Menactra®, solution for injection

INDICATIONS AND USAGE

Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.

CONTRAINDICATIONS

Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine, or to any component of Menactra [see DESCRIPTION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Febrile or Acute Disease

Vaccination should be postponed in case of febrile or acute disease that is moderate or severe. However, a minor febrile or non-febrile illness, such as mild upper respiratory infection, is not usually a valid reason to postpone immunization.

DOSAGE AND ADMINISTRATION

Preparation for Administration

Menactra is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered.

Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.

Dose and Schedule

Menactra is administered as a single 0.5 mL dose by intramuscular injection, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass.

Do not administer this product intravenously or subcutaneously.

Primary Vaccination:

• In children 9 through 23 months of age, Menactra is given as a 2-dose series at least three months apart.
• Individuals 2 through 55 years of age, Menactra is given as a single dose.

Booster Vaccination:

• A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.