FrancophonIA/ELRC3.0 huggingface dataset:
English: ¾ The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Romanian: ¾ Riscul scăderii în greutate la pacienţii subponderali şi necesitatea de a monitoriza greutatea corporală la fiecare vizită şi de a opri tratamentul în cazul unui eveniment clinic îngrijorător şi inexplicabil de scădere în greutate.
English: ¾ The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Romanian: ¾ Riscul potenţial de infecţii: tratamentul cu Daliresp nu trebuie iniţiat sau tratamentul trebuie oprit la pacienţi cu boli infecţioase acute severe.
English: ¾ The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Romanian: ¾ Lipsa datelor clinice pentru a susţine administrarea în asociere cu teofilină şi faptul că această asociere nu este recomandată.
English: ¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
Romanian: ¾ Lipsa de experienţă la pacienţi cu infecţie cu HIV sau hepatită activă, cu afecţiuni imunologice severe (de exemplu scleroza multiplă, lupus eritematos, leucoencefalopatie multifocală) sau trataţi cu imunosupresoare (altele decât corticosteroizi administraţi sistemic ca tratament de scurtă durată) şi faptul că tratamentul cu Daliresp nu trebuie iniţiat sau trebuie oprit la aceşti pacienţi.
English: ¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
Romanian: ¾ Faptul că expunerea crescută poate să apară la anumite grupe de pacienţi şi poate creşte riscul de intolerabilitate persistentă: o Grupe speciale de pacienţi care prezintă o inhibare crescută de PDE4, cum sunt femei de culoare, nefumătoare o Pacienţi trataţi concomitent cu un inhibitor al CYP 1A2 (cum este fluvoxamina) sau cu inhibitori concomitenţi ai CYP 3A4 şi 1A2 (cum sunt enoxacin şi cimetidina)
English: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Romanian: • Rezumatul Caracteristicilor Produsului şi Prospectul pentru Daliresp
English: ¾ The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Romanian: ¾ Riscul potenţial de tumori maligne şi lipsa experienţei la pacienţii cu antecedente de neoplasm.
English: The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Romanian: Faptul că Daliresp nu este indicat în tratamentul pacienţilor cu BPOC alţii decât cei din indicaţia aprobată, nici la pacienţii cu astm bronşic sau deficit de alfa-1antitripsină.
English: • Copies of the patient card to be given to patients before they receive Daliresp
Romanian: • Copii ale cărţii pacientului trebuie date pacienţilor înainte de a li se administra Daliresp
English: ¾ The limited or missing information in patients with liver impairment.
Romanian: ¾ Date limitate sau absente în cazul pacienţilor cu insuficienţă hepatică.
English: That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Romanian: Faptul că tratamentul cu Daliresp poate determina scădere în greutate şi că pacienţii trebuie să-şi monitorizeze greutatea periodic şi să noteze valorile greutăţii în cartea pacientului.
English: Hence, the need to carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression and to inform patients to report any changes in behaviour, mood and any suicidal ideation.
Romanian: ¾ Riscul de tulburări psihice cum sunt insomnia, anxietatea, depresia la pacienţi în tratament cu Daliresp şi riscul potenţial de suicid şi, prin urmare, necesitatea de a evalua atent raportul risc beneficiu acestui tratament la pacienţii cu simptome psihice existente sau cu antecedente de depresie şi de a informa pacienţii dsă raporteze orice modificare a comportamentului, dispoziţiei şi orice ideaţie suicidară.
English: • cancer
Romanian: • neoplasm
English: This summary was last updated in 10-2010.
Romanian: Prezentul rezumat a fost actualizat ultima dată în 10-2010.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Romanian: Sistemul imunitar va putea apoi produce anticorpi mai rapid atunci când va fi din nou expus virusului.
English: This may help to protect against the disease caused by the virus.
Romanian: Aceasta poate ajuta la protecţia organismului împotriva bolii provocate de virus.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Romanian: Totuşi, ar putea fi indicat să se administreze vaccinul acestor pacienţi în timpul unei pandemii, în condiţiile în care sunt disponibile echipamente de resuscitare.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Romanian: Potrivit criteriilor stabilite de CHMP, un vaccin prepandemic trebuie să genereze niveluri protectoare de anticorpi la cel puţin 70% din persoane pentru a fi considerat adecvat.
English: The vaccine has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Romanian: Vaccinul a fost dezvoltat pentru a oferi protecţie împotriva acestei tulpini, astfel încât poate fi utilizat înaintea sau în timpul unei pandemii de gripă.
English: The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Romanian: Vaccinul conţine un „adjuvant” (un compus care conţine ulei) pentru a intensifica răspunsul imun.
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Romanian: În primul studiu, la 21 de zile după cea de-a doua injecţie, aproximativ 90% din persoanele cu vârsta sub 60 de ani şi aproximativ 80% din cele cu vârsta peste 60 de ani prezentau niveluri de anticorpi suficiente pentru a le proteja împotriva H5N1.
English: This vaccine contains some parts of the H5N1 virus.
Romanian: Acest vaccin conţine fragmente din virusul H5N1.
English: The vaccine is given by injection into the shoulder muscle in two single doses, at least three weeks apart.
Romanian: Vaccinul se administrează prin injecţie în muşchiul umărului în două doze individuale, la interval de cel puţin trei săptămâni.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Romanian: Când unei persoane i se administrează vaccinul, sistemul imunitar al acesteia recunoaşte fragmentele de virus ca fiind „străine” şi produce anticorpi împotriva acestora.
English: The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
Romanian: Studiile au examinat capacitatea vaccinului de a declanşa producţia de anticorpi („imunogenitate”) conform criteriilor CHMP pentru vaccinurile prepandemice.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Romanian: Acesta este un tip de vaccin care se va utiliza pentru protejarea împotriva unei noi tulpini de virus gripal ce poate cauza o viitoare pandemie de gripă.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Romanian: Experţii din domeniul sănătăţii sunt îngrijoraţi de faptul că o viitoare pandemie de gripă ar putea fi cauzată de tulpina H5N1 a virusului.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Romanian: O pandemie de gripă are loc atunci când apare o nouă tulpină de virus gripal care se poate răspândi cu uşurinţă de la o persoană la alta, deoarece oamenii nu au imunitate (protecţie) împotriva acesteia.
English: The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Romanian: CHMP a observat că există probabilitatea ca, în viitor, o tulpină H5N1 a virusului gripal să cauzeze o pandemie.
English: The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Romanian: EPAR-ul complet pentru Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics poate fi consultat pe site-ul agenţiei la ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Romanian: Documentul explică modul în care Comitetul pentru produse medicamentoase de uz uman (CHMP) a evaluat medicamentul, pentru a emite avizul în favoarea acordării autorizaţiei de introducere pe piaţă şi recomandările privind condiţiile de utilizare pentru Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Romanian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics nu se administrează pacienţilor care au prezentat o reacţie anafilactică (reacţie alergică severă) la oricare dintre componentele vaccinului, inclusiv la cele prezente în concentraţii minime (niveluri foarte scăzute), cum ar fi proteine de ou sau pui, ovalbumină (o proteină întâlnită în albuşul de ou), kanamicină sau neomicină sulfat (antibiotice), formaldehidă şi bromură de cetiltrimetilamoniu.
English: In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
Romanian: În cazul unei pandemii declarate oficial, cauzate de tulpina H5N1 a virusului gripal A, persoanelor care au fost deja vaccinate cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (cu una sau două doze) li se poate administra doar încă o doză, în locul celor două doze recomandate pentru persoanele nevaccinate.
English: For more information about treatment with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Romanian: Pentru mai multe informaţii referitoare la tratamentul cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, citiţi prospectul (care face parte, de asemenea, din EPAR) sau adresaţi-vă medicului sau farmacistului.
English: The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Romanian: Cele mai frecvente efecte secundare ale vaccinării cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (observate la mai mult de 1 din 10 pacienţi) sunt dureri de cap, mialgie (dureri musculare), reacţii la locul de injectare (umflătură, durere, induraţie şi roşeaţă) şi oboseală (extenuare).
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Romanian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics conţine o tulpină similară tulpinii de virus gripal numite A/Vietnam/1194/2004 (H5N1) (NIBRG-14).
English: In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Romanian: Într-unul din studii, la care au participat 3 372 de persoane, subiecţilor li s-a administrat fie un vaccin antigripal sezonier, urmat de două doze de Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics la interval de trei săptămâni, fie placebo (un vaccin inactiv), urmat de două doze dintr-un vaccin sezonier cu adjuvant la interval de trei săptămâni.
English: In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules.
Romanian: În cel de-al doilea studiu, care a inclus 240 de persoane, subiecţilor li s-a administrat Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics prin utilizarea unor scheme de vaccinare diferite.
English: Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years.
Romanian: Două studii principale au furnizat date privind vaccinarea cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics la adulţi sănătoşi cu vârste sub şi peste 60 de ani.
English: The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics's benefits are greater than its risks and recommended that it be given marketing authorisation.
Romanian: CHMP a hotărât că beneficiile Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics sunt mai mari decât riscurile asociate şi a recomandat eliberarea unei autorizaţii de introducere pe piaţă pentru acest produs.
English: The second study established that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be given as two doses at least three weeks apart.
Romanian: Cel de-al doilea studiu a stabilit că Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics trebuie administrat în două doze la interval de cel puţin trei săptămâni.
English: The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Romanian: Solicitantul a prezentat date privind modele experimentale cu vaccinuri similare cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Romanian: Rezumat EPAR destinat publicului vaccin gripal prepandemic (H5N1) (antigen de suprafaţă, inactivat, cu adjuvant)
English: The studies showed that overall Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics produced an antibody response that met these criteria.
Romanian: Studiile au demonstrat că, în general, Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics a produs un răspuns imun care a întrunit aceste criterii.
English: This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Romanian: Prezentul document este un rezumat al Raportului european public de evaluare (EPAR) pentru Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet.
Romanian: Pentru lista completă a efectelor secundare raportate asociate cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, a se consulta prospectul.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Romanian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics este destinat utilizării la adulţi pentru protejarea împotriva gripei cauzate de tulpina H5N1 („gripa aviară”) a virusului gripal A. Vaccinul se administrează conform recomandărilor oficiale.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Romanian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics este un vaccin „prepandemic”.
English: Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Romanian: Alte informaţii despre Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Romanian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics este un vaccin.
English: What benefit has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics shown during the studies?
Romanian: Ce beneficii a prezentat Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics pe parcursul studiilor?
English: What is the risk associated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Romanian: Care sunt riscurile asociate cu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved?
Romanian: De ce a fost aprobat Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l.
Romanian: Comisia Europeană a acordat Novartis Vaccines and Diagnostics S.r.l o autorizaţie de introducere pe piaţă pentru Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, valabilă pe întreg teritoriul Uniunii Europene, la 29 noiembrie 2010.
English: How has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been studied?
Romanian: Cum a fost studiat Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Romanian: Ce este Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work?
Romanian: Cum acţionează Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used?
Romanian: Cum se utilizează Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used for?
Romanian: Pentru ce se utilizează Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: The studies varied between 28 days and 13 months.
Romanian: Duratele de derulare a studiilor au variat între 28 de zile și 13 luni.
English: Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Romanian: (fentanil) sunt înregistrați la nivel național în următoarele 24 de țări din cadrul Spațiului Economic European (SEE): Austria, Belgia, Croația, Cipru, Republica Cehă, Danemarca, Finlanda, Franța, Germania, Grecia, Ungaria, Islanda, Irlanda, Italia, Luxemburg, Malta, Țările de Jos, Norvegia, Polonia, Portugalia, Slovenia, Spania, Suedia și Regatul Unit.
English: There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Romanian: Sunt disponibili plasturi cu 5 concentrații diferite: 12, 25, 50, 75 și 100 μg/h.
English: In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
Romanian: tratament ar trebui să depășească riscurile (deprimare a sistemului nervos central și deprimare respiratorie).