hualan bio Group ACYW135 Meningococcal Polysaccharide Vaccine according to WHO recommended standard

[Drug Name] Generic Name: Group ACYW135 Meningococcal Polysaccharide Vaccine  English Name: Group ACYW135 Meningococcal Polysaccharide Vaccine  Chinese Pinyin: ACYW135 Qun Naomoyanqiujun Duotang Yimiao [Constituents and Characters] Meningococcal Polysaccharide Vaccine Group ACYW135 is lyophilized preparation made from Group A, C, Y, W135 Neisseria meningitides culture by extracting and purifying the respective polysaccharide antigen, mixing and then adding in suitable stabilizer. The final product looks like a white crisp cake, and after reconstitution by adding the attached solvent, it turns into a clear liquid. Active ingredients: Group A, C, Y, W135 Neisseria meningitides capsule polysaccharide.

Excipient: lactose.

Solvent: sterile, non-pyrogenic PBS. 

[Vaccination Subjects]   At present, the vaccine is only recommended to be used in high-risk population (children and adults) over 2 years of age in the following conditions: 

（1） Travelers or inhabitants of high-risk regions of the serogroup A, C, Y and W135 Neisseria meningitis epidemic areas like Sub-Saharan Africa. 

（2） Persons who do laboratory or vaccine production work and might come in contact with the serogroupA, C, Y and W135 Neisseria meningitis in the air. 

（3） High-risk population in the serogroups Y and W135 Neisseria meningitis epidemic areas estimated by the national Ministry of Health and CDC according to the epidemiological survey. 

[Function and Use]   The vaccine is used against the epidemic cerebrospinal meningitis caused by Neisseria meningitides serogroup A, C, Y and W135. [Specifications]   Reconstituted as per labeled amount, each vial is 0.5ml, and 0.5ml for each human dose containing 50μg of respective serogroup A, C, Y and W135 polysaccharide.

[Administration and Dosages]

 (1) Reconstitute vaccine by adding the accompanying solvent into the vaccine to dissolve. Shake and inject immediately.

(2) The vaccine should be injected subcutaneously at deltoid insertion area of the lateral upper arm.

(3)  Vaccinate a single 0.5ml dose before meningococcal epidemic season.  

(4) Re-vaccination (recommended by foreign countries): one booster dose shall be given 2 ~3 years after the primary immunization to people who remain at risk of invasive meningococcal disease, especially to children who were younger than 4 years at the time of primary immunization. Though whether re-vaccination is necessary for older children and adults has not been determined, re-vaccination should be considered within 3~5 years after primary immunization in case that antibody levels rapidly decline within 2~3 years after vaccination.  

There is no current information available on immune persistence and strengthening of immunization regarding this vaccine in clinical research.  

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