natgillin/translations-raw huggingface dataset:
If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.
Če je v času dojenja potrebno zdravljenje z zdravilom Lutathera, je otroka treba odstaviti.
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.
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 %.
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.
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.
− One (1) sterile tubing line with a clamp to regulate or stop the flow
− en (1) sterilni vod cevke s sponko za uravnavanje ali ustavitev pretoka;
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.
(PFS - Progression-free survival), ocenjeno glede na merila odzivnosti pri solidnih tumorjih (RECIST 1.1) na podlagi neodvisne radiološke ocene.
− One (1) Long needle (90 - 100 mm)
− ena (1) dolga igla (90-100 mm);
Lutathera should be infused directly from its original container.
Zdravilo Lutathera je treba infundirati neposredno iz originalnega vsebnika.
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.
V vsakem primeru, če se zdravnik odloči za zdravljenje, je treba bolniku dati jasne informacije o tveganjih, povezanih z apliciranjem zdravila Lutathera.
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.
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.
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.
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.
It is not known if there is of interaction between glucocorticosteroids used intermittently for the prevention of nausea and vomiting during Lutathera administration.
Ni znano ali obstajajo interakcije med glukokortikosteroidi, uporabljenimi sočasno za preprečevanje navzee in bruhanja med aplikacijo zdravila Lutathera.
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.
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
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.
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.
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.
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.
Breast-feeding should be avoided during treatment with this medicinal product.
Med zdravljenjem s tem zdravilom se je treba izogibati dojenju.
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).
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).
Injection site reaction11
Reakcije na mestu injiciranja11
* The concomitant amino acids infusion is always administered at full dose (see section 4.4).
*Sočasno infuzijo aminokislin vedno apliciramo v celotnem odmerku (glejte poglavje 4.4).
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.
Če je kadar koli med pripravo tega zdravila ogrožena integriteta tega vsebnika in viale, zdravila ne smete uporabiti.
The recommended infusion method for administration of Lutathera is the gravity method.
Priporočena metoda za aplikacijo infuzije zdravila Lutathera je gravitacijska metoda.
The use of Lutathera does involve exposure to amounts of radioactivity.
Uporaba zdravila Lutathera vključuje izpostavljenost majhnim količinam radioaktivnosti.
If this does occur to you, your doctor may decide to delay or stop the treatment administration.
Če pride do tega, se lahko zdravnik odloči odložiti ali prekiniti zdravljenje.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Odmerek sevanja zaradi terapevtske izpostavljenosti lahko povzroči večjo pojavnost rakavih obolenj in mutacij.
In the case of overdose, an increase in the frequency of the adverse reactions related to radiotoxicity is expected.
V primeru prevelikega odmerjanja je pričakovati zvečanje pogostnosti neželenih učinkov, povezanih z radiotoksičnostjo.
In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered.
V primeru hude navzee ali bruhanja med infuzijo raztopine aminokislin se lahko aplicira antiemetik drugega farmakološkega razreda.
Amino acid solution, either extemporaneously compounded (1 L) or commercial (1.5 L to 2.2 L)
Raztopina aminokislin, pripravljena ex tempore (1 l) ali komercialno dostopna (1,5-2,2 l)
• Kidney function (creatinine and creatinine clearance)
• delovanje ledvic (kreatinin in kreatininski očistek);
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.
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.
Total activity administered is equal to the activity in the vial before infusion minus the activity remaining in the vial after the infusion.
Skupna aplicirana aktivnost je enaka aktivnosti v viali pred infuzijo, zmanjšana za aktivnost, ki je v viali ostala po infuziji.
What you need to know before Lutathera is used 3.
Kaj morate vedeti, preden boste prejeli zdravilo Lutathera 3.
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.
Ko je bila priporočena sočasna aminokislinska infuzija, dovajana v 4-urnem časovnem obdobju, so poročali o povprečnem zmanjšanju izpostavljenosti ledvic sevanju za približno 47 %.
The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used.
Raztopino je treba pred uporabo pregledati za poškodbami in onesnaženostjo, uporabiti pa je dovoljeno samo bistro raztopino brez vidnih delcev.
a. If the observed toxicity continues beyond 16 weeks after the last infusion, treatment with Lutathera must be definitively stopped.
a. Če opažena toksičnost vztraja po preteku 16 tednov po zadnji infuziji, je treba zdravljenje z zdravilom Lutathera dokončno ukiniti.
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).
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).
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.
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.
Thrombocytopenia of grade 2 or superior (CTCAE)**.
Trombocitopenija 2. ali višje stopnje (CTCAE)**.
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.
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.
Ionizing radiations of lutetium (177Lu) oxodotreotide may potentially have temporary toxic effects on female and male gonads.
Ionizirajoče sevanje lutecijevega (177Lu) oksodotreotida ima lahko potencialno začasne toksične učinke na ženske in moške spolne žleze.
The patient should also be encouraged to defecate every day and to use laxative if needed.
Bolnika je treba tudi spodbuditi, da gre vsak dan na blato in da po potrebi uporabi odvajalo.
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.
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.
Urine and faeces should be disposed according to the national regulations.
Urin in iztrebke je treba odstraniti v skladu z nacionalnimi predpisi.
** CTCAE: Common Terminology Criteria for Adverse Events, National Cancer Institute
**CTCAE: Skupni kriteriji za terminologijo neželenih učinkov (CTCAE - Common Terminology Criteria for
• Information that PPRT can cause serious side effects during or after treatment and that any side effect should be reported to the physician.
• 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.
This medicinal product contains up to 3.5 mmol (81.1 mg) sodium per dose.
To zdravilo vsebuje do 3,5 mmol (ali 81,1 mg) natrija na odmerek.
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.
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.
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.
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.
The posology can be adapted according to the patient's status at the discretion of the physician.
Odmerjanje je mogoče prilagoditi glede na stanje bolnika po presoji zdravnika.
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).
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
Concomitant use of somatostatin analogues
Sočasna uporaba somatostatinskih analogov
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).
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).
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.
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.
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.
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.
Patients should be encouraged to empty their bladder as frequently as possible during the administration of amino acids and the hours after administration.
Bolnike je treba spodbujati, da svoj mehur praznijo čim pogosteje med aplikacijo aminokislin in v urah po aplikaciji.
It is necessary to wear waterproof gloves and suitable aseptic techniques when handling the medicinal product.
Pri ravnanju z zdravilom je treba nositi vodotesne rokavice in uporabljati ustrezne aseptične tehnike.
• The short needle should be inserted into the Lutathera vial, so that it does not touch the radiopharmaceutical solution.
• Kratko iglo je treba vstaviti v vialo Lutathera, tako da se ne bo dotikala raztopine radiofarmaka.
There is some evidence that corticosteroids can induce down-regulation of SST2 receptors.
Obstajajo dokazi, da lahko kortikosteroidi inducirajo zmanjšanje izražanja receptorja SSTR2.
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).
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);
Median 95%CI
95 % IZ Mediana
− One (1) Short needle
− ena (1) kratka igla;
Temporarily discontinue the treatment until resolution or stabilisation.
Zdravljenje začasno prekinite do izboljšanja ali stabilizacije stanja.
Not reached p-value of Log-rank test Hazard ratio (95%-CI)
Ni bila dosežena p-vrednost v testu Log-rank Razmerje tveganja (95 %-IZ)
In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys.
Skupaj z zdravilom Lutathera boste prejeli tudi infuzijo aminokislin, da bi zaščitili vaše ledvice.
Feeling abnormal
Neobičajno počutje
Dose-modifying toxicity (DMT) criteria
Merila za toksičnost, ki zahteva prilagoditev odmerka (DMT)
N Patients with events Censored patients Median months (95%-CI)
N Bolniki z dogodki Okrnjeni (cenzurirani) vzorec bolnikov Mediana v mesecih (95 %-IZ)
Men and women of child-bearing potential must refrain from procreation by using effective contraceptive methods during the treatment and for 6 months after.
Plodni moški in ženske se morajo v času zdravljenja in 6 mesecev po njem vzdržati oploditve z učinkovitimi kontracepcijskimi metodami.
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.
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).
− Calibrated radioactivity measurement system and Geiger counter to monitor the radioactivity of Lutathera
− Umerjeni sistem za merjenje radioaktivnosti in Geigerjev števec za nadzor radioaktivnosti zdravila Lutathera.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Postopke aplikacije je treba izvajati tako, da se čim bolj zmanjša tveganje za kontaminacijo zdravila in obsevanje osebja.
Musculoskeletal pain8 Muscle spasms
Mišično-skeletna bolečina8 Mišični spazmi
Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
Radioaktivnost v viali zdravila Lutathera je treba izmeriti tik pred infuzijo z uporabo umerjenega sistema za merjenje radioaktivnosti.
Lutathera should be administered over 20 to 30 minute time span.
Zdravilo Lutathera je treba aplicirati v od 20 do 30
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.
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.
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.
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.
• Renal or urinary tract morphological abnormalities;
• Morfološke abnormalnosti ledvic ali urinarnega trakta;
Staphylococcal infections Streptococcal bacteraemia
Stafilokokne okužbe Streptokokna bakteriemija
The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion.
Skupna količina radioaktivnosti na vialo z enim odmerkom je 7.400 MBq ob datumu in uri infuzije.
• Care supplies and equipment:
• Material in oprema za nego:
It is strongly recommended to limit contact with children and pregnant women for 7 days after the administration.
Stik z otroki in nosečnicami je zelo priporočljivo omejiti še 7 dni po tem, ko ste prejeli zdravilo.
The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow.
Najpogostejši neželeni učinek pri bolnikih, ki se zdravijo z zdravilom Lutathera, je vpliv na kostni mozeg.
Frequency of adverse reactions reported from clinical trials and from post-marketing surveillance
Preglednica 7: Pogostost neželenih učinkov, o katerih so poročali v kliničnih preskušanjih in v času spremljanja zdravila v obdobju trženja
therefore treatment with Lutathera in those patients is not recommended.
Lutathera pri teh bolnikih ni priporočljivo.
Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.
Bistra, brezbarvna steklena viala tipa I, zaprta z bromobutilnim gumijastim zamaškom in aluminijasto folijo.
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.
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.
These finding are supported by in vitro metabolism data in human hepatocytes, in which no metabolic degradation of lutetium (175Lu) oxodotreotide was observed.
Ti rezultati so potrjeni s podatki o presnovi in vitro za humane hepatocite, v katerem niso opazili nobene presnovne degradacije lutecijevega (175Lu) oksodotreotida.
Blood catecholamines c-reactive protein increased
Zvečanje vrednosti c reaktivnega proteina
• Blood chemistry monitoring: serum creatinine and glycaemia.
• kemijske preiskave krvi: serumsko koncentracijo kreatinina in glikemije.
The patient should be encouraged to urinate as much as possible after Lutathera adminiastration.
Bolnika je treba spodbuditi, da po uporabi zdravila Lutathera čim več urinira.
Room and equipment preparation:
Priprava prostora in opreme: • Prostor za aplikacijo:
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.
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.
The median PFS for Lutathera was not reached at the time of analysis whereas the one of octreotide LAR was 8.5 months.
Mediana PFS za zdravilo Lutathera v času analize ni bila dosežena, medtem ko je pri oktreotidu LAR znašala 8,5 mesecev.
01630, Saint Genis Pouilly France
01630, Saint Genis Pouilly Francija
Cryopreservation of sperm or eggs may be offered to you before the treatment.
Morda vam bodo pred zdravljenjem ponudili krioprezervacijo sperme ali jajčec.
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.
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.