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[PMID]:28465097
[Au] Autor:Cohet C; Rosillon D; Willame C; Haguinet F; Marenne MN; Fontaine S; Buyse H; Bauchau V; Baril L
[Ad] Endereço:GSK Vaccines, Wavre, Belgium. Electronic address: catherine.x.cohet@gsk.com.
[Ti] Título:Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.
[So] Source:Vaccine;35(23):3041-3049, 2017 05 25.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Indústria Farmacêutica/legislação & jurisprudência
Tecnologia Farmacêutica/legislação & jurisprudência
Vacinas/efeitos adversos
[Mh] Termos MeSH secundário: Vacina contra Varicela/efeitos adversos
Seres Humanos
Vacinas contra Influenza/efeitos adversos
Vacinas Antimaláricas/efeitos adversos
Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos
Vacinas contra Papillomavirus/efeitos adversos
Medição de Risco
Vacinas contra Rotavirus/efeitos adversos
Tecnologia Farmacêutica/métodos
Tecnologia Farmacêutica/organização & administração
Vacinação
Vacinas/administração & dosagem
Vacinas Atenuadas
Vacinas Combinadas/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Influenza Vaccines); 0 (Malaria Vaccines); 0 (Measles-Mumps-Rubella Vaccine); 0 (Papillomavirus Vaccines); 0 (Rotavirus Vaccines); 0 (Vaccines); 0 (Vaccines, Attenuated); 0 (Vaccines, Combined); 0 (measles, mumps, rubella, varicella vaccine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE


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[PMID]:28465096
[Au] Autor:Nicoli F; Appay V
[Ad] Endereço:Sorbonne Universités, UPMC Univ Paris 06, DHU FAST, Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), F-75013 Paris, France; INSERM, U1135, CIMI-Paris, F-75013 Paris, France. Electronic address: nclfnc1@unife.it.
[Ti] Título:Immunological considerations regarding parental concerns on pediatric immunizations.
[So] Source:Vaccine;35(23):3012-3019, 2017 05 25.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Despite the fundamental role of vaccines in the decline of infant mortality, parents may decide to decline vaccination for their own children. Many factors may influence this decision, such as the belief that the infant immune system is weakened by vaccines, and concerns have been raised about the number of vaccines and the early age at which they are administered. Studies focused on the infant immune system and its reaction to immunizations, summarized in this review, show that vaccines can overcome those suboptimal features of infant immune system that render them more at risk of infections and of their severe manifestations. In addition, many vaccines have been shown to improve heterologous innate and adaptive immunity resulting in lower mortality rates for fully vaccinated children. Thus, multiple vaccinations are necessary and not dangerous, as infants can respond to several antigens as well as when responding to single stimuli. Current immunization schedules have been developed and tested to avoid vaccine interference, improve benefits and reduce side effects compared to single administrations. The infant immune system is therefore capable, early after birth, of managing several antigenic challenges and exploits them to prompt its development.
[Mh] Termos MeSH primário: Imunização/psicologia
Pais/psicologia
Vacinas/imunologia
[Mh] Termos MeSH secundário: Imunidade Adaptativa
Criança
Conhecimentos, Atitudes e Prática em Saúde
Seres Humanos
Imunidade Inata
Imunização/efeitos adversos
Esquemas de Imunização
Lactente
Mortalidade Infantil
Vacinas/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE


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[PMID]:28457894
[Au] Autor:Zupancic O; Bernkop-Schnürch A
[Ad] Endereço:Department of Pharmaceutical Technology, Institute of Pharmacy, Leopold-Franzens-University Innsbruck, Innrain 80/82, Center for Chemistry and Biomedicine, 6020 Innsbruck, Austria.
[Ti] Título:Lipophilic peptide character - What oral barriers fear the most.
[So] Source:J Control Release;255:242-257, 2017 Jun 10.
[Is] ISSN:1873-4995
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Peptide therapeutics is currently one of the fastest growing markets worldwide and consequently convenient ways of administration for these drugs are highly on demand. In particular, oral dosage forms would be preferred. A relative large molecular weight and high hydrophilicity, however, result in comparatively very low oral bioavailability being in most cases below 1%. Lipid based formulations (LBF), in particular self-emulsifying drug delivery systems (SEDDS) and solid lipid nanoparticles (SLN) as well as liposomes are among the most promising tools for oral peptide delivery. Key to success in orally delivering peptides via LBF seems to be a sufficiently high lipophilic character of those therapeutic agents. Hence, different non-covalent and covalent peptide lipidization methods from drug delivery point of view are presented. On the one hand, among non-covalent lipidization methods hydrophobic ion pairing seems to be a promising way to sufficiently increase peptide lipophilicity providing high drug payloads in the lipid phase, a protective effect against presystemic metabolism via thiol-disulphide exchange reactions and proteolysis as well as an improved intestinal membrane permeability. On the other hand, covalent methods like conjugating fatty acids via amidation, esterification, reversible aqueous lipidization (REAL) and cyclization also show potential. The present review therefore describes those lipidization methods in detail and critically evaluates their contribution in successfully overcoming the oral barriers.
[Mh] Termos MeSH primário: Lipídeos/química
Peptídeos/química
[Mh] Termos MeSH secundário: Administração Oral
Animais
Sistemas de Liberação de Medicamentos
Seres Humanos
Absorção Intestinal
Peptídeos/administração & dosagem
Peptídeos/farmacocinética
Peptídeos/uso terapêutico
Proteólise
Vacinas
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Lipids); 0 (Peptides); 0 (Vaccines)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE


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[PMID]:28456526
[Au] Autor:Adjagba A; MacDonald NE; Ortega-Pérez I; Duclos P; 2016 Global NITAG Network Meeting Participants
[Ad] Endereço:Health Policy and Institutional Development (HPID) Center, Agence de Médecine Préventive, Paris, France.
[Ti] Título:Strengthening and sustainability of national immunization technical advisory groups (NITAGs) globally: Lessons and recommendations from the founding meeting of the global NITAG network.
[So] Source:Vaccine;35(23):3007-3011, 2017 05 25.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.
[Mh] Termos MeSH primário: Comitês Consultivos
Saúde Global
Política de Saúde
Programas de Imunização/organização & administração
[Mh] Termos MeSH secundário: Comitês Consultivos/legislação & jurisprudência
Comitês Consultivos/organização & administração
Comitês Consultivos/estatística & dados numéricos
Congressos como Assunto
França
Seres Humanos
Programas de Imunização/legislação & jurisprudência
Programas de Imunização/estatística & dados numéricos
Programas de Imunização/tendências
Colaboração Intersetorial
Vacinas
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170501
[St] Status:MEDLINE


  5 / 14771 MEDLINE  
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[PMID]:28455189
[Au] Autor:Kelly SH; Shores LS; Votaw NL; Collier JH
[Ad] Endereço:Duke University, Department of Biomedical Engineering, United States.
[Ti] Título:Biomaterial strategies for generating therapeutic immune responses.
[So] Source:Adv Drug Deliv Rev;114:3-18, 2017 May 15.
[Is] ISSN:1872-8294
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Biomaterials employed to raise therapeutic immune responses have become a complex and active field. Historically, vaccines have been developed primarily to fight infectious diseases, but recent years have seen the development of immunologically active biomaterials towards an expanding list of non-infectious diseases and conditions including inflammation, autoimmunity, wounds, cancer, and others. This review structures its discussion of these approaches around a progression from single-target strategies to those that engage increasingly complex and multifactorial immune responses. First, the targeting of specific individual cytokines is discussed, both in terms of delivering the cytokines or blocking agents, and in terms of active immunotherapies that raise neutralizing immune responses against such single cytokine targets. Next, non-biological complex drugs such as randomized polyamino acid copolymers are discussed in terms of their ability to raise multiple different therapeutic immune responses, particularly in the context of autoimmunity. Last, biologically derived matrices and materials are discussed in terms of their ability to raise complex immune responses in the context of tissue repair. Collectively, these examples reflect the tremendous diversity of existing approaches and the breadth of opportunities that remain for generating therapeutic immune responses using biomaterials.
[Mh] Termos MeSH primário: Autoimunidade/efeitos dos fármacos
Materiais Biocompatíveis/uso terapêutico
Citocinas/antagonistas & inibidores
Inflamação/tratamento farmacológico
Inflamação/imunologia
Vacinas/imunologia
[Mh] Termos MeSH secundário: Animais
Autoimunidade/imunologia
Citocinas/imunologia
Seres Humanos
Cicatrização/imunologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Biocompatible Materials); 0 (Cytokines); 0 (Vaccines)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170430
[St] Status:MEDLINE


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[PMID]:27774815
[Au] Autor:Kassegne K; Abe EM; Chen JH; Zhou XN
[Ad] Endereço:a National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, WHO Collaborating Centre for Tropical Diseases, National Center for International Research on Tropical Diseases, Key Laboratory of Parasite and Vector Biology of the Chinese Ministry of Health , Shanghai ,
[Ti] Título:Immunomic approaches for antigen discovery of human parasites.
[So] Source:Expert Rev Proteomics;13(12):1091-1101, 2016 12.
[Is] ISSN:1744-8387
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Genetics combined with proteomics allows for a better understanding of parasite-host interactions and host immune responses. Immunomics elucidates that antigens are targets of induced or naturally acquired immunity (NAI), a promising solution to the challenge of eradicating human infections. High-throughput protein microarrays enhance rapid antigen discovery for the development of serodiagnostic tests/vaccines. Areas covered: This review systematically analyzes the emergence of protein microarrays as a powerful technology for parasite antigen discovery and subsequently summarizes some of the attributes and disadvantages of these approaches. Major insights on novel/validated serological biomarkers or vaccine candidates against malaria and Neglected Tropical Diseases (NTDs) are highlighted. We conclude with a brief description of the processes involved in immunomic protein microarrays. Expert commentary: Interesting discoveries have been made using protein microarrays. However, there is a need to evaluate targets that elicit strong immunogenicity and correlates of protective efficacy to aid prioritization and guide further clinical development. The goal of parasitic disease elimination will be best achieved through an integrated strategy that will incorporate and implement the different control components.
[Mh] Termos MeSH primário: Antígenos de Helmintos
Parasitos/imunologia
Análise Serial de Proteínas/métodos
Proteômica/métodos
Vacinas
[Mh] Termos MeSH secundário: Animais
Ensaios de Triagem em Larga Escala/métodos
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antigens, Helminth); 0 (Vaccines)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161108
[St] Status:MEDLINE


  7 / 14771 MEDLINE  
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[PMID]:29369273
[Au] Autor:Chapman C; Delahanty K
[Ad] Endereço:At the University of California at San Diego, Christie Chapman is an infection preventionist and Kim Delahanty is the administrative director of infection prevention clinical epidemiology.
[Ti] Título:Global convergence of emerging infectious diseases: Only a plane ride away.
[So] Source:Nursing;48(2):14-16, 2018 Feb.
[Is] ISSN:1538-8689
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aeronaves
Doenças Transmissíveis Emergentes/transmissão
Saúde Global
Doença Relacionada a Viagens
[Mh] Termos MeSH secundário: Doenças Transmissíveis Emergentes/prevenção & controle
Seres Humanos
Microbiota
Modelos Biológicos
Fatores de Risco
Vacinas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:180126
[St] Status:MEDLINE
[do] DOI:10.1097/01.NURSE.0000526905.68616.4f


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[PMID]:29420462
[Au] Autor:Kim DK; Riley LE; Hunter P
[Ti] Título:Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2018.
[So] Source:MMWR Morb Mortal Wkly Rep;67(5):158-160, 2018 Feb 09.
[Is] ISSN:1545-861X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:In October 2017, the Advisory Committee on Immunization Practices (ACIP) voted to approve the Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018. The 2018 adult immunization schedule summarizes ACIP recommendations in two figures and a table of contraindications and precautions for vaccines recommended for adults, and is intended is to assist health care providers in implementing the current ACIP recommendations for vaccinating adults. The schedule can be found at https://www.cdc.gov/vaccines/schedules.* The full ACIP recommendations for each vaccine are available at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. The 2018 adult immunization schedule has also been approved by the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), and the American College of Nurse-Midwives (http://www.midwife.org). The ACIP-recommended use of each vaccine is developed after an in-depth review of vaccine-related data, including data on disease epidemiology, vaccine efficacy and effectiveness, vaccine safety, feasibility of program implementation, and economic aspects of immunization policy (1).
[Mh] Termos MeSH primário: Esquemas de Imunização
Imunização/normas
Guias de Prática Clínica como Assunto
Vacinas/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Comitês Consultivos
Centers for Disease Control and Prevention (U.S.)
Feminino
Seres Humanos
Masculino
Meia-Idade
Gravidez
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180209
[St] Status:MEDLINE
[do] DOI:10.15585/mmwr.mm6705e3


  9 / 14771 MEDLINE  
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[PMID]:29420458
[Au] Autor:Robinson CL; Romero JR; Kempe A; Pellegrini C; Szilagyi P
[Ti] Título:Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger - United States, 2018.
[So] Source:MMWR Morb Mortal Wkly Rep;67(5):156-157, 2018 Feb 09.
[Is] ISSN:1545-861X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:In October 2017, the Advisory Committee on Immunization Practices (ACIP) approved the Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger - United States, 2018. The 2018 child and adolescent immunization schedule summarizes ACIP recommendations, including several changes from the 2017 immunization schedules, in three figures and footnotes to the figures. These documents can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules/index.html). These immunization schedules are approved by ACIP (https://www.cdc.gov/vaccines/acip/index.html), the American Academy of Pediatrics (https://www.aap.org), the American Academy of Family Physicians (https://www.aafp.org), and the American College of Obstetricians and Gynecologists (https://www.acog.org). Health care providers are advised to use the figures and the footnotes together. The full ACIP recommendations for each vaccine, including contraindications and precautions, can be found at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. Providers should be aware that changes in recommendations for specific vaccines can occur between annual updates to the childhood/adolescent immunization schedules. If errors or omissions are discovered within the child and adolescent schedule, CDC posts revised versions on the CDC immunization schedule website.
[Mh] Termos MeSH primário: Esquemas de Imunização
Imunização/normas
Guias de Prática Clínica como Assunto
Vacinas/administração & dosagem
[Mh] Termos MeSH secundário: Adolescente
Comitês Consultivos
Centers for Disease Control and Prevention (U.S.)
Criança
Pré-Escolar
Feminino
Seres Humanos
Lactente
Masculino
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180209
[St] Status:MEDLINE
[do] DOI:10.15585/mmwr.mm6705e2


  10 / 14771 MEDLINE  
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[PMID]:29296158
[Au] Autor:Manakongtreecheep K
[Ad] Endereço:Yale University, New Haven, USA.
[Ti] Título:SMS-reminder for vaccination in Africa: research from published, unpublished and grey literature.
[So] Source:Pan Afr Med J;27(Suppl 3):23, 2017.
[Is] ISSN:1937-8688
[Cp] País de publicação:Uganda
[La] Idioma:eng
[Ab] Resumo:Immunization for children against vaccine-preventable diseases is one of the most important health intervention method in the world, both in terms of its health impact and cost-effectiveness. Through EPI and various other programs such as the Decades of Vaccines, immunization has been improving the health of children around the world. However, this progress falls short of global immunization targets of the Global Vaccine Action Plan (GVAP). Furthermore, the African region still lags behind in immunization, and suffers from a high proportion of vaccine preventable diseases as a result. Reminders and recall for vaccination have been shown to improve health care-seeking behaviours, and have been recommended for application in routine and supplemental measles immunization activities. With mobile phones becoming more accessible in Africa, SMS vaccine reminder system has been proposed as a convenient and easily scalable way to inform caregivers of the disease and the importance of immunization, to address any concerns related to immunization safety, and to remind them of vaccination schedules and campaigns. There have been 6 published articles and 1 unpublished article on the effect of SMS reminder system for immunization in Africa. The studies done has shown that SMS vaccination reminder has led to improvements in vaccination uptakes in various metrics, whether is through the increase in vaccination coverage, decrease in dropout rates, increase in completion rate, or decrease in delay for vaccination.
[Mh] Termos MeSH primário: Programas de Imunização/métodos
Sistemas de Alerta
Vacinação
Vacinas/administração & dosagem
[Mh] Termos MeSH secundário: África
Telefone Celular
Criança
Saúde Global
Seres Humanos
Esquemas de Imunização
Vacina contra Sarampo/administração & dosagem
Aceitação pelo Paciente de Cuidados de Saúde
Mensagem de Texto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Measles Vaccine); 0 (Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180215
[Lr] Data última revisão:
180215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180104
[St] Status:MEDLINE
[do] DOI:10.11604/pamj.supp.2017.27.3.12115



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