FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending upon its seriousness, this event should be declared as an adverse reaction.
Slovenian: Ta dogodek je treba glede na njegovo resnost prijaviti kot neželeni učinek.
English: Toilets must be used in a seated position, even for men.
Slovenian: Uporaba stranišča Stranišče je treba uporabljati v sedečem položaju, kar velja tudi za moške.
English: • History of other malignant tumours unless the patient is considered to be in remission for at least 5 years.
Slovenian: • anamneza drugih malignih tumorjev, razen če velja, da je bolnik v remisiji vsaj 5 let.
English: • Medicinal products to be administered:
Slovenian: • Zdravila, ki jih je treba aplicirati:
English: This will equilibrate pressure thus reducing any risk of leakage.
Slovenian: To bo uravnotežilo tlak in tako zmanjšalo nevarnost puščanja.
English: Between 18 and 24 g
Slovenian: 18-24 g
English: Colleretto Giacosa (TO) Italy
Slovenian: Colleretto Giacosa (TO) Italija
English: Social circumstances
Slovenian: Socialne okoliščine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1226/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1226/001
English: The medicine infusion takes 20 to 30 minutes; but the complete administration procedure will take approximately 5 hours.
Slovenian: Infundiranje zdravila traja od 20 do 30 minut; celoten postopek pa traja približno 5 ur.
English: In all cases it is necessary to ensure that the risks of the radiation exposure are less than from the disease itself.
Slovenian: V vseh primerih je treba zagotoviti, da je tveganje za izpostavljenost sevanju manjše kot pri sami bolezni.
English: The main analysis has been conducted on 811 Dutch patients with different somatostatin receptor positive tumour types.
Slovenian: Glavna analiza je bila izvedena za 811 nizozemskih bolnikov z različnimi vrstami tumorjev s pozitivnimi somatostatinskimi receptorji.
English: Liver toxicity defined as either:
Slovenian: Jetrna toksičnost, opredeljena kot:
English: These tests should be performed at least once within 2 to 4 weeks prior to administration and shortly before the administration.
Slovenian: Te preiskave je treba izvesti vsaj enkrat v 2-4 tednih pred aplikacijo in tik pred aplikacijo.
English: The final OS analysis is foreseen after 158 cumulative deaths.
Slovenian: Končna analiza OS je predvidena po skupaj 158 smrtnih primerih.
English: Contact with children and pregnant women
Slovenian: Stik z otroki in nosečnicami
English: Therefore, it is recommended to monitor those patients more frequently during the treatment.
Slovenian: Zato je te bolnike priporočljivo med zdravljenjem spremljati pogosteje.
English: Furthermore, drink frequently and try to urinate every hour on the day you received treatment and on the day after.
Slovenian: Poleg tega morate pogosto piti in poskusite urinirati vsako uro dneva, ko prejmete to zdravilo, in naslednjega dneva.
English: Patients should sleep in a separate bedroom for 7 days, what should be extended to 15 days in case of pregnant partners or children.
Slovenian: Bolniki morajo 7 dni spati v ločeni spalnici, kar je treba podaljšati na 15 dni, če imajo nosečo partnerico ali otroke.
English: Given the half-life of 177Lu it is specially recommended to avoid internal contamination.
Slovenian: Glede na razpolovno dobo 177Lu se je notranji kontaminaciji še posebej priporočljivo izogniti.
English: • Urinary incontinence;
Slovenian: • urinarna inkontinenca;
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Slovenian: Obstajajo strogi zakoni o uporabi in odstranjevanju radiofarmacevtskih zdravil ter ravnanju z njimi.
English: Travel Keep the discharge letter with you whenever you are travelling for at least 3 months after treatment.
Slovenian: Potovanje Odpustnico imejte s sabo vedno, ko potujete znotraj vsaj 3 mesecev po zdravljenju.
English: Careful monitoring of the vital signs during the infusion is recommended.
Slovenian: Priporočljivo je skrbno spremljanje vitalnih znakov med infuzijo.
English: Lutathera will only be used in special controlled areas.
Slovenian: Zdravilo Lutathera bo uporabljeno samo v posebno nadzorovanih prostorih.
English: Pancreatic 133 7 5% 74 56% 47 35% 81 61% 52% 69% 16.3 12.1 21.8 Foregut** 12 1 8% 6 50% 4 33% 7 58% 28% 85% 22.3 0.0 38.0 Midgut
Slovenian: Bronhialni 19 0 0 % 7 37 % 11 58 % 7 37 % 16 % 62 % 23,9 1,7 30,0 Pankreatski 133 7 5 % 74 56 % 47 35 % 81 61 % 52 % 69 % 16,3 12,1 21,8 Sprednje črevesje** 12 1 8 % 6 50 % 4 33 % 7 58 % 28 % 85 % 22,3 0,0 38,0 Srednje črevesje 183 3 2 % 58 32 % 115 63 % 61 33 % 27 % 41 % 15,3 10,5 17,7 Zadnje črevesje 13 0 0 % 6 46 % 6 46 % 6 46 % 19 % 75 % 17,8 6,2 29,9
English: Dosing may need to be modified based on the tests results.
Slovenian: Odmerjanje bo morda treba prilagoditi glede na rezultate preiskav.
English: People who are confined to the bed or have reduced mobility will preferably receive assistance by a care provider.
Slovenian: Ljudje, ki so omejeni na posteljo ali z omejeno mobilnostjo, bodo po možnosti prejeli pomoč poklicnega negovalca.
English: You might be asked to bring the bag back to your treatment facility, or, after 70 days, the bag may be removed as the other household waste.
Slovenian: Morda vam bodo naročili, da vrečke prinesete nazaj v svojo zdravstveno ustanovo ali pa da vrečko po 70 dneh zavržete kot ostale gospodinjske odpadke.
English: This medicinal product must not be injected as a bolus.
Slovenian: Tega zdravila se ne sme injicirati kot bolus.
English: Due to the radiation emitted by this medicine, during the administration procedure, you should be isolated from other patients who are not receiving the same treatment.
Slovenian: Zaradi sevanja, ki ga oddaja to zdravilo, vas bodo morali med postopkom apliciranja izolirati od drugih bolnikov, ki ne prejemajo enakega zdravila.
English: It is also recommended to record the time of extravasation and the estimated volume extravasated.
Slovenian: Priporočljivo je tudi zabeležiti čas ekstravazacije in ocenjen volumen ekstravazirane tekočine.
English: This might induce nausea and vomiting; you will also receive an injection before the start of the treatment to reduce these symptoms.
Slovenian: To lahko povzroča občutek siljenja na bruhanje in bruhanje; pred začetkom postopka boste prejeli tudi injekcijo za zmanjšanje teh simptomov.
English: In order to accelerate medicinal product dispersion and to prevent its stagnation in tissue, it is recommended to increase blood flow by elevating the affected arm.
Slovenian: Za pospešitev disperzije zdravila in preprečevanje njegove stagnacije v tkivu je priporočljivo povečati pretok krvi z dvigom prizadete roke.
English: Hormonal crises
Slovenian: Hormonske krize
English: PFS differed significantly (p<0.0001) between the treatment groups.
Slovenian: Vrednost PFS se je pomembno razlikovala (p < 0,0001) med zdravljenima skupinama.
English: Lutetium (177Lu) has a half-life of 6.647 days.
Slovenian: Lutecij (177Lu) ima razpolovno dobo 6.647 dni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2017
Slovenian: Datum prve odobritve: 26. september 2017
English: The measurements should be performed using a calibrated system.
Slovenian: Meritve je treba izvesti z umerjenim sistemom.
English: This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: Z zdravilom bodo ravnale in vam ga dale samo osebe, usposobljene in kvalificirane za njegovo varno uporabo.
English: General rule
Slovenian: Splošno pravilo
English: The infusion should be stopped once the radioactivity emission from the vial becomes stable for several minutes (or during two consecutive measurements).
Slovenian: Infuzijo je treba ustaviti, ko radioaktivno sevanje iz viale ostane za nekaj minut stabilno (ali pri dveh zaporednih meritvah).
English: If for any reason you require emergency medical assistance or unplanned hospitalisation occurs during the 3 months after your treatment, you should inform the medical providers about the nature, the date and the dose of your radioactive treatment.
Slovenian: Če boste v 3 mesecih po zdravljenju iz kakršnega koli razloga potrebovali nujno medicinsko pomoč ali nepredvideno hospitalizacijo, morate zdravstvene delavce obvestiti o vrsti, datumu in odmerku vašega radioaktivnega zdravljenja.
English: Monitor biological parameters every 2 weeks, and treat appropriately if needed; in case of renal failure, good hydration is recommended if not otherwise contraindicated.
Slovenian: Biološke parametre spremljajte vsaka 2 tedna in po potrebi uvedite ustrezno zdravljenje; v primeru ledvične odpovedi je priporočljiva dobra hidracija, razen če je ta sicer kontraindicirana.
English: The tumour needs to have somatostatin receptors on the surface of its cells in order for the medicine to be effective.
Slovenian: Tumor mora imeti somatostatinske receptorje na površini svojih celic, da bi bilo zdravilo učinkovito.
English: Subsequent checks of the radioactivity emission should be performed approximately every 5 minutes at the level of the patient's thorax and vial.
Slovenian: Naknadna preverjanja radioaktivnega sevanja je treba izvesti približno vsakih 5 minut v višini bolnikovega prsnega koša in viale.
English: Keep the specific plastic trash bags separated from the other trash; keep the bags away from children and animals.
Slovenian: Priporočila za odstranjevanje smeti Uporabljene ločene plastične vrečke za smeti imejte ločeno od ostalih smeti; vrečke hranite nedosegljive otrokom in živalim.
English: • Previous chemotherapy;
Slovenian: • predhodna kemoterapija;
English: <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: • Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin,
Slovenian: • delovanje jeter (alanin aminotransferaza [ALAT], aspartat aminotransferaza [ASAT], albumin,
English: This medicinal product is not intended for regular or continuous administration.
Slovenian: Zdravilo ni namenjeno redni ali neprekinjeni aplikaciji.
English: A patient presenting with any of the conditions below is more prone to develop adverse reactions.
Slovenian: Bolnik, pri katerem je opazen kateri koli pogoj, naveden spodaj, je bolj nagnjen k razvoju neželenih učinkov.
English: The nuclear medicine physician and the radiopharmacist should be informed.
Slovenian: Obvestiti je treba zdravnika nuklearne medicine in radiofarmacevta.
English: The pharmacokinetics profile in elderly patients (≥ 75 years) has not been established.
Slovenian: Farmakokinetičnega profila pri starejših bolnikih (≥ 75 let) niso ugotovili.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Slovenian: Te bodo posebej pozorne na varno uporabo zdravila in vas bodo sproti obveščale o svojem ravnanju.
English: Decreased appetite
Slovenian: Zmanjšanje apetita
English: Octreotide LAR
Slovenian: Oktreotid LAR
English: The infusion of the medicinal product must be immediately ceased and the administration device (catheter, etc.) removed.
Slovenian: Infuzijo zdravila je treba nemudoma prekiniti in odstraniti pripomoček za apliciranje (kateter itd.).
English: Patients should be instructed to drink substantial quantities of water (1 glass every hour) on the day of infusion and the day after to facilitate elimination.
Slovenian: Bolnike je treba naročiti, da pijejo velike količine vode (1 kozarec vsako uro) na dan infundiranja in dan po njem, da bi spodbudili izločanje.
English: During the administration the recommended precaution measures should be undertaken (see section 6.6).
Slovenian: Med apliciranjem je treba izvesti priporočene previdnostne ukrepe (glejte poglavje 6.6).
English: It is necessary to use protective high quality (latex/nitrile) gloves to avoid direct contact with the radiopharmaceutical (vial/syringe).
Slovenian: Treba je uporabljati kakovostne zaščitne rokavice (iz lateksa/nitrila), da se prepreči neposreden stik z radiofarmakom (vialo/brizgo).
English: Possible delayed (> first 24 hours) side effects of the radiation include fatigue.
Slovenian: Možni zapozneli (po prvih 24 urah) neželeni učinki sevanja vključujejo utrujenost.
English: • Previous oncologic radiometabolic therapies with 131I-compounds or any other therapy using unshielded radioactive sources;
Slovenian: • predhodna onkološka radiometabolična zdravljenja s spojinami 131I- ali kakršno koli drugo zdravljenje z uporabo nezaščitenih radioaktivnih virov;
English: This can lead to the decrease of the different types of blood cells, most importantly, red blood cells (responsible for transporting the oxygen from the lungs to the different organs), platelets (a special cell which helps the blood to clot), and other blood cells such as white blood cells (helps to fight infection).
Slovenian: To lahko privede do zmanjšanja števila krvnih celic različnih vrst, najpomembneje pa rdečih krvnih celic (ki prenašajo kisik iz pljuč do različnih organov), trombocitov (posebne celice, ki pomagajo pri strjevanju krvi) in drugih krvnih celic, kot so bele krvne celice (pomagajo v boju proti okužbi).
English: The nuclear medicine physician should determine when the patient can leave the controlled area of the hospital, i.e. when the radiation exposure to third parties does not exceed regulatory thresholds.
Slovenian: Zdravnik nuklearne medicine mora določiti, kdaj lahko bolnik zapusti nadzorovano območje bolnišnice, tj. ko izpostavljenost drugih oseb sevanju ne presega več zakonsko predpisanih mejnih vrednosti.
English: Before the use of Lutathera, pregnancy should be excluded using an adequate/validated test.
Slovenian: Nosečnost je treba pred uporabo zdravila Lutathera izključiti z uporabo primerne/potrjene preiskave.
English: This will allow for the complete extraction of the radiopharmaceutical solution.
Slovenian: To bo omogočilo popolno ekstrakcijo raztopine radiofarmaka.
English: Tumour type n % n % N % n % 95%CI Median 95%CI
Slovenian: Vrsta tumorja n % n % N % n % 95 % IZ Mediana 95 % IZ
English: Leukopenia5 Neutropenia6
Slovenian: Levkopenija5 Nevtropenija6
English: In consequence, your doctor will ask you to have regular blood tests in order to check your eligibility for this treatment and to detect any side effects as early as possible.
Slovenian: Zato vas bo zdravnik napotil na redne preiskave krvi, da preveri, ali izpolnjujete pogoje za to zdravljenje in da bi morebitne neželene učinke odkrili čim prej.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Slovenian: Zdravnik nuklearne medicine vas bo seznanil z običajnim časom za izvedbo postopka.
English: MedDRA System Organ Class (SOC)
Slovenian: Organski sistemi MedDRA (SOC)
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Slovenian: Kadar se načrtuje dajanje radiofarmakov ženski v rodni dobi, je pomembno ugotoviti, ali je morda noseča.
English: DoR (months)
Slovenian: DoR (mesecev)
English: As long as the patient's skin is not contaminated, such as from the leakage of the infusion system or because of urinary incontinence, radioactivity contamination is not expected on the skin and in the vomited mass.
Slovenian: Če bolnikova koža ni kontaminirana, na primer zaradi puščanja infuzijskega sistema ali zaradi urinarne inkontinence, radioaktivna kontaminacija na koži ali v izbljuvani masi ni pričakovana.
English: Because this medicine is radioactive, you will have to follow the instructions described below to minimize radiation exposure to others.
Slovenian: To zdravilo je radioaktivno, zato boste morali upoštevati spodaj navedena navodila za zmanjšanje izpostavljenosti drugih ljudi sevanju.
English: - Wash your underwear, pyjamas, sheets and any clothes that contain sweat, blood or urine separately from the laundry of other members of your household, using a standard washing cycle.
Slovenian: - svoje spodnje perilo, pižame, posteljnino in vsa oblačila, ki vsebujejo znoj, kri ali urin operite ločeno od perila drugih članov gospodinjstva, z uporabo standardnega pralnega cikla.
English: It is recommended that when providing assistance in the bathroom, the care provider wears disposable gloves for 7 days after administration.
Slovenian: Priporočljivo je, da negovalec pri zagotavljanju pomoči v kopalnici nosi rokavice za enkratno uporabo 7 dni po aplikaciji zdravila.
English: Before each administration and during the treatment, biological tests are required to re-assess the patient's condition and adapt the therapeutic protocol if necessary (dose, infusion interval, number of infusions).
Slovenian: Pred vsako aplikacijo in med zdravljenjem je treba izvesti biološke preiskave za ponovno oceno bolnikovega stanja in po potrebi prilagoditev protokola zdravljenja (odmerka, infuzijskega intervala, števila infuzij).
English: The vial must not be opened.
Slovenian: Viale ni dovoljeno odpirati.
English: Absorption The medicinal product is administered intravenously and is immediately and completely bioavailable.
Slovenian: Zdravilo se aplicira intravensko in je takoj ter popolnoma biološko uporabno.
English: Organ absorbed dose (mGy/MBq) (n = 20)
Slovenian: Absorbirani odmerek v organih (mGy/MBq) (n = 20)
English: In the case of the use of special medical equipment such as catheters, colostomy bags bedpan, water nozzle, or anything that could be contaminated by your body fluids these must be emptied immediately in the toilet and then cleaned.
Slovenian: V primeru uporabe posebne medicinske opreme, kot so katetri, vrečke za kolostomijo, nočne posode, vodne šobe ali kar koli, kar bi lahko onesnažili s svojimi telesnimi tekočinami, je treba takoj izprazniti v stranišče in nato očistiti.
English: − Two (2) peripheral intravenous plastic catheters
Slovenian: − dva (2) periferna intravenska plastična katetra;
English: Somatostatin and its analogues competitively bind to somatostatin receptors.
Slovenian: Somatostatin in njegovi analogi se povsem vežejo na somatostatinske receptorje.
English: • Either in a container made of polymethyl methacrylate (PMMA), a transparent radioprotection container that allows a direct visual inspection of the vial,
Slovenian: • V vsebniku iz polimetilmetakrilata (PMMA), prosojnem vsebniku za zaščito proti sevanju, ki omogoča neposredni vizualni pregled viale,
English: Volume: {Y} mL
Slovenian: Prostornina: {Y} ml
English: The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT) (see Table 5).
Slovenian: Priporočeni interval med vsakim apliciranjem je 8 tednov, ki ga je mogoče podaljšati do največ 16 tednov v primeru toksičnosti, ki zahteva prilagoditev odmerka (DMT - Dose modifying toxicity) (glejte Preglednica 5).
English: Keep this medicine out of the sight and reach of children.
Slovenian: Zdravilo shranjujte izven pogleda in dosega otrok.
English: This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered, hence radioprotection rules should be followed (section 4.4).
Slovenian: To lahko zadeva ožje družinske člane zdravljenih posameznikov ali splošno javnost, kar je odvisno od stopnje aplicirane aktivnosti, zato je treba upoštevati pravila za radiološko zaščito (glejte poglavje 4.4).
English: Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
Slovenian: Zdravilo Lutathera smejo dajati samo osebe, pooblaščene za ravnanje z radiofarmaki v za to namenjenih kliničnih prostorih (glejte poglavje 6.6) in po tem, ko bolnika pregleda usposobljen zdravnik.
English: Healthcare personnel are advised to limit the time of close contact with patients injected with Lutathera.
Slovenian: Zdravstvenemu osebju svetujemo, da omejijo čas tesnega stika z bolniki, ki so prejeli zdravilo Lutathera.
English: Based on the results, your doctor may decide to delay or stop your treatment with this medicine if necessary.
Slovenian: Na podlagi izvidov se lahko zdravnik odloči za odložitev ali prekinitev zdravljenja s tem zdravilom, če je to potrebno.
English: It is also recommended to perform these tests every 4 weeks for at least 3 months after the last infusion of Lutathera and every 6 months thereof, in order to be able to detect possible delayed adverse reactions (see section 4.8).
Slovenian: Te preiskave je priporočljivo izvesti tudi vsake 4 tedne v obdobju vsaj 3 mesecev po zadnji infuziji zdravila Lutathera in vsakih 6 mesecev za tem, da bi bilo mogoče zaznati morebitne zapoznele neželene učinke (glejte poglavje 4.8).
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Radiofarmake sme sprejemati, uporabljati in aplicirati samo pooblaščeno osebje v za to namenjenih kliničnih prostorih.
English: The extravasation area should be delimited with an indelible pen and a picture should be taken if possible.
Slovenian: Območje ekstravazacije je treba označiti z neizbrisnim pisalom, po možnosti pa ga tudi fotografirati.
English: If you are taking somatostatin analogues you might be asked to stop and/or adapt your treatment for a short period of time.
Slovenian: Če jemljete analoge somatostatina, vam bodo morda naročili, da zdravljenje z njimi za kratek čas prekinete in/ali prilagodite.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV Nadzor kakovosti
English: The vial must not be opened or the solution transferred to another container.
Slovenian: Viale se ne sme odpirati, raztopino pa se ne sme prenesti v drug vsebnik.
English: Ionizing radiations of the medicine may potentially decrease your fertility.
Slovenian: Ionizirajoče sevanje tega zdravila lahko potencialno zmanjša vašo plodnost.
English: • Or in the lead container in which Lutathera is delivered.
Slovenian: • ali v svinčenem vsebniku, v katerem je zdravilo Lutathera bilo dostavljeno.
English: Osteogenic Cells Skin
Slovenian: Osteogenske celice Koža
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Slovenian: Vaš osebni zdravnik in zdravnik nuklearne medicine sta presodila, da klinične koristi tega postopka z radiofarmacevtskim zdravilom pri vas odtehtajo tveganje zaradi sevanja.
English: As a consequence, a decrease in the various blood cell types may put you at risk for bleeding, fatigue, shortness of breath, and infection.
Slovenian: Posledično lahko zmanjšanje števila krvnih celic različnih vrst za vas predstavlja nevarnost pojava krvavitev, utrujenosti, zasoplosti in okužbe.
English: Ionizing radiation is dangerous for the foetus, therefore pregnancy is contraindicated.
Slovenian: Ionizirajoče sevanje je nevarno za plod, zato je nosečnost kontraindicirana.
English: The complete SmPC of Lutathera is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Slovenian: Celoten povzetek glavnih značilnosti zdravila Lutathera je na voljo kot ločeni dokument v pakiranju zdravila, njegov cilj pa je zdravstvenim delavcem ponuditi druge dodatne znanstvene in praktične informacije o aplikaciji in uporabi tega radiofarmacevtskega zdravila.