FrancophonIA/ELRC3.0 huggingface dataset:
English: It was to be used in patients whose disease had come back after previous treatment.
Romanian: Zemfirza ar fi trebuit să se utilizeze pentru tratarea pacientelor a căror boală revine după tratament anterior.
English: The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors.
Romanian: Substanța activă din Zemfirza, cediranibul, blochează activitatea receptorilor „factorului de creștere a endoteliului vascular” (FCEV).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company.
Romanian: Prin urmare, la momentul retragerii cererii, CHMP considera că nu s-a făcut dovada că beneficiile Zemfirza ar depăși riscurile asociate, astfel încât a solicitat clarificări suplimentare de la companie.
English: In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.
Romanian: În plus, efectul de ameliorare observat în privința supraviețuirii fără progresia bolii în urma tratamentului cu Zemfirza a fost considerat modest și au existat motive de îngrijorare legate de reacțiile adverse provocate de administrarea medicamentului, în special diaree și oboseală, care au dus la oprirea timpurie a tratamentului în cazul a numeroase paciente.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review.
Romanian: În scrisoarea prin care compania înștiințează agenția cu privire la retragerea cererii, aceasta menționează că își retrage cererea din cauza întrebărilor la care nu există încă un răspuns în acest stadiu avansat al procesului de analiză.
English: Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen).
Romanian: Zemfirza ar fi trebuit să se utilizeze pentru tratarea femeilor care suferă de cancer ovarian, inclusiv de cancer al tuburilor falopiene care fac legătura ovarelor cu uterul, și de cancer al peritoneului (membrana care căptușește abdomenul).
English: These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells.
Romanian: Acești receptori se găsesc în număr mare pe celulele vaselor de sânge, contribuind la dezvoltarea de noi vase de sânge, care alimentează celulele canceroase cu nutrienți.
English: In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period.
Romanian: În cadrul studiului, Zemfirza a fost comparat cu placebo (un preparat inactiv) și a fost administrat în timpul tratamentului inițial împreună cu medicamente pe bază de platină, iar ulterior, pe parcursul unei perioade de întreținere, a fost administrat în monoterapie.
English: By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.
Romanian: Este de așteptat ca, prin blocarea receptorilor FCEV, acest medicament să reducă alimentarea cu sânge a celulelor canceroase, încetinind astfel dezvoltarea și răspândirea cancerului.
English: Zemfirza is a cancer medicine that contains the active substance cediranib.
Romanian: Zemfirza este un medicament utilizat în tratamentul cancerului, care conține substanța activă cediranib.
English: What was Zemfirza expected to be used for?
Romanian: Pentru ce ar fi trebuit să se utilizeze Zemfirza?
English: How does Zemfirza work?
Romanian: Cum acționează Zemfirza?
English: The company had not responded to the last round of questions at the time of the withdrawal.
Romanian: În momentul retragerii cererii, compania nu oferise răspunsurile la ultima serie de întrebări.
English: You may need to read it again.
Romanian: S-ar putea să fie necesar sa-l recititi.
English: Kit - 48 months.
Romanian: Kit- 48 luni.
English: • Keep this leaflet.
Romanian: • Pastrati acest prospect.
English: You produce many different kinds of antibodies.
Romanian: Dumneavoastra produceti diferite tipuri de anticorpi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1997
Romanian: DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAŢIEI Data primei autorizari: 14 Februarie 1997
English: 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or
Romanian: 6.2 Incompatibilităţi Acest produs nu trebuie amestecat cu alte medicamente, cu exceptia celor mentionate la punctele 6.6 sau
English: Hypersensitivity
Romanian: Hipersensibiltatea
English: None of these were considered serious, and all resolved without sequelae.
Romanian: Niciuna din acestea nu au fost considerate grave si ambele s-au rezolvat fara sechele.
English: Average Dose µGy/MBq
Romanian: Doza medie µGy/MBq
English: Do not store above 25°C.
Romanian: A nu se pastra la temperaturi peste 25°C.
English: • It is possible to have a serious allergic reaction to LeukoScan.
Romanian: • Este posibil sa aveti reactii alergice grave la LeukoScan.
English: These values were calculated according to Medical Internal Radiation Dosimetry.
Romanian: Valorile au fost calculate conform Medical Internal Radiation Dosimetry.
English: This dose of radioactivity is safe and will be gone from the body in about 24
Romanian: Doza de radioactivitate este sigura si dispare din corp in aproximativ 24 ore.
English: There are, as yet, limited data on safety following repeated use.
Romanian: Pana in prezent, exista putine informatii despre siguranta folosirii repetate.
English: The radiolabelled product should not contain more than 10% free technetium.
Romanian: Produsul radiomarcat nu trebuie sa contina mai mult de 10% technetiu liber.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
Romanian: Va rugam sa spuneti doctorului dumneavoastra dacă luaţi sau aţi luat recent orice alte medicamente, inclusiv dintre cele eliberate fără prescripţie medicală.
English: The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Romanian: Solutia rezultata are un pH de 4,5 - 5,5 si este doar pentru administrare intravenoasa.
English: These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging
Romanian: Aceste beneficii sunt de asemenea insotite de o reducere substantiala (85,4%) a numarului de pacienti care ar mai necesita alte proceduri
English: The kit does not include the
Romanian: Kitul nu include
English: Radiolabelling must take place immediately after reconstitution of product.
Romanian: Marcarea radioactiva se realizeaza imediat dupa reconstituirea produsului.
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
Romanian: Primirea, pastrarea, utilizarea, transportul si eliminarea sa sunt supuse reglementarilor si/sau autorizatiilor corespunzatoare, din partea organizatiilor locale oficiale competente.
English: No interactions with other medicines have been described to date.
Romanian: Pana la aceasta data nu s-au semnalat interactiuni cu alte medicamente.
English: Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject.
Romanian: Administrarea LeukoScan la subiectii tineri, trebuie efectuata doar dupa luarea in considerare a posibilelor riscuri si beneficii pentru fiecare subiect in parte.
English: • 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.
Romanian: • 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.
English: This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
Romanian: Aceasta il va ajuta pe medic sa determine daca exista infectie la nivelul osului si ce fel de tratament sa utilizeze.
English: This helps your doctor make a diagnosis and evaluate the extent of your illness.
Romanian: Aceasta il ajuta pe medicul dumneavoastra sa va stabileasca un diagnostic si sa evalueze extinderea bolii.
English: * Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.
Romanian: * Echivalentul dozei efective si Doza efectiva sunt exprimate in unitati µSv/MBq.
English: Pharmacokinetic studies were performed after the intravenous administration of the product.
Romanian: S-au efectuat studii farmacocinetice dupa administrarea intravenoasa a produsului.
English: Calculate the percent free technetium as follows:
Romanian: Se calculeaza procentul de technetiu liber conform:
English: It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction.
Romanian: Ar trebui notat ca, oricum, aceste studii nu evalueaza potentialul carcinogen, toxicitatea genica sau toxicitatea fata de functia de reproducere.
English: In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
Romanian: In vitro, s-a observat o legare pozitiva de limfocite de pana la 2-6%.
English: Reconstituted and radiolabelled material - 4 hours.
Romanian: Produsul reconstituit si radiomarcat - 4 ore.
English: This medicinal product is for diagnostic use only.
Romanian: Acest produs medicamentos este folosit numai in scop diagnostic.
English: % Free Technetium = Activity in top half of strip × 100
Romanian: % Technetium Liber = Activitatea din jumatatea de sus a benzii × 100
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Romanian: Pentru fiecare pacient, expunerea la radiatiile ionizante trebuie sa se justifice prin prisma beneficiului posibil.
English: These revealed no remarkable findings.
Romanian: Acestia nu au relevat aspecte deosebite.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Romanian: PRECAUŢII SPECIALE PRIVIND ELIMINAREA MEDICAMENTELOR NEUTILIZATE SAU A MATERIALELOR REZIDUALE PROVENITE DIN ASTFEL DE
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.
Romanian: 4.4 Atenţionări speciale şi precauţii speciale pentru utilizare Siguranta si acuratetea diagnosticului in cazul persoanelor sub virsta de 21 de ani, nu au fost inca stabilite.
English: For instructions for preparation see section 6.6.
Romanian: Pentru instructiuni privind prepararea a se vedea pct. 6.6.
English: Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Romanian: Grupul farmacoterapeutic: Radiofarmaceutice diagnostice.
English: Read all of this leaflet carefully before you start using this medicine.
Romanian: Citiţi cu atenţie şi în întregime acest prospect înainte de a începe să luaţi acest medicament
English: Date of approval of latest variation or transfer: MM/YYYY
Romanian: Datum schválení poslední změny nebo převodu: ZZ/LL/AAAA
English: The maximum amount of LeukoScan that can be administered has not been determined.
Romanian: Cantitatea maxima de LeukoScan care va poate fi administrata nu a fost stabilita.
English: Alternative techniques which do not involve ionising radiation should be considered.
Romanian: În asemenea situaţii trebuie luate in considerare tehnicile alternative care nu implica utilizarea radiatiilor ionizante.
English: HAMA titers should be determined before repeated administration of LeukoScan.
Romanian: Titrul de HAMA trebuie determinat inainte de administrarea repetata a LeukoScan.
English: Higher doses may be justified in some clinical circumstances.
Romanian: In unele circumstante clinice se pot justifica doze mai mari.
English: When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Romanian: 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.
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.
Romanian: 4.5 Interacţiuni cu alte medicamente şi alte forme de interacţiune 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.
English: LeukoScan is prepared for a single injection.
Romanian: LeukoScan este preparat pentru o singura injectie.
English: After injection, any remaining portion of the reconstituted solution should be discarded.
Romanian: Dupa injectare, orice cantitate de solutie astfel reconstituita trebuie aruncata.
English: LeukoScan is not recommended for use in children.
Romanian: LeukoScan nu este recomandat pentru a fi utilizat la copii.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Romanian: B. CONDIŢIILE EMITERII AUTORIZAŢIEI DE PUNERE PE PIAŢĂ C. OBLIGAŢIILE SPECIFICE CARE TREBUIE ÎNDEPLINITE DE CĂTRE
English: If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Romanian: Daca administrarea este considerata necesara, alaptarea trebuie intrerupta iar laptele exprimat trebuie indepartat.
English: It is produced in mice and purified so that it can be used in humans.
Romanian: Este produs de soareci si purificat astfel incat poate fi utilizat si de catre oameni.
English: Some side effects, although not common, have been reported.
Romanian: S-au raportat unele reacţii adverse, desi nu frecvent.
English: The radiolabelled solution should be administered as an intravenous injection.
Romanian: Solutia marcata radioactiv trebuie administrata sub forma de injectie intravenoasa.
English: An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Romanian: Un anticorp este o substanta naturala produsa de corp care adera de substante straine pentru a ajuta la indepartarea acestora din corp.
English: It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.
Romanian: 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.
English: Immunoscintigraphy should be performed one to eight hours after injection.
Romanian: Imunoscintigrafia trebuie efectuata in intervalul de 1-8 ore dupa injectare.
English: Patients have been given four times the amount you will receive with no adverse reactions.
Romanian: Au fost pacienti carora li s-a administrat de 4 ori cantitatea care vi se administreaza dumneavoastra fara a dezvolta reactii adverse.
English: No studies effects of food/drink have been performed.
Romanian: Nu s-au realizat studii in ceea ce priveste efectele alimentelor sau bauturilor
English: The eosinophil count increased from 2.7% preinjection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
Romanian: 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.
English: • You should not be given LeukoScan if you are pregnant.
Romanian: • Nu trebuie sa vi se administreze LeukoScan daca sinteti gravida.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Romanian: Expunerea la radiatii ionizante este asociata cu inducerea cancerului si cu posibilitatea aparitiei defectelor ereditare.
English: Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Romanian: Este recomandata realizarea de imagini in mod de lucru analog/digital si cu o matrice de cel putin 128x128.
English: The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located.
Romanian: Medicul face aceasta folosind o camera de imagistica speciala care evidentiaza zonele de radioactivitate pentru a vedea unde sint localizate infectiile.
English: For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
Romanian: 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.
English: The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Romanian: Rezultatele clinice au aratat ca pentru diferitele localizari ale osteomileitei, LeukoScan poate arata rezultate diferite.
English: • If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be
Romanian: • Daca solutia preparata de LeukoScan are modificari de culoare sau contine particule, nu trebuie
English: This material will then be injected into your vein.
Romanian: Acest produs vi se injecteaza in vena.
English: Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
Romanian: De aceea doctorul dumneavoastra trebuie sa va tina sub observatie atenta pentru o perioada de timp scurta dupa administrarea acestui
English: Patients with known allergies or hypersensitivity to mouse proteins.
Romanian: Pacientii cu alergii sau hipersensibilitate cunoscute la proteinele de soarece.
English: Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Romanian: Pacientii carora li se administrase anterior produse cu anticorpi monoclonali de murine este mai probabil sa prezinte HAMA.
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.
Romanian: • 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.
English: LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Romanian: LeukoScan este un fragment de anticorp care este legat de o substanta radioactiva numita technetiu.
English: LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Romanian: LeukoScan [99mTc] poate fi utilizat dupa 10 minute si trebuie folosit in decurs de 4 ore de la preparare.
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.
Romanian: 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.
English: There was no doseresponse effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg
Romanian: 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.
English: Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
Romanian: Ca toate medicamentele, LeucoScan poate provoca reactii adverse, cu toate că nu apar la toate persoanele.
English: Reconstituted and radiolabelled material - Do not store above 25ºC.
Romanian: Produsul reconstituit si radiomarcat - A nu se depozita la temperaturi de peste 25ºC.
English: When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis.
Romanian: Cind o scanare a osului este negativa, imaginea cu LeukoScan poate rareori sa arate un raspuns pozitiv si acest lucru poate indica osteomielita timpurie.
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Romanian: Cand este necesara administrarea de produse radioactive la femeile cu potential fertil, trebuie intotdeauna cerute informatii despre sarcina.
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
Romanian: 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.
English: For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv.
Romanian: 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.
English: No studies on the effects on the ability to drive and use machines have been performed.
Romanian: Nu exista studii cu privire la capacitatea de a conduce sau utiliza masini.
English: 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.
Romanian: 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.
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.
Romanian: 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.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Romanian: Oricare femeie care prezinta absenta unei menstre trebuie considerata ca fiind gravida pana la stabilirea etiologiei acesteia.
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.
Romanian: 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.