natgillin/translations-raw huggingface dataset:
It is produced in mice and purified so that it can be used in humans. 
Este produs de soareci si purificat astfel incat poate fi utilizat si de catre oameni.
Some side effects, although not common, have been reported. 
S-au raportat unele reacţii adverse, desi nu frecvent.
The radiolabelled solution should be administered as an intravenous injection. 
Solutia marcata radioactiv trebuie administrata sub forma de injectie intravenoasa.
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body. 
Un anticorp este o substanta naturala produsa de corp care adera de substante straine pentru a ajuta la indepartarea acestora din corp.
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. 
De obicei se recomanda reluarea alaptarii in momentul in care nivelul de radiatie din lapte nu va prezenta, pentru copil, o doza de radiatie mai mare de 1 mSv.
Immunoscintigraphy should be performed one to eight hours after injection. 
Imunoscintigrafia trebuie efectuata in intervalul de 1-8 ore dupa injectare.
Patients have been given four times the amount you will receive with no adverse reactions. 
Au fost pacienti carora li s-a administrat de 4 ori cantitatea care vi se administreaza dumneavoastra fara a dezvolta reactii adverse.
No studies effects of food/drink have been performed. 
Nu s-au realizat studii in ceea ce priveste efectele alimentelor sau bauturilor
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. 
Numarul eozinofilelor a crescut de la 2,7% inainte de injectare la 2,9% la 24 ore dupa injectare si la 3,9% la 10 zile, amplitudinea ambelor cresteri fiind importanta statistic.
• You should not be given LeukoScan if you are pregnant. 
• Nu trebuie sa vi se administreze LeukoScan daca sinteti gravida.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 
Expunerea la radiatii ionizante este asociata cu inducerea cancerului si cu posibilitatea aparitiei defectelor ereditare.
Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended. 
Este recomandata realizarea de imagini in mod de lucru analog/digital si cu o matrice de cel putin 128x128.
The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located. 
Medicul face aceasta folosind o camera de imagistica speciala care evidentiaza zonele de radioactivitate pentru a vedea unde sint localizate infectiile.
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. 
Pentru acest produs medicamentos, doza efectiva rezultata din administrarea unei activitati de 750 MBq este de 7,7 mSv pentru un individ de 70 kg.
The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results. 
Rezultatele clinice au aratat ca pentru diferitele localizari ale osteomileitei, LeukoScan poate arata rezultate diferite.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be 
• Daca solutia preparata de LeukoScan are modificari de culoare sau contine particule, nu trebuie
This material will then be injected into your vein. 
Acest produs vi se injecteaza in vena.
Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine. 
De aceea doctorul dumneavoastra trebuie sa va tina sub observatie atenta pentru o perioada de timp scurta dupa administrarea acestui
Patients with known allergies or hypersensitivity to mouse proteins. 
Pacientii cu alergii sau hipersensibilitate cunoscute la proteinele de soarece.
Patients who have previously received murine monoclonal antibody products are more likely to have HAMA. 
Pacientii carora li se administrase anterior produse cu anticorpi monoclonali de murine este mai probabil sa prezinte HAMA.
• 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. 
• Daca ati folosit vreodata LeukoScan sau vreun alt produs provenit dintr-un anticorp de soarece, medicul dumneavoastra trebuie sa va recolteze o proba de sange pentru analize pentru a fi sigur ca nu ati dezvoltat vreo alergie fata de LeukoScan.
LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium. 
LeukoScan este un fragment de anticorp care este legat de o substanta radioactiva numita technetiu.
LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation. 
LeukoScan [99mTc] poate fi utilizat dupa 10 minute si trebuie folosit in decurs de 4 ore de la preparare.
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. 
Parametrii recomandati de realizare imagistica SPECT sunt: 60 de proiectari in tehnica de 360o step-and-shoot, 30 secunde per vizualizare intr-o matrice de 64x64.
There was no doseresponse effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg 
Nu au existat efecte dependente de doze asupra eficacitatii imagisticii (sensibilitate sau specificitate) pentru dozele de anticorpi curpinse intre 0,1 si 1,0 mg.
Like all medicines, LeukoScan can cause side effects, although not everybody gets them. 
Ca toate medicamentele, LeucoScan poate provoca reactii adverse, cu toate că nu apar la toate persoanele.
Reconstituted and radiolabelled material - Do not store above 25ºC. 
Produsul reconstituit si radiomarcat - A nu se depozita la temperaturi de peste 25ºC.
When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis. 
Cind o scanare a osului este negativa, imaginea cu LeukoScan poate rareori sa arate un raspuns pozitiv si acest lucru poate indica osteomielita timpurie.
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. 
Cand este necesara administrarea de produse radioactive la femeile cu potential fertil, trebuie intotdeauna cerute informatii despre sarcina.
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 
Studiile in vitro au demonstrat ca LeukoScan nu are efect asupra reglarii in sensul cresterii sau scaderii numarului de receptori de la nivelul granulocitelor, dar LeukoScan pare sa adere mai degraba la granulocitele activate decat la cele in repaus.
For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv. 
In cazul celor mai multe investigatii diagnostice care implica procedura de medicina nucleara, doza de radiatie furnizata (doza efectiva/EDE) este mai mica de 20 mSv.
No studies on the effects on the ability to drive and use machines have been performed. 
Nu exista studii cu privire la capacitatea de a conduce sau utiliza masini.
The product is more sensitive (93.9% vs. 80.6%), but less specific (51.6% vs. 72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis. 
Produsul este mai sensibil (93,9% comparativ cu 80,6%), dar mai putin specific (51,6% comparativ cu 72,9%), in diagnosticarea osteomielitei la pacientii cu ulcere diabetice ale piciorului decat la pacientii cu alte localizari ale osteomielitei osului lung.
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. 
La 49,7% din pacienti, LeukoScan s-a presupus ca ofera un beneficiu clinic care nu poate fi atins prin alte metode diagnostice imagistice disponibile, cu posibilitatea ca diagnosticul sa poate fi realizat doar de LeukoScan singur la 70,3% din pacienti.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise. 
Oricare femeie care prezinta absenta unei menstre trebuie considerata ca fiind gravida pana la stabilirea etiologiei acesteia.
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. 
Inaintea de administrarea unui produs radioactiv unei mame care alapteaza, trebuie evaluat dacă investigaţia poate fi amânată în condiţii rezonabile pana la intreruperea alaptarii si, de asemenea, dacă s-a ales cel mai potrivit radiofarmaceutic, având în vedere posibilitatea excreţiei substanţei radioactive în laptele matern.
• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor. 
• Daca stiti ca sunteti alegic (hipersensibil) la sulesomaba sau la orice proteina care provine de la soareci, va rugam sa va informati medicul.
Formal studies have not been performed in patients with renal or hepatic impairment. 
Nu s-au efectuat studii oficiale la pacientii cu insuficienta renala sau hepatica.
When a bone scan is positive and imaging with LeukoScan is negative, infection is unlikely. 
Cind o scanare a osului este pozitiva si imaginea cu LeukoScan este negativa, infectia este putin probabila.
After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law. 
Dupa amestecarea cu Tc, produsul final trebuie distrus ca deseu radioactiv in concordanta cu legile locale.
These dose estimates assume a urinary bladder voiding interval of two hours. 
Aceste doze presupun un interval de golire a vezicii de 2 ore.
LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes. 
LeukoScan (sulesomaba) este un tip special de anticorp care adera de suprafata unui anumit tip de celule sanguine numite leucocite.
The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis. 
Importanta acestor cresteri a fost estimata de cercetatori ca neavand consecinte clinice la nivel individual.
Swirl and shake the vial contents gently for 30 seconds to insure dissolution. 
Se agita cu grija continutul flaconului timp de 30 secunde pentru a se asigura dizolvarea.
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self 
Experienta post-autorizare se refera in prezent la mai mult de 70000 flacoane vindute, si consta in 2 reactii
If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to 
Daca medicul decide sa va mai administreze produsul dupa un interval de cateva saptamani sau luni, va trebui sa vi se faca o testare sanguina intai pentru a vedea daca ati dezvoltat alergia fata de LeukoScan.
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