FrancophonIA/ELRC3.0 huggingface dataset:
English: Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
Romanian: 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.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Romanian: PROSPECT: INFORMAŢII PENTRU UTILIZATOR LeukoScan (0,31 mg pulbere pentru solutie injectabila) (sulesomaba)
English: This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Romanian: Acest radiofarmaceutic poate fi primit, folosit si administrat doar de personal autorizat, in conditii clinice desemnate.
English: Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
Romanian: In cazul aparitiei unei reactii adverse trebuie sa fie accesibile facilitati adecvate de resuscitare cardiopulmonare si personal pregatit pentru interventie imediata.
English: The overall radiation dose received by the patient over time should also be taken into
Romanian: De asemenea trebuie luata in calcul si totalitatea dozelor de radiatie administrate pacientului de-a lungul timpului.
English: Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Romanian: D-64293 Darmstadt
English: 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.
Romanian: 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.
English: 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.
Romanian: 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.
English: You will receive a single dose of 0.25 mg of LeukoScan.
Romanian: Vi se administreaza o singura doza de LeukoScan de 0,25 mg.
English: Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Romanian: Produsele radiofarmaceutice trebuie folosite doar de personalul calificat cu autorizare guvernamentala corespunzatoare pentru utilizarea si manipularea radionuclizilor.
English: C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Romanian: OBLIGAŢIILE SPECIFICE CARE TREBUIE ÎNDEPLINITE DE CĂTRE DEŢINĂTORUL
English: LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Romanian: LeukoScan nu a fost utilizat pentru diagnosticul osteomielitei la pacientii cu siclemie.
English: LeukoScan is used in patients with suspected infection of the bone called osteomyelitis.
Romanian: LeukoScan este folosit la pacientii cu suspiciune de infectie la nivelul oaselor numita osteomielita.
English: Kit for the preparation of 99mTc-labelled LeukoScan.
Romanian: Kit pentru prepararea LeukoScan marcat 99mTc.
English: LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
Romanian: LeukoScan se reconstituie cu 0,5 ml solutie de clorura de sodiu izotonica injectabila.
English: Kit - Store in a refrigerator (2ºC - 8ºC).
Romanian: Kit - A se pastra la frigider (2ºC - 8ºC).
English: Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Romanian: Folosindu-se solutie salina, se realizeaza un volum final de solutie de 0,1 ml.
English: • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Romanian: • Radiofarmaceuticele trebuie preparate de utilizator in asa fel incat sa indeplineasca atat cerintele de siguranta radiologica cat si cele de calitate farmaceutica.
English: However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not
Romanian: Cu toate acestea, datorita dozei scazute de proteina adminstrata, precum si timpului de injumatatire plasmatica scazut al 99mTc, probabil ca ajustarea dozei nu este necesara la acesti pacienti.
English: In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the
Romanian: In cazul putin probabil al administrarii unei supradozari cu LeukoScan, doza absorbita de pacient poate fi redusa sau scazuta prin administrarea orala sau intravenoasa de lichide pentru a grabi excretia
English: • After use, the container should be disposed of as radioactive waste.
Romanian: • Dupa folosire, recipientul trebuie indepartat ca deseu radioactiv.
English: LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
Romanian: Nu este de asteptat ca LeukoScan sa adere de leucocitele pacientilor cu hemoglobinurie paroxistica
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
Romanian: Radioactivitatea administrata trebuie ajustata astfel incat doza de radiatie rezultata sa fie doza cea mai mica posibila, dar care sa permita obtinerea rezultatelor diagnostice dorite.
English: BEFORE YOU USE LEUKOSCAN You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection
Romanian: ÎNAINTE SĂ UTILIZAŢI LEUKOSCAN Nu trebuie sa folositi LeukoScan 0,31 mg, pulbere pentru solutie injectabila
English: Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Romanian: Radiofarmaceuticele trebuie preparate de catre utilizatori astfel incat sa indeplineasca atit cerintele de siguranta radiologica cit si cele de calitate farmaceutica.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL LABEL)
Romanian: MINIMUM DE INFORMAŢII CARE TREBUIE SĂ APARĂ PE AMBALAJELE PRIMARE MICI
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Romanian: A. PRODUCĂTORUL(II) SUBSTANŢEI(LOR) BIOLOGIC ACTIVE ŞI DEŢINĂTORUL(II) AUTORIZAŢIEI DE FABRICAŢIE RESPONSABIL(I)
English: One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Romanian: Un flacon contine 0,31 mg de LeukoScan fragmente de anticorp monoclonal liofilizat.
English: After use, the container should be disposed of as radioactive waste.
Romanian: Dupa utilizare, containerul trebuie distrus ca deseu radioactiv.
English: Do not
Romanian: A nu se tine la
English: This leaflet only applies to LeukoScan.
Romanian: Prospectul se refera strict la LeukoScan.
English: In the unlikely event of a radiation overdose being administered with LeukoScan [99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion
Romanian: In eventualitatea putin probabil a unui supradozaj cu LeukoScan [99mTc], doza absorbita de pacient poate fi redusa prin administrarea orala sau intravenoasa de lichide pentru a creste excretia radiofarmaceuticului.
English: For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Romanian: Pentru reconstituirea pulberii liofilizate, se adauga cu o seringa sterila 0,5 ml de solutie salina in flaconul de LeukoScan protejat, de 3 ml.
English: Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Romanian: Fiecare flacon contine clorura stanoasa, clorura de sodiu, tartrat de sodiu si potasiu, acetate de sodiu,
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Romanian: ALTĂ(E) ATENŢIONARE(ĂRI) SPECIALĂ(E), DACĂ ESTE(SUNT) NECESARĂ(E) Produs folosit numai pentru diagnostic.
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Romanian: Fiecare flacon de 3 ml contine sulesomaba (IMMU - MN3 murin Fab' - SH fragmente de anticorp monoclonal antigranulocitar) 0,31 mg pentru prepararea LeukoScan marcat cu 99mTc.
English: 6.6 Special precautions for disposal and other handling Read complete directions thoroughly before starting the preparation procedure.
Romanian: A se citi cu atentie in intregime instructiunile inainte de a se incepe procedura de preparare.
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Romanian: Procedurile care implica radionuclizi si care sunt aplicate gravidelor presupun de asemenea doze de radiatii si asupra fatului.
English: LeukoScan is contraindicated in pregnancy.
Romanian: Administrarea LeukoScan este contraindicata in timpul sarcinii.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Quality control
Romanian: INSTRUCŢIUNI PRIVIND PREPARAREA MEDICAMENTELOR RADIOFARMACEUTICE
English: Lactation
Romanian: Alaptarea
English: (77.5% vs. 75.8%, respectively).
Romanian: Cu toate acestea, exista o acuratete diagnostica echivalenta intre cele 2 metode (77,5% comparativ cu 75,8%).
English: LeukoScan [99mTc] can be stored at room temperature after formulation.
Romanian: Dupa reconstituire LeukoScan [99mTc] poate fi pastrat la temperatura camerei.
English: Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc.
Romanian: Numele şi adresa producătorului(ilor) substanţei(lor) biologic active
English: NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI LeukoScan 0,31 mg pulbere pentru solutie injectabila
English: Pack size: one vial per carton container.
Romanian: Marimea ambalajului:cutie cu un flacon.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
Romanian: • 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
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Romanian: Fiecare flacon de 3 ml contine sulesomaba (IMMU - MN3 murin Fab' - SH fragmente de anticorp
English: Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal)
Romanian: Se recomanda si procesarea datelor prin proiectarea filtrata inapoi si reconstituirea in 3 planuri
English: Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
Romanian: Acetat de sodiu trihidrat
English: NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Romanian: LeukoScan 0,31 mg pulbere pentru solutie injectabila 0,31 mg sulesomaba liofilizat, clorura stanoasa si conservanti.
English: Medicinal product subject to medical prescriptio
Romanian: Medicament cu eliberare pe bază de prescripţie medicală.
English: Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12).
Romanian: Anterior administrarii, solutia trebuie examinata vizual pentru observarea eventualelor particule de substanta si a modificarilor de culoare.
English: • If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you
Romanian: Daca alaptati, trebuie sa intrerupeti alaptarea cel putin 24 de ore dupa ce vi s-a administrat LeukoScan.
English: This medicine
Romanian: DOZIMETRIE
English: The kit does not include the radioisotope.
Romanian: Contine izotopul de techentiu radioactiv in
English: Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Romanian: Pentru prepararea LeukoScan [99mTc], continutul flaconului se reconstituie imediat inaintea de folosire, in forma nemarcata.
English: Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Romanian: Oricand sunt administrate subsatante care contin proteine de soarece sunt posibile reactii anafilactice si alte reactii de hipersensibilitate.
English: 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]
Romanian: Rezumatul Dozimetriei la nivelul organelor in conditii normale pentru un pacient mediu adult (70 kg) dupa administrarea intravenoasa a unei doze de LeukoScan
English: Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Romanian: A se rehidrata cu pertechnetat de sodiu 99mTc, steril si apirogen.
English: Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Romanian: CONŢINUTUL PE MASĂ, VOLUM SAU UNITATEA DE DOZĂ Contine sulesomaba liofilizat 0,31 mg , clorura stanoasa si conservanti.
English: ATC code: VO4D At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert
Romanian: LeukoScan nu pare sa exercite vreun efect farmacodinamic la concentratiile si activitatile intalnite in
English: 300 American Road
Romanian: Otto-Röhm-Straße 69
English: Marketing Authorisation Holder and Manufacturer
Romanian: DEŢINĂTORULUI AUTORIZAŢIEI DE PUNERE PE PIAŢĂ
English: Appropriate aseptic precautions should be taken,
Romanian: Trebuie luate masuri adecvate de precautie aseptica, conform cu cerintele GMP pentru medicamente.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Romanian: Detinatorul autorizatiei de punere pe piata si producatorul Immunomedics GmbH
English: ‘Complicated' means that the infection is difficult to treat.
Romanian: „Complicată” înseamnă că infecția este dificil de tratat.
English: It was intended for use only when other antibiotics were not suitable.
Romanian: Medicamentul era destinat utilizării numai în cazurile în care alte antibiotice nu erau adecvate.
English: Because the medicine blocks the production of new proteins, the bacteria cannot multiply and they eventually die.
Romanian: Deoarece medicamentul blochează producerea de noi proteine, bacteriile nu se pot înmulți și în cele din urmă mor.
English: 15 September 2017 EMA/589782/2017 EMEA/H/C/4419
Romanian: 15 septembrie 2017 EMA/589782/2017 EMEA/H/C/4419
English: EMA/589782/2017
Romanian: (tigeciclină) EMA/589782/2017
English: Tigecycline Accord was developed as a ‘generic medicine'.
Romanian: Tigecycline Accord a fost dezvoltat ca „medicament generic”.
English: As for every medicine, the company also provided studies on the quality of Tigecycline Accord.
Romanian: De asemenea, ca în cazul tuturor medicamentelor, compania a furnizat studii cu privire la calitatea Tigecycline Accord.
English: On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Romanian: La data de 12 septembrie 2017, Accord Healthcare Limited a informat oficial Comitetul pentru medicamente de uz uman (CHMP) că dorește să-și retragă cererea de autorizare de punere pe piață pentru Tigecycline Accord, pentru tratamentul anumitor infecții complicate.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the medicine for marketing reasons because of the issues at the manufacturing site.
Romanian: În scrisoarea prin care înștiințează agenția cu privire la retragerea cererii, compania a declarat că retrage medicamentul din motive comerciale, din cauza problemelor existente în cadrul unității de producție.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tigecycline Accord.
Romanian: Compania a informat CHMP că nu există consecințe pentru pacienții implicați în prezent în studii clinice cu Tigecycline Accord.
English: Tigecycline Accord was expected to be used to treat adults and children older than 8 years with complicated infections of the skin and soft tissue (the tissue below the skin), except foot infections in people with diabetes.
Romanian: Tigecycline Accord ar fi trebuit să fie utilizat pentru tratarea adulților, adolescenților și copiilor cu vârsta peste 8 ani care suferă de infecții complicate ale pielii și ale țesuturilor moi (țesuturile de sub piele), cu excepția infecțiilor piciorului la persoanele cu diabet.
English: This means that Tigecycline Accord contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Tygacil.
Romanian: Aceasta înseamnă că Tigecycline Accord conține aceeași substanță activă și urma să acționeze în același mod cu un „medicament de referință” autorizat deja în Uniunea Europeană, numit Tygacil.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Tygacil, and did not need to be repeated for Tigecycline Accord.
Romanian: Au fost deja efectuate studii cu privire la beneficiile și riscurile asociate cu substanța activă în utilizările aprobate pentru medicamentul de referință, Tygacil, și nu a fost necesar să fie repetate pentru Tigecycline Accord.
English: It was also intended to treat complicated infections in the abdomen (belly).
Romanian: De asemenea, medicamentul era destinat pentru tratarea infecțiilor complicate de la nivelul abdomenului (burții).
English: Tigecycline Accord is an antibiotic medicine that contains the active substance tigecycline.
Romanian: Tigecycline Accord este un medicament antibiotic care conține substanța activă tigeciclină.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tigecycline Accord could not have been approved to treat complicated infections.
Romanian: Pe baza analizării datelor, în momentul retragerii cererii CHMP avea unele motive de îngrijorare și a dat un aviz provizoriu potrivit căruia Tigecycline Accord nu putea fi aprobat pentru tratamentul infecțiilor complicate.
English: The CHMP's main concern was lack of compliance with Good Manufacturing Practice (GMP) by the manufacturing site for the medicine's active substance.
Romanian: Principalul motiv de îngrijorare al CHMP a fost neconformitatea unității de producție a substanței active din medicament cu bunele practici de fabricație (BPF).
English: The active substance in Tigecycline Accord and Tygacil, tigecycline, is one of a group of antibiotics called ‘glycylcyclines'.
Romanian: Substanța activă din Tigecycline Accord și Tygacil, tigeciclina, face parte din grupa de antibiotice numită „glicilcicline”.
English: What is Tigecycline Accord?
Romanian: Ce este Tigecycline Accord?
English: There was no need for ‘bioequivalence' studies to investigate whether Tigecycline Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Romanian: Nu au fost necesare studii de „bioechivalență” pentru a se investiga dacă Tigecycline Accord este absorbit în același mod cu medicamentul de referință, pentru a produce aceeași concentrație de substanță activă în sânge, deoarece Tigecycline Accord se administrează prin perfuzie intravenoasă, ceea ce înseamnă că substanța activă ajunge direct în fluxul sanguin.
English: It was to be available as a powder to make a solution for infusion (drip) into a vein.
Romanian: Medicamentul urma să fie disponibil sub formă de pulbere pentru soluție perfuzabilă (picurare în venă).
English: It works against the bacteria that cause infections by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made.
Romanian: bacterieni, părțile celulei unde se produc noi proteine.
English: How does Tigecycline Accord work?
Romanian: Cum acționează Tigecycline Accord?
English: What was Tigecycline Accord expected to be used for?
Romanian: Pentru ce ar fi trebuit să se utilizeze Tigecycline Accord?
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Romanian: Grupa farmacoterapeutică: Antiepileptice, alte antiepileptice, codul ATC: N03AX16
English: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
Romanian: • Modificări la înregistrarea activităţii electrice (ECG) a inimii, care corespund unor tulburări ale ritmului inimii.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Sandoz GmbH have had thoughts of harming or killing themselves.
Romanian: • Un număr redus de pacienţi trataţi cu antiepileptice, cum este Pregabalin Sandoz GmbH, au avut gânduri de autovătămare sau sinucidere.
English: These platelet changes were not present in rats or in humans based on short-term and limited long-term clinical data.
Romanian: Aceste modificări trombocitare nu au fost prezente la şobolan sau la om, fapt bazat pe datele clinice pe termen scurt şi pe datele clinice limitate pe termen lung .
English: These symptoms may occur more commonly or severely if you have been taking Pregabalin Sandoz GmbH for a longer period of time.
Romanian: Aceste simptome pot fi mai frecvente sau mai severe dacă aţi luat Pregabalin Sandoz GmbH pentru o perioadă mai lungă de timp.
English: Eesti filiaal Pärnu mnt105
Romanian: Pärnu mnt105
English: If you have the impression that the effect of Pregabalin Sandoz GmbH is too strong or too weak, talk to your doctor or pharmacist.
Romanian: Dacă aveţi impresia că efectul Pregabalin Sandoz GmbH este prea puternic sau prea slab, spuneţi medicului dumneavoastră sau farmacistului.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Sandoz GmbH than you should.
Romanian: S-ar putea să vă simţiţi somnolent, confuz, agitat sau neliniştit din cauza faptului că aţi luat mai mult Pregabalin Sandoz GmbH decât trebuie.
English: Pregabalin Sandoz GmbH should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Romanian: Pregabalin Sandoz GmbH nu trebuie utilizat în timpul sarcinii decât dacă este absolut necesar (beneficiul terapeutic matern depăşeşte net riscul potenţial pentru făt).
English: • Pregabalin Sandoz GmbH may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Romanian: • Pregabalin Sandoz GmbH poate cauza înceţoşarea sau pierderea vederii sau alte modificări ale vederii, dintre care multe sunt temporare.
English: If you take more Pregabalin Sandoz GmbH than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Romanian: Dacă luaţi mai mult Pregabalin Sandoz GmbH decât trebuie Contactaţi medicul sau mergeţi imediat la cea mai apropiată unitate medicală de urgenţă.