FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Namen izobraževalnega programa je povečati zavedanje bolnikov glede tveganj radiološke toksičnosti pri poklicni izpostavitvi in neželeni izpostavitvi radionuklidni terapiji s peptidnimi receptorji in zagotoviti informacije o nujnih previdnostnih ukrepih za omejevanje nepotrebne izpostavitve njih samih in drugih oseb.
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.
Slovenian: • informacije o previdnostnih ukrepih, ki jih mora bolnik upoštevati pred, med in po postoku aplikacije, v bolnišnici ter doma, zato da omeji nepotrebno izpostavitev sevanju samega sebe in svojih spremljevalcev;
English: Lu) oxodotreotide) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity.
Slovenian: Lu) oksodotreotid) ne kažejo posebnega tveganja na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti.
English: For minimising radiation exposure, always use the principles of time, distance and shielding (reducing the manipulation of the vial and using the material already supplied par the manufacturer).
Slovenian: Za zmanjšanje izpostavljenosti sevanju vedno uporabljajte načelo časa, razdalje in zaščite (zmanjšanje ravnanja z vialo in uporaba materiala, ki ga je dobavil proizvajalec).
English: Other very common adverse reactions reported include fatigue (27.7%) and decreased appetite
Slovenian: Drugi zelo pogosti neželeni učinki, o katerih so poročali, vključujejo utrujenost (27,7 %) in zmanjšanje apetita (13,4 %).
English: Hyperbilirubinaemia9
Slovenian: Hiperbilirubinemija9
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C!
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Slovenian: Dajanje radiofarmakov predstavlja tveganje za druge osebe zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja itd.
English: • Previous external beam radiotherapy involving more than 25% of the bone marrow;
Slovenian: • predhodna radioterapija z zunanjim žarkom, ki je vključevala več kot 25 % kostnega mozga;
English: Moving the patient's arm position should be avoided if possible (extreme flexion or extension which could lead to vein compression).
Slovenian: Spreminjanju položaja bolnikove roke se je treba po možnosti izogniti (skrajno upogibanje ali iztegovanje lahko povzroči kompresijo ven).
English: − The floor and the furniture should be covered with tissue paper to avoid any accidental contamination
Slovenian: − Tla in pohištvo je treba zaščititi z vpojnim papirjem, da preprečimo nenamerno kontaminacijo.
English: However, it is recommended that when conducting standard care or exams with medical devices or other instruments which contact the skin (e.g. electrocardiogram (ECG)), basic protection measures should be observed such as wearing gloves, installing the material/electrode before the start of radiopharmaceutical infusion, changing the material/electrode after measurement, and eventually monitoring the radioactivity of equipment after use.
Slovenian: Je pa priporočljivo, da se pri izvajanju standardne oskrbe ali preiskav z medicinskimi pripomočki ali drugimi instrumenti, ki prihajajo v stik s kožo (npr. elektrokardiogram (EKG)), upošteva osnovne varnostne ukrepe, na primer nošenje rokavic, nameščanje materiala/elektrode pred začetkom infuzije radiofarmaka, menjava materiala/elektrode po meritvi in na koncu tudi preverjanje radioaktivnosti opreme po uporabi.
English: A summary of side effects is given below by order of frequency:
Slovenian: Povzetek neželenih učinkov je naveden v nadaljevanju po pogostnosti:
English: The amino acid solution can be prepared as a compounded product, in compliance with the hospital's sterile medicinal product preparation good practices and according to the composition specified in Table 1.
Slovenian: Raztopino aminokislin je mogoče pripraviti kot sestavljeni izdelek v skladu z dobrimi praksami bolnišnice za sterilno pripravo zdravil in glede na sestavo, navedeno v preglednici 1.
English: Dry skin
Slovenian: Suha koža
English: The minimum laboratory tests needed before each infusion are:
Slovenian: Pred vsako infuzijo so potrebne vsaj naslednje laboratorijske preiskave:
English: At the concentration used (about 10 μg/mL in total, for both free and radiolabeled forms), the peptide oxodotreotide does not exert any clinically relevant pharmacodynamic effect.
Slovenian: Pri uporabljeni koncentraciji (skupaj približno 10 μg/ml skupaj za proste in radiološko označene oblike) peptid oksodotreotid ne povzroča nikakršnih klinično pomembnih farmakodinamičnih učinkov.
English: Total Body *n=11 (male patients only) **n=9 (female patients only)
Slovenian: Maternica** Celotno telo *n=11 (samo moški) **n=9 (samo ženske)
English: Etiology of this therapy related secondary myeloid neoplasms (t-MNs) is unclear.
Slovenian: Etiologija teh z zdravljenjem povezanih sekundarnih mieloidnih neoplazij (t-MNs) je nejasna.
English: Treatment can be resumed after resolution or stabilisation.
Slovenian: Zdravljenje je mogoče nadaljevati po izboljšanju ali stabilizaciji.
English: To facilitate that, carry your discharge letter with you at all times.
Slovenian: Za pospešitev obveščanja morate s seboj vedno nositi svojo odpustnico.
English: − Antiemetics
Slovenian: − antiemetiki.
English: • Kidney is not a critical organ if a co-infusion of an appropriate amino acids solution is performed.
Slovenian: • Ledvice niso kritičen organ, če je izvedena sočasna infuzija ustrezne raztopine aminokislin.
English: The long-term trend of progressive glomerular filtration function deterioration demonstrated in the clinical studies confirms that Lutathera-related nephropathy is a chronic kidney disease that develops progressively over months or years after exposure.
Slovenian: V kliničnih študijah dokazano dolgoročno progresivno poslabšanje funkcije glomerularne filtracije potrjuje, da je nefropatija, povezana z zdravilom Lutathera, kronična bolezen ledvic, ki se razvija progresivno več mesecev ali let po izpostavljenosti.
English: • Bilirubinemia > 3 times the upper limit of normal,
Slovenian: • bilirubinemija > 3-krat večja od zgornje meje normalnih vrednosti;
English: Patients with a history of chronic use of glucocorticosteroids should be carefully evaluated for sufficient somatostatin receptor expression.
Slovenian: Bolnike z anamnezo kronične uporabe glukokortikosteroidov je treba skrbno oceniti glede zadostnega izražanja somatostatinskega receptorja.
English: Prior to launch of Lutathera in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred sprostitvijo zdravila Lutathera na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom glede vsebine in oblike izobraževalnega programa, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
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.
Slovenian: Toksičnost s štirimi ponovljenimi aplikacijami 1.250 µg/kg hladne spojine vsaka 2 tedna pri podganah in 80 µg/kg pri psih niso opazili.
English: Treatment with Lutathera can have an impact on blood cells, liver and kidneys (see section 4).
Slovenian: Zdravljenje z zdravilom Lutathera lahko vpliva na krvne celice, jetra in ledvice (glejte poglavje 4).
English: The recommended dose is 7,400 MBq (megabecquerel, the unit used to express radioactivity) in a single infusion, which is given at 4 times once every 8 weeks.
Slovenian: Priporočeni odmerek je 7.400 MBq (megabequerel je enota za izražanje radioaktivnosti) v eni sami infuziji, ki jo boste prejeli 4-krat - enkrat vsakih 8 tednov.
English: During treatment with Lutathera and for a minimum of the following 6 months after the end of the treatment, appropriate measures must be taken to avoid pregnancy; this applies to patients of both genders.
Slovenian: Med zdravljenjem z zdravilom Lutathera in za vsaj 6 mesecev po koncu zdravljenja je treba sprejeti ustrezne ukrepe za preprečitev nosečnosti; to velja za bolnike obeh spolov.
English: Therefore, it is recommended to monitor ALAT, ASAT, bilirubin and albumin serum during treatment (see section 4.2).
Slovenian: Zaradi tega je med zdravljenjem priporočljivo spremljati vrednosti ALAT, ASAT, bilirubina in albumina v serumu (glejte poglavje 4.2).
English: Precautions with respect to environmental hazard see section 6.6.
Slovenian: Previdnostni ukrepi glede nevarnosti za okolje so navedeni v poglavju 6.6.
English: Lutathera is for intravenous use.
Slovenian: Zdravilo Lutathera je za intravensko uporabo.
English: Therefore, glucocorticosteroids should be avoided as preventive anti-emetic treatment.
Slovenian: Zato se je treba izogibati uporabi glukokortikosteroidov za antiemetično zdravljenje.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines including somatostatin analogues, glucocorticoids (also called corticosteroids), since they may interfere with your treatment.
Slovenian: Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z analogi somatostatina, glukokortikoidi (imenovanimi tudi kortikosteroidi), saj lahko ovirajo zdravljenje.
English: The Nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Slovenian: Zdravnik nuklearne medicine vas bo obvestil, če boste po uporabi tega zdravila morali upoštevati kakršne koli posebne previdnostne ukrepe.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 4.2. 6.3 Rok uporabnosti
English: Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff.
Slovenian: Meritve na lokaciji in med delom so ključnega pomena in jih je treba izvajati za natančnejše in kakovostnejše določanje skupnega odmerka sevanja, ki ga prejmejo zdravstveni delavci.
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10XX04
Slovenian: Farmakoterapevtska skupina: Drugi radioterapevtiki, oznaka ATC: V10XX04 Mehanizem delovanja
English: Hospitalisation and Emergency Care
Slovenian: Hospitalizacija in nega na urgenci
English: Depending on the situation, the nuclear medicine physician should inform the patient about the risks linked to extravasation injury, and give advice about potential treatment and necessary follow-up requirements.
Slovenian: Zdravnik nuklearne medicine mora glede na okoliščine bolnika obvestiti o tveganjih, povezanih z ekstravazacijsko poškodbo, in svetovati o morebitnem zdravljenju in potrebnih nadaljnjih posegih.
English: What Lutathera is and what it is used for 2.
Slovenian: Kaj je zdravilo Lutathera in za kaj ga uporabljamo 2.
English: Lutathera is contraindicated in pregnant women.
Slovenian: Zdravilo Lutathera je kontraindicirano pri nosečnicah.
English: There is no efficacy data in patients with known brain metastases therefore individual benefit-risk must be assessed in these patients.
Slovenian: Podatkov o učinkovitosti pri bolnikih z znanimi metastazami v možganih, zato je pri teh bolnikih treba oceniti individualne koristi in tveganja.
English: The pole height should be adjusted in order to compensate any increase or reduction of pressure inside the vial.
Slovenian: Višino infuzijskega stojala je treba prilagoditi, da se izravna vsako zvečanje ali zmanjšanje tlaka v viali.
English: • Severe heart failure defined as class III or IV in the NYHA classifications;
Slovenian: • hudo srčno popuščanje, opredeljeno kot razred III ali IV po razvrstitvah NYHA;
English: During the first 2 days following administration of this medicinal product, special precautions should be taken with patients with urinary incontinence to avoid spread of radioactive contamination.
Slovenian: Bolniki z urinsko inkontinenco V prvih 2 dneh po aplikaciji tega zdravila so potrebni posebni previdnostni ukrepi pri bolnikih z urinsko inkontinenco, da preprečimo širjenje radioaktivnega onesnaženja.
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).
Slovenian: Po zdravljenju z zdravilom Lutathera se lahko pojavijo krize zaradi prekomernega sproščanja hormonov ali bioaktivnih snovi, zato je treba v nekaterih primerih razmisliti o opazovanju bolnikov s hospitalizacijo čez noč (npr. bolnikov s slabim farmakološkim nadzorom simptomov).
English: Infusion rate (mL/h)
Slovenian: Hitrost infundiranja (ml/h)
English: Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death.
Slovenian: Zdravilo Lutathera se veže na te receptorje in oddaja radioaktivnost neposredno v tumorske celice, zaradi česar odmrejo.
English: All*
Slovenian: Vsi*
English: The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
Slovenian: V vsakem primeru je treba aplicirati čim manjšo aktivnost, ki še omogoča doseganje potrebnega terapevtskega učinka.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Slovenian: Radionuklidni postopki, izvedeni pri nosečnicah, vključujejo tudi odmerek sevanja na plod.
English: A risk to the suckling child associated with ionising radiation cannot be excluded.
Slovenian: Tveganja, povezanega z ionizirajočim sevanjem, za dojenega otroka ni mogoče izključiti.
English: If at any time in the preparation of this medicinal product the integrity of this vial is compromised, it should not be used.
Slovenian: Če je kadar koli med pripravo tega zdravila ogrožena integriteta te viale, zdravila ne smete uporabiti.
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).
Slovenian: Delovanje ledvic, ki ga določa serumska koncentracija kreatinina in izračunani kreatininski očistek, je treba oceniti v izhodišču, med in vsaj v prvem letu po zdravljenju (glejte poglavje 4.2).
English: Concomitant use of cold somatostatin analogues may be needed for disease symptoms control.
Slovenian: Za nadzor simptomov bolezni bo morda potrebna sočasna uporaba hladnih somatostatinskih analogov.
English: Severe heart failure (defined as grade III or IV of the New York Heart Association (NYHA) classification)
Slovenian: Hudo srčno popuščanje (opredeljeno kot razred III ali IV po razvrstitvi New York Heart Association
English: It binds to malignant cells which overexpress sst2 receptors.
Slovenian: Veže se na maligne celice, ki čezmerno izražajo receptorje sst2.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden prejmete to zdravilo.
English: During the administration only disposable materials should be used.
Slovenian: Med aplikacijo je treba uporabljati le materiale za enkratno uporabo.
English: Two intravenous plastic catheters should be inserted into patient's peripheral veins, one on each arm.
Slovenian: V bolnikovi periferni veni je treba vstaviti dva intravenska plastična katetra - po enega v vsako roko.
English: Breast-feeding must be stopped.
Slovenian: Dojenje je treba prekiniti.
English: For recommendations in case of extravasation, see section 4.4.
Slovenian: Za priporočila v primeru ekstravazacije glejte poglavje 4.4.
English: If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.
Slovenian: Če je v času dojenja potrebno zdravljenje z zdravilom Lutathera, je otroka treba odstaviti.
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.
Slovenian: Najpogostejša neželena učinka pri bolnikih, ki so prejemali zdravilo Lutathera, sta bila navzea in bruhanje, ki sta nastopila na začetku infundiranja v 58,9 % oziroma 45,5 %.
English: You must avoid close contact with people who live with you, and should try to keep a distance of at least one meter for 7 days after you receive Lutathera.
Slovenian: Izogibati se morate tesnemu stiku z ljudmi, ki živijo z vami, in 7 dni po tem, ko ste prejeli zdravilo Lutathera, od njih poskusiti vzdrževati razdaljo vsaj enega metra.
English: − One (1) sterile tubing line with a clamp to regulate or stop the flow
Slovenian: − en (1) sterilni vod cevke s sponko za uravnavanje ali ustavitev pretoka;
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by response evaluation criteria in solid tumours (RECIST 1.1), based on independent radiology assessment.
Slovenian: (PFS - Progression-free survival), ocenjeno glede na merila odzivnosti pri solidnih tumorjih (RECIST 1.1) na podlagi neodvisne radiološke ocene.
English: − One (1) Long needle (90 - 100 mm)
Slovenian: − ena (1) dolga igla (90-100 mm);
English: Lutathera should be infused directly from its original container.
Slovenian: Zdravilo Lutathera je treba infundirati neposredno iz originalnega vsebnika.
English: Nevertheless, if the physician decides to start the treatment, clear information should be given to the patient regarding the risks associated with the administration of Lutathera.
Slovenian: V vsakem primeru, če se zdravnik odloči za zdravljenje, je treba bolniku dati jasne informacije o tveganjih, povezanih z apliciranjem zdravila Lutathera.
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.
Slovenian: Količino radioaktivnosti v viali je treba pred infuzijo izmeriti z uporabo ustreznega umerjenega sistema za merjenje radioaktivnosti, da bi potrdili, da je dejanska količina radioaktivnosti za aplikacijo enaka načrtovani količini v času infuzije.
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.
Slovenian: Zdravnik nuklearne medicine mora bolniku pred odpustom razložiti potrebna pravila za zaščito pred sevanjem pri stiku z družinskimi člani in drugimi osebami, poleg tega pa tudi splošne previdnostne ukrepe, ki jih mora izvajati med vsakodnevnimi dejavnostmi po zdravljenju (kot je navedeno v naslednjem odstavku in v navodilu za uporabo), da se zmanjša izpostavitev drugih oseb sevanju.
English: It is not known if there is of interaction between glucocorticosteroids used intermittently for the prevention of nausea and vomiting during Lutathera administration.
Slovenian: Ni znano ali obstajajo interakcije med glukokortikosteroidi, uporabljenimi sočasno za preprečevanje navzee in bruhanja med aplikacijo zdravila Lutathera.
English: Demographics as well as patients and disease characteristics were very balanced between groups with median age of 64 years and 82.1% Caucasian in the general population.
Slovenian: Demografski podatki in lastnosti bolnikov ter bolezni so bili zelo uravnoteženi pri obeh skupinah, ki sta vključevali splošno populacijo s srednjo starostjo 64 let in
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.
Slovenian: Glede na nespremenljivo volumetričnost aktivnost 370 MBq/ml ob datumu in uri umerjanja je prostornina raztopine prilagojena na od 20,5 ml do 25,0 ml, da bi se zagotovila zahtevana količina radioaktivnosti ob datumu in uri infuzije.
English: Specification
Slovenian: Specifikacije
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.
Slovenian: Zdravilo Lutathera je indicirano za zdravljenje neizrezljivih ali metastatskih, progresivnih, dobro diferenciranih (G1 in G2) gastroenteropankreatskih nevroendokrinih tumorjev (GEP-NETGastroenteropancreatic neuroendocrine tumours) s pozitivnimi somatostatinskimi receptorji pri odraslih.
English: Breast-feeding should be avoided during treatment with this medicinal product.
Slovenian: Med zdravljenjem s tem zdravilom se je treba izogibati dojenju.
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).
Slovenian: Če vam kdo pomaga očistiti bruhanje, kri, urin ali blato, mora nositi plastične rokavice; rokavice je treba nato zavreči v ločeni plastični vrečki za smeti (v skladu s Priporočili za odstranjevanje smeti, navedenimi spodaj).
English: Injection site reaction11
Slovenian: Reakcije na mestu injiciranja11
English: * The concomitant amino acids infusion is always administered at full dose (see section 4.4).
Slovenian: *Sočasno infuzijo aminokislin vedno apliciramo v celotnem odmerku (glejte poglavje 4.4).
English: If at any time in the preparation of this medicinal product the integrity of this container and vial is compromised it should not be used.
Slovenian: Če je kadar koli med pripravo tega zdravila ogrožena integriteta tega vsebnika in viale, zdravila ne smete uporabiti.
English: The recommended infusion method for administration of Lutathera is the gravity method.
Slovenian: Priporočena metoda za aplikacijo infuzije zdravila Lutathera je gravitacijska metoda.
English: The use of Lutathera does involve exposure to amounts of radioactivity.
Slovenian: Uporaba zdravila Lutathera vključuje izpostavljenost majhnim količinam radioaktivnosti.
English: If this does occur to you, your doctor may decide to delay or stop the treatment administration.
Slovenian: Če pride do tega, se lahko zdravnik odloči odložiti ali prekiniti zdravljenje.
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Slovenian: Odmerek sevanja zaradi terapevtske izpostavljenosti lahko povzroči večjo pojavnost rakavih obolenj in mutacij.