natgillin/translations-raw huggingface dataset:
LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/ inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Zdravilo LeukoScan je indicirano za diagnostično slikanje za določitev mesta in obsega okužbe ali vnetja kosti pri bolnikih, pri katerih obstaja sum na osteomielitis, vključno z bolniki, ki imajo razjede na diabetični nogi.
2 This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
2 Ta radiofarmak sme biti prevzet, uporabljen in apliciran samo s strani pooblaščenih oseb v določenih kliničnih ustanovah.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licenses of local competent official organisations.
Njegov prevzem, shranjevanje, uporaba, premeščanje in uničenje so predmet posebnih predpisov in/ ali ustreznih pooblastil pristojnih lokalnih uradnih organov.
For instructions for preparation see section 6.6.
Za navodila za pripravo glejte poglavje 6. 6.
For readministration see section 4.4.
Za ponovni vnos (readministracijo) glejte poglavje 4. 4.
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.
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.
Image acquisition in analogue and/ or digital word-mode and at least a 128 x 128 matrix is recommended.
Priporočljivo je snemanje slike v analognem in/ ali digitalnem modusu in z matriko najmanj 128 x 128.
SPECT acquisition parameters recommended are:
Priporočeni SPECT parametri so:
60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
60 projekcij v 360° “ step- and- shoot ” tehniki, 30 sekund za posamezno smer, z matriko najmanj 64 x 64.
3 Hypersensitivity
3 Kadar so bolnikom aplicirani mišji proteini, so anafilaktične in druge preobčutljivostne reakcije vedno možne.
Readministration
Ponovni vnos (readministracija zdravila)
4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje:
Administration of 750 MBq LeukoScan will give an estimated absorbed dose of 4.1 mGy to an embryo or fetus at an early stage.
Vnos 750 MBq zdravila LeukoScan pomeni ocenjeno absorbirano dozo sevanja 4, 1 mGy na zarodek ali plod v zgodnjem stadiju razvoja.
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].
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 LeukoScan [99m- Tc].
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self- limiting allergic reactions.
Postmarketinška izkušnja trenutno zajema preko 70. 000 prodanih vial zdravila in 2 poročili o samoomejujoči alergijski reakciji.
Statistically significant reductions in white blood cell (WBC) count were observed in the controlled studies at 24 hours post-injection, from a mean value of 8.9 to a mean value of 8.0 (× 103/ mm3), but remained within the normal range, and returned to their pre-injection values by the time of the next measurement at 10 days.
Statistično značilna zmanjšanja števila belih krvnih celic so bila pri kontroliranih študijah opažena 24 ur po injiciranju zdravila, in sicer od srednje vrednosti 8, 9 x 103/ mm3 na 8, 0 x 103/ mm3, a so ostala znotraj normalnega razpona in so se do naslednjega štetja po 10 dneh povrnila na vrednosti pred injiciranjem zdravila.
The eosinophil count increased from 2.7% pre- injection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
Delež eozinofilcev je od 2, 7% pred injiciranjem porasel na 2, 9% v 24 urah po injiciranju in na 3, 9% v 10 dneh po injiciranju, pri čemer sta bila oba porasta statistično značilna.
In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
In vitro je bila pokazana pozitivna vezava na limfocite v obsegu 2- 6%.
5 4.
5 4.
For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/ EDE) is less than 20 mSv.
Za večino diagnostičnih preiskav, kjer je uporabljen nuklearni medicinski postopek, je oddana doza sevanja (efektivna doza/ EDE) manjša od 20 mSv.
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 dose.
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 učinkov.
ATC code:
Radiofarmaki za diagnostiko oznaka ATC:
The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
Protitelo (IMMU- MN3) prepozna antigensko strukturo površinskega glikoproteina (NCA- 90) granulocitov in tumorskega označevalca, karcinoembrionskega antigena (CEA).
In a single-group, open-label, uncontrolled study of 53 patients with acute or chronic infections of unknown origin or extent, doses of LeukoScan from 0.1 mg to 1.0 mg were studied.
V odprti, nekontrolirani študiji ene skupine 53 bolnikov z akutnimi ali kroničnimi infekcijami neznanega izvora ali stopnje so znašali preiskovani odmerki zdravila LeukoScan od 0, 1mg do 1, 0 mg.
There was no dose- response effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg to 1.0 mg.
Pri odmerkih protiteles v razponu od 0, 1 mg do 1, 0 mg velikost odmerka ni vplivala na učinkovitost slikanja (občutljivost ali specifičnost).
On the basis of two controlled clinical trials of LeukoScan to demonstrate the safety and effectiveness of this product for defining the presence and location of osteomyelitis, in a total of 175 evaluable patients, LeukoScan had a sensitivity of 88.2%, a specificity of 65.6%, an accuracy of 76.6%, a positive predictive value of 70.8%, and a negative predictive value of 85.5%.
Na osnovi dveh kontroliranih kliničnih študij zdravila LeukoScan, s katerima so želeli dokazati varnost in učinkovitost zdravila pri definiranju prisotnosti in lokacije osteomielitisa, skupno na 175 ocenljivih bolnikih, je imelo zdravilo LeukoScan 88, 2% občutljivost, 65, 6% specifičnost, 76, 6% natančnost, pozitivno napovedno vrednost 70, 8% in negativno napovedno vrednost 85, 5%.
69.4%).
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%).
72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
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
6 (77.5% vs.
6 lokalizacijami osteomielitisa dolgih kosti.
75.8%, respectively).
Diagostična natančnost pa je pri teh dveh pojavnih oblikah enaka (77, 5% vs 75, 8%).
An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Ovrednotenje potencialnega kliničnega vpliva zdravila LeukoScan je pokazalo, da bi zdravilo LeukoScan lahko spremenilo klinično obravnavo pri 50. 2% ali izboljšalo klinični izid pri 43, 4% izmed 175 ocenljivih bolnikov s sumom na osteomielitis.
In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients.
Za 49, 7% bolnikov so predpostavljali, da bi zdravilo LeukoScan lahko doprineslo klinično korist, ki z drugimi razpoložljivimi diagnostičnimi metodami slikanja ni dosegljiva, z možnostjo, da bi bila diagnoza pri 70, 3% bolnikov lahko postavljena zgolj z uporabo zdravila LeukoScan.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging procedures.
Te prednosti so bile spremljane tudi z znatnim zmanjšanjem (85, 4%) števila bolnikov, ki bi potrebovali druge diagnostične postopke slikanja.
The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration.
Razpolovni čas porazdelitve je znašal približno 1, 5 ure, pot izločanja je pretežno renalna, 41% radioaktivnega označevalca se izloči z urinom v prvih 24 urah po vnosu.
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
kositrov klorid dihidrat koncentrirana ocetna kislina (sledovi) natrijev kalijev tartrat tetrahidrat saharoza
Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
natrijev klorid klorovodikova kislina (sledovi) natrijev acetat trihidrat dušik
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or 12.
To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6. 6 ali 12.
6.3 Shelf-life
6. 3 Rok uporabnosti:
Reconstituted and radiolabelled material - Do not store above 25ºC.
Rekonstituiran in radioaktivno označen material – Shranjujte pri temperaturi do 25 °C.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Ena viala je pripravljena tako, da vsebuje 0, 31 mg liofiliziranih LeucoScan fragmentov monoklonalnih protiteles.
Pack size: one vial per carton container.
1 viala v kartonski škatli
6.6 Special precautions for disposal and other handling
6. 6 Navodila za pripravo in ravnanje z zdravilom
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).
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).
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.
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.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Tako pripravljena raztopina ima pH 4, 5 – 5, 5 in je namenjena samo za intravensko uporabo.
Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
8 Vzemite 900 ± 200 MBq sveže izpranega 99mTc eluata natrijevega pertehnetata iz kateregakoli 1. komercialno dostopnega vira, ki je bil izpran v zadnjih 24 urah.
Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Dodajte toliko 0, 9% raztopine natrijevega klorida za injiciranje, da bo končni volumen eluata znašal 1, 0 ml.
For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
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.
Total volume in vial equals 1.5 ml.
Celokupni volumen v viali znaša 1, 5 ml.
Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1100 MBq of 99mTc, see Dosage and Administration).
Na osnovi merjenja aktivnosti v kalibratorju aktivnosti odvzemite zadostno količino pripravka za zagotovitev željene aktivnosti (750- 1100 MBq 99mTc, glejte Odmerjanje in način uporabe).
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Nemčija
14 February 1997
14. februar 1997
Date of lastest renewal:
Datum zadnjega podaljšanja dovoljenja za promet:
Date of approval of latest variation or transfer:
Datum odobritve zadnje spremembe ali prenosa:
MM/ YYYY
DD/ MM/ LLLL
For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
9 Za to zdravilo tipični učinkoviti ekvivalent doze, ki izhaja iz aplicirane aktivnosti 750 MBq, za 70 kg težko osebo znaša 7, 7 mSv.
9 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.
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.
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.
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.
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]
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]
Average Dose µGy/ MBq
povprečna doza μGy/ MBq organ
Kidneys Urinary Bladder Wall Spleen Heart Wall Lungs Liver Bone Surfaces Adrenals Red Marrow Pancreas Thyroid Gall Bladder Wall Uterus Ovaries Small Intestine Stomach
ledvice stena sečnega mehurja vranica stena srca pljuča jetra površine kosti adrenalne žleze rdeči kostni mozeg trebušna slinavka ščitnica stena žolčnega mehurja maternica jajčniki tanko črevo želodec stena zgornjega dela debelega črevesa stena spodnjega dela debelega črevesa priželjc celo telo mišice moda (testisi) prsi možgani koža ekvivalent efektivne doze efektivna doza
Effective Dose Equivalent and Effective Dose are in units of µSv/ MBq.
Ekvivalent efektivne doze in efektivna doza sta izražena v enotah µSv/ MBq.
12.
10 12.
10 LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
LeukoScan rekonstituiramo z 0, 5 ml izotonične raztopine natrijevega klorida za injiciranje.
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99m Tc pertechnetate (approximately 1.2 ml).
Priporočeni odmerek za odrasle je 0, 25 mg Fab 'fragmenta, označenega z 900 ± 200 MBq tehnecijevega 99m Tc pertehnetata (približno 1, 2 ml).
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.
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 (ITLC – Instant Thin Layer Chromatography) na s silikagelom impregniranih ploščicah iz steklenih vlaken, 1 x 9 cm, topilo je aceton.
% Free Technetium = Activity in top half of strip × 100 Total Activity.
% prostega tehnecija = aktivnost v zgornji polovici ploščice x 100 skupna aktivnost
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK (IMETNIKI) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
300 American Road Morris Plains, New Jersey 07950, USA
300 American Road Morris Plains, New Jersey 07950, ZDA
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE; PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
15 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
(CONTAINER PACKAGE LABEL)
(ŠKATLA)
LeukoScan 0.31 mg, powder for solution for injection sulesomab
LeukoScan 0, 31 prašek za raztopino za injiciranje sulezomabu
One vial contains 0.31 mg sulesomab
1 viala vsebuje 0, 31 mg sulezomaba
0.31 mg sulesomab Powder for solution for injection
prašek za raztopino za injiciranje 0, 31 mg sulezomabu
METHOD AND ROUTe(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA
For Intravenous Use.
Za intravensko uporabo.
16 EXP MM/ YYYY
MM/ LLLL
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany Telephone: +49-6151- 66 715 66 Fax: +49-6151-66 715 77
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Nemčija Tel: +49- 6151 - 66 715 66 Fax: +49- 6151- 66 715 77 e- mail: europe@ immunomedics. com
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE ZDRAVILA
For intravenous use.
LeukoScan 0, 31 mg prašek za raztopino za injiciranje 0, 31 mg liofiliziranega sulezomaba, kositrov klorid in stabilizatorji Za intravensko uporabo.
EXP 48 Months
Uporabno do:
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Vsebuje 0, 31 mg liofiliziranega sulezomaba, kositrov klorid in stabilizatorje.
INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
19 NAVODILO ZA UPORABO INFORMACIJA ZA UPORABNIKA LeukoScan (0, 31 prašek za raztopino za injiciranje) sulezomaba
You may need to read it again. • It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
Morda ga boste želeli ponovno prebrati. • Navodilo ne vsebuje vseh informacij o zdravilu, ki jih boste morda potrebovali, zato poglejte Povzetek glavnih značilnosti zdravila ali se posvetujte z zdravnikom ali sestro, če imate vprašanja.
This leaflet only applies to LeukoScan. • If you have any further questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
To navodilo se nanaša samo na zdravilo LeukoScan. • Če imate dodatna vprašanja, se posvetujte z zdravnikom. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
What LeukoScan is used for 2.
Kaj je zdravilo LeukoScan in za kaj ga uporabljamo 2.
Before you use LeukoScan 3.
Kaj morate vedeti, preden boste uporabili zdravilo LeukoScan 3.
How to use LeukoScan 4.
Kako uporabljati zdravilo LeukoScan 4.
How to store LeukoScan 6.
Kako shranjevati zdravilo LeukoScan 6.
BEFORE YOU USE LEUKOSCAN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LEUKOSCAN
You should not use LeukoScan 0.31 mg, sulesomab, powder for solution for injection
Zdravila LeukoScan 0, 31 mg, prašek za raztopino za injiciranje ne smete uporabiti
• 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.
• Če ste kadarkoli že prejeli zdravilo LeukoScan ali drugo zdravilo, pripravljeno iz mišjih protiteles, mora zdravnik vzeti vzorec vaše krvi, da se prepriča, da niste razvili alergije na zdravilo.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be used.
• Če je pripravljena raztopina zdravila LeukoScan videti razbarvana ali vsebuje delce, ne sme biti uporabljena.
Using Leukoscan with food and drink
Uporaba zdravila LeukoScan s hrano in pijačo
No studies effects of food/ drink have been performed.
Raziskave vpliva hrane/ pijače niso bile izvedene.
• If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given LeukoScan.
• Če dojite, morate po prejetju zdravila LeukoScan prenehati dojiti svojega otroka za najmanj 24 ur.
21 • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
• Radiofarmake je potrebno pripraviti na način, ki bo zadoščal tako zaščiti pred sevanjem kakor tudi farmacevtskim zahtevam po kakovosti.
• After use, the container should be disposed of as radioactive waste.
21 • Po uporabi je potrebno vsebnik zavreči kot radioaktivni odpadek.
You will receive a single dose of 0.25 mg of LeukoScan.
Dobili boste en odmerek 0, 25 mg zdravila LeukoScan.
Method and/ or route(s) of administration
Postopek in/ ali pot( i) uporabe zdravila
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
Vaš zdravnik bo pripravil zdravilo LeukoScan in radioaktivni izotop tehnecija, pripravljeni volumen bo znašal 1, 5 ml.
0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
0, 25 mg zdravila LeukoScan bo označenega s 740 – 1110 MBq tehnecija.
Some side effects, although not common, have been reported.
22 Poročali so o nekaterih neželenih učinkih, ki pa niso bili pogosti.
HOW TO STORE LEUKOSCAN
SHRANJEVANJE ZDRAVILA LEUKOSCAN
Store in a refrigerator (2°C-8°C).
komplet - 48 mesecev Shranjujte v hladilniku (2 °C - 8 °C).
What LeukoScan contains
Kaj vsebuje zdravilo LeukoScan
Kit for the preparation of 99mTc-labelled LeukoScan.
Komplet za pripravo 99mTc označenega zdravila LeukoScan Komplet ne vsebuje radioizotopa.
The kit does not include the radioisotope.
Zdravilna učinkovina je: sulezomaba.
The active substance is sulesomab Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′ -SH antigranulocyte monoclonal antibody fragments).
Vsaka 3 ml viala vsebuje 0, 31 mg sulezomaba (IMMU- MN3 fragmenti Fab '- SH antigranulocitnih monoklonalnih protiteles glodalcev).
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
Pomožne snovi so: kositrov klorid dihidrat koncentrirana ocetna kislina (sledovi) natrijev kalijev tartrat tetrahidrat saharoza
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Ena viala je pripravljena tako, da vsebuje 0, 31 mg liofilizaranih LeucoScan fragmentov monoklonalnih protiteles.
The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
1 viala v kartonski škatli
Pack size: one vial per carton container.
Imetnik dovoljenja za promet z zdravilom in izdelovalec
23 Marketing Authorisation Holder and Manufacturer
23 Nemčija