FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of overdose, an increase in the frequency of the adverse reactions related to radiotoxicity is expected.
Slovenian: V primeru prevelikega odmerjanja je pričakovati zvečanje pogostnosti neželenih učinkov, povezanih z radiotoksičnostjo.
English: In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered.
Slovenian: V primeru hude navzee ali bruhanja med infuzijo raztopine aminokislin se lahko aplicira antiemetik drugega farmakološkega razreda.
English: Amino acid solution, either extemporaneously compounded (1 L) or commercial (1.5 L to 2.2 L)
Slovenian: Raztopina aminokislin, pripravljena ex tempore (1 l) ali komercialno dostopna (1,5-2,2 l)
English: • Kidney function (creatinine and creatinine clearance)
Slovenian: • delovanje ledvic (kreatinin in kreatininski očistek);
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.
Slovenian: V primeru aplikacije prevelikega odmerka sevanja z zdravilom Lutathera je treba absorbirani odmerek pri bolniku zmanjšati, kadar je to mogoče, tako da se poveča izločanje radionuklida iz telesa s pogostim uriniranjem ali prisilno diurezo in pogostim praznjenjem mehurja v 48 urah po infuziji.
English: Total activity administered is equal to the activity in the vial before infusion minus the activity remaining in the vial after the infusion.
Slovenian: Skupna aplicirana aktivnost je enaka aktivnosti v viali pred infuzijo, zmanjšana za aktivnost, ki je v viali ostala po infuziji.
English: What you need to know before Lutathera is used 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Lutathera 3.
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.
Slovenian: Ko je bila priporočena sočasna aminokislinska infuzija, dovajana v 4-urnem časovnem obdobju, so poročali o povprečnem zmanjšanju izpostavljenosti ledvic sevanju za približno 47 %.
English: The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used.
Slovenian: Raztopino je treba pred uporabo pregledati za poškodbami in onesnaženostjo, uporabiti pa je dovoljeno samo bistro raztopino brez vidnih delcev.
English: a. If the observed toxicity continues beyond 16 weeks after the last infusion, treatment with Lutathera must be definitively stopped.
Slovenian: a. Če opažena toksičnost vztraja po preteku 16 tednov po zadnji infuziji, je treba zdravljenje z zdravilom Lutathera dokončno ukiniti.
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).
Slovenian: Sekundarni opazovani dogodki so vključevali objektivni odziv na zdravljenje (ORR - objective response rate), stopnjo preživetja (OS - Overall survival), čas do napredovanja tumorja (TTP - Time to tumour progression), varnost in prenašanje zdravila in kakovost življenja (QoL - Quality of life).
English: Factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors for MDS/AL.
Slovenian: Dejavniki, kot so starost > 70 let, okvarjeno delovanje ledvic, izhodiščne citopenije, število predhodnih zdravljenj, predhodna izpostavljenost kemoterapevtikov (zlasti alkilirajočih sredstev) in predhodna radioterapija se štejejo med potencialne dejavnike tveganja in/ali napovedne faktorje za MDS/AL.
English: Thrombocytopenia of grade 2 or superior (CTCAE)**.
Slovenian: Trombocitopenija 2. ali višje stopnje (CTCAE)**.
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.
Slovenian: Vse materiale v pripomočku za apliciranje je treba shraniti, tako da je mogoče merjenje preostale radioaktivnosti in dejansko aplicirane aktivnosti, na koncu pa je treba izračunati absorbirani odmerek.
English: Ionizing radiations of lutetium (177Lu) oxodotreotide may potentially have temporary toxic effects on female and male gonads.
Slovenian: Ionizirajoče sevanje lutecijevega (177Lu) oksodotreotida ima lahko potencialno začasne toksične učinke na ženske in moške spolne žleze.
English: The patient should also be encouraged to defecate every day and to use laxative if needed.
Slovenian: Bolnika je treba tudi spodbuditi, da gre vsak dan na blato in da po potrebi uporabi odvajalo.
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.
Slovenian: Pri hormonskih krizah so priporočena naslednja zdravljenja: visok intravenski odmerek somatostatinskih analogov, intravenske tekočine, kortikosteroidi in popravek elektrolitskih motenj pri bolnikih z drisko in/ali bruhanjem.
English: Urine and faeces should be disposed according to the national regulations.
Slovenian: Urin in iztrebke je treba odstraniti v skladu z nacionalnimi predpisi.
English: ** CTCAE: Common Terminology Criteria for Adverse Events, National Cancer Institute
Slovenian: **CTCAE: Skupni kriteriji za terminologijo neželenih učinkov (CTCAE - Common Terminology Criteria for
English: • Information that PPRT can cause serious side effects during or after treatment and that any side effect should be reported to the physician.
Slovenian: • informacije o tem, da zdravljenje PRRT lahko povzroči resne neželene učinke med zdravljenjem in po njem, ter da mora o vseh neželenih učinkih poročati zdravniku.
English: This medicinal product contains up to 3.5 mmol (81.1 mg) sodium per dose.
Slovenian: To zdravilo vsebuje do 3,5 mmol (ali 81,1 mg) natrija na odmerek.
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.
Slovenian: Preden prejmete zdravilo Lutathera se posvetujte z zdravnikom, saj lahko povzroči: - sekundarnega krvnega raka (mielodisplastični sindrom ali akutno levkemijo), ki se lahko redko pojavi več let po tem, ko ste končali zdravljenje z zdravilom Lutathera.
English: An analysis performed with human plasma to determine the extent of plasma protein binding of non-radioactive compound (lutetium (175Lu) oxodotreotide) showed that about 50% of the compound is bound to plasmatic proteins.
Slovenian: Analiza, izvedena s humano plazmo za določitev obsega vezave plazemskih proteinov z neradioaktivno spojino (lutecijev (175Lu) oksodotreotid) je pokazala, da se je približno 50 % spojine vezalo na plazemske proteine.
English: The posology can be adapted according to the patient's status at the discretion of the physician.
Slovenian: Odmerjanje je mogoče prilagoditi glede na stanje bolnika po presoji zdravnika.
English: Transfusion
Slovenian: Transfuzija
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).
Slovenian: Uporaba zdravila Lutathera je kontraindicirana v primeru ugotovljene nosečnosti ali suma nanjo ali kadar nosečnost ni bila izključena zaradi tveganja, povezanega z ionizirajočim sevanjem (glejte poglavje
English: Concomitant use of somatostatin analogues
Slovenian: Sočasna uporaba somatostatinskih analogov
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).
Slovenian: Pred začetkom zdravljenja z zdravilom Lutathera mora slikanje somatostatinskih receptorjev (scintigrafija ali pozitronska emisijska tomografija [PET]) potrditi prekomerno izražanje teh receptorjev v tumorskem tkivu s privzemom v tumorju, ki je vsaj tako visok kot običajni privzem v jetrih (rezultat za privzem v tumorju ≥ 2).
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.
Slovenian: Bolnika, zdravljenega z zdravilom Lutathera je treba ločiti od drugih bolnikov med apliciranjem in dokler dosega mejo emisije sevanja, ki jih določa veljavna zakonodaja, običajno še 4-5 ur aplikaciji zdravila.
English: Testes*
Slovenian: Testisi*
English: Overdose is unlikely with Lutathera as this medicinal product is supplied as a “single dose” and “ready to use” product containing a predefined amount of radioactivity.
Slovenian: 4.9 Preveliko odmerjanje Preveliko odmerjanje zdravila Lutathera je malo verjetno, saj se to zdravilo dobavlja kot »enkratni odmerek« in »pripravljeno za uporabo« ter vsebuje predhodno določeno količino radioaktivnosti.
English: Patients should be encouraged to empty their bladder as frequently as possible during the administration of amino acids and the hours after administration.
Slovenian: Bolnike je treba spodbujati, da svoj mehur praznijo čim pogosteje med aplikacijo aminokislin in v urah po aplikaciji.
English: It is necessary to wear waterproof gloves and suitable aseptic techniques when handling the medicinal product.
Slovenian: Pri ravnanju z zdravilom je treba nositi vodotesne rokavice in uporabljati ustrezne aseptične tehnike.
English: • The short needle should be inserted into the Lutathera vial, so that it does not touch the radiopharmaceutical solution.
Slovenian: • Kratko iglo je treba vstaviti v vialo Lutathera, tako da se ne bo dotikala raztopine radiofarmaka.
English: There is some evidence that corticosteroids can induce down-regulation of SST2 receptors.
Slovenian: Obstajajo dokazi, da lahko kortikosteroidi inducirajo zmanjšanje izražanja receptorja SSTR2.
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).
Slovenian: Predmete, ki jih ni mogoče odplakniti v stranišču, kot so higienski vložki in povoji, je treba vstaviti v ločeno plastično vrečko za smeti (v skladu s Priporočili za odstranjevanje smeti, navedenimi spodaj);
English: Median 95%CI
Slovenian: 95 % IZ Mediana
English: − One (1) Short needle
Slovenian: − ena (1) kratka igla;
English: Temporarily discontinue the treatment until resolution or stabilisation.
Slovenian: Zdravljenje začasno prekinite do izboljšanja ali stabilizacije stanja.
English: Not reached p-value of Log-rank test Hazard ratio (95%-CI)
Slovenian: Ni bila dosežena p-vrednost v testu Log-rank Razmerje tveganja (95 %-IZ)
English: In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys.
Slovenian: Skupaj z zdravilom Lutathera boste prejeli tudi infuzijo aminokislin, da bi zaščitili vaše ledvice.
English: Feeling abnormal
Slovenian: Neobičajno počutje
English: Dose-modifying toxicity (DMT) criteria
Slovenian: Merila za toksičnost, ki zahteva prilagoditev odmerka (DMT)
English: N Patients with events Censored patients Median months (95%-CI)
Slovenian: N Bolniki z dogodki Okrnjeni (cenzurirani) vzorec bolnikov Mediana v mesecih (95 %-IZ)
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.
Slovenian: Plodni moški in ženske se morajo v času zdravljenja in 6 mesecev po njem vzdržati oploditve z učinkovitimi kontracepcijskimi metodami.
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.
Slovenian: Če obstaja dvom glede nosečnosti (če je ženski izostala menstruacija, je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi alternativne tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
English: − Calibrated radioactivity measurement system and Geiger counter to monitor the radioactivity of Lutathera
Slovenian: − Umerjeni sistem za merjenje radioaktivnosti in Geigerjev števec za nadzor radioaktivnosti zdravila Lutathera.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Slovenian: Postopke aplikacije je treba izvajati tako, da se čim bolj zmanjša tveganje za kontaminacijo zdravila in obsevanje osebja.
English: Musculoskeletal pain8 Muscle spasms
Slovenian: Mišično-skeletna bolečina8 Mišični spazmi
English: Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
Slovenian: Radioaktivnost v viali zdravila Lutathera je treba izmeriti tik pred infuzijo z uporabo umerjenega sistema za merjenje radioaktivnosti.
English: Lutathera should be administered over 20 to 30 minute time span.
Slovenian: Zdravilo Lutathera je treba aplicirati v od 20 do 30
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.
Slovenian: Ena viala vsebuje količino, ki variira od 20,5 do 25,0 ml raztopine, kar ustreza aktivnosti 7.400 MBq na datum in čas infuzije.
English: What Lutathera looks like and contents of the pack Lutathera is a clear and colourless solution for infusion, supplied in a colourless glass vial closed with a rubber stopper and sealed with an aluminium capsule.
Slovenian: Izgled zdravila Lutathera in vsebina pakiranja Zdravilo Lutathera je bistra in brezbarvna raztopina za infundiranje v brezbarvni stekleni viali, ki je zaprta z gumijastim zamaškom in zatesnjena z aluminijasto kapsulo.
English: • Renal or urinary tract morphological abnormalities;
Slovenian: • Morfološke abnormalnosti ledvic ali urinarnega trakta;
English: Staphylococcal infections Streptococcal bacteraemia
Slovenian: Stafilokokne okužbe Streptokokna bakteriemija
English: The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion.
Slovenian: Skupna količina radioaktivnosti na vialo z enim odmerkom je 7.400 MBq ob datumu in uri infuzije.
English: • Care supplies and equipment:
Slovenian: • Material in oprema za nego:
English: It is strongly recommended to limit contact with children and pregnant women for 7 days after the administration.
Slovenian: Stik z otroki in nosečnicami je zelo priporočljivo omejiti še 7 dni po tem, ko ste prejeli zdravilo.
English: The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow.
Slovenian: Najpogostejši neželeni učinek pri bolnikih, ki se zdravijo z zdravilom Lutathera, je vpliv na kostni mozeg.
English: Frequency of adverse reactions reported from clinical trials and from post-marketing surveillance
Slovenian: Preglednica 7: Pogostost neželenih učinkov, o katerih so poročali v kliničnih preskušanjih in v času spremljanja zdravila v obdobju trženja
English: therefore treatment with Lutathera in those patients is not recommended.
Slovenian: Lutathera pri teh bolnikih ni priporočljivo.
English: Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.
Slovenian: Bistra, brezbarvna steklena viala tipa I, zaprta z bromobutilnim gumijastim zamaškom in aluminijasto folijo.
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.
Slovenian: Pri testiranju hladne spojine (neradioaktivnega lutecijevega (175Lu) oksodotreotida) v obliki posamične intravenske injekcije pri podganah in psih v odmerkih do 20.000 µg/kg (podgane) in 3.200 µg/kg (psi), so živali spojino dobro prenašale, smrti niso opazili.
English: These finding are supported by in vitro metabolism data in human hepatocytes, in which no metabolic degradation of lutetium (175Lu) oxodotreotide was observed.
Slovenian: Ti rezultati so potrjeni s podatki o presnovi in vitro za humane hepatocite, v katerem niso opazili nobene presnovne degradacije lutecijevega (175Lu) oksodotreotida.
English: Blood catecholamines c-reactive protein increased
Slovenian: Zvečanje vrednosti c reaktivnega proteina
English: • Blood chemistry monitoring: serum creatinine and glycaemia.
Slovenian: • kemijske preiskave krvi: serumsko koncentracijo kreatinina in glikemije.
English: The patient should be encouraged to urinate as much as possible after Lutathera adminiastration.
Slovenian: Bolnika je treba spodbuditi, da po uporabi zdravila Lutathera čim več urinira.
English: Room and equipment preparation:
Slovenian: Priprava prostora in opreme: • Prostor za aplikacijo:
English: Meldola (FC) Italy
Slovenian: Meldola (FC) Italija
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.
Slovenian: Podatki ORR (vključno s popolnim odzivom (CR) in delnim odzivom (PR) v skladu z merili RECIST) in trajanje odziva (DoR) za FAS nizozemske populacije z gastroenteropankreatičnimi (GEP) in bronhialnimi nevroendokrinimi tumorji (NET) (360 bolnikov) in po vrstah tumorjev so predstavljeni v preglednici 10.
English: The median PFS for Lutathera was not reached at the time of analysis whereas the one of octreotide LAR was 8.5 months.
Slovenian: Mediana PFS za zdravilo Lutathera v času analize ni bila dosežena, medtem ko je pri oktreotidu LAR znašala 8,5 mesecev.
English: 01630, Saint Genis Pouilly France
Slovenian: 01630, Saint Genis Pouilly Francija
English: Cryopreservation of sperm or eggs may be offered to you before the treatment.
Slovenian: Morda vam bodo pred zdravljenjem ponudili krioprezervacijo sperme ali jajčec.
English: Organ uptake At 4 hours after administration, the distribution pattern of lutetium (177Lu) oxodotreotide shows a rapid uptake in kidneys, tumour lesions, liver and spleen, and in some patients in the pituitary gland and in the thyroid.
Slovenian: Po 4 urah po aplikaciji distribucijski vzorec lutecijevega (177Lu) oksodotreotida kaže hiter privzem v ledvicah, tumorskih lezijah, jetrih in vranici in pri nekaterih bolnikih v hipofizi ter v ščitnici.
English: Other side effects include: nausea and vomiting (usually during the first 24 hours) and decreased appetite.
Slovenian: Drugi neželeni učinki vključujejo: občutek siljenja na bruhanje in bruhanje (običajno v prvih 24 urah)
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%).
Slovenian: Zaradi toksičnosti zdravila Lutathera za kostni mozeg so bili najpogosteje pričakovani neželeni učinki, povezani s hematološko toksičnostjo: trombocitopenija (25 %), limfopenija (22,3 %), anemija (13,4
English: For instructions on the medicinal product before administration, see section 12.
Slovenian: Za navodila glede zdravila pred dajanjem glejte poglavje 12.
English: OS Time (months)
Slovenian: OS Čas (mesecev)
English: The flow of Lutathera from the vial to the patient should be monitored during the entire infusion.
Slovenian: Pretok zdravila Lutathera iz viale k bolniku je treba nadzorovati ves čas infundiranja.
English: Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera (see section 4.8), occurring approximately 28 months (9 - 41) for MDS and 55 months (32 - 125) for AL after the end of treatment.
Slovenian: Mielodisplastični sindrom in akutna levkemija Po zdravljenju z zdravilom Lutathera so opazili pozen pojav mielodisplastičnega sindroma (MDS) in akutne levkemije (AL) (glejte poglavje 4.8), s pojavnostjo po približno 28 mesecih (9-41) za MDS in in 55 mesecih (32-125) za AL po koncu zdravljenja.
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)
Slovenian: − dva (2) kompleta za gravitacijsko intravensko infuzijo s sponko za uravnavanje ali ustavitev pretoka (eno za zdravilo Lutathera in eno za aplikacijo raztopine aminokislin);
English: Mechanism of action Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (sst2).
Slovenian: Lutecijev (177Lu) oksodotreotid ima visoko afiniteto za podtip 2 somatostatinskih receptorjev (sst2).
English: The use of Lutathera is contraindicated in patients with severe kidney failure (see section 4.3).
Slovenian: Uporaba zdravila Lutathera je kontraindicirana pri bolnikih s hudo ledvično odpovedjo (glejte poglavje 4.3).
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.
Slovenian: (tj. DMT se ne ponovi), je treba naslednjo(-e) preostalo(-e) aplikacijo zdravila nadaljevati s polnim odmerkom (tj. 7.400 MBq); če pa se po zdravljenju s polovičnim odmerkom
English: • The long needle should be connected to the pre-filled tubing line and then inserted into the Lutathera vial, so that it touches the bottom of the vial.
Slovenian: • Dolgo iglo je treba priključiti na predhodno napolnjen vod cevke in nato vstaviti v vialo zdravila Lutathera, tako da se bo dotikala dna viale.
English: • Or hypoalbuminemia < 30 g/L with a decreased prothrombin ratio < 70%.
Slovenian: • ali hipoalbuminemija < 30 g/l z zmanjšanim deležem protrombina < 70
English: The level of solution in the vial should remain constant during the entire infusion.
Slovenian: Raven raztopine v viali mora ostati konstantna med celotno infuzijo.
English: The catheters should be connected to the infusion sets (one for Lutathera, one for amino acid solution).
Slovenian: Katetre je treba priključiti na komplete za infuzijo (enega na zdravilo Lutathera in enega na raztopino aminokislin).
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.
Slovenian: Kmalu po začetku infuzije je treba z Geigerjevim števcem izmeriti radioaktivno sevanje nad bolnikovim prsnim košem, da se preveri prisotnost zdravila Lutathera v krvnem obtoku.
English: Marketing Authorisation Holder Advanced Accelerator Applications 20 rue Diesel
Slovenian: Imetnik dovoljenja za promet Advanced Accelerator Applications 20 rue Diesel