natgillin/translations-raw huggingface dataset:
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
Informatii importante privind unele componente ale LeukoScan Dacă medicul dumneavoastră v-a spus că aveţi intoleranţă la unele categorii de glucide, adresaţi-vă medicului înainte de a utiliza acest medicament.
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.
Aceasta diferenta se poate explica probabil prin prezentarea mai complicata clinic din punct de vedere anatomic si fiziopatologic a osteomielitei la piciorul diabetic, facand mai dificila diferentierea tesutului moale si a infectiei osoase decat in alte localizari ale osteomielitei osului lung.
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).
Urmatoarele reactii adverse, minore, autolimitate si rare, considerate cel putin posibil legate de LeukoScan, s-au raportat in cursul studiilor clinice: eozinofilie (3); si eruptie cutanata faciala (1).
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.
Nu exista nici o diferenta esentiala in detectarea prezentei sau absentei osteomielitei in intervalul de 1-2 ore sau 5-8 ore dupa injectie.
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
Medicul prepara LeukoScan si izotopul radioactiv de techenetiu intr-un volum de 1,5 ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING (CONTAINER PACKAGE LABEL)
INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR SI AMBALAJUL PRIMAR (ETICHETA AMBALAJULUI)
What LeukoScan looks like and contents of the pack
Cum arata LeukoScan si continutul ambalajului
Clean the rubber closure of each vial such as with an alcohol wipe.
Curatati dopul de cauciuc al fiecarui flacon cu un tampon cu alcool.
Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Se evalueaza fiecare tub cu ajutorul unui contor de scintilatii gamma, calibrator de doze sau analizor radiocromatograf.
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.
Intr-un interval de 1-8 ore dupa injectare, veti fi asezat pe o masa speciala si vi se vor face fotografii cu o camera nucleara standard.
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.
Timpul de injumatatire plasmatica a fost de aproximativ 1,5 ore; calea de eliminare este predominant renala cu un procent de 41% din radioactivitate eliminat urinar in intr-un interval de 24 de ore de la administrare.
Human Anti-mouse Antibody (HAMA)
Anticorp uman anti-soarece (HAMA - Human Anti-mouse Antibody)
If you take more LeukoScan than you should
Daca utilizati mai mult decat trebuie din LeukoScan
The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Flaconul din sticla de tip I este inchis cu un dop din butil cauciuc gri cu un sigiliu flip-off de culoare
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.
Pentru observarea adecvata a zonei afectate, trebuie realizate, la 1-8 ore post-injectare, vizualizari plane din toate perspectivele necesare cu cel putin 500 k numarari sau 10 minute pe perspectiva.
Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
În caz de incertitudine, este important ca expunerea la radiatii sa fie mentinuta la nivelul minim necesar pentru obtinerea informatiilor clinice dorite.
The maximum amount of LeukoScan [99mTc] that can be administered safely has not been determined.
Nu s-a determinat cantitatea maxima de LeukoScan [99mTc] care poate fi administrata in siguranta.
Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Poate fi utilizata si tomografia computerizata cu emisie monofotonica (SPECT) care poate ajuta in diferentierea osteomileitei de infectiile tesutului moale.
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%.
In 2 studii clinice controlate in care s-a utilizat LeukoScan, pentru a demonstra siguranta si eficacitatea acestui produs in definirea prezentei si localizarii osteomielitei, la un total de 175 pacienti evaluati, LeukoScan a prezentat o sensibilitate de 88,2%, o specficitate de 65,6%, o acuratete de 76,6%, o valoare predictiva pozitiva de 70,8% si o valoare predictiva negativa de 85,5%.
Total volume in vial equals 1.5 ml.
Volumul total din flacon este de 1,5 ml.
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.
O evaluare a impactului clinic potential al LeukoScan a demonstrat ca acesta ar putea schimba abordarea clinica in 50,2% din cazuri sau ar putea imbunatati efectul clinic in 43,4% din cei 175 pacienti evaluati cu suspiciune de osteomielita.
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.
Pentru investigatiile diagnostice de medicina nucleara, datele disponibile in prezent sugereaza ca frecventa de aparitie a efectelor adverse este mica datorita dozei scazute de radiatii administrate.
The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.
Continutul initial al flaconului, nu trebuie administrat direct pacientilor inainte de radiomarcare.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
Trebuie luate masuri specifice aseptice, in concordanta cu regulile de buna practica in fabricatie (GMP) pentru farmaceutice.
The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
Anticorpul (IMMU-MN3) recunoaste o structura antigenica comuna glicoproteinelor (NCA-90) de pe suprafata granulocitelor si a markerului tumoral, antigenul carcinoembrionar (CAE).
These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Acestea includ o usoara crestere a numarului unor leucocite denumite eozinofile (dara fara simptome aparente) si eruptii cutanate.
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.
In cadrul unui studiu nectronolat, deschis, efectuat la un singur grup de 53 pacienti cu infectii cronice de origine sau extindere necunoscute, s-au studiat doze de LeukoScan intre 0,1 mg si 1,0 mg.
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.
Cand este combinat cu izotopul de technetiu radioactiv si va este injectat in vena, gaseste acumularea anormala de leucocite si se ataseaza la ele.
Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA
Deoarece LeukoScan interactioneaza cu CEA, trebuie tinut minte ca ar putea interactiona cu tumorile
Following reconstitution, 1 ml sodium pertechnetate [99mTc] is added.
Dupa reconstituire, se adauga 1 ml pertehentat de sodiu [99mTc].
LeukoScan is used to determine the presence of infections in long bones.
LeukoScan este folosit pentru determinarea prezentei infectiilor la nivelul oaselor lungi.
You must then not be given LeukoScan.
Nu trebuie deci sa vi se administreze LeukoScan.
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
LeukoScan este indicat in diagnosticarea imagistica pentru determinarea localizarii si extinderii infectiei/inflamatiei la nivelul oaselor, la pacientii supectati de osteomielita, inclusiv la pacientii cu ulcer
Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein.
La scurt timp dupa amestecarea LeukoScan cu izotopul radioactiv de technetiu, medicul va injecteaza produsul in vena.
Method and/or route(s) of administration
MODUL ŞI CALEA(CĂILE) DE ADMINISTRARE
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.
In studii controlate, la 24 ore dupa injectare s-au observat reduceri semnificative statistic ale leucocitelor, de la o valore medie de 8,9 la o valoare medie de 8,0 (x 103/mm3), dar au ramas in limite normale si au revenit la valoarea dinaintea injectarii pana la momentul urmatoarei masurari la 10 zile.
By contrast, in non-infected subjects, transient increases in WBC count were seen 24 hours after LeukoScan administration.
Prin contrast, la pacientii neinfectati, s-au observat cresteri tranzitorii ale numarului de leucocite la 24 ore dupa administrarea de LeukoScan.
If you have any further questions on the use of this product, ask your doctor.
Daca aveti orice intrebari suplimentare cu privire la acest produs, adresati-va medicului dumneavoastra sau farmacistului.
0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
0,25 mg LeukoScan este marcat cu 740 - 1110 MBq techenetiu.
Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique.
Radiofarmaceuticele reconstituite trebuie manevrate folosind manusi impermeabile, protectie adecvata pentru radioactivitate si tehnici aseptice.
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.
Technetiu [99mTc] se dezintegreaza, cu emisia de radiatii gamma cu o energie de 140 keV si o perioada de injumatatire de 6 ore, la technetiu [99Tc] care poate fi considerat cvasistabil.
The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
Anticorpul este capabil sa adere la suprafata leucocitelor care se infiltreaza in zona infectiei.
Store in a refrigerator (2°C-8°C).
A se pastra la frigider (2°C-8°C).
Administration of 750 MBq LeukoScan will give an estimated absorbed dose of 4.1 mGy to an embryo or fetus at an early stage.
Administrarea a 750 MBq LeukoScan va crea o doza absorbita de un embrion sau un fat intr-o perioada precoce de 4,1 mGy.
Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent.
S-a efectuat un numar redus de studii non-clinice atat cu agenti marcati cat si nemarcati.
At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
La o ora dupa injectare, nivelul sanguin a fost de 34% fata de nivelul initial, 17% la 4 ore si de 7% fata de nivelul initial dupa 24 de ore de la administrare.
EXP MM/YYYY
EXP LL/AAAA
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).
Pe baza activitatii masurate in calibratorul de activitate, se extrage o cantitate suficienta de produs pentru a asigura activitatea dorita (750 - 1100 MBq de 99mTc, vezi Doze si mod de administrarea).
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
In studiile clinice, doze unice de 1,0 mg de LeukoScan marcate radioactiv cu 900+/- 200 MBq de 99mTc s-au administrat la 11 pacienti cu diferite tipuri de infectii si nu au existat reactii adverse la aceasta doza.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC-8ºC).
CONDIŢII SPECIALE DE PĂSTRARE A se pastra la frigider (2ºC-8ºC).
QUALITATIVE AND QUANTITATIVE COMPOSITION Kit for the preparation of 99mTc-labelled LeukoScan.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ Kit pentru prepararea LeukoScan marcat cu 99mTc.
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.
Cand anticorpul adera de suprafata leucocitelor, medicul dumneavoastra poate determina localizarea infectiei folosind o camera de imagistica speciala care evidentiaza zonele de radioactivitate.
Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
Se obtin cel putin 1000MBq de eluat proaspat de pertechnetat de sodiu 99mTc, eliberat de orice sursa comerciala care a fost la randul ei curatata in ultimele 24 de ore.
In subjects with HAMA, there may be a greater chance of hypersensitivity reactions and
La pacientii cu HAMA, poate exista o sansa mai mare de reactii de hipersensibilitate si de eficacitate diminuata a imagisticii.
However, in vitro granulocyte function tests did not show significant changes when the sulesomab was added.
Oricum, testele functiei granulocitare in vitro nu au aratat schimbari deosebite in momentul
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
In studiile clinice care au inclus peste 350 de pacienti, nu s-a observat nici inducerea de anticorpi umani anti-soarece fata de fragmentele de anticorpi si nici cresterea nivelului HAMA la pacientii care prezentau
This suggests that imaging can be accomplished anytime between one and eight hours after injection (at the convenience of the nuclear
Aceasta sugereaza ca imagistica poate fi realizata oricand intre 1-8 ore de la injectare (la apreciarea departamentului de medicina nucleara si a pacientului).
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 este o formulare sterila si liofilizata, continind sulesomaba 0,31 mg pe flacon si clorura stanoasa dihidrat 0,22 mg, tartrat de sodiu si potasiu tetrahidrat 3,2 mg, acetate de sodiu trihidrat 7,4 mg, clorura de sodiu 5,5 mg, acid acetic glacial (urme), acid clorhidric (urme), zahar 37,8 mg, nitrogen (vid).
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].
Datorita timpului de injumatatire plasmatica scurt al 99mTc de doar sase ore, o doza mai mica de 1 mSv in laptele matern poate aparea la 24 de ore dupa administrarea de LeukoScan [99mTc].
• If you have any further questions, please ask your doctor.
• Daca aveti orice intrebari suplimentare, adresati-va medicului dumneavoastra sau farmacistului.
Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes.
Se adauga adauga 1,0 ml in flaconul protejat, se agita si se lasa 10 minute pentru a permite realizarea reactiei de marcare.
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.
Intr-un interval de 1-8 ore ulterior injectarii veti fi asezat pe o masa speciala si vi se vor face poze cu camere nucleare standard pentru a vedea localizarea infectiilor.
The doctor can also determine how much disease there is.
Medicul poate de asemenea aprecia extinderea bolii.
Any unused product or waste material should be disposed of in accordance with local requirements.
Orice produs neutilizat sau deseu, trebuie distrus in conformitate cu reglementarile locale.
Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.
Dupa reconsituire, radiofarmaceuticele si flacoanele neutilizate trebuie tratate ca deseu radioactiv si indepartate conform cu cerintele locale.
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.
Nu se cunoaste daca schimbarile observate la nivelul numarului eozinofilelor sau leucocitelor, desi fara vreo importanta clinica, se datoreaza vreunui efect tranzitor asupra functiei leucocitelor. Astfel, rezultatele clinice de laborator nu au oferit nicio concluzie cu privire la mecanismul(ele) implicate.
In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
Intr-un subgrup de pacienti la care LeukoScan s-a comparat direct cu testul actual de scanare cu leucocite (WBC) autologe marcate cu 111In (uneori cu Tc-99m), LeukoScan a aratat o crestere semnificativa statistic a sensibilitatii fata de cea a scanarii cu leucocite (87,7% comparativ cu 72,6%, p=0,003 prin testul McNemar), fara vreo scadere perceptibila a specficitatii fata de imagistica cu leucocite (67,1% comparativ cu 69,4%).
• This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
• Acest radiofarmaceutic poate fi primit, folosit si administrat doar de personal autorizat in conditii clinice desemnate.
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.
Agentul de imagistica, technetiu - 99m LeukoScan [technetiu - 99m sulesomaba], este format prin reconstituirea continutului flaconului de LeukoScan, cu 0,5 ml clorura de sodium pentru injectii, urmata de adaugarea a 1100MBq pertechnetat de sodiu [99mTc] intr-un ml clorura de sodium pentru injectii.
• Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
• Produsele radiofarmeceutice trebuie utilizate doar de personalul calificat cu autorizarea guvernamentala adecvata pentru utilizarea si manipularea radionuclizilor.
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99mTc pertechnetate (approximately 1.2 ml).
Doza recomandata pentru adulti este de 0,25 mg de fragment Fab` marcat cu 900 ± 200 MBq pertechentat de technetiu 99mTc (aproximativ 1,2 ml).
Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
Readministrarea ar trebui luata in calcul doar pentru pacientii in al caror ser nu se evidentiaza niveluri ridicate de anticorpi umani antisoarece (HAMA) din proba analizata.
PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
PROSPECT: INFORMAŢII PENTRU UTILIZATOR LeukoScan (0,31 mg pulbere pentru solutie injectabila) (sulesomaba)
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Acest radiofarmaceutic poate fi primit, folosit si administrat doar de personal autorizat, in conditii clinice desemnate.
Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
In cazul aparitiei unei reactii adverse trebuie sa fie accesibile facilitati adecvate de resuscitare cardiopulmonare si personal pregatit pentru interventie imediata.
The overall radiation dose received by the patient over time should also be taken into
De asemenea trebuie luata in calcul si totalitatea dozelor de radiatie administrate pacientului de-a lungul timpului.
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
D-64293 Darmstadt
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.
Dupa radiomarcarea anticorpului si diluarea a 10 µl de proba cu 1,5 ml solutie salina, se determina imediat puritatea radiochimica prin Cromatografia Instant in Strat Subtire pe gel de siliciu impregnat pe benzi din fibra de sticla, 1 x 9 cm.
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.
Dozele de radiatie absorbita estimate pentru un pacient adult mediu (70 kg) dupa administrarea intravenoasa de LeukoScan marcat cu 750 MBq de technetiu-99m sunt oferite in tabelul 1.
You will receive a single dose of 0.25 mg of LeukoScan.
Vi se administreaza o singura doza de LeukoScan de 0,25 mg.
Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Produsele radiofarmaceutice trebuie folosite doar de personalul calificat cu autorizare guvernamentala corespunzatoare pentru utilizarea si manipularea radionuclizilor.
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
OBLIGAŢIILE SPECIFICE CARE TREBUIE ÎNDEPLINITE DE CĂTRE DEŢINĂTORUL
LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
LeukoScan nu a fost utilizat pentru diagnosticul osteomielitei la pacientii cu siclemie.
LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
LeukoScan este folosit la pacientii cu suspiciune de infectie la nivelul oaselor numita osteomielita.
Kit for the preparation of 99mTc-labelled LeukoScan.
Kit pentru prepararea LeukoScan marcat 99mTc.
LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
LeukoScan se reconstituie cu 0,5 ml solutie de clorura de sodiu izotonica injectabila.
Kit - Store in a refrigerator (2ºC - 8ºC).
Kit - A se pastra la frigider (2ºC - 8ºC).
Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Folosindu-se solutie salina, se realizeaza un volum final de solutie de 0,1 ml.
• Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
• Radiofarmaceuticele trebuie preparate de utilizator in asa fel incat sa indeplineasca atat cerintele de siguranta radiologica cat si cele de calitate farmaceutica.