FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Poluvrijeme distribucije iznosilo je otprilike 1,5 sati; najvažniji put izlučivanja je putem bubrega s 41 % urinom izlučenog radioaktivnog biljega tijekom prva 24 sata nakon primjene.
English: These values were calculated according to Medical Internal Radiation Dosimetry.
Croatian: Vrijednosti su izračunate prema protokolu MIRD (Medical Internal Radiation Dosimetry).
English: LeukoScan is not recommended for use in children.
Croatian: LeukoScan se ne preporučuje za primjenu u djece.
English: For instructions for preparation see section 6.6.
Croatian: Za upute o pripremi lijeka prije primjene vidjeti dio 6.6.
English: The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
Croatian: Protutijelo ima sposobnost vezati se na površinu bijelih krvnih stanica koji infiltriraju područje infekcije.
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.
Croatian: Jedan do osam sati nakon ubrizgavanja poleći će Vas na poseban stol i snimiti standardnim nuklearnim kamerama.
English: Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes.
Croatian: Dodajte pripremljeni eluat u štitnikom zaštićenu bočicu, protresite i omogućite da se reakcija radioobilježavanja odvija deset minuta.
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Croatian: Kada je potrebno radioaktivni lijek primijeniti ženama reproduktivne dobi, uvijek je potrebno ispitati mogućnost trudnoće.
English: Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self
Croatian: Iskustvo nakon stavljanja lijeka u promet trenutno obuhvaća više od 70 000 prodanih bočica i dva izvješća o alergijskim reakcijama koje su prošle same od sebe.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Croatian: Svaka žena kojoj je izostala mjesečnica mora se smatrati trudnom dok se ne dokaže suprotno.
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.
Croatian: • Ako ste ikad ranije primili LeukoScan ili neki drugi lijek dobiven iz mišjih protutijela, Vaš će liječnik uzeti uzorak Vaše krvi radi pretrage kojom će se utvrditi jeste li na njega razvili alergiju.
English: Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Croatian: Anafilaktička i druge reakcije preosjetljivosti moguće su svaki puta kada se materijal dobiven iz proteina miša primjenjuje bolesnicima.
English: This helps your doctor make a diagnosis and evaluate the extent of your illness.
Croatian: Snimke će pomoći liječniku postaviti dijagnozu i procijeniti proširenost bolesti.
English: You must then not be given LeukoScan.
Croatian: U tom slučaju ne smijete primiti LeukoScan.
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.
Croatian: Tehnecij [99mTc] raspada se uz emisiju gama-zračenja energije 140 keV i poluživot od 6 sati na tehnecij [99Tc] koji se može smatrati gotovo stabilnim..
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.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcije s drugim lijekovima, ali do danas one nisu opisane,
English: Pack size: one vial per carton container.
Croatian: Veličina pakiranja: jedna bočica u jednom kartonskom spremniku.
English: The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.
Croatian: Nerekonstituirani sadržaj bočice prije njegovog obilježavanja radioizotopom ne smije se izravno primijeniti bolesniku.
English: LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes.
Croatian: LeukoScan (sulesomab) je posebna vrsta protutijela koja se vezuje na površinu određene vrste krvnih stanica koje nazivamo leukociti.
English: Clean the rubber closure of each vial such as with an alcohol wipe.
Croatian: Obrišite gumeni zatvarač svake bočice alkoholnim tupferom.
English: Total volume in vial equals 1.5 ml.
Croatian: Ukupni volumen u bočici odgovara 1,5 ml.
English: Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject.
Croatian: Primjena LeukoScana u mladih osoba smije se provesti samo nakon procjene mogućeg rizika i koristi za
English: Pharmacokinetic studies were performed after the intravenous administration of the product.
Croatian: Ispitivanja farmakokinetike provedena su nakon intravenske primjene lijeka.
English: HAMA titers should be determined before repeated administration of LeukoScan.
Croatian: Potrebno je utvrditi titrove HAMA prije ponovne primjene LeukoScana.
English: Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA
Croatian: Budući da LeukoScan unakrsno reagira s CEA, potrebno je imati na umu moguću interakciju s tumorima
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.
Croatian: Statistički značajno smanjenje broja leukocita primijećeno je u kontroliranim ispitivanjima 24 sata nakon injekcije, od srednje vrijednosti od 8,9 do 8,0 (× 103/mm3), ali je njihov broj ostao unutar normalnog raspona, a vratio se na vrijednost prije injekcije u vrijeme sljedećeg mjerenja za
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.
Croatian: Nije poznato je li zabilježena promjena broja leukocita i eozinofila, iako bez kliničkog značaja, posljedica prolaznog učinka na funkciju leukocita.
English: After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law.
Croatian: Nakon miješanja s Tc, konačni proizvod mora se zbrinuti kao radioaktivni otpad u skladu s važećim nacionalnim zakonskim propisima
English: ATC code: VO4D At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert
Croatian: ATK oznaka: VO4D U koncentracijama i pri radioaktivnosti koja se koristi u dijagnostičkim postupcima, ne čini se da LeukoScan ima ikakvog farmakodinamičkog učinka.
English: Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent.
Croatian: Provedena su samo ograničena neklinička ispitivanja s radiološki obilježenim ili neobilježenim agensom.
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.
Croatian: Razliku je možda moguće objasniti složenijim anatomskim i patofiziološkim kliničkim karakteristikama osteomijelitisa u dijabetičkom stopalu, što čini diferencijaciju infekcije mekih tkiva i kosti težom nego kod osteomijelitisa u dugim kostima.
English: Swirl and shake the vial contents gently for 30 seconds to insure dissolution.
Croatian: Pažljivo okrećite i protresite sadržaj bočice 30 sekundi kako bi se potpuno otopio.
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%.
Croatian: Na temelju ispitivanja LeukoScana u dva kontrolirana klinička ispitivanja radi dokazivanja sigurnosti i učinkovitosti ovog lijeka u utvrđivanju postojanja i lokacije osteomijelitisa, u ukupno 175 ispitanih bolesnika, LeukoScan je pokazao osjetljivost od 8,2 %, specifičnost od 55,6 %, točnost od 76,6 %, pozitivnu prediktivnu vrijednost od 70,8 % te negativnu prediktivnu vrijednost od 85,5 %.
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.
Croatian: Potrebno je učiniti planarno snimanje u svim prikazima potrebnim radi odgovarajuće vizualizacije zahvaćenog područja 1-8 sati nakon injekcije s najmanje 500 000 detektorom registriranih fotona ili
English: However, in vitro granulocyte function tests did not show significant changes when the sulesomab was added.
Croatian: In vitro funkcije granulocita nisu pokazivale značajnu promjenu kada se
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.
Croatian: U 49,7 % bolesnika, pretpostavilo se da će LeukoScan polučiti kliničku korist koju nije moguće postići drugim dijagnostičkim slikovnim metodama, uz mogućnost da se dijagnoza postavi samo uz pomoć LeukoScana u 70,3 % bolesnika.
English: There was no doseresponse effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg
Croatian: Nije bilo učinka na uspješnost snimanja (osjetljivost ili specifičnost) ovisnog o dozi u rasponu doziranja protutijela od 0,1 mg do 1,0 mg.
English: LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Croatian: LeukoScan je fragment protutijela koji se veže na radioaktivnu tvar zvanu tehnecij.
English: Some side effects, although not common, have been reported.
Croatian: Prijavljene su i neke nuspojave iako nisu bile česte.
English: Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: % Free Technetium = Activity in top half of strip × 100
Croatian: % slobodnog tehnecija = radioaktivnost u gornjoj polovici kromatografske trake × 100 Ukupna radioaktivnost
English: If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Croatian: Ako se primjena smatra neophodnom, dojenje treba prekinuti a izdojeno mlijeko baciti.
English: This suggests that imaging can be accomplished anytime between one and eight hours after injection (at the convenience of the nuclear
Croatian: To upućuje da se snimanje može obaviti bilo kada između jednog i osam sati nakon injiciranja (prema raspoloživosti odjela za nuklearnu medicinu i bolesnika).
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.
Croatian: Prema ispitivanjima iz područja nuklearnomedicinske dijagnostike, trenutni pokazatelji upućuju da će se neželjeni događaji javljati rijetko zbog primjenjivanih niskih doza zračenja.
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
Croatian: U kliničkim ispitivanjima koja su uključivala preko 350 bolesnika nije primijećena indukcija humanog anti-mišjeg protutijela (HAMA) na fragmente protutijela, niti je primijećen porast razine HAMA u bolesnika kod kojih su već postojala HAMA.
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.
Croatian: Kada se radioaktivno protutijelo veže na bijele krvne stanice, liječnik može odrediti gdje se infekcija nalazi pomoću posebnih kamera za snimanje koje omogućuju otkriti područja radioaktivnosti.
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.
Croatian: Uzmite 900 ± 200 MBq svježe eluiranog eluata 99mTc natrijevog pertehnetata iz bilo kojeg komercijalnog izvora, a koji je eluiran unutar posljednja 24 sata.
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.
Croatian: Dojenje Prije primijene radioaktivnog lijeka majci koja doji, potrebno je razmotriti je li poželjno pretragu odgoditi do prestanka dojenja, i je li je odabran odgovarajući radiofarmaceutik, imajući na umu izlučivanje radioaktivnosti u majčino mlijeko.
English: The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis.
Croatian: Ispitivači su veličinu ovog porasta ocijenili kao klinički beznačajnom za pojedinog bolesnika.
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.
Croatian: U otvorenom nekontroliranom ispitivanju u jedne skupine od 53 bolesnika s akutnom ili kroničnom infekcijom nepoznatog uzroka i opsega, ispitivana je primjena doze od 0,1 mg do 1,0 mg LeukoScana.
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.
Croatian: Kada se kombinira s radioaktivnim izotopom tehnecija i ubrizga u venu, ono pronalazi nenormalno nakupljanje bijelih kvnih stanica i na njih se veže.
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
Croatian: Ispitivanja in vitro pokazala su da LeukoScan nema učinka ni na pozitivnu niti na negativnu regulaciju granulocita, ali se čini da se lakše vezuje za aktivirane granulocite nego za granulocite u mirovanju.
English: The maximum amount of LeukoScan [99mTc] that can be administered safely has not been determined.
Croatian: Maksimalna doza LeukoScana [99mTc] koja se sa sigurnošću može primijeniti nije utvrđena.
English: These dose estimates assume a urinary bladder voiding interval of two hours.
Croatian: Ove procjene doze pretpostavljaju pražnjenje mokraćnog mjehura u razmacima od dva sata.
English: The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Croatian: I zatvorena sivim zatvaračem od butil-gume sa zelenim "flip-off" poklopcem.
English: You will receive a single dose of 0.25 mg of LeukoScan.
Croatian: Primit ćete jednokratnu dozu LeukoScana od 0,25 mg.
English: Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Croatian: Odredite količinu gama zračenja za svaku cijev u brojaču gama zračenja, kalibratoru doze ili radiokromatografskom analizatoru.
English: Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Croatian: Za bolesnike koji su ranije primili lijekove koji sadrže mišja monoklonska protutijela, vjerojatnije je da će imati HAMA.
English: • If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be
Croatian: • Ako pripremljena otopina LeukoScana izgleda kao da je promijenila boju ili da sadrži čestice, ne
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).
Croatian: Protutijelo (IMMU-MN3) prepoznaje antigenu strukturu glikoproteina (NCA-90) na površini granulocita i tumorskog biljega, karcinoembrionalnog antigena (CEA).
English: Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Croatian: Injiciranjem fiziološke otopine dopunite konačni volumen otopine eluata do 1,0 ml.
English: These revealed no remarkable findings.
Croatian: Dobiveni nalazi nisu od značaja.
English: Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
Croatian: LeukoScana s radioaktivnim izotopom tehnecija, liječnik će Vam ga ubrizgati u venu.
English: By contrast, in non-infected subjects, transient increases in WBC count were seen 24 hours after LeukoScan administration.
Croatian: Nasuprot ovome, u ispitanika bez infekcije, prolazni porast broja leukocita primijećen je 24 sata nakon primjene LeukoScana.
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Korisnik mora pripremiti radiofarmaceutik na način koji udovoljava zahtjevima zaštite od zračenja i farmaceutske kvalitete.
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
Croatian: LeukoScan je indiciran pri dijagnostičkim slikovnim metodama radi utvrđivanja lokacije i proširenosti infekcije/upale u kostima u bolesnika kod kojih se sumnja na postojanje osteomijelitisa, uključujući bolesnike s dijabetičkim ulkusom stopala.
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.
Croatian: Sigurnost primjene i dijagnostička pouzdanost u osoba mlađih od 21 godine još nisu ustanovljene.
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.
Croatian: Jedan do osam sati nakon ubrizgavanja poleći će Vas na poseban stol i snimiti standardnim nuklearnim kamerama kako bi se prikazalo gdje je smještena infekcija.
English: • If you have any further questions, please ask your doctor.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: Following reconstitution, 1 ml sodium pertechnetate [99mTc] is added.
Croatian: Nakon rekoonstitucije dodaje se 1 ml natrijevog pertehnetata [99mTc].
English: The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located.
Croatian: Snimke učinjene posebnim kamerama otkrivaju područja radioaktivnosti koja pokazuju gdje se nalazi infekcija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kit for the preparation of 99mTc-labelled LeukoScan.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Komplet za pripremu 99mTc-obilježenog LeukoScana.
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).
Croatian: Preporučena doze za odrasle je 0,25 mg Fab′ fragmenta označenog s 900 ± 200 MBq tehnecijevog 99mTc pertehnetata (približno 1,2 ml).
English: Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Croatian: Neposredno prije primjene sadržaj bočice se rekonstituira u radioizotopom neobilježenom obliku radi pripreme LeukoScana [99mTc].
English: • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: • Korisnik mora pripremiti radiofarmaceutik na način koji udovoljava zahtjevima zaštite od zračenja i farmaceutske kvalitete.
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
Croatian: U kliničkim ispitivanjima, pojedinačne doze od 1,0 mg LeukoScana radioaktivno obilježenog s 900 ± 200 MBq 99mTca primijenjene su 11 bolesnika s različitim vrstama infekcije i pri ovoj dozi nije bilo nuspojava.
English: Read all of this leaflet carefully before you start using this medicine.
Croatian: Pažljivo pročitajte cijelu uputu prije nego započnete s postupkom pripreme.
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).
Croatian: LeukoScan je sterilni liofilizirani pripravak koji sadrži 0,31 mg sulesomaba po bočici i uključuje 0,22 mg kositrovog klorida u obliku dihidrata, 3,2 mg kalijevog natrij-tartarata u obliku tetrahidrata, 7,4 mg natrijevog acetata u obliku trihidrata, 5,5 mg natrijevog klorida, ledenu octenu kiselinu (u tragovima), klorovodičnu kiselinu (u tragovima), 37,8 mg saharoze, dušik (vakuum).
English: Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
Croatian: Ponovna primjena treba se razmotriti samo u bolesnika kod kojih je pretraga seruma na fragmente negativna na porast ljudskog anti-mišjeg protutijela (HAMA).
English: Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
Croatian: Zato Vas liječnik mora pažljivo nadzirati neko vrijeme nakon što primite LeukoScan.
English: • If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you
Croatian: • Ako dojite, morate prestati dojiti dijete najmanje 24 sata nakon što ste primili LeukoScan.
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).
Croatian: Na temelju kalibratorom izmjerene radioaktivnosti izvadite dovoljnu količinu lijeka koja omogućuje željenu radioaktivnost (750-1100 MBq 99mTc, vidjeti odlomak Doziranje i primjena).
English: SPECT acquisition parameters recommended are: 60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
Croatian: 360o tehnikom "step-and-shoot", 30 sekundi po prikazu u matrici najmanje 64 x 64.
English: At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
Croatian: razina u krvi bila je 34 % početne vrijednosti, nakon 4 sata 17 % početne vrijednosti, a 7 % početne vrijednosti nakon 24 sata.
English: LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Croatian: LeukoScan još nije bio primjenjivan u dijagnosticiranju osteomijelitisa u bolesnika s anemijom srpastih
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.
Croatian: Primjenom 750 MBq LeukoScana embrio ili fetus u ranom stadiju dobit će procijenjenu apsorbiranu dozu od 4,1 mGy.