- Approval Id
- 9137c8688015dc2a
- Drug Name
- Vaxigrip Vaccine
- Product Name
- Vaxigrip Vaccine
- Approval Number
- SIN17277P
- Approval Date
- 2025-07-04
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Adults: one dose of 0.5 mL.</p>
<p><em>Paediatric population</em></p>
<ul class="dash">
<li><p>Children from 6 months to 17 years of age: one dose of 0.5 mL.<br>
For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.</p></li>
<li><p>Infants less than 6 months of age: the safety and efficacy of Vaxigrip administration (active immunisation) have not been established. No data are available.<br>
Regarding passive protection: one 0.5 mL dose given to pregnant women may protect infants from birth to less than 6 months of age; however, not all these infants will be protected (see Sections 4.4, 4.6 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li>
</ul>
<p><u>Method of administration</u></p>
<p>The preferred route of administration for this vaccine is intramuscular although it can also be given subcutaneously.</p>
<p>The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults.</p>
<p><em>Precautions to be taken before handling or administering the medicinal product</em></p>
<p>For instructions on preparation of the medicinal product before administration, see Section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Vaxigrip is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the influenza B virus type contained in the vaccine for:</p>
<ul class="dash">
<li>active immunisation of adults, including pregnant women, and children from 6 months of age and older.</li>
</ul>
<p>The use of Vaxigrip should be based on official recommendations on vaccination against influenza.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
