Product Description

Meningogoccal Polysaccharide Vaccine, Groups A, C, Y and W-135 combined, is indicated for active immunization against invasive meningococcal diseases caused by these serogroups.

Description
Vaccinated Population: The children above 2 years, the adult
Specs: 1 dose/ vial. After reconstitution with diluent as indicated on the label, the 0.5ml dose containing 50μ G of "isolated product" from each of Groups A, C, Y and W-135 is an isotonic sodium chloride solution.
Dosage Form: Freeze-dried preparation for subcutaneous use after reconstitution
Compendial Compliance: CP
Validity Period: 24 months
Storage: 2-8degrees. Protect from light. Do not freeze.
Package: 1 dose/ pack, and each pack contains 1 vial of lyophilized powder and 1 vial of diluent.
Immunization schedule: 1 dose

Administration and dosage:
Reconstitute the vaccine using only the diluent supplied for this purpose. Draw the volume of diluent shown on the diluent label into a suitable size syringe and inject into the vial containing the vaccine. Shake vial until the vaccine is dissolved.
The immunizing dose is a single injection of 0.5ml administered subcutaneously.
For both adults and children, vaccine is administered subcutaneously as a single 0.5ml dose. Revaccination of a single 0.5ml dose administered subcutaneously may be indicated for individuals at high-risk of infection.
Adverse reactions
The side effects are mild and consist principally of pain and redness at the injection site for 1 to 2 days.
Pain at the site of injection is most commonly reported adverse reaction, and a transient fever might develop in less than or equal to 2% of young children.
Contraindications
Immunization should be deferred during the course of any acuter illness.
It is a contraindication to administer this vaccine to individuals known to be sensitive to heimerosal or other component of the vaccine.

Precautions
Do not use in case that there is any crack in the container.
Epinephrine injection (1: 1000) must be immediately available to combat unexpected anaphylactic or other allergic reactions.
Special care should be taken to avoid injecting the vaccine inrtrademally, intramuscularly, or intravenously since clinical studies have not been done to establish safety and efficacy of the vaccine via these routes of administration