- Approval Id
- 766a9fa9c6b7b3f6
- Drug Name
- MENQUADFI SOLUTION FOR INJECTION
- Product Name
- MENQUADFI SOLUTION FOR INJECTION
- Approval Number
- SIN16454P
- Approval Date
- 2022-03-29
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<ul>
<li>Primary vaccination:</li>
<li>Individuals 12 months of age and older: One single dose (0.5 mL).</li>
</ul>
<ul>
<li>Booster vaccination:</li>
<li>A single 0.5 mL dose of MenQuadfi may be used to boost subjects who have previously received a meningococcal vaccine containing the same serogroups (see section Pharmacodynamic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Long-term antibody persistence data following vaccination with MenQuadfi are available up to 7 years after vaccination (see sections Special warnings and Precautions for use and Pharmacodynamic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>There are no data available to indicate the need for or timing of a booster dose of MenQuadfi (see section Pharmacodynamic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
<p><em>Other paediatric population</em><br>
The safety and immunogenicity of MenQuadfi in individuals under 12 months of age have not yet been established.</p>
<p><u>Method of administration</u><br>
For intramuscular injection only, preferably in the deltoid region or anterolateral thigh depending on the recipient's age and muscle mass.</p>
<p>For instructions on handling of the vaccine before administration, see section Special precautions for disposal and other handling – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by <em>Neisseria meningitidis</em> serogroups A, C, W, and Y.</p>
<p>The use of this vaccine should be in accordance with available official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients listed in section List of excipients or after previous administration of the vaccine or a vaccine containing the same components – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</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.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd