Comme PNEUMO 23, PNEUMOVAX n'est pas recommandé chez l'enfant de moins de 2 ans car l'innocuité et l'efficacité du vaccin n'ont pas été établies et parce que la réponse en anticorps peut être faible. Incidence rates per100 000 pop. 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. 10 Single-Dose 0.5-mL Vials, Pneumococcal Vaccine Polyvalent La mortalité d… Data are not available to assess the effects of Pneumovax 23 on the breastfed infant or on milk production/excretion. ], Do not administer Pneumovax 23 to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine. PNEUMOVAX® 23. PNEUMOVAX 23 is a vaccine that is given as a shot. 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). Solicited injection site adverse reactions that occurred during Days 1 through 5 postvaccination with Pneumovax 23, solicited systemic adverse reactions that occurred during Days 1 through 14, and fever that occurred during Days 1 through 5 postvaccination with Pneumovax 23 are presented in Table 2. Generic Name: pneumococcal vaccine polyvalent Medically reviewed by Drugs.com. The most common systemic adverse reactions with revaccination were headache (18.1%), asthenia/fatigue (17.9%), and myalgia (17.3%). Ces effets, dont l'incidence exacte ne peut être précisément calculée, ont été très rarement rapportés (<1/10000). It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus"). This vaccine does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection. You may call the VAERS number 1-800-822-7967 at no charge, or report online to www.vaers.hhs.gov. Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle. Cellulitis Denna sida använder cookies, för att anpassa innehåll, annonser och analysera trafik till webbplatsen. You can also call the Merck National Service Center at 1-800-622-4477. Aux fins des programmes de vaccination de masse, PNEUMOVAX® 23 peut également être offert en flacon à doses multiples contenant cinq doses de 0,5 mL de vaccin. Serious adverse experiences within 14 days after Pneumovax 23 included angina pectoris, heart failure, chest pain, ulcerative colitis, depression, and headache/tremor/stiffness/sweating. The rate of systemic adverse reactions was similar among both initial vaccinees and revaccinees within each age group. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Pneumovax 23 and any potential adverse effects on the breastfed child from Pneumovax 23 or from the underlying maternal condition. Available for Android and iOS devices. It does not take the place of talking to your doctor, nurse or other health care provider about the vaccine. Last updated on Sep 1, 2020. Un vaccin inactivé polysaccharidique 23‑valent contre le pneumocoque(Pneu‑P‑23) est distribué au Canada : Pneumovax 23 (Merck). Pneumovax 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. Discard vial after use. Protective efficacy was 76% and 92%, respectively, for the 6- and 12-valent vaccines, for the capsular types represented. Il ne doit pas être congelé. Patient Information about [See Adverse Reactions (6.1).]. Advise the patient to read the FDA-approved patient labeling (Patient Information). Pneumovax 23 is for people 50 years of age and older. Les effets indésirables suivants ont été rapportes avec PNEUMO 23, sur la base de déclarations spontanées, après la commercialisation du vaccin. by: Merck Sharp & Dohme Corp., a subsidiary of Arthritis, Nervous System Pneumovax 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae 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). The following list of adverse reactions includes those identified during post approval use of Pneumovax 23. In one clinical trial of Pneumovax 23, conducted post-licensure, a total of 629 subjects who were aged ≥65 years and 201 subjects who were aged ≥75 years were enrolled. Peripheral edema in the injected extremity, Hematologic/Lymphatic Copyright © 2011-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. The ACIP has recommendations for use of Pneumovax 23 in children 2 years of age or older, who have previously received pneumococcal vaccines, and who are at increased risk for pneumococcal disease. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. … Pneumovax 23: Effets secondaires 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). 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. 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. The pneumococcal vaccine protects against serious and potentially fatal pneumococcal infections. The most common local adverse reactions reported at the injection site after revaccination with Pneumovax 23 were pain/soreness/tenderness (77.2%), swelling (39.8%), and erythema (34.5%). The most common systemic adverse reactions reported after Pneumovax 23 were as follows: asthenia/fatigue, myalgia and headache. Inform the patient, parent or guardian of the benefits and risks associated with vaccination. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Lorsque vous ou votre enfant recevez le vaccin, les défenses naturelles du corps produisent des anticorps qui protègent des infections pneumococciques. 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. Pneumococcal bacteria can cause many diseases ranging from pneumonia (lung infection) and meningitis (brain infection) to severe infections of the blood. ATAGI recommends that Pneumovax 23 can be given at the same time as Zostavax if both are due. There were more females (n=219, 54.8%) than males (n=181, 45.3%). Le vaccin antipneumococcique appartient à la classe de médicaments appelés vaccins. Post-marketing reports have been received in which some elderly individuals had severe adverse experiences and a complicated clinical course following vaccination. The most common systemic adverse experiences were headache (17.6%), asthenia/fatigue (13.2%), and myalgia (11.9%). Cellulitis-like reactions 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. Trois doses du vaccin sont administrées, soit deux doses de SynflorixMD à l’âge de 2 et 4 mois et une dose de Prevnar 13MD à l’âge de 12 mois. "Le vaccin pneumocoque sert à protéger contre les infections à pneumocoque qui sont essentiellement des infections pulmonaires comme des pneumonies ainsi que des méningites, c'est-à-dire des infections des méninges, enveloppes qui entourent le cerveau", explique le Dr Valérie Delbos. Hemolytic anemia in patients who have had other hematologic disorders Some individuals with underlying medical conditions of varying severity experienced local reactions and fever associated with clinical deterioration requiring hospital care. Erythema multiforme, Investigations Developmental toxicity studies have not been conducted with Pneumovax 23 in animals. OPA testing was performed on evaluable serum samples from all subjects at baseline (Day 1) and Week 12, and on sera from a random subset of subjects (approximately 50% of subjects) at Week 30. La vaccination contre le pneumocoque est indiquée pour tous les enfants. Inom ramen för dessa syften delar vi också information om din användning av webbplatsen med våra betrodda partners inom sociala medier, annonsering och analys. 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. The product information for Pneumovax 23 states that Pneumovax 23 and Zostavax should not be given at the same time. † apparaissant peu de temps après l'administration du vaccin. For subjects aged 65 years or older, injection-site adverse reaction rate was higher following revaccination (79.3%) than following initial vaccination (52.9%). Initial vaccination was evaluated in a total of 444 subjects (average age 65 years; 32% male and 68% female; 93% Caucasian, 3.2% African-American, 3.4% Hispanic, and 1.1% Other). Anaphylactoid reactions 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). En plus du Pneu-P-23, l’immunisation par le vaccin Pneu-C-13 peut être envisagée au cas par cas pour les adultes immunocompétents n’ayant jamais reçu le vaccin contre le pneumocoque pour la prévention de la pneumonie d’origine communautaire et de la PI causée par les 13 sérotypes contenus dans le vaccin. Instruct the patient, parent or guardian to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov. Contains phenol 0.25% added as preservative. Pneumovax 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. MERCK & CO., INC., Whitehouse Station, NJ 08889, USA, For patent information: www.merck.com/product/patent/home.html. For a more complete list of side effects, ask your health care provider. 25 mcg of polysaccharide from All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. No dilution or reconstitution is necessary. In this trial, the safety of Pneumovax 23 in adults 65 years of age and older (N=629) was compared to the safety of Pneumovax 23 in adults 50 to 64 years of age (N=379). The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined. Aucune dos… The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with Pneumovax 23. In this study, 10 subjects had serious adverse experiences within 14 days of vaccination: 6 who received Pneumovax 23 and 4 who received placebo. Les pneumocoques sont à l'origine de tout un éventail d'affections qui s'étend de la pneumonie (une infection des poumons) et la méningite (une infection du cerveau) jusqu'à de graves infections du sang. Serious adverse experiences after placebo included heart failure and motor vehicle accident resulting in death. 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). Pneumovax 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures. Dès le retour de la pharmacie, votre vaccin doit être placé au frigo, pour sa conservation, entre + 2°C et + 8°C. In a study using a pneumococcal vaccine containing eight (types 1, 3, 6, 7, 14, 18, 19, and 23) capsular polysaccharides, vaccinated children and young adults aged 2 to 25 years who had sickle cell disease, congenital asplenia, or undergone a splenectomy experienced significantly less bacteremic pneumococcal disease than patients who were not vaccinated. What are the possible side effects of Pneumovax 23? It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus"). 3. It is used for the prevention of pneumonia caused by the 23 different types of pneumococci bacteria that are contained in the vaccine. Dans toutes les études examinées pour cette déclaration mise à jour, on a administré une dose de Pneu-P-23 aux personnes de 65 ans ou plus, quels que soient leurs antécédents de vaccination. † apparaissant peu de temps après l'administration du vaccin. All vaccine must be discarded after the expiration date. Provide the patient, parent or guardian with the vaccine information statements required by the National Childhood Vaccine Injury Act of 1986, with each immunization. Le vaccin est recommandé aux personnes âgées de 65 ans et plus. Consider administration of the two vaccines separated by at least 4 weeks. †† du membre vacciné. In a randomized, double-blind, placebo-controlled, multicenter study, healthy adults, 50 years of age and older, received Prevnar 13 followed by Pneumovax 23 either 8 weeks later (Group 1) or 26 weeks later (Group 2). Serious adverse experiences within 14 days after placebo included myocardial infarction complicated with heart failure, alcohol intoxication, angina pectoris, and edema/urinary retention/heart failure/diabetes. The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex. Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura Dans notre pays, deux vaccins contre les pneumocoques sont disponibles pour les personnes âgées : le PPV23 (Pneumovax 23®), qui existe depuis les années 1980 et qui protège contre 23 sérotypes (31,93 €), et le PCV13 (Prévenar 13®), plus récent, qui couvre 13 sérotypes (74,55 €). Administer a single 0.5-mL dose of Pneumovax 23 using a sterile needle and syringe. In this study, 81.4% of subjects in Group 1 and 64.0% of subjects in Group 2 reported at least 1 injection site adverse reaction from Days 1 through 5 postvaccination with Pneumovax 23, and 64.9% of subjects in Group 1 and 54.9% of subjects in Group 2 reported at least 1 systemic adverse reaction from Days 1 through 14 postvaccination with Pneumovax 23. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus"). ò¢(íÀI¬Š36ô¨mX‡ÄZSΧmÎ/ÊWÁ«Ê©\Åå:Êæv¸J÷ô¼ß̪‹»ÁŠ8]Ÿ©jÞSc'Ž¥qù-­ìØZjõÔN­Wœÿý[Ûö. By race, 84.8% of subjects were White, 9.3% were Black or African-American, and 6.1% were other racial groups; the majority of subjects were not Hispanic or Latino (n=322, 80.5%). c. Population pédiatrique. A retrospective cohort analysis study based on the U.S. Centers for Disease Control and Prevention (CDC) pneumococcal surveillance system, showed 57% (95%CI: 45% to 66%) overall protective effectiveness against invasive infections caused by serotypes included in Pneumovax 23 in persons ≥6 years of age, 65 to 84% effectiveness among specific patient groups (e.g., persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% (95%CI: 57% to 85%) effectiveness in immunocompetent persons aged ≥65 years of age. as preservative. NDC 0006-4943-00 Polyvalent Vaccine 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. It is used for the prevention of pneumonia caused by the 23 different types of pneumococci bacteria that are contained in the vaccine. 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. Prevnar, Prevnar 13, pneumococcal 13-valent vaccine. 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. Ce vaccin est injecté dans le muscle ou sous la peau par un professionnel de la santé. Lymphadenopathy It is also for people who are 2 years of age and older if they have certain medical conditions that put them at increased risk for infection. 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. Every subject is counted a single time for each applicable row and column. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. Read this leaflet before you or your child gets the vaccine called Pneumovax 23. c. Population pédiatrique. Malheureusement, aucun vaccin ne protège contre tous les types de pneumocoques. In both studies, participants in the control groups received either meningococcal polysaccharide serogroup A vaccine or saline placebo. Do not use in children less than 2 years of age. 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). For each of the shared serotypes, Week 12 OPA geometric mean titers (GMTs) in Group 1 were noninferior to those of Group 2, as the lower bounds of the 95% CIs for the OPA GMT ratios were >0.5 for all 12 shared serotypes. †† du membre vacciné. Il s'utilise pour la prévention de la pneumonie pouvant être causée par les 23 différents types de bactéries désignées pneumocoquescontenues dans le vaccin. Only your health care provider can decide if Pneumovax 23 is right for you or your child. Copyright © 1986-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. For most people, they will get Prevnar 13 in childhood, and Pneumovax 23 in their senior years. Cependant, les 23 types pneumococciques contenus dans le vaccin sont responsables de la plupart des infections dues aux pneumocoques (environ 9 infections sur 10).

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