natgillin/translations-raw huggingface dataset:
60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
60 de proiectari in tehnica de 360o step- and- shoot, 30 secunde per vizualizare intr- o matrice de 64x64.
Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal) is recommended.
Se recomanda si procesarea datelor prin proiectarea filtrata inapoi si reconstituirea in 3 planuri (transaxial, coronal si sagital).
3 Hypersensitivity
3 Oricand sunt administrate subsatante care contin proteine de soarece sunt posibile reactii anafilactice si alte reactii de hipersensibilitate.
Human Anti-mouse Antibody (HAMA)
Anticorp uman anti- soarece (HAMA - Human Anti- mouse Antibody)
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 pre-existing HAMA.
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 deja HAMA.
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 anti - soarece (HAMA) din proba analizata.
The overall radiation dose received by the patient over time should also be taken into account.
De asemenea trebuie luata in calcul si totalitatea dozelor de radiatie administrate pacientului de- a lungul timpului.
Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics.
Nu s- au efectuat studii oficiale cu privire la interactiunea cu alte medicamente, dar nu s- au descris interactiuni pana la aceasta data, inclusiv la pacientii tratati cu antibiotice.
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.
4 Lactation
4 Alaptarea
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.
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].
No studies on the effects on the ability to drive and use machines have been performed.
Nu s- au efectuat studii in acest sens.
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).
None of these were considered serious, and all resolved without sequelae.
Niciuna din acestea nu au fost considerate grave si ambele s- au rezolvat fara sechele.
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self- limiting allergic reactions.
Experienta post- autorizare se refera in prezent la mai mult de 70000 flacoane vindute, si consta in 2 reactii alergice autolimitate, raportate.
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.
The eosinophil count increased from 2.7% pre- injection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
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.
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.
If so, no inferences concerning the underlying mechanism(s) responsible may be derived from the clinical laboratory results.
Astfel, rezultatele clinice de laborator nu au oferit nicio concluzie cu privire la mecanismul( ele) implicate.
In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
In vitro, s- a observat o legare pozitiva de limfocite de pana la 2- 6%.
The effect on lymphocyte function has not been determined.
Efectul asupra functiei limfocitare nu s- a determinat
No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any patient administered LeukoScan.
La niciunul din pacientii carora li s- a administrat LeukoScan nu s- a observat aparitia HAMA care sa reactioneze cu fragmentele de anticorpi.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Pentru investigatiile diagnostice de medicina nucleara, datele
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.
5 disponibile in prezent sugereaza ca frecventa de aparitie a efectelor adverse este mica datorita dozei scazute de radiatii administrate.
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.
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.
In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this dose.
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.
Pharmacotherapeutic group:
Grupul farmacoterapeutic:
Diagnostic Radiopharmaceuticals.
Radiofarmaceutice diagnostice.
VO4D
V04D.
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).
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.
There was no dose- response effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg to 1.0 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.
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%.
69.4%).
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%).
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
6 (77.5% vs.
6 la pacientii cu alte localizari ale osteomielitei osului lung.
75.8%, respectively).
Cu toate acestea, exista o acuratete diagnostica echivalenta intre cele 2 metode (77, 5% comparativ cu 75, 8%).
An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
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.
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.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging procedures.
Aceste beneficii sunt de asemenea insotite de o reducere substantiala (85, 4%) a numarului de pacienti care ar mai necesita alte proceduri imagistice diagnostice.
Pharmacokinetic studies were performed after the intravenous administration of the product.
S- au efectuat studii farmacocinetice dupa administrarea intravenoasa a produsului.
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.
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.
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
Clorura stanoasa dihidrat Acid acetic glacial (urme) Tartrat de sodiu si potasiu, tetrahidrat Zahar
Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
Clorura de sodiu Acid clorhidric (urme) Acetat de sodiu trihidrat Nitrogen
7 6.2 Incompatibilities
7 6. 2 Incompatibilităţi
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or 12.
Acest produs nu trebuie amestecat cu alte medicamente, cu exceptia celor mentionate la punctele 6. 6 sau 12.
Kit - 48 months.
Kit – 48 luni Produsul reconstituit si radiomarcat – 4 ore.
Reconstituted and radiolabelled material - 4 hours.
6. 4 Precauţii speciale pentru păstrare
Reconstituted and radiolabelled material - Do not store above 25ºC.
Produsul reconstituit si radiomarcat – A nu se depozita la temperaturi de peste 25ºC.
Do not refrigerate or freeze.
A nu se tine la frigider sau congelator.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Un flacon cu LeukoScan liofilizat se prepara astfel incat sa contina fragment de anticorp monoclonal 0, 31 mg.
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 verde.
Pack size: one vial per carton container.
Marimea ambalajului: cutie cu un flacon.
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).
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.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Solutia rezultata are un pH de 4, 5 - 5, 5 si este doar pentru administrare intravenoasa.
Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
Folosindu- se solutie salina, se realizeaza un volum final de solutie de 0, 1 ml.
For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Pentru reconstituirea pulberii liofilizate, se adauga cu o seringa sterila 0, 5 ml de solutie salina in flaconul de LeukoScan protejat, de 3 ml.
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.
Total volume in vial equals 1.5 ml.
Volumul total din flacon este de 1, 5 ml.
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Germania
14 February 1997
14 Februarie 1997 Data ultimei reinnoiri a autorizatiei:
Date of approval of latest variation or transfer:
Datum schválení poslední změny nebo převodu:
MM/ YYYY
ZZ/ LL/ AAAA
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.
9 Technetium [99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.
9 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 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.
Table 1
Table 1
Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
Rezumatul Dozimetriei la nivelul organelor in conditii normale pentru un pacient mediu adult (70 kg) dupa administrarea intravenoasa a unei doze de LeukoScan marcat cu technetiu- 99m 750 MBq [Doza estimata la 13 pacienti 26 administrari]
Average Dose µGy/ MBq
Doza medie µGy/ MBq
Kidneys Urinary Bladder Wall Spleen Heart Wall Lungs Liver Bone Surfaces Adrenals Red Marrow Pancreas Thyroid Gall Bladder Wall Uterus Ovaries Small Intestine Stomach
Rinichi
44.9 21.5 15.7 11.8 10.0 9.0 8.0 7.2 7.1 6.8 6.7 6.2 5.9 4.9 4.8 4.8
44, 9
Upper Large Intestinal Wall Lower Large Intestinal Wall Thymus Total Body Muscle Testes Breasts Brain Skin
Peretele vezicii urinare Splina Peretele cardiac Plamani Ficat Suprafete osoase Suprarenale Maduva hematopoietica Pancreas Tiroida Peretele vezicii biliare Uter Ovare Intestinul subtire Stomac Peretele intestinului gros proximal Peretele intestinului gros distal Timus Corpul ca intreg Musculatura Testicule Sani Creier Piele Echivalentul dozei efective * Doza efectiva *
Effective Dose Equivalent* Effective Dose*
21, 5 15, 7 11, 8 10, 0 9, 0 8, 0 7, 2 7, 1 6, 8 6, 7 6, 2 5, 9 4, 9 4, 8 4, 8 4, 7 4, 7 4, 5 4, 2 3, 5 3, 0 2, 8 2, 4 2, 1 10, 3 8, 0
Effective Dose Equivalent and Effective Dose are in units of µSv/ MBq.
µSv/ MBq.
10 LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
10 Controlul de calitate
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99m Tc pertechnetate (approximately 1.2 ml).
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).
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. folosind acetona ca solvent.
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.
Cand frontul soventului este la 1 cm de la partea superioara a benzii, aceasta se indeparteaza, se taie in jumatate si se plaseaza fiecare jumatate intr- un tub din sticla.
% Free Technetium = Activity in top half of strip × 100 Total Activity.
% Technetium Liber = Activitatea din jumatatea de sus a benzii × 100 Activitatea totala.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
PRODUCĂTORUL( II) SUBSTANŢEI( LOR) BIOLOGIC ACTIVE ŞI DEŢINĂTORUL( II) AUTORIZAŢIEI DE FABRICAŢIE RESPONSABIL( I) PENTRU ELIBERAREA SERIEI
300 American Road Morris Plains, New Jersey 07950, USA
300 American Road Morris Plains, New Jersey 07950, SUA
• OTHER CONDITIONS
• ALTE CONDITII Nu se aplica
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
15 INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJUL SECUNDAR SI AMBALAJUL PRIMAR
LeukoScan 0.31 mg, powder for solution for injection sulesomab
LeukoScan 0, 31 mg pulbere pentru solutie injectabila sulesomaba
One vial contains 0.31 mg sulesomab
Un flacon contine sulesomaba 0, 31 mg
0.31 mg sulesomab Powder for solution for injection
Pulbere pentru solutie injectabila 0, 31 mg sulesomaba
METHOD AND ROUTe(S) OF ADMINISTRATION
MODUL ŞI CALEA( CĂILE) DE ADMINISTRARE
16 EXP MM/ YYYY
16 EXP LL/ AAAA
Store in a refrigerator (2ºC-8ºC).
A se pastra la frigider (2ºC- 8ºC).
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany Telephone: +49-6151- 66 715 66 Fax: +49-6151-66 715 77
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Germania Telefon: +49- 6151 - 66 715 66 Fax: +49- 6151- 66 715 77 e- mail: europe@ immunomedics. com
Medicinal product subject to medical prescription
ZZ/ LL/ AAAA
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
DENUMIREA COMERCIALĂ A MEDICAMENTULUI ŞI CALEA( CĂILE) DE ADMINISTRARE
LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
LeukoScan 0, 31 mg pulbere pentru solutie injectabila 0, 31 mg sulesomaba liofilizat, clorura stanoasa si conservanti.
EXP 48 Months
LL/ AAAA
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Contine sulesomaba liofilizat 0, 31 mg, clorura stanoasa si conservanti.
INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
INFORMAŢII PENTRU UTILIZATOR LeukoScan (0, 31 mg pulbere pentru solutie injectabila) (sulesomaba)
You may need to read it again. • It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
S- ar putea să fie necesar sa- l recititi. • Nu contine toate informatiile despre medicament de care s- ar putea sa aveti nevoie, asa ca va rugam sa cititi Rezumatul caracteristicilor produsului sau sa va adresati medicului dumneavoastra sau asistentei daca aveti intrebari.
This leaflet only applies to LeukoScan. • If you have any further questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Prospectul se refera strict la LeukoScan. • Daca aveti orice intrebari suplimentare, adresati- va medicului dumneavoastra sau farmacistului. • Daca vreuna dintre reactiile adverse devine grava sau daca observati orice reactie adversa nementionata in acest prospect, va rugam sa- i spuneti medicului dumneavoastra sau farmacistului
What LeukoScan is used for 2.
Ce este LeukoScan si pentru ce se utilizeaza 2.