Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. †† du membre vacciné. Overall, subjects were a mean age of 64.2 years (range: 50 to 97 years). The rate of vaccine-related systemic adverse experiences was higher following revaccination (33.1%) than following primary vaccination (21.7%) in subjects ≥65 years of age, and was similar following revaccination (37.5%) and primary vaccination (35.5%) in subjects 50 to 64 years of age. Estimated GMTs, GMT ratio, and 95% confidence intervals were obtained from a constrained Longitudinal Data Analysis model {1}. Opsonophagocytic activity (OPA) titers were measured at prevaccination, at Week 12 and at Week 30 for the 12 shared serotypes contained in both Pneumovax 23 and Prevnar 13 (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), 2 of the 11 serotypes unique to Pneumovax 23 (22F and 33F), and 1 serotype unique to Prevnar 13 (6A). In this clinical study an increased rate of local reactions was observed with revaccination at 3-5 years following initial vaccination. Five subjects reported serious adverse experiences that occurred outside the 14-day follow-up window: 3 who received Pneumovax 23 and 2 who received placebo. Il s'utilise pour la prévention de la pneumonie pouvant être causée par les 23 différents types de bactéries désignées pneumocoquescontenues dans le vaccin. In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomized to receive ZOSTAVAX and Pneumovax 23 concomitantly (N=237), or Pneumovax 23 alone followed 4 weeks later by ZOSTAVAX alone (N=236). Pneumovax 23 is a clear, sterile solution supplied in a (0.5-mL dose) single-dose vial and a single-dose, prefilled syringe. Inform the patient, parent or guardian of the benefits and risks associated with vaccination. PNEUMOVAX® 23 (vaccin polyvalent antipneumococcique, norme de MSD) Page 4 de 27 INDICATIONS ET USAGE CLINIQUE PNEUMOVAX® 23 (vaccin polyvalent antipneumococcique, norme de MSD) est indiqué pour la vaccination contre les infections causées par des pneumocoques des types capsulaires utilisés dans la préparation du vaccin. Consider administration of the two vaccines separated by at least 4 weeks. –Le vaccin polyosidique 23-valent = VPP23 –Le vaccin conjugué 13-valent = VPC13 qui a obtenu relativement ... •Durée de protection[Patterson]: l’étude actuarielle montre que, chez les vaccinés, les ... Durée de protection du PCV13. [See Description (11) and How Supplied/Storage and Handling (16). The subjects in this study had underlying chronic illness but were in stable condition; at least 1 medical condition at enrollment was reported by 86.3% of subjects who were 50 to 64 years old, and by 96.7% of subjects who were 65 to 91 years old. Cependant, les 23 types pneumococciques contenus dans le vaccin sont responsables de la plupart des infections dues aux pneumocoques (environ 9 infections sur 10). Tell your health care provider if you or your child has a side effect that bothers you or that does not go away. Discard vial after use. 25 µg de chacun des 23 polysaccharides capsulaires de Streptococcus pneumoniæsuivants : 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F et 33F; 2. Une étude clinique a été menée pour évaluer l'efficacité et l'immunogénicité de Pneumovax chez 102 individus, dont 25 sujets âgés de 2 à 17 ans, 27 sujets âgés de 18 à 49 ans et 50 sujets âgés de 50 ans et plus. Developmental toxicity studies have not been conducted with Pneumovax 23 in animals. PNEUMOVAX® 23 est offert en flacon à dose unique contenant 0,5 mL du vaccin en solution. Pneumovax 23: Pneumococcal vaccine belongs to the class of medications called vaccines. All rights reserved. PNEUMOVAX 23 0.5 ml enjeksiyonluk çözelti içeren flakon, berrak ve renksiz çözelti halindedir ve tıpası (kauçuk) ve geçme kapağı (plastik) olan bir flakon (cam) içinde 0.5 mL çözelti halinde 1 veya 5 dozluk ambalajlarda bulunmaktadır. You may also report any side effect to your or your child's health care provider, or directly to the Vaccine Adverse Event Reporting System (VAERS). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. Pneumovax 23 is a vaccine that is given as a shot. Guillain-Barré syndrome The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined. Three similar studies in South African young adult male novice gold miners were carried out by Dr. R. Austrian and associates using similar pneumococcal vaccines prepared for the National Institute of Allergy and Infectious Diseases, with pneumococcal vaccines containing a 6-valent formulation (types 1, 3, 4, 7, 8, and 12) or a 13-valent formulation (types 1, 2, 3, 4, 6, 7, 8, 9, 12, 14, 18, 19, and 25) capsular polysaccharides. Angioneurotic edema, Musculoskeletal System The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Inom ramen för dessa syften delar vi också information om din användning av webbplatsen med våra betrodda partners inom sociala medier, annonsering och analys. Protective efficacy was 76% and 92%, respectively, for the 6- and 12-valent vaccines, for the capsular types represented. †† du membre vacciné. Antibody responses to most pneumococcal capsular types are generally low or inconsistent in children less than 2 years of age. Some individuals with underlying medical conditions of varying severity experienced local reactions and fever associated with clinical deterioration requiring hospital care. Regardless of age, the observed increase in post vaccination use of analgesics (≤13% in the revaccinees and ≤4% in the initial vaccinees) returned to baseline by day 5. Anaphylactoid reactions Each 0.5-mL dose contains Chaque dose de Pneumovax 23 contient : 1. The OPA GMTs to the 12 shared serotypes and 2 unique serotypes (22F and 33F) when measured 4 weeks after dosing with Pneumovax 23 were generally similar between Group 1 (Week 12) and Group 2 (Week 30 subset). Arthritis, Nervous System Contains phenol 0.25% added as preservative. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or their causal relationship to product exposure. Radiculoneuropathy † apparaissant peu de temps après l'administration du vaccin. and Dist. A lung infection (pneumonia) that can also come with an infection in the blood. A specific adverse reaction appears in this table only if its incidence in one or more of the columns meets the incidence criterion in the table title, after rounding. All vaccine must be discarded after the expiration date. Le vaccin est recommandé aux personnes âgées de 65 ans et plus. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus"). If you would like more information, talk to your health care provider. Solicited systemic adverse reactions and any other adverse reactions were evaluated during Days 1 through 14 postvaccination, and any serious adverse events (SAEs) were collected throughout the study period (through Week 30). Increased serum C-reactive protein, In a randomized clinical study, a reduced immune response to ZOSTAVAX® as measured by gpELISA was observed in individuals who received concurrent administration of Pneumovax 23 and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. than 2 years of age. Warmth at the injection site as preservative. Discard syringe after use. In a randomized, double-blind, placebo-controlled crossover clinical trial, subjects were enrolled in four different cohorts defined by age (50-64 years of age and ≥65 years of age) and vaccination status (no pneumococcal vaccination or receipt of a pneumococcal polysaccharide vaccine 3-5 years prior to the study). A prospective study in France found a pneumococcal vaccine containing fourteen (types 1, 2, 3, 4, 6A, 7F, 8, 9N, 12F, 14, 18C, 19F, 23F, and 25) capsular polysaccharides to be 77% (95%CI: 51% to 89%) effective in reducing the incidence of pneumonia among male and female nursing home residents with a mean age of 74 (standard deviation of 4 years). Only your health care provider can decide if Pneumovax 23 is right for you or your child. General disorders and administration site conditions, pneumococcal vaccine polyvalent injection, solution, We comply with the HONcode standard for trustworthy health information -, FDA-approved patient labeling (Patient Information). Febrile convulsion, Skin Naidu L, Chiu C, Habig A, et al. For a more complete list of side effects, ask your health care provider. The rate of vaccine-related systemic adverse reactions was higher following revaccination (33.1%) than following initial vaccination (21.7%) in subjects 65 years of age or older, and was similar following revaccination (37.5%) and initial vaccination (35.5%) in subjects 50-64 years of age. Vaccin pneumococcique polyosidique; Distribution contingentée sur le marché de ville et des collectivités; Mise à disposition, à titre exceptionnel et transitoire auprès des PUI, de doses de la spécialité PNEUMOVAX 23, solution injectable en seringue préremplie, initialement destinées aux Pays-Bas, à partir du 29 avril 2020 Available human data from clinical trials of Pneumovax 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out. Pneumovax 23 is a clear, colorless solution. In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with Pneumovax 23. Bacterial sugars from 23 pneumococcal types: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F, STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN. Erythema multiforme, Investigations Decreased limb mobility The rate of systemic adverse reactions was similar among both initial vaccinees and revaccinees within each age group. PNEUMOVAX 23 is a vaccine that is given as a shot. PNEUMOVAX® 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).