natgillin/translations-raw huggingface dataset:
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. 
Zdravnik nuklearne medicine mora glede na okoliščine bolnika obvestiti o tveganjih, povezanih z ekstravazacijsko poškodbo, in svetovati o morebitnem zdravljenju in potrebnih nadaljnjih posegih.
What Lutathera is and what it is used for 2. 
Kaj je zdravilo Lutathera in za kaj ga uporabljamo 2.
Lutathera is contraindicated in pregnant women. 
Zdravilo Lutathera je kontraindicirano pri nosečnicah.
There is no efficacy data in patients with known brain metastases therefore individual benefit-risk must be assessed in these patients. 
Podatkov o učinkovitosti pri bolnikih z znanimi metastazami v možganih, zato je pri teh bolnikih treba oceniti individualne koristi in tveganja.
The pole height should be adjusted in order to compensate any increase or reduction of pressure inside the vial. 
Višino infuzijskega stojala je treba prilagoditi, da se izravna vsako zvečanje ali zmanjšanje tlaka v viali.
• Severe heart failure defined as class III or IV in the NYHA classifications; 
• hudo srčno popuščanje, opredeljeno kot razred III ali IV po razvrstitvah NYHA;
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. 
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.
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). 
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).
Infusion rate (mL/h) 
Hitrost infundiranja (ml/h)
Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death. 
Zdravilo Lutathera se veže na te receptorje in oddaja radioaktivnost neposredno v tumorske celice, zaradi česar odmrejo.
All* 
Vsi*
The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect. 
V vsakem primeru je treba aplicirati čim manjšo aktivnost, ki še omogoča doseganje potrebnega terapevtskega učinka.
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. 
Radionuklidni postopki, izvedeni pri nosečnicah, vključujejo tudi odmerek sevanja na plod.
A risk to the suckling child associated with ionising radiation cannot be excluded. 
Tveganja, povezanega z ionizirajočim sevanjem, za dojenega otroka ni mogoče izključiti.
If at any time in the preparation of this medicinal product the integrity of this vial is compromised, it should not be used. 
Če je kadar koli med pripravo tega zdravila ogrožena integriteta te viale, zdravila ne smete uporabiti.
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). 
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).
Concomitant use of cold somatostatin analogues may be needed for disease symptoms control. 
Za nadzor simptomov bolezni bo morda potrebna sočasna uporaba hladnih somatostatinskih analogov.
Severe heart failure (defined as grade III or IV of the New York Heart Association (NYHA) classification) 
Hudo srčno popuščanje (opredeljeno kot razred III ali IV po razvrstitvi New York Heart Association
It binds to malignant cells which overexpress sst2 receptors. 
Veže se na maligne celice, ki čezmerno izražajo receptorje sst2.
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. 
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.
During the administration only disposable materials should be used. 
Med aplikacijo je treba uporabljati le materiale za enkratno uporabo.
Two intravenous plastic catheters should be inserted into patient's peripheral veins, one on each arm. 
V bolnikovi periferni veni je treba vstaviti dva intravenska plastična katetra - po enega v vsako roko.
Breast-feeding must be stopped. 
Dojenje je treba prekiniti.
For recommendations in case of extravasation, see section 4.4. 
Za priporočila v primeru ekstravazacije glejte poglavje 4.4.
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.
Specification 
Specifikacije
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