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Prepandemic)
Potrivit criteriilor stabilite de CHMP, pentru a putea fi considerat adecvat, un vaccin prepandemic trebuie să producă niveluri protectoare de anticorpi la cel puţin 70% din adulţi.
According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.Nu utilizaţi Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics după data de expirare înscrisă pe cutie şi pe etichetă.
Do not use Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics after the expiry date which is stated on the carton and the label.Depunerea de RPAS-uri când Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics este folosit în timpul unei pandemii de gripă.
PSUR submission when Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic.În primele săptămâni după vaccinarea cu Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics rezultatele acestor teste pot să nu fie corecte.
In the first few weeks after vaccination with Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics the results of these tests may not be correct.Această secţiune descrie experienţa clinică pentru Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics după administrarea a două doze şi vaccinarea de rapel.
This section describes the clinical experience with Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics following a two-dose administration and booster.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.
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.Siguranţa şi eficacitatea Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics la subiecţi cu vârsta sub 18 ani nu au fost încă stabilite.
The safety and efficacy of Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in subjects under 18 years of age have not yet been established.Ca toate medicamentele, Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.
Like all medicines, Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can cause side effects, although not everybody gets them.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.
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.CHMP a hotărât că beneficiile„ vaccinului gripal prepandemic(H5N1)(virion fragmentat, inactivat, cu adjuvant) GlaxoSmithKline Biologicals” sunt mai mari decât riscurile pentru imunizarea împotriva subtipului H5N1 al virusului gripal A.
The CHMP decided that the benefits of‘ Prepandemic influenza vaccine(H5N1)(split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals' are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.Reacţiile adverse prezentate mai jos au apărut în cazul administrării Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics în cadrul studiilor clinice efectuate la adulţi, incluzând vârstnici.
The side effects listed below have occurred with Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in clinical studies in adults, including the elderly.Se estimează ca au fost vaccinate în timpul sarcinii mai mult de 90000 femei, cu vaccinul vH1N1 Focetria, care conţine aceeaşi cantitate de adjuvant MF59C.1 ca Prepandemic Influenza vaccine(H5N1)surface antigen, inactivated.
It is estimated that more than 90,000 women have been vaccinated during pregnancy with H1N1v vaccine Focetria which contains the same amount of adjuvant MF59C.1 as.Înainte de administrarea Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics în timpul alăptării, trebuie luate în considerare potenţialele beneficii pentru mamă şi riscurile la care este supus sugarul.
The potential benefits to the mother and risks to the infant should be considered before administering Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during breast-feeding.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.
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.S-au obţinut date limitate provenind de la femeile care au rămas gravide în timpul studiilor clinice în care s-a administrat Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Limited data was obtained from women who became pregnant with Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during the course of clinical trials.Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics poate fi administrat în cazul unor deficienţe ale sistemului imun, însă este posibil să nu se obţină un răspuns imun de protecţie.
In the presence of immune deficiencies Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be administered but a protective immune response may not be elicited.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.
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.Prin urmare, datele indică faptul că Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics poate fi administrat concomitent cu vaccinuri gripale sezoniere fără adjuvant(injecţiile administrându-se în membre diferite.
Therefore the data indicate that Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be co-administered with non-adjuvanted seasonal influenza vaccines(with injections made into opposite limbs.Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics este un vaccin destinat utilizării la adulţi(cu vârsta cuprinsă între 18 şi 60 ani) şi vârstnici(cu vârsta peste 60 ani.
Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults(from 18 to 60 years old). and elderly(over 60 years old.S-au obţinut date limitate provenind de la femeile care au rămas gravide în timpul studiilor clinice cu vaccinurile Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics(H5N1) sau vH1N1 cu adjuvant MF59C.1.
Limited data was obtained from women who became pregnant during the course of clinical trials with Prepandemic Influenza vaccine(H5N1)(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics or H1N1v vaccines adjuvanted with MF59C.1.
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