FrancophonIA/ELRC3.0 huggingface dataset:
English: Further precautions with respect to relatives, carers and hospital staff are provided in section 6.6.
Slovenian: Več previdnostnih ukrepov v zvezi s sorodniki, negovalci in bolnišničnim osebjem je navedenih v poglavju 6.6.
English: This could potentially result in osteosarcomas.
Slovenian: To lahko povzroči osteosarkome.
English: The use of television monitor systems to monitor the patients is recommended.
Slovenian: Priporočljiva je uporaba sistemov s televizijskim zaslonom za spremljanje bolnikov.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Slovenian: Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja pristojnega organa.
English: Duration of the procedure
Slovenian: Trajanje postopka
English: You will be asked to stop breast-feeding.
Slovenian: Zaprošeni boste, da prenehate dojiti.
English: This leaflet was last revised in {month YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL} Drugi viri informacij
English: In most countries, the exposure limit for hospital staff is set the same as for the general public at 1 mSv/year.
Slovenian: V večini držav je omejitev izpostavljenosti za bolnišnično osebje določena enako kot za splošno javnost, tj. pri 1 mSv/leto.
English: Withdrawals should be performed under aseptic conditions.
Slovenian: Odvzem je treba izvajati v aseptičnih pogojih.
English: The generally accepted threshold for discharge of the treated patient from the hospital is 20 µSv/h.
Slovenian: Splošno sprejeti prag za odpust zdravljenega bolnika iz bolnišnice je 20 µSv/h.
English: Most events are mild and transient.
Slovenian: Večina dogodkov je blagih in prehodnih.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Slovenian: Zdravnik nuklearne medicine vas bo obvestil o običajnem trajanju postopka.
English: Most of these events are mild and only temporary.
Slovenian: Večina dogodkov je blagih in samo začasnih.
English: Non carrier added (n.c.a.)
Slovenian: Brez dodanega nosilca (non carrier added - n.c.a.)
English: It has to be used in combination with other medicines (carrier medicines).
Slovenian: Uporabljati ga je treba skupaj z drugimi zdravili (nosilnimi zdravili).
English: Radiation Energy (keV)* Abundance (%)
Slovenian: Sevanje Energija (keV)* Delež (%)
English: (GBq: GigaBecquerel is the unit in which radioactivity is measured).
Slovenian: (GBq: gigabekerel je enota za merjenje radioaktivnosti.)
English: to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: These are duplicates of those identified in the literature.
Slovenian: Gre za iste primere, ki so že opredeljeni v literaturi.
English: Faecal and urinary elimination is slow.
Slovenian: Odstranjevanje z blatom in urinom je počasno.
English: Activity may be measured using an ionisation chamber.
Slovenian: Aktivnost je mogoče izmeriti z ionizacijsko celico.
English: All cases recovered with treatment.
Slovenian: V vseh primerih je ob ustreznem zdravljenju prišlo do okrevanja.
English: Of course, the nuclear medicine staff is expected to wear standard radiation protection.
Slovenian: Seveda se od osebja za nuklearno medicino pričakuje, da bo nosilo standardno zaščito pred sevanjem.
English: Observation of patients by overnight hospitalisation should be considered in some cases (e.g. patients with poor pharmacologic control of symptoms).
Slovenian: V nekaterih primerih je treba razmisliti o opazovanju bolnikov s hospitalizacijo preko noči (npr. bolnikov s slabim farmakološkim nadzorom simptomov).
English: The surface dose rates and the accumulated dose depend on many factors.
Slovenian: Površinske stopnje odmerka in nakopičeni odmerek so odvisni od več dejavnikov.
English: This radiation is used to treat certain diseases.
Slovenian: S tem sevanjem se zdravijo določene bolezni.
English: Pack size: 1 vial
Slovenian: Velikost pakiranja: 1 viala
English: Usual precautions regarding sterility and radioactivity should be respected.
Slovenian: Upoštevati je treba običajne previdnostne ukrepe glede sterilnosti in radioaktivnosti.
English: It is recommended to perform individual radiation dosimetry assessments of specific organs, which may not be the target organ of therapy.
Slovenian: Priporočljivo je izvesti individualne ocene dozimetrije sevanja za posamezne organe, ki morda niso ciljni organi zdravljenja.
English: Adequate shielding is mandatory.
Slovenian: Ustrezna zaščitna oprema je obvezna.
English: The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Slovenian: Učinkovitost keliranja je največja takoj po izpostavljenosti ali v eni uri po njej, ko radionuklid kroži ali je v tkivni tekočini in plazmi.
English: The cases occurred in close temporal proximity to the RLT, alternative aetiologies were excluded and most cases either met or were close to meeting formal criteria of TLS definition.
Slovenian: Primeri so se pojavili časovno blizu zdravljenja z RLT, alternativne etiologije so bile izključene in večina primerov je v celoti ali v veliki meri izpolnila formalna merila za diagnozo TLS.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Slovenian: V vsakem primeru je treba zagotoviti, da so tveganja zaradi sevanja manjša od tveganj bolezni same.
English: The following nuclear reaction is ongoing in the irradiation:
Slovenian: Pri obsevanju poteka naslednja jedrska reakcija:
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the procedure.
Slovenian: Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj bi ta zdravila lahko vplivala na postopek.
English: Store in the original package in order to avoid unnecessary radiation exposure.
Slovenian: Shranjujte v originalni ovojnini, da se izognete nepotrebni izpostavljenosti sevanju.
English: Activity measurements using an ionization chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Slovenian: Meritve aktivnosti z uporabo ionizacijske celice so zelo občutljive za geometrične faktorje in jih je zaradi tega treba izvajati samo pod geometričnimi pogoji,
English: The PRAC is of the view that although the number of identified cases is limited, the exposure to date is relatively low, and the association with tumour lysis syndrome is biologically plausible.
Slovenian: Odbor PRAC kljub omejenemu številu prepoznanih primerov meni, da je izpostavljenost do danes relativno nizka, povezava s sindromom tumorske lize pa je biološko verjetna.
English: The PRAC therefore recommends that the Product Information should be updated accordingly.
Slovenian: Odbor PRAC zato priporoča ustrezno posodobitev podatkov o zdravilu.
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 natančnejšo in informativno določitev skupnega odmerka sevanja za osebje.
English: The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as indicated by the customer and can be within 0 to 7 days starting from the day of manufacture.
Slovenian: Čas ART je ob 12:00 uri (opoldan) na predvideni dan radioaktivnega označevanja, ki ga določi stranka in lahko nastopi od 0 do 7 dni od dneva izdelave.
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Slovenian: Te osebe bodo posebno pozorne na varno uporabo radionuklidnega predhodnika in vas bodo sproti obveščale o svojem ravnanju.
English: For minimising radiation exposure resulting from repeated exposition there is no recommendation except the strict observance of the above ones.
Slovenian: Za zmanjšanje izpostavljenosti sevanju, do katere prihaja ob ponavljajoči se izpostavljenosti, ni priporočil, z izjemo strogega upoštevanja zgoraj navedenih.
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: For the next 28 days, further uptake of 177Lu can be observed in the bone, which is compensated in part by radioactive decay.
Slovenian: V naslednjih 28 dneh je mogoče v kosteh opaziti nadaljnji privzem 177Lu, ki ga delno kompenzira radioaktivni razpad.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Slovenian: Pri vsakem bolniku je treba izpostavljenost sevanju upravičiti z verjetno koristjo.
English: Patients with a history of renal insufficiency and high tumour burden may be at greater risk and should be treated with increased caution.
Slovenian: Pri bolnikih z anamnezo ledvične insuficience in velikim tumorskim bremenom je tveganje večje in jih je treba zdraviti previdneje.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Slovenian: Za shranjevanje tega zdravila v ustreznih prostorih je odgovoren specialist.
English: For this reason it is mandatory to use protective high quality (latex/nitrile) gloves in any direct contact with the radiopharmaceutical (vial/syringe) and with the patient.
Slovenian: V ta namen je obvezna uporaba zaščitnih visokokakovostnih rokavic (lateks/nitril) pri vsakem neposrednem stiku z radiofarmakom (viala/brizga) in bolnikom.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Any other person in close vicinity of the treated patient should be informed about possibilities to reduce his/her exposure due to radiation emitted from the patient.
Slovenian: Katero koli drugo osebo v neposredni bližini zdravljenega bolnika je treba obvestiti o tem, kako lahko zmanjša svojo izpostavljenost sevanju, ki ga oddaja bolnik.
English: The specific activity of the medicinal product at ART is indicated on the label and always greater than 3,000 GBq/mg.
Slovenian: ART je navedena na ovojnini in je vedno višja od 3.000 GBq/mg.
English: For instructions on preparation of the medicinal product before administration, see section 12.
Slovenian: Za navodila glede vnaprejšnje priprave zdravila pred dajanjem glejte poglavje 12.
English: This waiver does however not extend to any therapeutic uses of the product when linked to a carrier molecule (see section 4.2 for information on paediatric use).
Slovenian: Vendar pa se ta odstop ne nanaša na nobeno terapevtsko uporabo zdravila, ko je povezano z nosilno molekulo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In any case, the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of radiotoxicity.
Slovenian: V vsakem primeru je treba spremljati krvne parametre bolnika in, če obstaja radiotoksičnost, takoj ustrezno ukrepati.
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10X
Slovenian: Farmakoterapevtska skupina: drugi radioterapevtiki, oznaka ATC: V10X
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če zdravilo ni porabljeno takoj, je za čas shranjevanja med uporabo in pogoje pred uporabo odgovoren uporabnik.
English: Absorbed dose per unit radioactivity administered (mSv/MBq) Adult (73.7 kg)
Slovenian: Absorbirani odmerek na enoto dane radioaktivnosti (mSv/MBq) Odrasli (73,7 kg)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Dose reduction may be necessary in affected patients.
Slovenian: Pri prizadetih bolnikih bo morda odmerek treba zmanjšati.
English: In bone, the content increases from 0.01 %ID/g at 5 min to 0.23 %ID/g after 12 hours.
Slovenian: V kosteh se vsebnost poveča z 0,01 % ID/g po 5 minutah na 0,23 % ID/g po 12 urah.
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Slovenian: Odmerek sevanja, ki izvira iz terapevtske izpostavljenosti, lahko povzroči povečano incidenco raka in mutacij.
English: - Nausea - Vomiting
Slovenian: - navzea - bruhanje
English: However, in the case of an overdose or an inadvertent intravenous injection of the unlabelled product, you will receive appropriate treatment that will remove the radionuclide from the body.
Slovenian: Vendar boste v primeru prevelikega odmerjanja ali nenamernega intravenskega injiciranja neoznačenega zdravila prejeli ustrezno zdravljenje, s katerim bo radionuklid odstranjen iz telesa.
English: This should be taken into account when considering the benefit/risk, especially in patients with possible risk factors like prior exposure to chemotherapeutic agents (such as alkylating agents).
Slovenian: To je treba upoštevati pri ocenjevanju razmerja med koristjo in tveganjem, zlasti pri bolnikih z možnimi dejavniki tveganja, kot je predhodna izpostavitev kemoterapevtskim učinkovinam
English: As a result of both excretion and radioactive decay, the total radioactivity remaining in the body after 28 days is about 1.8 % of the injected dose.
Slovenian: Zaradi izločanja in radioaktivnega razpada je skupna radioaktivnost, ki ostane v telesu po 28 dneh, približno 1,8 % injiciranega odmerka.
English: This may result in abnormal blood test results, irregular heartbeat, kidney failure or seizures within a week of treatment.
Slovenian: To lahko povzroči nenormalne izvide krvnih preiskav, nepravilno bitje srca, odpoved ledvic ali epileptične napade v enem tednu po zdravljenju.
English: Doubling the distance to the patient to 2 meters reduces the dose rate by a factor of 4, to 0.9 µSv/h.
Slovenian: Če se razdalja do bolnika podvoji na dva metra, se odmerek zmanjša za faktor 4, na 0,9 µSv/h.
English: In case of hormonal crises, treatments may include: intravenous high dose somatostatin analogues, intravenous fluids, corticosteroids, and correction of electrolyte disturbances in patients with diarrhoea and/or vomiting.
Slovenian: V primeru hormonskih kriz lahko zdravljenje vključuje: visok intravenski odmerek somatostatinskih analogov, intravenske tekočine, kortikosteroide in popravek elektrolitskih motenj pri bolnikih z drisko in/ali bruhanjem.
English: Reported symptoms include flushing and diarrhoea associated with hypotension.
Slovenian: Simptomi, o katerih so poročali, vključujejo vročinske oblive in diarejo, povezano s hipotenzijo.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je treba pripraviti na način, ki bo zadostil zahtevam glede zaščite pred sevanjem in zahtevam farmacevtske kakovosti.
English: Before administering radiopharmaceuticals to a mother who is breastfeeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Slovenian: Pred dajanjem radiofarmakov doječi materi je treba pretehtati možnost zakasnitve dajanja radionuklida, dokler mati ne neha dojiti, in se odločiti za najprimernejši radiofarmak, pri čemer je treba upoštevati izločanje aktivnosti v materino mleko.
English: Before use, packaging and radioactivity should be checked.
Slovenian: Pred uporabo je treba preveriti ovojnino in radioaktivnost.
English: Before the use of 177Lu-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Slovenian: Pred uporabo z lutecijem (177Lu) označenih zdravil je treba z ustreznim/veljavnim testom nosečnost izključiti.
English: Management should be in accordance with local protocols.
Slovenian: Bolnika je treba obravnavati skladno z lokalnimi protokoli.
English: The toxicity of non-radioactive Lutetium chloride has been studied in different mammalian species and using different administration routes.
Slovenian: Toksičnost neradioaktivnega lutecijevega klorida so proučevali pri različnih sesalcih in z uporabo različnih poti uporabe.
English: It is important that all glassware, syringe needles etc., used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities.
Slovenian: Pomembno je, da so vsa steklovina, igle za brizge itd., ki se uporabljajo za pripravo radioaktivno označenih zdravil, temeljito očiščene, tako da se zagotovi odsotnost nečistot v obliki kovin v sledovih.
English: In the absence of compatibility studies, this medicinal product must not be mixed with medicinal products other than the medicinal products to be radiolabelled.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili, razen z zdravili, namenjenimi za radioaktivno označevanje.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Taking into account the radioactive half-life of 177Lu of 6.647 days, the radioactivity remaining in the bone after 28 days is only about 0.06 %ID/g.
Slovenian: Z upoštevanjem radioaktivne razpolovne dobe 177Lu, ki znaša 6,647 dneva, je po 28 dneh radioaktivnost v kosteh le približno 0,06 % ID/g.
English: Your doctor will perform blood tests to monitor you for this syndrome.
Slovenian: Zdravnik bo opravil krvne preiskave, da bo pri vas spremljal pojav tega sindroma.
English: In case of extravasation, infusion of the medicinal product should be immediately ceased, and the nuclear medicine physician and the radiopharmacist should be promptly informed.
Slovenian: V primeru ekstravazacije je treba takoj prekiniti infundiranje zdravila ter obvestiti zdravnika s področja nuklearne medicine in radiofarmacevta.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Radiofarmake sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v pooblaščenih zdravstvenih ustanovah.
English: Tell your doctor if you have muscle cramping, muscle weakness, confusion, or shortness of breath.
Slovenian: Zdravniku povejte, če se pri vas pojavijo mišični krči, mišična oslabelost, zmedenost ali zasoplost.
English: According to literature reports and taking a conservative approach (maximum patient dose of 10 GBq, average labeling yield and no additional measures), it may be considered that 177Lu-labelled medicinal products do not lead to reproductive toxicity including spermatogenetic damage in male testes or genetic damage in male testes or female ovaries.
Slovenian: Glede na poročila v literaturi in s konzervativnim pristopom (največji odmerek za bolnika 10 GBq, povprečni izkoristek označevanja in brez dodatnih ukrepov) lahko velja, da z lutecijem 177Lu označena zdravila nimajo škodljivih učinkov na sposobnost razmnoževanja, vključno s spermatogenetskimi okvarami v moških testisih ali genetskimi okvarami v moških testisih ali ženskih jajčnikih.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: Z radionuklidnim predhodnikom bodo rokovale in vam ga dajale le osebe, usposobljene za njegovo varno uporabo.
English: Very common side effects (may affect more than 1 in 10 people): - Reduction in blood cell counts (platelets, red or white blood cells)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - zmanjšanje števila krvnih celic (krvnih ploščic, rdečih ali belih krvnih celic)
English: EndolucinBeta is not to be used directly in childrens and adolescent patients under 18 years old.
Slovenian: Radionuklidni predhodniki EndolucinBeta se ne sme uporabljati neposredno pri otrocih in mladostnikih, mlajših od 18 let.
English: It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the medicine you take with EndolucinBeta and what it is used for.
Slovenian: To bo najmanjša količina, ki je potrebna za doseganje ustreznega izida, odvisno od zdravila, ki ga boste vzeli skupaj z radionuklidnim predhodnikom EndolucinBeta, in od tega, za kaj se to zdravilo uporablja.
English: Given the long half-life of Lutetium (177Lu), it is specially recommended to avoid internal contamination.
Slovenian: Glede na dolg razpolovni čas lutecija (177Lu) je še posebno priporočljivo, da se izognete notranji kontaminaciji.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Slovenian: Pri teh bolnikih je potrebno skrbno upoštevati razmerje med koristmi in tveganji, saj lahko pride do povečane izpostavljenosti sevanju.
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Slovenian: Če ste v dvomih, je pomembno, da se posvetujete z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
English: If in 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, če je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi nadomestne tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
English: Treatment with Lutetium (177Lu) radioligand therapy may lead to the following side effects - a reduced number of red blood cells (anaemia) - a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding - a reduced number of white blood cells (leukopenia, lymphopenia or neutropenia) which are important for protecting the body against infection
Slovenian: Zdravljenje z radioligandno terapijo z lutecijem (177Lu) lahko privede do naslednjih neželenih učinkov: - zmanjšanega števila rdečih krvnih celic (anemije); - zmanjšanega števila krvnih ploščic v krvi (trombocitopenija), ki so pomembne za zaustavitev krvavitve; - zmanjšanega števila belih krvnih celic (levkopenija, limfopenija ali nevtropenija), ki so pomembne za zaščito telesa pred okužbo.
English: Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Slovenian: Uporabljajo se lahko samo igle za brizge (na primer nekovinske) z dokazano odpornostjo proti razredčenim kislinam, da se zmanjša raven nečistot v obliki kovin v sledovih.
English: Due to the capacity of the chelating ligands (DTPA, EDTA) of forming water soluble complexes, the complexes and bound Lutetium (177Lu) are rapidly eliminated by the kidneys.
Slovenian: Zaradi zmožnosti kelatnih ligandov (DTPA, EDTA), da tvorijo v vodi topne komplekse, se kompleksi in vezani lutecij (177Lu) hitro izločijo prek ledvic.