FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternative techniques, which do not involve ionising radiation, should be considered.
Slovenian: Razmisliti moramo o uporabi alternativnih tehnik, ki ne vključujejo ionizirajočega sevanja.
English: This scan will show exactly the distribution of the radioactivity within the body.
Slovenian: Ta slika bo natančno pokazala porazdelitev radioaktivnosti v telesu.
English: One to 18% of the injected dose of radioactivity appeared in the urine at 4 hours after injection.
Slovenian: Ena do 18% injicirane doze radioaktivnosti se pojavi v urinu 4 ure po injekciji.
English: Studies have not been conducted to evaluate carcinogenic potential or effects on fertility.
Slovenian: Študije za oceno karcinogenega potenciala ali učinkov na plodnost niso izvedene.
English: Re-administration: Clinical data reflecting safety and efficacy of multiple injections are only available in 13 patients.
Slovenian: Ponovna uporaba: O varnosti in učinkovitosti večkratnih injekcij so na voljo klinični podatki za samo 13 bolnikov.
English: The radioactive amount of the diluted generator eluate must not exceed 1.8 GBq when it is added to the vial.
Slovenian: Količina radioaktivnosti razredčenega eluata iz generatorja ne sme preseči 1,8 GBq, ko se ga dodaja v vialo.
English: After use, dispose of as radioactive waste.
Slovenian: Po uporabi odstranite kot radioaktivne odpadke.
English: For a full list of excipients, see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Patients with a negative FNA should be followed up clinically as some FNA biopsies may give false negative results.
Slovenian: Bolnike z negativnim FNA izvidom je treba klinično spremljati, ker lahko nekatere FNA biopsije dajo lažne negativne rezultate.
English: Experience from clinical trials indicates that no dose adjustment is required.
Slovenian: Izkušnje iz kliničnih študij kažejo, da prilagajanje odmerka ni potrebno.
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the local competent official organisations.
Slovenian: Prevzem, shranjevanje, uporaba, prenos in odlaganje so predmet predpisov in/ali ustreznih
English: Count each strip section in a dose calibrator and interpret the results as follows:
Slovenian: Odčitajte štetje za vsak kos traku v kalibratorju odmerka in interpretirajte rezultate kot sledi:
English: Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken.
Slovenian: Ker vsebuje spojina majhno količino radioaktivnosti, jo lahko zaznamo zunaj telesa z uporabo posebnih kamer in lahko posnamemo sliko, znano kot sken (pregledni posnetek).
English: It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Slovenian: Z njim bo ravnalo in ga uporabljalo samo osebje, ki je izšolano in usposobljeno za varno rokovanje z radioaktivnimi snovmi.
English: Diagnostic agent for scintigraphic imaging.
Slovenian: Diagnostično sredstvo za scintigrafsko slikanje.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of the likely benefit.
Slovenian: Pri vsakem bolniku mora biti izpostavljanje ionizirajočem sevanju upravičeno glede na verjetne koristi.
English: Because there are strict laws covering the use, handling and disposal of radioactivity, NeoSpect will always be used in a hospital or a similar setting.
Slovenian: Ker so predpisi, ki urejajo uporabo, ravnanje in odstranjevanje radioaktivnosti strogi, se bo NeoSpect vedno uporabljal samo v bolnišnicah ali podobnih ustanovah.
English: In view of the false negative rate of FNA (5-8% false negative rate reported), thoracotomy is considered to be the gold standard.
Slovenian: Glede na odstotek lažnih negativnih rezultatov pri FNA (poročajo o 5-8% lažno negativnih rezultatov), velja torakotomija za zlati merilo.
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
English: The values are listed in descending order as mGy/MBq and assume urinary bladder emptying at 4.8 hours.
Slovenian: Vrednosti so navedene v padajočem vrstnem redu kot mGy/MBq in predvidevajo praznenje sečnega mehurja v 4,8 urah.
English: For most diagnostic investigations using nuclear medicine procedures, the radiation dose delivered (effective dose equivalent) is less than 20 mSv.
Slovenian: Pri večini diagnostičnih preiskav z uporabo nuklearnih medicinskih postopkov je prejeta doza sevanja (ekvivalent učinkovite doze) manjša od 20 mSv.
English: NeoSpect is for use in patients over the age of 18 years.
Slovenian: NeoSpect je namenjen za uporabo pri bolnikih starejših od 18 let.
English: Estimated absorbed radiation dose Target Organ mGy/MBq
Slovenian: Ocena absorbirane doze ionizirajočega sevanja Izpostavljeni organ mGy/MBq
English: 18 months.
Slovenian: 6.3 Rok uporabnosti 18 mesecev.
English: Total clearance averaged 2 to 4 ml/min/kg.
Slovenian: Celotni očistek je bil povprečno 2 do 4 ml/min/kg.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmacevtske izdelke mora uporabnik pripravljati tako, da ustrezajo zahtevam o varnosti sevanja in zahtevam o farmacevtski kakovosti.
English: This radiopharmaceutical may be handled only by authorised persons in designated clinical settings.
Slovenian: S tem radiofarmacevtskim izdelkom smejo ravnati samo pooblaščene osebe v pooblaščenih kliničnih ustanovah.
English: Following reconstitution and radiolabelling, the material must be used within 5 hours as radiochemical purity and stability have been demonstrated for 5 hours at 25°C.
Slovenian: Po rekonstituciji in radioaktivnem označevanju se mora raztopina uporabiti v 5 urah, ker sta bili radiokemična čistost in stabilnost dokazani za 5 ur pri 25°C.
English: Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive
Slovenian: Shranjevanje radiofarmacevtskih izdelkov mora biti v skladu z lokalnimi predpisi o radioaktivnih snoveh.
English: Add distilled water up to the 50 ml mark, mix thoroughly.
Slovenian: Dodajte destilirano vodo do oznake 50 ml, temeljito premešajte.
English: Solid sodium chloride should remain at the bottom of the jar; if there is no residue, add more solid sodium chloride and shake again for 10 to 15 minutes.
Slovenian: Trdni natrijev klorid mora ostati na dnu posode; če ni ostanka, dodajte še natrijevega klorida in ponovno stresajte 10 do 15 minut.
English: After use, the container and any unused material must be disposed of as radioactive waste in
Slovenian: Po uporabi, se mora vsebnik in ves neporabljen material zavreči kot radioaktvne odpadke v skladu z
English: - if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or - if there is any possibility that you are pregnant.
Slovenian: Če ste alergični na (preobčutljivi za) depreotid ali katerokoli sestavino zdravila NeoSpect ali na Če obstaja kakršnakoli možnost, da ste noseči.
English: You should tell your doctor if there is any possibility that you are pregnant, or if you are breast
Slovenian: Zdravnika morate obvestiti, če obstaja kakršnakoli možnost, da ste noseči ali če dojite.
English: The effective dose (ED) calculated in accordance with ICRP Publication 60 (Pergamon Press, 1991) gave a value of 0.016 mSv/MBq, corresponding to 11.84 mSv after
Slovenian: Učinkovitadoza (ED), izračunana v skladu z ICRP Publication 60 (Pergamon Press, 1991), je dala vrednost 0,016 mSv/MBq, kar ustreza 11,84 mSv po dajanju 740 Mbq.
English: Before removing the syringe from the vial, withdraw a volume of gas from above the solution equal to the volume of pertechnetate added in order to normalise the pressure inside the vial.
Slovenian: Preden odstranite brizgo iz viale, izvlecite enak volumen plina nad raztopino, kot je volumen dodanega pertehnetata, da normalizirate tlak v viali.
English: Your doctor may recommend that you drink plenty of fluids to speed removal of traces of the radiopharmaceutical from your body.
Slovenian: Zdravnik vam lahko priporoči pitje velikih količin tekočine za pospešitev odstranjevanja sledov radiofarmacevtskega
English: Studies in healthy volunteers have demonstrated that the tracer confers three-compartment pharmacokinetic characteristics with a distribution half-life of less than 5 minutes and a terminal halflife of about 20 hours, and a steady-state volume of distribution of 1.5 to 3 l/kg.
Slovenian: Študije z zdravimi prostovoljci so dokazale, da označevalec daje tridelne farmakokinetične značilnosti s porazdelitvenim razpolovnim časom manj kot 5 minut in končnim razpolovnim časom približno 20 ur, ter volumnom porazdelitve v dinamičnem ravnotežju (“steady state”) 1,5 do 3 l/kg.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals.
Slovenian: Glede aseptičnosti se mora izvajati ustrezne previdnostne ukrepe v sladu z Dobro proizvodno prakso (GMP) za zdravila.
English: NeoSpect is a radiopharmaceutical product used for diagnostic purposes.
Slovenian: NeoSpect je radiofarmacevtski izdelek, ki se uporablja za diagnostične namene.
English: For this product, the effective dose resulting from an administered activity of 555-740 MBq is typically 8.88-11.84 mSv for a 70 kg individual.
Slovenian: Pri tem zdravilu, je učinkovita doza po dajanju 555-740 MBq aktivnosti, tipično 8,88-11,84 mSv za 70 kg težko osebo.
English: Care should be exercised in patients with impaired renal function, due to lower renal excretion and probable increase in exposure to radioactivity.
Slovenian: Previdnost je potrebna pri bolnikih z okvarjeno ledvično funkcijo, zaradi slabšega ledvičnega izločanja in verjetnega povečanja izpostavljenosti sevanju.
English: If overdose is suspected, symptomatic treatment will be administered.
Slovenian: Kadar se sumi na prevelik odmerek, se uvede simptomatsko zdravljenje.
English: The negative predictive value was 87.5% (CI 66.5-96.7%) for all lesions and 87.5% for lesions equal to or less than 3cm.
Slovenian: Negativna napovedna vrednost je bila 87,5% (IZ 66,5-96,7 %) za vse lezije in 87,5% za lezije enake ali manjše od 3 cm.
English: However, histology was predominantly obtained by fine needle aspiration (FNA) with 5 out of 49 patients having open thoracotomies.
Slovenian: Vendar pa so vzorce za histologijo dobili predvsem z aspiracijsko biopsijo s tanko iglo (FNA), 5 od 49 bolnikov je imelo odprto torakotomijo.
English: NeoSpect is a powder for solution for injection that has to be dissolved and labelled with radioactive technetium before use.
Slovenian: NeoSpect je prašek za raztopino za injiciranje, ki ga moramo pred uporabo raztopiti in označiti z radioaktivnim tehnecijem.
English: For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse events will occur with low frequency because of the low radiation doses incurred.
Slovenian: Dosedanji podatki za preiskave v diagnostični nuklearni medicini nakazujejo, da se bodo ti neželeni dogodki pojavljali zelo redko, zaradi nizkih doz sevanja.
English: Technetium-99m disintegrates by isomeric transition with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99, which can be regarded as quasi stable.
Slovenian: Tehnecij-99m razpada z izomeričnim prehodom z emisijo gama sevanja z energijo 140 keV in razpolovnim časom 6 ur v tehnecij-99, ki ga lahko štejemo za skoraj stabilnega.
English: In the absence of incompatibility studies, 99mTc-depreotide must not be mixed with other medicinal products.
Slovenian: Zaradi pomankanja študij kompatibilnosti, 99mTc-depreotida ne smemo mešati z drugimi zdravili.
English: The medicinal product is for hospital use or in designated Nuclear Medicine Facilities only, by persons experienced in radioisotope diagnostic imaging.
Slovenian: Zdravilo je namenjeno samo za uporabo v bolnišnicah ali v pooblaščenih enotah za nuklearno medicino, z osebjem izkušenim za radioizotopsko diagnostično slikanje.
English: Therapy with octreotide acetate can produce severe hypoglycaemia in patients with insulinomas, and other somatostatin analogues are known to impair glucose tolerance.
Slovenian: Zdravljenje z oktreotid acetatom lahko povzroči pri bolnikih z insulinomom hudo hipoglikemijo in znano je da drugi analogi somatostatina zmanjšajo glukozno toleranco.
English: A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour).
Slovenian: Diagnostični radiofarmacevtski izdelek je izdelek, ki se po injiciranju začasno nakopiči v določenem delu telesa (n.pr.
English: Renal clearance averaged about 0.3 ml/min/kg.
Slovenian: Ledvični očistek je bil povprečno 0,3 ml/min/kg.
English: Add more distilled water or sodium chloride as needed for subsequent use always maintaining some undissolved sodium chloride at the bottom of the chamber.)
Slovenian: Za ponovno uporabo dodajte po potrebi še destilirane vode ali natrijevega klorida, tako da vedno ostane nekaj neraztopljenega natrijevega klorida na dnu komore.)
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavljanje ionizirajočem sevanju je povezano z nastankom raka in možnostjo razvoja genetskih okvar.
English: Do not allow the spots to dry.
Slovenian: Pazite, da se nanešene kapljice ne posušijo.
English: In a clinical study examining the pharmacodynamic effects of the recommended dose of the peptide in human volunteers during an oral GTT (Glucose Tolerance Test), no effects were observed other than the normal physiologic response to oral glucose challenge.
Slovenian: V klinični študiji s prostovoljci, s katero so raziskovali farmakodinamične učinke priporočenega odmerka peptida med peroralnim GTT (glukozni tolerančni test), niso opazili nobenega učinka, razen normalnega fiziološkega odziva na obremenitev z glukozo.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit: visually inspect the reconstituted solution at a safe distance through leaded glass.
Slovenian: Zdravila za parenteralno uporabo moramo pred uporabo vizuelno pregledati na prisotnost delcev in spremembo barve, kadarkoli to raztopina in vsebnik dopuščata: vizuelno preglejte rekonstituirano raztopino iz varne razdalje skozi svinčeno steklo.
English: There is only limited data available regarding interactions with other products.
Slovenian: O medsebojnem delovanju z drugimi zdravili so na voljo le omejeni podatki.
English: Do not use NeoSpect after the expiry date which is stated on the label.
Slovenian: Zdravila NeoSpect ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: 99mTc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy
Slovenian: 99mTc-depreotid se veže na plazemske proteine v obsegu do približno 12% pri bolnikih in zdravih
English: External whole-body gamma scintigraphy showed highest location of radioactivity in the abdomen.
Slovenian: Eksterna gama scintigrafija celotnega telesa je pokazala največjo radioaktivnost v predelu trebuha.
English: 99mTc-depreotide, must be handled with care, and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.
Slovenian: Z 99mTc-depretoidom se mora ravnati previdno in uporabljati se mora ustrezne varnostne ukrepe za zmanjševanje izpostavljenosti kliničnega osebja sevanju.
English: Based on human data, the absorbed radiation doses by individual organs of an average human adult (70 kg) from an intravenous injection of the agent are listed below.
Slovenian: Na podlagi podatkov pri človeku, so spodaj navedene absorbirane doze sevanja za posamezne organe po intravenski injekciji učinkovine pri povprečnem odraslem človeku (70kg).
English: These receptors are hyper-expressed by malignant tumours.
Slovenian: Ti receptorji so pretirano izraženi pri malignih tumorjih.
English: Any 99mTc-depreotide which remains in your body, will naturally lose its radioactivity within 2-3 days.
Slovenian: Ves v telesu preostali 99mTc- depreotid, bo izgubil svojo radioaktivnost po naravni poti v 2-3 dneh.
English: Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No. 1 rev., Soc. Nucl.
Slovenian: Doza je izračunana po standardni MIRD metodi (MIRD Pamphlet No.1 rev., So.Nucl.
English: See Cautionary notes 1 and 2
Slovenian: Glejte spodaj Previdnostna opozorila, točka 1 in 2).
English: CAUTION: Do not allow the needle to touch the strip.
Slovenian: OPOZORILO: z iglo se ne smete dotakniti traku.
English: What NeoSpect looks like and contents of the pack
Slovenian: Izgled zdravila NeoSpect in vsebina pakiranja
English: Most frequently reported were headache, nausea, vomiting, diarrhoea, abdominal pain, dizziness, flushing and fatigue.
Slovenian: Najpogosteje so poročali o glavobolu, slabosti, bruhanju, driski, bolečini v trebuhu, omotici, rdečici in utrujenosti.
English: Like all medicines, NeoSpect can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo NeoSpect neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: This solution is ready for injection into a vein.
Slovenian: Ta raztopina je pripravljena za injiciranje v veno.
English: The majority of the radioactivity excreted in urine is in parent form.
Slovenian: Večina radioaktivnosti se izloči z urinom v nespremenjeni obliki.
English: Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential.
Slovenian: Bistveno je dobro poznavanje postopkov in tehnik reševanja ter zdravljenja anafilaksije.
English: Care should also be taken to minimise radiation exposure to the patient, consistent with proper patient management.
Slovenian: Paziti moramo tudi, da je bolnik čim manj izpostavljen sevanju, v skladu s pravilnim obravnavanjem bolnika.
English: Observed changes in the laboratory parameters are: increased WBC count, basophils, eosinophils, monocytes and neutrophils, AST, ALT, LDH, total bilirubin and total protein; lowered RBC count and
Slovenian: Opažene spremembe laboratorijskih parametrov so: povečano število belih krvnih celic, bazofilcev, eozinofilcev, monocitov in nevtrofilcev, AST, ALT, LDH, celotni bilirubin in celotne beljakovine; znižano število rdečih krvnih celic in celotnih beljakovin.
English: Re-administration
Slovenian: Ponovna uporaba
English: Please read this leaflet carefully.
Slovenian: Natančno preberite to navodilo za uporabo.
English: Mark two Gelman ITLC-SG strips with a light pencil at 1 cm from the bottoms of each.
Slovenian: Dva Gelman ITLC-SG trakova označite s svetlim svinčnikom 1 cm od kraja.
English: Store in a freezer at or below -10 °C.
Slovenian: Shranjujte v zmrzovalniku pri ali pod -10°C.
English: The labelling reaction involved in the preparation of 99mTc-depreotide depends upon maintaining tin in the divalent (reduced) state.
Slovenian: Reakcija označevanja, ki poteka pri pripravi 99mTc depreotida je odvisna od vzdrževanja kositra v dvovalentni (reducirani) obliki.
English: 99mTc-depreotide was not mutagenic in vitro in the Ames test or mouse lymphoma test, and it was not clastogenic in vivo in the mouse micronucleus test.
Slovenian: 99mTc-depreotid ni bil mutagen in vitro v Amesovem testu ali mišjem limfomskem testu in ni bil klastogen in vivo v mišjem mikronukleusnem testu.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študije o vplivu na sposobnost za vožnjo in upravljanje strojev niso bile opravljene.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung.
Slovenian: NeoSpect se uporablja za pridobitev slik, ki kažejo mesto suspektnega malignega rakastega tkiva (tumorja) v pljučih.
English: For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Slovenian: Za scintigrafsko slikanje suspektnih malignih tumorjev v pljučih po začetnem odkritju, v kombinaciji z računalniško tomografijo (CT) ali rentgenskim slikanjem prsnega koša pri bolnikih s posameznimi
English: Care should be exercised in patients with reduced liver function.
Slovenian: Previdnost je potrebna pri bolnikih z zmanjšanim delovanjem jeter.
English: SPECIAL STORAGE CONDITIONS Store in a freezer at or below -10 °C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v zmrzovalniku pri ali pod - 10˚C.
English: It is essential that the user follows the directions carefully and adheres to aseptic procedures during the preparation of the radiopharmaceutical.
Slovenian: Bistveno je, da uporabnik natančno upošteva navodila in dosledno izvaja antiseptični postopek pri pripravi
English: White powder for solution for injection.
Slovenian: Bel prašek za raztopino za injiciranje
English: Do not use bacteriostatic sodium chloride solution for injection as a diluent for pertechnetate, because it might adversely affect the radiochemical purity and, hence, the biological distribution of the
Slovenian: Za redčenje pertehnetata ne uporabljajte raztopin natrijevega klorida za injiciranje, ki vsebujejo konzervans, ker lahko negativno vpliva na radiokemijsko čistost in s tem na biološko
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti
English: The activity of 99mTc-depreotide administered to the patient should be measured using a suitably calibrated dose calibrator immediately prior to administration to the patient.
Slovenian: Aktivnost 99mTc-depreotida za dajanje bolniku se mora meriti s pomočjo ustrezno kalibriranega kalibratorja doze neposredno pred dajanjem bolniku.
English: Radiolabelled NeoSpect is administered as a single injection into a vein.
Slovenian: Radioaktivno označen NeoSpect se daje kot enkratno injekcijo v veno.
English: Do not use if the solution is not clear or if it contains visible particulate matter.
Slovenian: Raztopine ne uporabljajte, če ni bistra ali vsebuje
English: Spot one drop (approximately 5-10 microlitres) of 99mTc-depreotide at the origin of each strip using the hypodermic needle.
Slovenian: Kanite kapljico (približno 5-10 mikrolitrov) 99mTc-depreotida na začetek vsakega traku z uporabo hipodermične igle.
English: Percent technetium-99m non-mobile material = A
Slovenian: Odstotni delež tehnecija-99m nemobilna faza = A
English: What NeoSpect is and what it is used for.
Slovenian: KAJ JE ZDRAVILO NeoSpect IN ZA KAJ GA UPORABLJAMO
English: The recommended dosage is approximately 47 micrograms depreotide (one vial) labelled with
Slovenian: Priporočeno odmerjanje je približno 47 mikrogramov depreotida (ena viala) označenega
English: The contents of the NeoSpect vial are sterile.
Slovenian: Vsebina NeoSpect vial je sterilna.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Uradnih specifičnih študij medsebojnega delovanje z drugimi zdravili niso izvedli.
English: Most of the adverse reactions reported were transient and of mild intensity.
Slovenian: Večina neželenih učinkov o katerih so poročali, je bila prehodna in blage narave.