- Approval Id
- 290f3f3596d40041
- Drug Name
- Menactra®, solution for injection
- Product Name
- Menactra®, solution for injection
- Approval Number
- SIN13922P
- Approval Date
- 2011-02-24
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>Preparation for Administration</strong></p>
<p>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.</p>
<p>Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.</p>
<p><strong>Dose and Schedule</strong></p>
<p>Menactra is administered as a single 0.5 mL dose by <strong>intramuscular</strong> injection, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass.</p>
<p>Do not administer this product intravenously or subcutaneously.</p>
<p><strong>Primary Vaccination:</strong></p>
<ul>
<li>In children 9 through 23 months of age, Menactra is given as a 2-dose series at least three months apart.</li>
<li>Individuals 2 through 55 years of age, Menactra is given as a single dose.</li>
</ul>
<p><strong>Booster Vaccination:</strong></p>
<ul>
<li>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.</li>
</ul>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong></p>
<p>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 <em>Neisseria meningitidis</em> 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 <em>N meningitidis</em> serogroup B disease.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p><strong>Hypersensitivity</strong></p>
<p>Severe allergic reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM<sub>197</sub>-containing vaccine, or to any component of Menactra [see <strong>DESCRIPTION</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><strong>Febrile or Acute Disease</strong></p>
<p>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.</p>
- Atc Code
- J07AH08
- Atc Item Name
- meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
