroids used intermittently for the prevention of nausea and vomiting during Lutathera administration.
Croatian: Nije poznato postoje li interakcije između glukokortikosteroida koji se povremeno koriste za prevenciju mučnine i povraćanja tijekom primjene lijeka Lutathera.
English: Renal function as determined by serum creatinine and calculated creatinine clearance must be assessed at baseline, during and at least for the first year after treatment (see section 4.2).
Croatian: Funkcija bubrega utvrđena serumskim kreatininom i izračunatim klirensom kreatinina mora se procijeniti na početku, tijekom liječenja i barem tijekom prve godine nakon liječenja (vidjeti dio 4.2).
English: Toxicity with four repeated administrations, once every 2 weeks, of 1,250 µg/kg of the cold compound in rats and 80 µg/kg in dogs was not observed.
Croatian: Nije zabilježena toksičnost s četiri ponovljene primjene, jednom svaka dva tjedna, u dozi od 1250 μg/kg „hladnog“ spoja kod štakora i 80 μg/kg kod pasa.
English: Patients with urinary incontinence
Croatian: Bolesnici s urinarnom inkontinencijom
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Croatian: Te će osobe posebno paziti kako bi lijek primijenile na siguran način i govorit će Vam što u pojedinom trenutku rade.
English: The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies:
Croatian: Sljedeći zaključci o liječenju lijekom Lutathera utvrđeni su dozimetrijskom analizom provedenom u kliničkim ispitivanjima:
English: In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys.
Croatian: Osim primjene lijeka Lutathera, dobit ćete infuziju s aminokiselinama kako bi se zaštitili Vaši bubrezi.
English: Transfusion
Croatian: Transfuzija