FrancophonIA/ELRC3.0 huggingface dataset:
English: Formal studies have not been performed in patients with renal or hepatic impairment.
Slovenian: Uradne študije na bolnikih z okvarjenim delovanjem ledvic ali jeter niso bile izvedene.
English: The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
Slovenian: Protitelo (IMMU-MN3) prepozna antigensko strukturo površinskega glikoproteina (NCA-90) granulocitov in tumorskega označevalca, karcinoembrionskega antigena (CEA).
English: The maximum amount of LeukoScan [99mTc] that can be administered safely has not been determined.
Slovenian: 4.9 Preveliko odmerjanje Največja količina zdravila LeukoScan [99mTc], ki je lahko varno aplicirana, ni bila določena.
English: LeukoScan [99mTc] can be stored at room temperature after formulation.
Slovenian: Zdravilo LeukoScan [99mTc] se po pripravi lahko shranjuje pri sobni temperaturi.
English: LeukoScan is not recommended for use in children.
Slovenian: Uporaba zdravila LeukoScan pri otrocih ni priporočljiva.
English: At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
Slovenian: Eno uro po infuziji so krvne vrednosti znašale 34% izhodiščne vrednosti, štiri ure po infuziji 17% izhodiščne vrednosti in 24 ur po infuziji 7% izhodiščne vrednosti.
English: When the radioactive antibody binds to the white blood cells, your doctor can determine where the infection is located by using a special imaging camera that reveals areas of radioactivity.
Slovenian: Ko se radioaktivno protitelo veže na bele krvne celice, lahko vaš zdravnik z uporabo posebne kamere, ki zaznava področja radioaktivnosti, določi, na katerem mestu v telesu poteka vnetje.
English: The maximum amount of LeukoScan that can be administered has not been determined.
Slovenian: Največja količina zdravila LeukoScan, ki je lahko dana bolniku, ni bila določena.
English: The product is more sensitive (93.9% vs. 80.6%), but less specific (51.6% vs. 72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
Slovenian: Zdravilo je pri diagnosticiranju osteomielitisa pri bolnikih z diabetičnimi razjedami stopal bolj občutljivo (93,9% vs 80,6%), toda manj specifično (51,6% vs 72,9%) kakor pri bolnikih z drugimi lokalizacijami osteomielitisa dolgih kosti.
English: Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
Slovenian: V primeru neželene reakcije mora biti za takojšnjo uporabo na razpolago vsa oprema za kardiopulmonalno reanimacijo in ustrezno usposobljeno osebje.
English: In clinical trials involving over 350 patients, no induction of human anti-mouse antibody (HAMA) to antibody fragments has been observed nor has there been any elevation of HAMA levels in patients with
Slovenian: V kliničnih študijah, ki so vključevale preko 350 bolnikov, niso opazili indukcije nastanka človeških protiteles proti mišjemu antigenu (HAMA) zaradi vnosa fragmentov mišjih protiteles, ravno tako pa pri bolnikih, ki so HAMA že razvili, niso opazili porasta HAMA vrednosti.
English: Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Slovenian: D-64293 Darmstadt
English: Technetium [99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.
Slovenian: Tehnecij [99mTc] z emisijo gama žarčenja z energijo 140 KeV in razpolovnim časom, ki znaša 6 ur, razpada na tehnecij [99Tc], ki je kvazi stabilen.
English: This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Ta radiofarmak sme biti prevzet, uporabljen in apliciran samo s strani pooblaščenih oseb v določenih kliničnih ustanovah.
English: • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: • Radiofarmake je potrebno pripraviti na način, ki bo zadoščal tako zaščiti pred sevanjem kakor tudi farmacevtskim zahtevam po kakovosti.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: However, in vitro granulocyte function tests did not show significant changes when the sulesomab was added.
Slovenian: Vendar pa in vitro funkcijski testi granulocitov po dodatku sulezomaba niso pokazali
English: • This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: • Ta radiofarmak sme biti prevzet, uporabljen in apliciran samo s strani pooblaščenih oseb v določenih kliničnih ustanovah.
English: LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
Slovenian: LeukoScan je sterilen, liofiliziran pripravek, ki v posamezni viali vsebuje 0,31 mg sulezomaba in vključuje 0,22 mg kositrovega klorida dihidrata, 3,2 mg kalijevega natrijevega tartrata tetrahidrata, 7,4 mg natrijevega acetata trihidrata, 5,5 mg natrijevega klorida, koncentrirano ocetno kislino (v sledovih), klorovodikovo kislino (v sledovih), 37,8 mg saharoze, dušik (vakuum).
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Vsa neporabljena količina zdravila ali odpadni material morata biti odstranjena v skladu z lokalnimi predpisi.
English: * Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.
Slovenian: povprečna doza μGy/MBq ekvivalent efektivne doze efektivna doza * Ekvivalent efektivne doze in efektivna doza sta izražena v enotah µSv/MBq.
English: Method and/or route(s) of administration
Slovenian: Postopek in/ali pot(i) uporabe zdravila
English: In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this
Slovenian: V kliničnih študijah so bile posamezne doze 1,0 mg zdravila LeukoScan, ki je bil radiološko označen z 900 ± 200 MBq 99mTc, aplicirane 11 bolnikom z različnimi tipi infekcij in pri teh odmerkih niso opazili neželenih
English: LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Slovenian: Zdravilo LeukoScan ni bilo uporabljeno za diagnosticiranje osteomielitisa pri bolnikih s srpasto celično
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC-8ºC).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C - 8 °C).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL LABEL)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH (VIALA)
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je potrebno pripraviti na način, ki bo zadoščal tako zaščiti pred sevanjem kakor tudi farmacevtskim zahtevam po kakovosti.
English: Following reconstitution, 1 ml sodium pertechnetate [99mTc] is added.
Slovenian: Po rekonstituciji dodamo 1 ml raztopine natrijevega pertehnetata [99mTc].
English: Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Slovenian: Radiofarmake sme uporabljati samo strokovno usposobljeno osebje z ustreznim uradnim pooblastilom za uporabo in ravnanje z radionuklidi.
English: In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
Slovenian: V podskupini bolnikov, pri katerih je bilo zdravilo LeukoScan neposredno primerjano s trenutno razpoložljivim z 111In označenim (priložnostno z 99mTc označenim) avtolognim presejalnim testom z belimi krvnimi celicami, je zdravilo LeukoScan v primerjavi s presejalnim testom z belimi krvnimi celicami pokazalo statistično pomemben porast občutljivosti (87,7% vs 72,6%, p = 0,003, ob uporabi McNemarovega testa), brez razločnega zmanjšanja specifičnosti v primerjavi s slikanjem z označenimi belimi krvnimi celicami (67,1% vs 69,4%).
English: The radiolabelled solution should be administered as an intravenous injection.
Slovenian: Z radioaktivnim izotopom označena raztopina mora biti aplicirana v obliki intravenske injekcije.
English: Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.
Slovenian: Po rekonstituciji morata biti vsa neporabljena količina radiofarmaka in viala tretirana kot radioaktivni odpadek in morata biti odstranjena v skladu z lokalnimi
English: • Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Slovenian: • Radiofarmake sme uporabljati samo strokovno usposobljeno osebje z ustreznim uradnim pooblastilom za uporabo in ravnanje z radionuklidi.
English: Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Slovenian: Pri bolnikih, ki so predhodno že prejemali zdravila, ki vsebujejo glodalska monoklonalna protitelesa, je verjetnost, da bodo razvili HAMA, večja.
English: • You should not be given LeukoScan if you are pregnant.
Slovenian: • Če ste noseči, ne smete prejeti zdravila LeukoScan.
English: The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Slovenian: Sredstvo za prikazovanje, tehnecij-99m LeukoScan (tehnecij-99m sulezomab), nastane pri rekonstituciji vsebine viale zdravila LeukoScan z 0,5 ml raztopine natrijevega klorida za injiciranje, ki ji sledi dodatek 1100 MBq natrijevega pertehnetata [99mTc] v 1 ml raztopine natrijevega klorida za injiciranje.
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: Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Slovenian: Vsaka viala vsebuje kositrov klorid, natrijev klorid, natrijev kalijev tartrat, natrijev acetat, saharozo, dušik.
English: Swirl and shake the vial contents gently for 30 seconds to insure dissolution.
Slovenian: 30 sekund nežno vrtite in stresajte vialo, da se bo vsebina raztopila.
English: When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis.
Slovenian: Če je rentgenski posnetek kosti pozitiven in slikanje z LeukoScanom daje negativen rezultat, infekcija ni Če je rentgenski posnetek kosti negativen, slikanje z LeukoScanom v redkih primerih lahko daje pozitivni odgovor, kar lahko pomeni zgodnjo stopnjo osteomielitisa.
English: LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
Slovenian: Ni pričakovano, da bi se zdravilo LeukoScan vezalo na levkocite bolnikov s paroksizmalno nočno
English: Due to the short six-hour, half-life of 99mTc, a dose of less than 1 mSv in mother's milk can be expected 24 hours after the administration of LeukoScan [99mTc].
Slovenian: Zaradi kratke razpolovne dobe 99m-Tc, ki znaša 6 ur, se odmerek, ki je manjši od 1 mSv, v materinem mleku lahko pričakuje 24 ur po vnosu zdravila
English: If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Slovenian: Če je vnos radiofarmaka nujen, je potrebno dojenje prekiniti in mleko zavreči.
English: One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Slovenian: Ena viala je pripravljena tako, da vsebuje 0,31 mg liofiliziranih LeucoScan fragmentov monoklonalnih
English: Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
Slovenian: natrijev klorid klorovodikova kislina (sledovi) natrijev acetat trihidrat
English: After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law.
Slovenian: Po mešanju s tehnecijem mora biti končni produkt odstranjen kakor radioaktivni odpadek v skladu z
English: Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Slovenian: Farmakoterapevtska skupina: Radiofarmaki za diagnostiko oznaka ATC: VO4D
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Slovenian: Ena 3 ml viala vsebuje 0,31 mg sulezomaba (IMMU-MN3 fragmenti Fab'-SH antigranulocitnih monoklonalnih protiteles glodalcev) za pripravo 99mTc označenega zdravila LeukoScan.
English: Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
Slovenian: O ponovnem vnosu je mogoče razmisliti le pri bolnikih, katerih preiskava serumskih fragmentov je dala negativen rezultat na človeška protitelesa proti mišjim antigenom (HAMA).
English: • After use, the container should be disposed of as radioactive waste.
Slovenian: • Po uporabi je potrebno vsebnik zavreči kot radioaktivni odpadek.
English: The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.
Slovenian: Ocenjene absorbirane doze sevanja za povprečnega odraslega bolnika (70 kg) po intravenskem vnosu zdravila LeukoScan, označenega s 750 MBq tehnecija-99m so navedene v tabeli 1.
English: There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Slovenian: Če je bila preiskava opravljena 1-2 uri ali pa 5-8 ur po injiciranju, se rezultati zaznavanja prisotnosti oziroma odsotnosti osteomielitisa niso bistveno razlikovali.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Slovenian: NAVODILO ZA UPORABO INFORMACIJA ZA UPORABNIKA LeukoScan (0,31 prašek za raztopino za injiciranje) sulezomaba
English: LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
Slovenian: Zdravilo LeukoScan se uporablja pri bolnikih s sumom na vnetje kosti, imenovano osteomielitis.
English: NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA LeukoScan 0,31 mg prašek za raztopino za injiciranje 0,31 mg liofiliziranega sulezomaba, kositrov klorid in stabilizatorji
English: Store in a refrigerator (2°C-8°C).
Slovenian: Komplet - Shranjujte v hladilniku (2 °C - 8 °C).
English: In the unlikely event of a radiation overdose being administered with LeukoScan [99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion
Slovenian: V primeru prevelike doze sevanja, prejete ob vnosu zdravila LeukoScan [99mTc], kar pa ni verjetno, se absorbirana doza lahko zmanjša s povečanim peroralnim ali intravenskim vnosom tekočin, kar pospeši
English: For diagnostic nuclear medicine investigations, the current evidence suggests that the adverse effects will occur with low frequency because of the low radiation doses incurred.
Slovenian: Zaradi nizkih doz sevanja, ki so jim bolniki izpostavljeni, dosedanji dokazi nakazujejo, da se bodo pri diagnostičnih nuklearnih medicinskih preiskavah neželeni učinki redko pojavljali.
English: Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
Slovenian: Povzetek doze, ki jo prejmejo normalni organi pri povprečnem odraslem bolniku (70 kg) po intravenskem vnosu zdravila LeukoScan, označenega s 750 MBq tehnecija-99m[ocenjena doza sevanja pridobljena na osnovi 13 oseb in 26 vnosov]
English: LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
Slovenian: LeukoScan rekonstituiramo z 0,5 ml izotonične raztopine natrijevega klorida za injiciranje.
English: In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the
Slovenian: V primeru prevelike doze sevanja, prejete ob vnosu zdravila LeukoScan, kar pa ni verjetno, se absorbirana doza lahko zmanjša s povečanim peroralnim ali intravenskim vnosom tekočin, kar pospeši izločanje
English: After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
Slovenian: Po radioaktivni označitvi protitelesa in spiranju 10µl vzorca z 1,5 ml 0,9% raztopine natriejvega klorida za injiciranje takoj določite radiokemijsko čistoto s tenkoplastno kromatografijo hitre izvedbe (ITLCInstant Thin Layer Chromatography) na s silikagelom impregniranih ploščicah iz steklenih vlaken, 1 x 9 cm, topilo je aceton.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: (77.5% vs. 75.8%, respectively).
Slovenian: Diagostična natančnost pa je pri teh dveh pojavnih oblikah enaka (77,5% vs 75,8%).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Slovenian: Vsi postopki, ki vključujejo uporabo radionuklidov in so izvedeni na nosečih ženskah, hkrati pomenijo določeno obsevalno dozo za zarodek.
English: Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Slovenian: Priporočljivo je snemanje slike v analognem in/ali digitalnem modusu in z matriko
English: The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99mTc pertechnetate (approximately 1.2 ml).
Slovenian: Priporočeni odmerek za odrasle je 0,25 mg Fab' fragmenta, označenega z 900 ± 200 MBq tehnecijevega
English: 6.6 Special precautions for disposal and other handling Read complete directions thoroughly before starting the preparation procedure.
Slovenian: Preden pričnete s postopkom priprave natančno preberite celotno navodilo.
English: HAMA titers should be determined before repeated administration of LeukoScan.
Slovenian: Pred ponovnim vnosom zdravila LeukoScan je potrebno določiti HAMA titre.
English: After use, the container should be disposed of as radioactive waste.
Slovenian: Po uporabi je potrebno vsebnik zavreči kot radioaktivni odpadek.
English: Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Slovenian: Kadar so bolnikom aplicirani mišji proteini, so anafilaktične in druge preobčutljivostne reakcije vedno možne.
English: These dose estimates assume a urinary bladder voiding interval of two hours.
Slovenian: Te doze so ocenjene na osnovi predpostavke, da se mehur prazni vsaki dve uri.
English: Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Slovenian: Rehidrirajte s sterilno, apirogeno raztopino natrijevega pertehnetata [99mTc].
English: BEFORE YOU USE LEUKOSCAN You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LEUKOSCAN Zdravila LeukoScan 0,31 mg, prašek za raztopino za injiciranje ne smete uporabiti
English: For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Slovenian: Za rekonstituiranje liofiliziranega praška s sterilno odstranljivo brizgo dodajte 0,5 ml 0,9% raztopine natrijevega klorida za injiciranje v 3ml vialo zdravila LeukoScan, nameščeno v zaščitnem vsebniku.
English: Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Slovenian: Dodajte toliko 0,9% raztopine natrijevega klorida za injiciranje, da bo končni volumen eluata znašal 1,0 ml.
English: NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
Slovenian: IME ZDRAVILA LeukoScan 0,31 Prašek za raztopino za injiciranje
English: 4.9 Overdose
Slovenian: 6.2 Inkompatibilnosti
English: If either are present, the
Slovenian: Če je prisotno karkoli od naštetega, je potrebno zdravilo
English: ATC code: VO4D At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert
Slovenian: V koncentracijah in ob aktivnostih, uporabljenih za diagnostične postopke, ni videti, da bi zdravilo LeukoScan izkazovalo kakršnekoli farmakodinamične učinke.
English: These values were calculated according to Medical Internal Radiation Dosimetry.
Slovenian: Vrednosti so bile izračunane v skladu z MIRD
English: 300 American Road
Slovenian: Otto-Röhm-Straße 69
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: (IMETNIKI) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: RELEASE
Slovenian: Izračunajte
English: • If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
Slovenian: • Če ste kadarkoli že prejeli zdravilo LeukoScan ali drugo zdravilo, pripravljeno iz mišjih protiteles,
English: Medicinal product subject to medical prescription
Slovenian: Ponovni vnos (readministracija zdravila)
English: Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
Slovenian: Vaš zdravnik bo pripravil zdravilo LeukoScan in radioaktivni izotop tehnecija, pripravljeni volumen bo znašal 1,5 ml. 0,25 mg zdravila LeukoScan bo označenega s 740 - 1110 MBq tehnecija.
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Slovenian: Komplet za pripravo 99mTc označenega zdravila LeukoScan Vsaka 3 ml viala vsebuje 0,31 mg sulezomaba (IMMU-MN3 fragmenti Fab'-SH antigranulocitnih natrijev klorid klorovodikova kislina (sledovi) natrijev acetat trihidrat
English: 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or
Slovenian: To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6 ali 12. 6.3 Rok uporabnosti: komplet - 48 mesecev rekonstituiran in radioaktivno označen material - 4 ure