FrancophonIA/ELRC3.0 huggingface dataset:
English: In the most recent clinical study in which 123 patients were administered Scintimun, the most commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14 % of the patients, after a single administration (16 positive over 116 assayed one and/or three months after the administration).
Slovenian: 4.8 Neželeni učinki V večini nedavnih kliničnih študij, v katerih je 123 preiskovancev prejelo zdravilo Scintimun, je bila najpogosteje ugotovljen neželeni učinek nastanek humanih protiteles proti mišjim protitelesom (HAMA) pri 14 % preiskovancev po eni uporabi (16 pozitivnih od 116 testiranih en in/ali tri mesece po uporabi zdravila).
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Slovenian: S tem radiofarmakom prejmete majhne količine ionizirajočega sevanja, ki je povezano z zelo majhnim tveganjem za razvoj raka in dednih nepravilnosti.
English: Using a syringe, introduce through the rubber seal 5 mL of 0.9% sodium chloride solution.
Slovenian: Z brizgo skozi zamašek iz kavčuka vnesite 5 ml 0,9-odstotne raztopine natrijevega klorida.
English: MedDRA System Organ Classes
Slovenian: Skupine organskih sistemov po MedDRA
English: One mL of the radiolabelled solution contains less than 4 mg of sodium.
Slovenian: En mililiter radioaktivno označene raztopine vsebuje manj kot 4 mg natrija.
English: The recommended activity of technetium (99mTc) besilesomab should be between 400 MBq and
Slovenian: Priporočena aktivnost tehnecijevega (99mTc) besilesomaba mora biti med 400 MBq in 800 MBq.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/602/001 one multidose vial Scintimun and one vial solvent for Scintimun EU/1/09/602/002 two multidose vials Scintimun and two vials solvent for Scintimun
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/602/001 ena večodmerna viala zdravila Scintimun in ena viala vehikla za zdravilo Scintimun
English: Scintimun contains sorbitol therefore patients with rare hereditary problems of fructose intolerance should not be administered this product.
Slovenian: Zdravilo Scintimun vsebuje sorbitol, zato ga ne smejo prejeti preiskovanci z redko dedno intoleranco na fruktozno.
English: Should you have any further questions on the use of Scintimun, please ask the nuclear medicine doctor who supervises the procedure.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Scintimun, se posvetujte z zdravnikom nuklearne medicine, ki je nadzoroval postopek.
English: Do not let air enter the vial to be tested and store all vials containing radioactive solution in lead shielding.
Slovenian: Postopek Pazite, da zrak ne vstopi v vialo, ki jo boste preskusili, in da shranjujete vse viale z radioaktivno raztopino v svinčenih oklepih.
English: Human Anti-Mouse Antibodies (HAMA)
Slovenian: Humana protitelesa proti mišjim protitelesom (HAMA)
English: (WBCs) images in 119 patients with suspected osteomyelitis, the agreement rate between the two methods was 83 % (lower 95 % confidence interval limit: 80 %).
Slovenian: Stopnja ujemanja med metodama je bila 83 % (spodnja meja 95-odstotnega intervala zaupanja: 80 %).
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (se lahko pojavijo pri več kot 1 od 10 bolnikov):
English: If the integrity of this vial is compromised, the product should not be used
Slovenian: Če je integriteta viale ogrožena, zdravila ne smete uporabiti.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vzamete to zdravilo.Če obstaja možnost, da ste noseči, vam je izostala menstruacija ali dojite, o tem pred uporabo zdravila Scintimun obvestite zdravnika nuklearne medicine.
English: Administration of murine monoclonal antibodies can lead to the development of Human Anti-Mouse Antibodies (HAMA).
Slovenian: Uporaba mišjih monoklonskih protiteles lahko povzroči nastanek humanih protiteles proti mišjim protitelesom (HAMA).
English: In vitro, besilesomab cross-reacts with CEA.
Slovenian: Besilesomab navzkrižno reagira s CEA in vitro.
English: The radiochemical purity corresponds to the percentage of bound technetium (99mTc) and is calculated as follows after correcting data for background noise:
Slovenian: Radiokemijska čistoča ustreza odstotku vezanega tehnecija (99mTc) in se po korekciji podatkov za izhodiščni šum izračuna po naslednjem postopku:
English: For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in radioaktivnem označevanju glejte poglavje 6.3.
English: Each vial of Scintimun contains 2 mg of sorbitol.
Slovenian: Vsaka viala zdravila Scintimun vsebuje 2 mg sorbitola.
English: Other medicines and Scintimun
Slovenian: Druga zdravila in zdravilo Scintimun
English: Introduce the ITLC-SG or RBM-1 paper strip immediately into the chromatography tank using forceps to avoid formation of pertechnetate (99mTc) due to oxygen.
Slovenian: ITLC-SG ali RBM-1 papirnati trak nemudoma s pinceto prenesite v kromatografsko kopel, da preprečite nastanek pertehnetata (99mTc) zaradi kisika.
English: Bone marrow (red) Muscles
Slovenian: Tanko črevo Kostni mozeg (rdeči)
English: However, after sodium pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained.
Slovenian: Ko se doda natrijev (99mTc) pertehnetat, pa je treba ves čas uporabljati ustrezen ščit pred sevanjem končnega pripravka.
English: Scintimun contains sorbitol and sodium
Slovenian: Zdravilo Scintimun vsebuje sorbitol in natrij
English: The radiochemical purity (the percentage of bound Technetium (99mTc)) must be more than or equal to 95 %.
Slovenian: Radiokemijska čistoča (odstotek vezanega tehnecija (99mTc)) mora biti vsaj 95 %.
English: Introduce the solvent into the chromatography tank to a depth of approximately 2 cm. Cover the tank and allow to equilibrate for at least 5 minutes.
Slovenian: Prenesite topilo v kromatografsko kopel do višine približno 2 cm. Kopel pokrijte in omogočite,
English: Talk to the nuclear medicine specialist before using Scintimun: - if you have previously been administered Scintimun, because you should only be administered
Slovenian: Pred začetkom uporabe zdravila Scintimun se posvetujte s specialistom nuklearne medicine: - če ste že kdaj prejeli zdravilo Scintimun, saj ga lahko prejmete le enkrat v življenju.
English: Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you should avoid close contact with young children and pregnant women during this period of time.
Slovenian: Ker lahko v prvih 12 urah po injiciranju oddajate sevanje, ki je nevarno zlasti za otroke, se morate v tem času izogibati tesnim stikom z majhnimi otroki.
English: Possible side effects are listed in the order of their frequency below:
Slovenian: Spodaj so našteti možni neželeni učinki po padajoči pogostnosti:
English: If the administration is considered necessary, breast-feeding should be interrupted for three days and the expressed feeds discarded.
Slovenian: Če menite, da je uporaba radiofarmaka potrebna, je treba dojenje prekiniti za tri dni in iztisnjeno mleko zavreči.
English: In order to obtain images of best quality and to reduce the radiation exposure of your bladder, you should drink sufficient amounts and empty your bladder prior to and after the scintigraphic examination.
Slovenian: Da bi dobili najkakovostnejše slike in zmanjšali izpostavitev sečnega mehurja sevanju, morate piti zadostne količine tekočin ter izprazniti sečni mehur pred in po scintigrafski preiskavi.
English: If you are breast-feeding you must stop breast-feeding for 3 days after your injection and the expressed milk should be discarded.
Slovenian: Če dojite, morate za 3 dni po injiciranju prekinete z dojenjem in zavreči iztisnjeno mleko.
English: Organ mSv/MBq
Slovenian: Organ mSv/MBq referenčni moški referenčna ženska
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Slovenian: Zato je treba upoštevati morate ukrepe za zaščito pred sevanjem v skladu z lokalnimi predpisi.
English: In order to obtain images of best quality and to reduce the radiation exposure of the bladder, patients should be encouraged to drink sufficient amounts and to empty their bladder prior to and after the scintigraphic examination.
Slovenian: Da bi dobili najkakovostnejše slike in zmanjšali izpostavitev sečnega mehurja sevanju, morate preiskovance spodbujati k pitju zadostnih količin tekočin ter k izpraznjenju sečnega mehurja pred in po scintigrafski preiskavi.
English: For each organ, or group of organs, the absorbed doses have been calculated using the methodology developed by the MIRD (Medical Internal Radiation Dose).
Slovenian: Izračunani so absorbirani odmerki za vsak organ ali skupino organov z metodologijo MIRD (Medical
English: Inquiry on possible previous exposure to murine monoclonal antibodies and a HAMA test should be made prior to administration of Scintimun; a positive response would contraindicate the administration of Scintimun (see section 4.3).
Slovenian: Pred uporabo zdravila Scintimun morate preiskovanca vprašati o morebitnih predhodnih izpostavitvah mišjim monoklonskim protitelesom in opraviti preiskavo za HAMA; pozitiven odziv oz. rezultat kontraindicira uporabo zdravila Scintimun (glejte poglavje 4.3).
English: For an administered activity of 800 MBq the typical radiation dose to the target organ bone is 14.2 mGy and the typical radiation doses to the critical organs, bone marrow, spleen and kidneys are 19.4 mGy, 21.7 mGy, and 16.8 mGy respectively.
Slovenian: Za odmerjeno aktivnost 800 MBq je značilen odmerek sevanja za ciljni organ (kost) 2,0 mGy in značilen odmerek sevanja za kritične organe (kostni mozeg) je 19,4 mGy,
English: Transfer 1 mL of this solution with a hypodermic syringe into a vial of Scintimun (green crimped aluminium capsule).
Slovenian: Prenesite 1 ml te raztopine s hipodermijsko brizgo v vialo z oznako Scintimun (z zelenim aluminijevim pokrovčkom).
English: This medicinal product should be reconstituted and radiolabelled before administration to the patient.
Slovenian: Zdravilo je treba pred dajanjem bolniku rekonstituirati in nato radioaktivno označiti.
English: Scintimun is used for the preparation of a radioactive solution for injection of technetium(99mTc)besilesomab.
Slovenian: Zdravilo Scintimun se uporablja za pripravo radioaktivne raztopine za injiciranje, ki vsebuje tehnecijev (99mTc) besilesomab.
English: Eluates should only be taken from a technetium (99mTc)-generator that has been eluted within the past 24 hours (i.e. with less than 24 h in-grow).
Slovenian: - Uporabite lahko le izpirke iz generatorja tehnecija (99mTc), ki se je izpiral v zadnjih 24 urah (tj.
English: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped capsule (green) containing 5.02 mg of powder.
Slovenian: 15 ml viala iz brezbarvnega stekla tipa I, zaprta z zamaškom iz klorobutilnega kavčuka in aluminijevim pokrovčkom (zelenim), ki vsebuje 5,02 mg praška.
English: Administration of Scintimun and conduct of the procedure Scintimun is administered intravenously.
Slovenian: Dajanje zdravila Scintimun in izvajanje postopka Zdravilo Scintimun se daje intravensko.
English: Repeated use
Slovenian: Ponovna uporaba
English: Scintimun contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo Scintimun vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni “brez natrija”.
English: Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called granulocytes (a type of white blood cells involved in the inflammation process) in your body.
Slovenian: To protitelo je usmerjeno proti specifičnim celicam, ki jim pravimo granulociti (vrsta belih krvnih celic, ki sodeluje pri vnetjih), v vašem telesu.
English: Disinfect the septum and allow drying.
Slovenian: Razkužite septum in počakajte, da se posuši.
English: Positive screening test for human anti-mouse antibody (HAMA).
Slovenian: Pozitivni presejalni test za humana protitelesa proti mišjim protitelesom (HAMA).
English: The active substance is besilesomab (anti-granulocyte monoclonal antibody from mouse origin).
Slovenian: - Zdravilna učinkovina je besilesomab (monoklonsko protitelo mišjega izvora proti granulocitom).
English: Interpretation of images
Slovenian: Interpretacija slik
English: Scintimun should be given to sufficiently hydrated patients.
Slovenian: Priprava bolnika Zdravilo Scintimun dajemo zadostno hidriranim preiskovancem.
English: For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.
Slovenian: Za navodila o rekonstituciji in radioaktivnem označevanju zdravila pred dajanjem glejte poglavje 12.
English: Notes on the instructions - Solvent for Scintimun must NEVER be radiolabelled first and then added to Scintimun.
Slovenian: Opombe v zvezi z navodili: - Vehikla za zdravilo Scintimun ne smete NIKOLI radioaktivno označiti pred dodatkom zdravila
English: Scintimun should not be used for the diagnosis of diabetic foot infection.
Slovenian: Zdravilo Scintimun se ne sme uporabljati za diagnozo okužbe diabetičnega stopala.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Slovenian: Pri posameznem bolniku mora biti izpostavitev sevanju utemeljena s pričakovano koristjo.Uporabljena aktivnost mora biti v vsakem primeru tista najmanjša, s katero je še mogoče pridobiti potrebne diagnostične informacije.
English: Place the vial of Scintimun in an appropriate lead shielding container.
Slovenian: Vialo z oznako Scintimun položite v ustrezno posodo s svinčenim oklepom.
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Slovenian: Radiofarmaki se shranjujejo v skladu z nacionalnimi predpisi za radioaktivne materiale.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Slovenian: Shranjevanje radiofarmakov mora biti v skladu s predpisi o radioaktivnih snoveh.
English: Scintimun once in your lifetime.
Slovenian: Scintimun še enkrat.
English: Medicines reducing inflammation and medicines affecting the production of your blood cells (such as corticosteroids or antibiotics) may affect the results of your examination.
Slovenian: Na rezultate preiskave lahko vplivajo zdravila, ki zmanjšajo vnetje, ter zdravila, ki vplivajo na nastajanje krvnih celic (kot so kortikosteroidi in antibiotiki).
English: However Scintimun should not be used for the diagnosis of diabetic foot infection.
Slovenian: Vendar se zdravilo Scintimun ne sme uporabljati za diagnozo okužbe diabetičnega stopala.
English: 4.5 Interaction with other medicinal products and other forms of interaction Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics and corticosteroids) may lead to false negative results.
Slovenian: Zdravilne učinkovine, ki zavirajo vnetje ali vplivajo na krvotvorni sistem (kot so antibiotiki in kortikosteroidi), lahko povzročijo lažno negativne rezultate.
English: Do not store the reconstituted and radiolabelled product above 25 °C.
Slovenian: Pripravljeno in radioaktivno označeno zdravilo shranjujte pri temperaturah do 25 °C.
English: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium capsule (yellow) containing 2.82 mg of powder.
Slovenian: 10 ml viala iz brezbarvnega stekla tipa I, zaprta z zamaškom iz klorobutilnega kavčuka in aluminijevim pokrovčkom (rumenim), ki vsebuje 2,82 mg praška.
English: 5 How Scintimun is stored Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Scintimun Vsebina pakiranja in dodatne informacije
English: Scintimun should only be used once in a patient's lifetime.
Slovenian: Zdravilo Scintimun se lahko pri preiskovancu uporabi samo enkrat.
English: If you get any side effects, talk to your doctor or the specialist in nuclear medicine.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali specialistom nuklearne medicine.
English: Method of preparation To ensure the highest radiolabelling efficiency: Radiolabelling is performed using freshly eluted sodium pertechnetate (99mTc).
Slovenian: Za zagotovitev največje učinkovitosti radioaktivnega označevanja: - Radioaktivno označevanje opravite s sveže izpranim natrijevim pertehnetatom (99mTc).
English: Pharmacotherapeutic group: Diagnostic radiopharmaceuticals, inflammation and infection detection, Technetium (99mTc) compounds.
Slovenian: Farmakoterapevtska skupina: Radiodiagnostiki, zaznavanje vnetja in okužbe, Tehnecijeve spojine (99mTc); oznaka ATC: V09HA03
English: If you get any side effects, talk to your nuclear medicine doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine ali farmacevtom.
English: This medicinal product is for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel.
Slovenian: Zdravilo se lahko uporablja le v odobrenih ustanovah za nuklearno medicino.
English: Solvent for Scintimun vial:
Slovenian: Vehikel za vialo zdravila Scintimun:
English: There are insufficient data on the use of Scintimun for the diagnosis of diabetic foot infection.
Slovenian: Podatkov o uporabi zdravila Scintimun za diagnozo okužbe diabetičnega stopala je premalo.
English: After reconstitution with the solvent provided and the radiolabelling with sodium pertechnetate (99mTc) injection, the resulting clear and colourless solution for injection of technetium (99mTc)-besilesomab has a pH of 6.5-7.5.
Slovenian: pertehnetatom za injiciranje dobite bistro in brezbarvno raztopino tehnecijevega (99mTc) besilesomaba za injiciranje s pH vrednostjo od 6,5 do 7,5.
English: % bound technetium (99mTc) = 100 % - % free Technetium (99mTc)
Slovenian: % vezanega tehnecija (99mTc) = 100 % - % prostega tehnecija (99mTc) pri čemer je % prostega tehnecija (99mTc) = Aktivnostodrezanega traka od Rf 0,5 do 1,0 x 100
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Scintimun
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo Scintimun
English: Scintimun must not be used: - if you are allergic to besilesomab, to antibody from mouse origin or any other antibodies, or to sodium pertechnetate (99mTc) solution or any of the other ingredients of this medicine listed in section 6.
Slovenian: - če ste alergični na besilesomab, protitelesa mišjega izvora ali katerakoli druga protitelesa ali raztopino natrijevega (99mTc) pertehnetata ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če je bil test za humana protitelesa proti mišjim protitelesom (HAMA) pozitiven.
English: 4.8 Undesirable effects
Slovenian: Neželeni učinek
English: Scintimun has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Scintimun nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Do not store above 25 °C after radiolabelling.
Slovenian: Po radioaktivnem označevanju shranjujte pri temperaturah do 25 °C.
English: The kit contains one or two multidose vials of Scintimun with one or two vials of solvent.
Slovenian: Komplet vsebuje eno ali dve večodmerni viali zdravila Scintimun in eno ali dve viali vehikla.
English: The vial of solvent for Scintimun contains a white powder.
Slovenian: Viala vehikla za zdravilo Scintimun vsebuje bel prašek.
English: Formal studies have not been performed in patients with renal or hepatic impairment.
Slovenian: Okvarjeno delovanje ledvic/okvarjeno delovanje jeter Uradne študije pri bolnikih z okvarjenim delovanjem ledvic in jeter niso bile opravljene.
English: Stomach
Slovenian: Mišice
English: Method of administration The radiolabelled solution should be administered intravenously as a single dose only.
Slovenian: Radioaktivno označena raztopina se uporabi intravensko kot en odmerek.
English: Scintimun 1 mg kit for radiopharmaceutical preparation besilesomab
Slovenian: Scintimun 1 mg komplet za pripravo radiofarmaka besilesomab
English: - if you have a tumoral pathology involving a secretion of carcino-embryonic antigen (CEA)
Slovenian: - če imate tumorsko patologijo, ki izloča karcinoembrionalni antigen (CEA), saj lahko moti to preiskavo,
English: Before administration of Scintimun
Slovenian: Pred dajanjem zdravila Scintimun
English: Adsorbent: strips (2.5 x 20 cm) for thin layer chromatography coated with silica gel (ITLC-SG) or for paper chromatography (RBM-1).
Slovenian: - Adsorbent: trakovi (2,5 x 20 cm) za tankoplastno kromatografijo, prevlečeni s silikagelom
English: The first eluate taken from a technetium (99mTc)-generator that has not been eluted over the weekend must NOT be used.
Slovenian: Tc), ki se ni izpiral preko konca tedna, NE smete uporabiti.
English: Driving and using machines It is considered unlikely that Scintimun will affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bo imelo zdravilo Scintimun vpliv na spodobnost upravljanja vozil in strojev.
English: 1, 1, 3, 3-propane tetraphosphonic acid tetrasodium salt dihydrate, stannous chloride dihydrate, sodium hydroxide, hydrochloric acid, nitrogen.
Slovenian: 1,1,3,3-propantetrafosfonska kislina, tetranatrijeva sol, dihidrat; kositrov klorid dihidrat; natrijev hidroksid; klorovodikova kislina; dušik
English: Czerny-Ring, 22
Slovenian: GLYCOTOPE Biotechnology GmbH Czerny-Ring, 22
English: PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation.
Slovenian: Zdravilo Scintimun je komplet za pripravo radiofarmaka.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija, artralgija redka
English: Procedure
Slovenian: POSTOPEK UPORABE
English: - if you have had a scintigraphy with technetium in the last 2 days.
Slovenian: Če ste negotovi o predhodni uporabi zdravila, se posvetujte z zdravnikom, - če ste v zadnjih 2 dneh že opravili scintigrafijo s tehnecijem,
English: Excipients: Sodium dihydrogen phosphate anhydrous, disodium monohydrogen phosphate anhydrous, sorbitol, under nitrogen atmosphere.
Slovenian: Pomožne snovi: natrijev dihidrogenfosfat, brezvodni; natrijev hidrogenfosfat, brezvodni; sorbitol; v dušikovi atmosferi
English: Sodium dihydrogen phosphate, anhydrous Disodium monohydrogen phosphate, anhydrous Sorbitol E420
Slovenian: Viala zdravila Scintimun: natrijev dihidrogenfosfat, brezvodni natrijev hidrogenfosfat, brezvodni sorbitol E420
English: One vial of Scintimun contains 1 mg of besilesomab.
Slovenian: Ena viala zdravila Scintimun vsebuje 1 mg besilesomaba.
English: Preclinical toxicity and safety studies were performed using commercial kits reconstituted with decayed technetium (99mTc) and thus the effect of radiation has not been assessed.
Slovenian: pripravljenimi z razpadlim tehnecijem (99mTc), zato učinki sevanja niso bili ovrednoteni.
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Občasni (se lahko pojavijo pri največ 1 od 100 bolnikov):
English: 800 MBq.
Slovenian: 3 do 8 ml.
English: Take a vial of Solvent for Scintimun (yellow crimped aluminium capsule) from the kit.
Slovenian: Postopek Iz kompleta vzemite vialo z oznako Vehikel za zdravilo Scintimun (z rumenim aluminijevim pokrovčkom).