FrancophonIA/ELRC3.0 huggingface dataset:
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Slovenian: Pri vsakem bolniku mora biti izpostavljenost ionizirajočemu sevanju upravičljiva na osnovi možne koristi za bolnika.
English: Patients with known allergies or hypersensitivity to mouse proteins.
Slovenian: Bolniki z znanimi alergijami ali preobčutljivostjo na mišje beljakovine.
English: Human Anti-mouse Antibody (HAMA)
Slovenian: Človeška protitelesa proti mišjemu antigenu (HAMA)
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE; PREDPISANI IMETNIKU
English: Do not refrigerate or freeze.
Slovenian: Po pripravi ne shranjujte v hladilniku.
English: • If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be
Slovenian: • Če je pripravljena raztopina zdravila LeukoScan videti razbarvana ali vsebuje delce, ne sme biti
English: When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Slovenian: Ko fronta topila doseže 1 cm do zgornjega roba ploščice, ploščico vzemite iz komore, prerežite na pol in vsako od polovic namestite v stekleno cevko.
English: These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Slovenian: Poročila so vključevala majhen porast v številu določenih belih krvnih celic, imenovanih eozinofilci, (vendar brez vidnih simptomov) in izpuščaj.
English: 4.5 Interactions with other medicinal products and other forms of interaction Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Uradne študije medsebojnega delovanja z drugimi zdravili niso bile izvedene, vendar do danes ni bila opisana nobena reakcija medsebojnega delovanja z drugimi zdravili, vključno z antibiotiki.
English: 4.4 Special warnings and special precautions for use Safety and diagnostic accuracy in persons under 21 years of age have not been established.
Slovenian: Varnost in diagnostična natančnost pri osebah, mlajših od 21 let, nista bili določeni.
English: Total volume in vial equals 1.5 ml.
Slovenian: Celokupni volumen v viali znaša 1,5 ml.
English: Some side effects, although not common, have been reported.
Slovenian: Poročali so o nekaterih neželenih učinkih, ki pa niso bili pogosti.
English: These revealed no remarkable findings.
Slovenian: Te niso podale pomembnejših izsledkov.
English: None of these were considered serious, and all resolved without sequelae.
Slovenian: Nobeden od teh dogodkov ni bil resen in vsi so minili brez
English: Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc.
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin) Immunomedics, Inc.
English: For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv.
Slovenian: Za večino diagnostičnih preiskav, kjer je uporabljen nuklearni medicinski postopek, je oddana doza sevanja (efektivna doza/EDE) manjša od 20 mSv.
English: After injection, any remaining portion of the reconstituted solution should be discarded.
Slovenian: Po injiciranju je vsak preostanek rekonstituirane raztopine potrebno zavreči.
English: LeukoScan is contraindicated in pregnancy.
Slovenian: Zdravilo LeukoScan je v nosečnosti kontraindicirano.
English: One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras.
Slovenian: Eno do osem ur po injekciji vas bodo položili na posebno mizo in naredili posnetke s standardnimi nuklearnimi kamerami.
English: LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Slovenian: Zdravilo LeukoScan [99mTc] se lahko uporabi po desetih minutah in mora biti uporabljeno v štirih urah po pripravi.
English: Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12).
Slovenian: Pred uporabo je potrebno preveriti, če raztopina ne vsebuje vidnih delcev ali razbarvanja in izvesti kontrolo kakovosti (glejte poglavje 12).
English: If you take more LeukoScan than you should
Slovenian: Če ste uporabili večji odmerek zdravila LeukoScan, kot bi smeli
English: 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.
Slovenian: 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.
English: This difference is perhaps explained by the anatomically and pathophysiology more complicated clinical setting of osteomyelitis in the diabetic foot, making differentiation of soft tissue and bone infection more difficult than in other presentations of long bone osteomyelitis.
Slovenian: To razliko je morda mogoče razložiti z anatomsko in patofiziološko bolj zapleteno klinično sliko osteomielitisa pri diabetičnem stopalu, kjer je razlikovanje med infekcijo mehkih tkiv in kosti težje kakor pri drugih vrstah osteomielitisa dolgih kosti.
English: This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
Slovenian: Postopek bo zdravniku pomagal ugotoviti, če je vnetje kosti prisotno, in se odločiti za način zdravljenja.
English: Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
Slovenian: Zaradi tega vas mora vaš zdravnik nekaj časa po injiciranju tega zdravila skrbno opazovati.
English: The overall radiation dose received by the patient over time should also be taken into
Slovenian: Upoštevati je potrebno tudi celokupno dozo sevanja, ki jo pacient prejme v določenem obdobju.
English: The eosinophil count increased from 2.7% preinjection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
Slovenian: 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.
English: It will contain the radioactive technetium isotope in an amount called 740-1110 MBq.
Slovenian: Vseboval bo radioaktivni tehnecijev izotop v količini, ki se imenuje 740 - 1110 MBq.
English: Date of approval of latest variation or transfer: MM/YYYY
Slovenian: Datum odobritve zadnje spremembe ali prenosa: DD/MM/LLLL
English: No studies effects of food/drink have been performed.
Slovenian: Uporaba zdravila LeukoScan s hrano in pijačo Raziskave vpliva hrane/pijače niso bile izvedene.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavitev ionizirajočemu sevanju je povezana z indukcijo raka in možnostjo za nastanek dednih napak.
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Slovenian: Če je potrebno aplicirati radioaktivna zdravila ženski v rodni dobi, je vedno potrebno pridobiti informacijo o nosečnosti.
English: When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them.
Slovenian: Ko je kombinirano z radioaktivnim tehnecijevim izotopom in injicirano v vašo veno, najde nenormalno nakopičenje belih krvnih celic in se veže nanje.
English: Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Slovenian: Opravite meritev vsake cevke v gama scintilacijskem števcu, doznem kalibratorju ali radiokromatogramskem analizatorju.
English: LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes.
Slovenian: LeukoScan (sulezomab) je posebne vrste protitelo, ki se veže na površino določene vrste krvnih celic, imenovanih levkociti.
English: Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
Slovenian: Kmalu po mešanju zdravila LeukoScan z radioaktivnim tehnecijevim izotopom bo zdravnik zdravilo vbrizgal v vašo veno.
English: Pharmacokinetic studies were performed after the intravenous administration of the product.
Slovenian: Farmakokinetične študije so bile izpeljane po intravenskem vnosu zdravila.
English: The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Slovenian: Klinični rezultati nakazujejo, da lahko pri različnih vrstah osteomielitisa zdravilo LeukoScan daje različne rezultate.
English: Important information about some ingredients of LeukoScan If you have been told that you have an intolerance to some sugars, inform your doctor before you are
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila LeukoScan Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila
English: 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.
Slovenian: Za to zdravilo tipični učinkoviti ekvivalent doze, ki izhaja iz aplicirane aktivnosti 750 MBq, za 70 kg težko osebo znaša 7,7 mSv.
English: 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).
Slovenian: Na osnovi merjenja aktivnosti v kalibratorju aktivnosti odvzemite zadostno količino pripravka za zagotovitev željene aktivnosti (750-1100 MBq 99mTc, glejte Odmerjanje in način uporabe).
English: Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique.
Slovenian: Pri ravnanju z rekonstituiranimi radiofarmaki je potrebno uporabljati vodotesne rokavice, ustrezno zaščito pred radioaktivnostjo in aseptično tehniko.
English: 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.
Slovenian: 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.
English: Radiolabelling must take place immediately after reconstitution of product.
Slovenian: Označevanje z radioaktivnim označevalcem mora biti opravljeno takoj po rekonstituciji.
English: Before administering a radioactive medicinal product to a mother who is breast feeding, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of activity in breast milk.
Slovenian: Pred vnosom radioaktivnega zdravila materi, ki doji, je potrebno pretehtati, če je mogoče preiskavo preložiti na čas, ko mati ne bo več dojila, oziroma če je bil z ozirom na njegovo izločanje v mleku izbran najustreznejši radiofarmak.
English: 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.
Slovenian: 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.
English: Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo LeukoScan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: This medicine
Slovenian: Zdravilo je
English: LeukoScan is used to determine the presence of infections in long bones.
Slovenian: Zdravilo LeukoScan se uporablja za določanje prisotnosti vnetij v dolgih kosteh.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA
English: Reconstituted and radiolabelled material - Do not store above 25ºC.
Slovenian: Rekonstituiran in radioaktivno označen material - Shranjujte pri temperaturi do 25 °C.
English: It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.
Slovenian: Običajno doječa mati prejme nasvet, da lahko ponovno prične z dojenjem, ko raven radioaktivnosti v mleku za otroka ne bo presegla obsevalne doze 1 mSv.
English: Pack size: one vial per carton container.
Slovenian: Velikost pakiranja: 1 viala v kartonski škatli
English: Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent.
Slovenian: Tako z označenim kot z neoznačenim zdravilom so bile opravljene samo zelo omejene neklinične študije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: You will receive a single dose of 0.25 mg of LeukoScan.
Slovenian: Dobili boste en odmerek 0,25 mg zdravila LeukoScan.
English: Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal)
Slovenian: Priporočljiva je obdelava podatkov s filtrirano vzvratno projekcijo in rekonstrukcijo v treh ravninah (transaksialni,
English: This leaflet only applies to LeukoScan.
Slovenian: To navodilo se nanaša samo na zdravilo LeukoScan.
English: One to eight hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras to see where the infections are located.
Slovenian: Eno do osem ur pozneje vas bodo položili na posebno mizo in naredili posnetke s standardnimi nuklearnimi kamerami, da bodo videli, na katerem mestu potekajo vnetja.
English: If so, no inferences concerning the underlying mechanism(s) responsible may be derived from the clinical laboratory results.
Slovenian: Če je temu tako, iz kliničnih laboratorijskih izvidov ni mogoče izpeljati sklepov o osnovnih odgovornih mehanizmih (mehanizmu).
English: Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Slovenian: Opravljena je lahko tudi enofotonska izsevna tomografija (SPECT), ki lahko služi kot pomoč pri razločevanju osteomielitisa od infekcij mehkih tkiv.
English: LeukoScan is prepared for a single injection.
Slovenian: Zdravilo LeukoScan je pripravljeno za enkratno injiciranje.
English: • If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you
Slovenian: • Če dojite, morate po prejetju zdravila LeukoScan prenehati dojiti svojega otroka za najmanj 24 ur.
English: Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
Slovenian: Vzemite 900 ± 200 MBq sveže izpranega 99mTc eluata natrijevega pertehnetata iz kateregakoli komercialno dostopnega vira, ki je bil izpran v zadnjih 24 urah.
English: Alternative techniques which do not involve ionising radiation should be considered.
Slovenian: Razmisliti je potrebno tudi o alternativnih tehnikah, ki ne
English: In vitro studies have demonstrated that LeukoScan has no effect on either up-regulation or downregulation of granulocytes, but LeukoScan does appear to bind more avidly to activated rather than resting
Slovenian: In vitro študije so pokazale, da zdravilo LeukoScan nima učinka na povišanje ali znižanje števila granulocitov, toda zdi se, da se zdravilo LeukoScan raje veže na aktivirane kot na mirujoče granulocite.
English: It is unknown whether the changes in WBC or eosinophil counts observed, although of no clinical significance, are due to a transient effect on WBC function.
Slovenian: Ni znano, če so opažene spremembe v številu belih krvnih celic in eozinofilcev, čeprav klinično nepomembne, posledica prehodnega vpliva na funkcijo belih krvnih celic.
English: The following minor, self-limiting, rare adverse events were reported in the clinical trials and considered at least possibly related to LeukoScan: eosinophilia (3); and facial rash (1).
Slovenian: Pri kliničnih študijah so poročali o naslednjih manj pomembnih, samoomejujočih, redkih neželenih dogodkih, za katere so menili, da obstaja vsaj možnost, da so povezani z zdravilom LeukoScan: eozinofilija (3) in izpuščaj po obrazu (1).
English: 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%.
Slovenian: 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%.
English: Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
Slovenian: V primeru dvoma je pomembno, da je izpostavitev sevanju le tolikšna, kot je najmanj potrebno za pridobitev željene klinične informacije.
English: This suggests that imaging can be accomplished anytime between one and eight hours after injection (at the convenience of the nuclear
Slovenian: To dejstvo pove, da je preiskava lahko izvršena kadarkoli v časovnem obdobju ene do osmih ur po injiciranju (tako, da je najugodneje za oddelek
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: Aplicirana aktivnost mora biti tolikšna, da je rezultirajoče sevanje z ozirom na potrebo po pridobitvi nameravanega diagnostičnega rezultata kolikor je mogoče nizko.
English: What LeukoScan looks like and contents of the pack
Slovenian: IZGLED ZDRAVILA LEUKOSCAN IN VSEBINA PAKIRANJA
English: The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
Slovenian: Protitelo se je sposobno vezati na površino belih krvnih celic, ki se nabirajo na področju vnetja.
English: Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA
Slovenian: Ker zdravilo LeukoScan navzkrižno reagira s CEA (karcinoembrionski antigen), je potrebno upoštevati, da lahko reagira s tumorji, ki proizvajajo CEA.
English: LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Slovenian: Zdravilo LeukoScan je fragment (delček) protitelesa, vezan na radioaktivno snov, ki se imenuje tehnecij.
English: The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Slovenian: Steklena viala (steklo tipa I) je zaprta s sivim z zamaškom iz butilne gume z zeleno zaporko z varnostnim
English: Administration of 750 MBq LeukoScan will give an estimated absorbed dose of 4.1 mGy to an embryo or fetus at an early stage.
Slovenian: Vnos 750 MBq zdravila LeukoScan pomeni ocenjeno absorbirano dozo sevanja 4,1 mGy na zarodek ali plod v zgodnjem stadiju razvoja.
English: By contrast, in non-infected subjects, transient increases in WBC count were seen 24 hours after LeukoScan administration.
Slovenian: Nasprotno so pri osebah, ki niso bile okužene, opazili prehoden porast števila belih krvnih celic v času 24 ur po vnosu zdravila LeukoScan.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: Clean the rubber closure of each vial such as with an alcohol wipe.
Slovenian: Očistite gumijasti zamašek vsake viale z blazinico, namočeno v alkohol.
English: In subjects with HAMA, there may be a greater chance of hypersensitivity reactions and
Slovenian: Pri osebah s HAMA lahko obstaja večja verjetnost za nastanek preobčutljivostnih reakcij in zmanjšano učinkovitost slikanja.
English: Planar imaging in all views necessary to adequately visualise the affected area at 1-8 h post-injection with at least 500 k counts or ten minutes per view should be made.
Slovenian: Eno do osem ur po injiciranju naj bo pravljeno ploskovno snemanje iz vseh smeri, ki so potrebne za vizualizacijo prizadetega področja, in sicer z najmanj 500 000 impulzi oziroma v trajanju 10 minut za posamezno smer.
English: 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
Slovenian: 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
English: The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located.
Slovenian: Zdravniku pri tem pomaga uporaba posebne kamere, ki zaznava področja radioaktivnosti, s čimer lahko vidi, na katerem mestu v telesu poteka vnetje.
English: However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not
Slovenian: Vseeno zaradi nizkega odmerka vnešenih beljakovin in kratkega razpolovnega časa 99mTc prilagoditev odmerka pri teh
English: You must then not be given LeukoScan.
Slovenian: V tem primeru zdravila LeukoScan ne smete prejeti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kit for the preparation of 99mTc-labelled LeukoScan.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Komplet za pripravo 99mTc označenega zdravila LeukoScan
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Quality control
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV