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23-valent Pneumococcal Polysaccharide Vaccine



 Market Approval time
Launched into market on March 22, 2017

 Introduction
DESCRIPTION
23-valent Pneumococcal Polysaccharide Vaccine is a clear and colorless solution composed of saccharidesof the capsular antigens of Streptococcus pneumonia (S. pneumoniae), serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. It’s free of preservative.

Active constituent: 23 serotypes of capsular pneumococcal polysaccharides
Excipients: Sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate

INDICATIONS
The vaccine is indicated for active immunization to prevent pneumococcal disease caused by the 23 serotypescontained 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)in individuals aged ≧2 years.

The vaccine is strongly recommended for the following groups:
• The elderly;
• Subjects of normal immune function but with chronic diseases (such as cardiovascular disease, lung diseases, diabetes, alcoholism and liver cirrhosis);
• Subjects who have lost their spleen or whose spleen is not working.
• Subjects with weak immune function: drepanocytosis, hodgkin's disease, lymphoma, multiple myeloma, chronic renal failure, nephrotic syndrome, and history of organ transplantation;
• Asymptomatic and symptomatic HIV carriers;
• Subjects with cerebrospinal fluid leakage;
• Special population:Residents or staff in high risk environment of pneumococcal infection or other pneumococcal complication (the elderly of long-term hospitalization, staff in charity organizations, etc).

ADMINISTRATION AND DOSAGE
The vaccine is for intramuscular or subcutaneousinjection in the deltoid region.
Primary immunization consisting one injection shall be carried out. A booster dose of 0.5ml is recommended for:
• Subjects with high risk of pneumococcal infection (such as subjects with history of splenectomy)with≧5 years history of primary immunization.
• Subjects with significant decrease in antibody concentration (such as subjects with nephrotic syndrome, renal failure or organ transplantation)
• Children≦10 years old with nephrotic syndrome, history of splenectomy and drepanocytosis with an interval of 3-5 years.
Re-vaccination is not recommended for subjects with vaccination history of the vaccine.

PACKAGING
Prefilled syringe. 1 dose.

SHELF LIFE
24 months.