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HSA Approval

Menactra®, solution for injection

SIN13922P

Menactra®, solution for injection

Menactra®, solution for injection

February 24, 2011

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence HolderSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

**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.

INTRAMUSCULAR

Medical Information

**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.

J07AH08

meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Sanofi Pasteur Inc.

Active Ingredients

Meningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate)

4 mcg/dose (0.5 ml)

Meningococcal (Serogroup W-135) Polysaccharide (Monovalent Conjugate)

4 mcg/dose (0.5 ml)

Diphtheria Toxoid Protein

48 mcg/dose (0.5 ml) (Diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio)

Meningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate)

4 mcg/dose (0.5 ml)

Meningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate)

4 mcg/dose (0.5 ml)

Documents

Package Inserts

Menactra Solution for Injection PI.pdf

Approved: June 19, 2019

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Menactra®, solution for injection - HSA Approval | MedPath