FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma radioactivity is predominantly (>90%) in parent form, i.e. as 99mTc-depreotide.
Slovenian: Plazemska radioaktivnost je pretežno (90%) v nespremenjeni obliki, to je kot 99mTc-depreotid.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: B. POGOJI ZA DOVOLJENJE ZA PROMET Z ZDRAVILOM
English: Store the reconstituted solution for injection for no more than 5 hours at 15 °C - 25 °C using appropriate radiation shielding.
Slovenian: Rekonstituirano raztopino za injiciranje shranjujte do največ 5 ur pri 15°C - 25°C z uporabo ustreznega ščitnika proti sevanju.
English: Technetium (99mTc) depreotide solution for injection is a diagnostic radiopharmaceutical based upon a synthetic peptide that binds to somatostatin receptors.
Slovenian: Raztopina tehnecijevega (99mTc) depreotida za injiciranje je radiodiagnostik na osnovi sintetičnega peptida, ki se veže na somatostatinske receptorje.
English: The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.
Slovenian: Zdravstveno osebje mora nositi nepremočljive rokavice in ščitnik ves čas rokovanja z rekonstituiranimi vialami ali brizgami, ki vsebujejo radioaktivno
English: Prepare a boiling water bath containing a lead vial shield standing in and equilibrated with the boiling water bath.
Slovenian: Pripravite kopel z vrelo vodo v kateri stoji svinčeni ščitnik za vialo in je uravnotežen s kopeljo vrele vode.
English: Intravenous use
Slovenian: Za intravensko uporabo.
English: CAUTION: Do not allow the sides of the strip to contact the side of the tank.
Slovenian: OPOZORILO: Pazite, da se robovi traku ne dotaknejo stranic generatorja.
English: Place the second ITLC-SG strip in the SSCS developing solvent.
Slovenian: Postavite drugi ITLC-SG trak v SSCS topilo, ki se razvija.
English: Allow the vial kit to warm to 15 °C - 30 °C and place it in a suitable shielding container and sanitise the rubber septum with sanitising alcohol swab.
Slovenian: Pustite komplet z vialo, da se segreje na 15˚C-30˚C in ga namestite v primeren zaščitni vsebnik in očistite gumijasto pregrado s čistilno alkoholno blazinico.
English: May be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber; add approximately 10 millilitres of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes.
Slovenian: 1) Nasičena raztopina natrijevega klorida (SSCS) Pripravi se jo lahko z dodajanjem 5 gramov natrijevega klorida na dno ene od kromatografskih komor; trdnemu natrijevemu kloridu dodajte približno 10 mililitrov destilirane vode in periodično stresajte 10 do 15 minut.
English: below) 1:1 (v/v) methanol / 1M ammonium acetate (MAM)2 (2 See section 2.)
Slovenian: 1:1 (v/v) metanol/1M amonijev acetat (MAM)2(2Glejte točko 2.
English: Place one ITLC-SG strip in the MAM developing solvent.
Slovenian: Postavite eden ITLC-SG trak v MAM topilo, ki se razvija.
English: 1:1 Methanol / 1M Ammonium Acetate (MAM) - Carefully mix one part methanol with one part 1M Ammonium Acetate.
Slovenian: 1:1 metanol/1M amonijev acetate (MAM) - Previdno pomešajte en del metanola z enim delom 1M amonijevega acetate.
English: As with all injectable medicinal products, anaphylactic or anaphylactoid reactions may occur after administration.
Slovenian: Kot pri vseh zdravilih za injiciranje, se lahko po injiciranju pojavijo anafilaktične ali anafilaktoidne reakcije.
English: Most of the side effects reported were transient and of mild intensity.
Slovenian: Večina neželenih učinkov o katerih so poročali, je bila prehodnih in blage narave.
English: Sodium α-D-glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate, hydrochloric
Slovenian: Natrijev α-D-glukoheptonat dihidrat, kositrov (II) klorid dihidrat, dinatrijev edetat, klorovodikova
English: Pour the MAM and SSCS into separate developing tanks to a depth of approximately 0.5 cm. Cover the tanks and allow to equilibrate with the solvent vapours.
Slovenian: Natočite MAM in SSCD v dva ločena generatorja za razvijanje do globine približno 0,5 cm. Pokrijte in počakajte, da se uravnotežijo pare topila.
English: In a recent clinical study with a prevalence of malignancy of 49%, the positive predictive value for NeoSpect in association with CT/chest X-ray was 84% (CI 63.1-94.7%) for all SPNs and 81.8% for lesions equal to or less than 3cm.
Slovenian: V nedavni klinični šudiji s prevalenco malignosti 49%, je bila pozitivna napovedna vrednost za NeoSpect v povezavi s CT/ rentgenom prsnega koša 84% (IZ 63,1-94,7) za vse SPN in 81,8% za lezije enake ali manjše od 3 cm.
English: Manufacturer responsible for batch release:
Slovenian: Izdelovalec odgovoren za sproščanje serij:
English: In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90-96% at a disease prevalence of 30-50%.
Slovenian: V študijah je bila negativna napovedna vrednost za NeoSpect v povezavi z CT za posamezne pljučne vozliče(SPN) 90-96% pri 30- 50% prevalenci bolezni.
English: The contents of NeoSpect are intended only for use in the preparation of 99mTc-depreotide solution for injection (see section 12).
Slovenian: Vsebina NeoSpecta je namenjena za uporabo samo pripravljena z raztopino 99mTc-depreotida za injiciranje (glejte poglavje 12).
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Vpliv na sposobnost upravljanja vozil in uporabo strojev Študije o vplivu na sposobnost za vožnjo in upravljanje strojev niso bile opravljene.
English: Add approximately 15 ml of distilled water to the flask, stopper, and swirl to dissolve the solid.
Slovenian: Dodajte približno 15 ml destilirane vode v bučko, začepite in z vrtinčenjem raztapljajte trdno snov.
English: Due to the short, six-hour half-life of technetium-99m, less than 0.1% of the radioactivity remains
Slovenian: Zaradi kratkega, 6 urnega razpolovnega časa tehnecija-99m, ostane 60 ur po dajanju manj kot
English: Any oxidant present in the sodium pertechnetate (99mTc) solution for injection might adversely affect the quality of the preparation.
Slovenian: Prisotnost kateregakoli oksidanta v raztopini natrijevega pertehnetata (99mTc) za injiciranje lahko negativno vpliva na kvaliteto pripravka.
English: One 1 ml syringe and 21-gauge needle Suitable counting equipment
Slovenian: )spodaj) Eno 1 ml injekcijsko brizgo in 21 gauge iglo Primeren števec
English: It is not known whether 99mTc-depreotide is excreted in human milk, 99mTc-depreotide is therefore contraindicated during lactation.
Slovenian: Dojenje Ni znano, ali se 99mTc-depreotid pri človeku izloča z mlekom, zato je med dojenjem uporaba 99mTc depreotida kontraindicirana.
English: The binding affinity of 99mTc-depreotide to SSTR was shown in studies of pancreatic tumours in Lewis rats and in vitro in human tumour membranes.
Slovenian: Vezalna afiniteta 99mTc-depreotida za SSTR je bila dokazana v študijah tumorja trebušne slinavke pri Lewisovih podganah in in vitro na tumorskih membranah pri človeku.
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Slovenian: Pri radionuklidnem slikanju nosečnic dobi odmerek sevanja tudi plod.
English: ITLC-SG SSCS: cut the strip at Rf 0.75 (75% of the distance from the origin to the solvent
Slovenian: ITLC-SG MAM: odrežite trak pri Rf 0,40 (40% razdalje od začetka do linije topila) ITLC-SG SSCS: odrežite trak pri Rf 0,75 (75% razdalje od začetka do linije topila).
English: To minimise the dose of radiation absorbed by the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection.
Slovenian: Za zmanjševanje absorbirane doze ionizirajočega sevanja mehurja, je treba bolnika spodbuditi k primerni hidraciji, ki omogoča pogosto praznjenje mehurja v prvih urah po injekciji.
English: Kit for radiopharmaceutical preparation Depreotide
Slovenian: Komplet za pripravo radiofarmaka Depreotid
English: To minimise the dose of radiation absorbed by the bladder, the intake of fluids should be increased during the first few hours after injection to permit frequent voiding.
Slovenian: Za zmanjševanje absorbirane doze ionizirajočega sevanja, mehurja, morate povečati vnos tekočine prvih nekaj ur po injekciji, da omogočite pogosto praznjenje mehurja.
English: 99mTc-depreotide is indicated for single use only.
Slovenian: 99mTc-depreotid je namenjen samo za enkratno uporabo.
English: Percent technetium (99mTc) pertechnetate, technetium-99m labelled glucoheptonate and
Slovenian: Odstotni delež tehnecijevega (99mTc) pertehnetata, s tehnecijem-99m označenega glukoheptonata in s tehnecijem-99m označenega edetata = B
English: NeoSpect is supplied in packs of 1 vial and 5 vials, each vial containing 47 micrograms depreotide.
Slovenian: NeoSpect je pakiran v škatlah po 1 vialo in 5 vial, vsaka viala vsebuje 47 mikrogramov depreotida.
English: However, it is not considered likely that NeoSpect will affect your ability to drive or to operate
Slovenian: Vendar je pri NeoSpectu le malo verjetno, da bo vplival na vaše sposobnosti za upravljanje vozil in
English: After reconstitution, store at 15 °C - 25 °C and use within 5 hours.
Slovenian: Po rekonstituciji, shranjujte pri temperaturi med 15˚C -in 25˚C in uporabite v manj kot 5 urah.
English: Allow the solvent front to move to the top of the strip.
Slovenian: Počakajte, da topilo pripotuje do vrha traku.
English: NeoSpect is for diagnostic use only.
Slovenian: NeoSpect je samo za diagnostične namene.
English: Using a shielded syringe, inject the required radioactivity of up to 1.8 GBq of sodium pertechnetate (99mTc) solution for injection, (diluted as appropriate with sodium chloride 0.9%
Slovenian: Z uporabo brizge s ščitnikom, injicirajte zahtevano radioaktivnost do 1,8 GBq raztopine natrijevega pertehnetata (99mTc) za injiciranje, (ustrezno razredčene z 0,9 % m/v raztopino natrijevega klorida za injiciranje do skupno 1 ml) v vialo s ščitnikom.
English: Since depreotide also binds to somatostatin receptors, caution should be exercised when administering this medicinal product to patients with insulinomas or diabetes mellitus.
Slovenian: Ker se tudi depretoid veže na somatostatinske receptorje, je potrebna previdnost pri uporabi tega zdravila pri bolnikih z
English: The vial contains no bacteriostatic preservative.
Slovenian: Viala ne vsebuje konzervansa.
English: Kit for radiopharmaceutical preparation.
Slovenian: Komplet za pripravo radiofarmaka.
English: Place the strips upright in the respective developing solvent such that the spot is above the solvent line and the top of each strip leans against the side of the tank.
Slovenian: Trakova postavite navpično v ustrezni topili v razvijanju tako, da je točka z nanosom nad gladino topila in da vrh vsakega traku stoji od roba generatorja.
English: Stannous chloride dihydrate 50 micrograms (essential excipient)
Slovenian: kositrov (II) klorid dihidrat 50 mikrogramov (obvezna pomožna snov)
English: Sticker label to be applied after reconstitution:
Slovenian: Po rekonstituciji označite s signaturo:
English: The administration of radiopharmaceutical creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Local regulations for radioactive materials must be applied in the radiation protection precautions and waste disposal.
Slovenian: Pri dajanju radiofarmakov obstaja za druge osebe tveganje pred zunanjim sevanjem ali onesnaženjem z razlitjem urina, bruhanjem itd.
English: Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG MAM strip
Slovenian: radioaktivnost spodnjega kosa ITLC-SG MAM traku (Rf 0-0,40) A = 100 x ------------------------------------------------------------------------------Celotna radioaktivnost obeh kosov ITLC-SG MAM traku
English: Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x -----------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG SSCS Strip
Slovenian: radioaktivnost zgornjega kosa ITLC-SG SSCS traku (Rf 0,75 - 1,0) A = 100 x -----------------------------------------------------------------------------------Celotna radioaktivnost obeh kosov ITLC-SG SSCS traku
English: The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors.
Slovenian: Podatki kažejo, da ima 99mTc depreotid visoko vezalno afiniteto za somatostatinske receptorje.
English: In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3
Slovenian: Podatki in vitro in študije na laboratorijskih živalih kažejo, da se 99mTc-depreotid veže z visoko afiniteto na podtipe 2,3 in 5 somatostatinskih receptorjevg
English: When injected, the radiolabelled compound binds to malignant cancer tissue.
Slovenian: Po injiciranju, se radioaktivno označena spojina veže na maligno rakasto tkivo.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Sodium pertechnetate (99mTc) solution for injection containing oxidants ought not to be used for the
Slovenian: Raztopine natrijevega pertehnetata (99mTc) za injiciranje, ki vsebujejo oksidante, ne smemo uporabljati za
English: The contents of the NeoSpect vial are not radioactive; however, after the addition of sodium pertechnetate (99mTc) solution for injection, adequate shielding of the final preparation must be
Slovenian: Vsebina NeoSpect viale ni radioaktivna; vendar je po dodatku raztopine natrijevega pertehnetata (99mTc) za injiciranje potrebno zagotavljati ustrezno zaščito pred sevanjem
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata.
English: The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 6178% respectively.
Slovenian: Ustrezna negativna in pozitivna napovedna vrednost za NeoSpect v povezavi z rentgensko sliko prsnega koša je bila 96-98% oziroma 61-78%.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: 1 vial containing 47 micrograms of depreotide.
Slovenian: 1 viala vsebuje 47 mikrogramov depreotida.
English: NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group.
Slovenian: NeoSpect se ne priporoča za uporabo pri otrocih mlajših od 18 let, ker za to starostno skupino ni podatkov.
English: Name and address of the manufacturer responsible for batch release CIS bio international
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CIS bio international
English: History of hypersensitivity reaction to depreotide, any of the excipients of NeoSpect or sodium pertechnetate (99mTc) solution for injection.
Slovenian: V anamnezi navedena preobčutljivost za depretoid, katerokoli pomožno snov NeoSpekta ali raztopino natrijevega pertehnetata (99mTc) za injiciranje.
English: NeoSpect is used for preparation of technetium (99mTc) depreotide solution for injection.
Slovenian: NeoSpect se uporablja za pripravo raztopine tehnecijevega (99mTc) depreotida za injiciranje.
English: 5 vials, each vial containing 47 micrograms of depreotide.
Slovenian: 5 vial, vsaka viala vsebuje 47 mikrogramov depreotida.
English: NeoSpect 47 micrograms.
Slovenian: NAVODILO ZA UPORABO NeoSpect 47 mikrogramov.
English: The radiation dose from 18FDG-PET (Fluorodeoxyglucose - Positron Emission Tomography) is lower than that from NeoSpect, whilst still achieving high sensitivity and specificity.
Slovenian: Doza sevanja je pri 18FDG-PET (Fluorodeoksiglukoza - pozitron emisijska tomografija) nižji kot pri
English: An assay of the radiochemical purity of the prepared injection can be performed using the following
Slovenian: Test radiokemijske čistosti pripravljene raztopine za injiciranje se lahko izvede s pomočjo naslednjih kromatografskih postopkov.
English: Two Gelman ITLC-SG strips (2 cm x 10 cm) Two developing tanks and covers
Slovenian: Dva Gelman ITLC-GS trakova (2 cm x 10 cm) Dva generatorja za razvijanje s pokrovi Nasičena raztopina natrijevega klorida (SSCS)1 (1 Glejte točko 1.)
English: Assay the total radioactivity, complete the user radiation label and attach it to the lead shielded vial.
Slovenian: Izmerite skupno radioaktivnost, izpišite signaturo s podatki o sevanju za uporabnika in jo pritrdite
English: When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed.
Slovenian: Ko v vialo dodamo raztopino radioaktivne spojine natrijevega pertehnetata (99mTc), nastane 99mTc-depreotid.
English: Remove the strip from the tank and allow the strip to dry behind a lead shield.
Slovenian: Odstranite trak iz generatorja in ga dajte sušiti za svinčeno zaščitno ploščo.
English: - The active substance is 47 micrograms depreotide as depreotide trifluoroacetate.
Slovenian: - Zdravilna učinkovina je 47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata.
English: * fatigue
Slovenian: * utrujenosti
English: SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation.
Slovenian: Za optimalno tolmačenje slik, je potrebno SPEC slike (računalniška tomografija emisije posameznih fotonov) posneti 2 do 4 ure po injekciji 99m Tc-depreotida.
English: 99mTc-depreotide is administered intravenously in a single dose.
Slovenian: 99mTc-depreotid se daje intravensko v enkratnem odmerku.
English: Hydrochloric acid and/or sodium hydroxide (pH adjustment) 6.2 Incompatibilities
Slovenian: klorovodikova kislina in/ali natrijev hidroksid (pH uravnavanje)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka Depreotid
English: The volume of diluted sodium pertechnetate (99mTc) solution for injection, added to the vial
Slovenian: Volumen razredčene raztopine natrijevega pertehnetata (99mTc) za injiciranje dodane v vialo
English: Label the solution with a one month expiration date.
Slovenian: Označite raztopino z enomesečnim datumom zapadlosti.
English: 99mTc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group.
Slovenian: Pri bolnikih mlajših od 18 let, uporabe 99mTc-depretoida ne priporočamo, ker za to starostno skupino ni podatkov.
English: Sodium chloride 0.9% w/v solution for injection must be used as the diluent.
Slovenian: Za redčenje moramo uporabljati 0,9% (m/v) raztopino natrijevega klorida za injiciranje.
English: * nausea
Slovenian: * bruhanju
English: Immediately transfer the reaction vial to a lead safe in the boiling water bath, maintaining the vial in the upright position.
Slovenian: Takoj prenesite reakcijsko vialo v kopel z vrelo vodo v svinčev ščitnik.
English: 2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask.
Slovenian: 1M amonijev acetat - dodajte 3,9 ± 0,1 grama trdnega amonijevega acetate v 50 ml graduirano bučko.
English: The product is a kit for radiopharmaceutical preparation.
Slovenian: Zdravilo je komplet za pripravo radiofarmaka.
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation.
Slovenian: IME ZDRAVILA NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka
English: - if you are suffering from diabetes or other related conditions - if you have a renal disease - if you have a liver disease
Slovenian: Bodite posebno pozorni pri uporabi zdravila NeoSpect Če imate sladkorno bolezen ali druga z njo povezana stanja Če imate ledvično bolezen
English: The solution may be diluted with sodium chloride 0.9% w/v solution for injection for more convenient injection.
Slovenian: Za prikladnejšo injekcijo se raztopino lahko redči z 0,9% (m/v) raztopino natrijevega klorida za injiciranje.
English: * abdominal pain
Slovenian: * trebušni bolečini
English: - The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate,
Slovenian: - Druge sestavine so natrijev α-D-glukoheptonat dihidrat, kositrov (II) klorid dihidrat, dinatrijev edetat, klorovodikova kislina in/ali natrijev hidroksid za uravnavanje pH.
English: To be reconstituted with sodium pertechnetate (99mTc) solution for injection (not included in this kit).
Slovenian: Rekonstituira se z raztopino natrijevega pertehnetata (99mTc) za injiciranje (ni priložena v tem
English: Place the developing tanks behind a lead shield.
Slovenian: Namestite generatorja za razvijanje za svinčeno zaščitno ploščo.
English: Most frequently reported were:
Slovenian: Najpogosteje so poročali o: * glavobolu
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical for use in tumour detection
Slovenian: Farmakoterapevtska skupina: Radiodiagnostiki za tumorje
English: Bone surface
Slovenian: Površina kosti
English: Kidneys Spleen
Slovenian: Ledvice Vranica Moda
English: Thyroid gland Bone marrow Liver
Slovenian: Ščitnica Kostni mozeg Jetra
English: The amount of radioactivity is calculated according to the planned time of injection to the patient, to obtain a single patient dose of 555 - 740 MBq from the entire
Slovenian: Količino radioaktivnosti se izračuna glede na načrtovani čas injiciranja bolniku tako, da se doseže odmerek za enega bolnika 555-740 MBq iz celotne rekonstituirane viale Varnost in učinkovitost 99mTc-depreotida so ugotovili v kliničnih študijah z uporabo raziskovalnega materiala, ki je imel pred dajanjem bolniku z ITLC določeno radiokemijsko
English: Sodium pertechnetate (99mTc) solution for injection (Ph.Eur) is used for reconstitution.
Slovenian: Za rekonstitucijo se uporablja raztopino natrijevega pertehnetata (99mTc) za injiciranje (Ph.Eur).
English: information should always be sought about pregnancy.
Slovenian: Kadar je treba uporabiti radioaktivna zdravila pri ženskah v rodnem obdobju, moramo vedno pridobiti podatke o nosečnosti.
English: No specific interaction studies with other medicinal products have been performed, and there are little available data on such interactions.
Slovenian: O takšnem medsebojnem delovanju je razpoložljivih le malo podatkov.
English: The containers are closed with butyl rubber stoppers and sealed with aluminium caps.
Slovenian: Zdravilo je polnjeno v 5 ml viale iz stekla tipa I. Viale so zaprte z butilnimi gumijastimi zamaški in zapečatene z aluminijastimi kapicami.
English: NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide
Slovenian: NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka Depreotid
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
Slovenian: Uporabljen mora biti postopek z najnižjo dozo sevanja, ki omogoča iskani diagnostični
English: 99mTc-depreotide is therefore contraindicated in pregnancy.
Slovenian: Zato je 99mTc-depretoid v nosečnosti kontraindiciran (Glejte 4.3).
English: After labelling with the radioactive sodium pertechnetate (99mTc) solution for injection, radiolabelled NeoSpect will be injected
Slovenian: Po označevanju z raztopino radioaktivnega natrijevega pertehnetata (99mTc) za injiciranje, vam bodo injicirali radioaktivno Slikanje (skeniranje) je lahko 2-4 ure po injekciji NeoSpecta.