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Group ACYW135 Meningococcal Polysaccharide Vaccine

Product Name
Generic name: Group ACYW135 Meningococcal Polysaccharide Vaccine*

Product Description
This product is a lyophilized vaccine of purified meningococcal capsular polysaccharides of group A, C, Y and W135 Neisseria meningitides (N. meningitides). The vaccine is in compliance with the recommendations issued by WHO in relation to meningococcal polysaccharide vaccines. The Group ACYW135 Meningococcal Polysaccharide Vaccine (MPV ACYW135) is provided as a single human dose with a vial of white loose sterile powder and another vial of diluent. The lyophilized polysaccharide vaccine should be reconstituted immediately before use with the accompanying diluent (sterile water for injection). After reconstitution with diluent, the vaccine shall immediately turn into a clear, colorless solution.

Composition
The vaccine is supplied as a single dose vial of lyophilized powder, with corresponding single dose of diluent. Each dose of 0.5 mL contains:
Active ingredients:

Polysaccharide for serogroup A, C, Y and W135

50 μg each

Excipients

Lactose 4 mg

Sodium chloride 4.25 mg

Diluent

Sterile water for injection 0.5 mL

 

  
Indication
This vaccine is indicated for active immunization to prevent invasive meningococcal diseases caused by N. meningitidis serogroups A, C, Y and W135.
This vaccine is indicated for use in individuals aged 2 years and above who are at high risk of getting meningococcal diseases caused by N. meningitidis serogroups A, C, Y and W135:
(1)People who are travelling to or living in high-risk areas, such as SubSaharan Africa (Group A, C, Y and W135 meningococcal diseases epidemic area);
(2)People who are working in a laboratory with Group A, C, Y, W135 meningococcus or in vaccine workshops and may be infected with meningococcal diseases from the air;
(3)According to epidemiological investigation by the Ministry of Health and the Centers for Disease Control, high-risk population in predicted outbreak areas of group Y and W135 meningococcal diseases.
The vaccine does not protect against diseases caused by N. meningitidis serogroups that are not contained in the vaccine.

Dosage and Administration
(1)Reconstitute the vaccine using the diluent provided in the pack and dissolve the lyophilized powder by gentle shaking. After reconstitution, withdraw 0.5 ml of the vaccine and use immediately.
(2)The vaccine shall be injected subcutaneously into the deltoid muscle of the lateral upper arm.
(3)Revaccination: high-risk individuals in infectious areas, especially children below 4 years old after the first vaccination, if sustained at high risk, revaccination should be administered after 2-3 years from the first vaccination. Although it has not been confirmed the necessity for the older children and adults to be revaccinated, if the antibody level has rapidly declined after the first vaccination, then revaccination should be considered after primary immunization within 3-5 years.

Contraindications

This vaccine should not be administered to:
(1)Individuals with known epilepsy, convulsion, brain disorder or allergic history.
(2)Individuals with kidney diseases, heart diseases or active tuberculosis.
(3)Individuals with acute infectious diseases or fever.

Storge Conditions
The vaccine should be stored and transported at 2℃ to 8℃; protect from light.
The diluent should be stored and transported at 2℃ to 30℃.
The vaccine should be used before the expiration date stated on the label.

Shelf Life
The shelf life is 24 months. The expiration date of the vaccine is indicated on the label and packaging.
 
 
 
 *This product awarded Halal certification issued by Majelis Ulama Indonesia (MUI)