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A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use,
is a freeze-dried preparation of the group-specific polysaccharide antigens from
Group A, Group C, Group
and Group W-135.
are cultivated with Mueller Hinton agar
and Watson Scherp
media. The purified
polysaccharide is extracted from the
cells and separated from the media by procedures which include
centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration. No preservative is
added during manufacture.
The 0.78 mL vial of diluent contains sterile, preservative-free, pyrogen-free distilled water and is used for reconstitution of
product supplied in 1 mL vials. The 6 mL vial of diluent contains sterile, pyrogen-free distilled water to which thimerosal
(mercury derivative) 1:10,000 is added as a preservative. The 6 mL vial is for reconstitution of product supplied in 10 mL vials.
After reconstitution with diluent as indicated on the label, the 0.5 mL dose is formulated to contain 50 μg of “isolated product”
from each of Groups A, C
and W-135 in an isotonic sodium chloride solution.
Each dose of vaccine is also formulated to contain 2.5 mg to 5 mg of lactose added as a stabilizer.
The vaccine when
reconstituted is a clear colorless liquid.
Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography
method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO)
Meningococcal Polysaccharide Vaccine.
THIS VACCINE CONFORMS TO THE WORLD HEALTH ORGANIZATION (WHO) REQUIREMENTS