- Approval Id
- bf8c35b97120c474
- Drug Name
- AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
- Product Name
- AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
- Approval Number
- SIN17377P
- Approval Date
- 2025-10-29
- Registrant
- SEQIRUS PTE. LTD.
- Licence Holder
- SEQIRUS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>4.2 DOSE AND METHOD OF ADMINISTRATION</strong></p>
<p>Individuals 6 months of age and older: Administer two doses (0.5 mL each), at least 21 days apart.</p>
<p>Elderly: No dose adjustment is required in elderly individuals ≥ 65 years of age.</p>
<p>Booster dose: The need for a booster dose(s) following the primary vaccination schedule has not been established.</p>
<p><u><strong>Method of administration</strong></u></p>
<p>The vaccine should be administered by intramuscular injection.</p>
<p>For persons 12 months of age and over, the preferred injection site is the deltoid muscle of the upper arm; for those 6 to less than 12 months of age, the preferred injection site is the anterolateral thigh.</p>
<p>AUDENZ® must not be mixed with other products.</p>
<p><u><strong>Instructions for Use and Handling</strong></u></p>
<p>Gently shake before use. After shaking, the normal appearance of the vaccine is a milky-white suspension.</p>
<p>Visually inspect the contents of each pre-filled syringe for particulate matter and/or variation in appearance prior to administration. If either condition is observed, do not administer the vaccine.</p>
<p>AUDENZ® pre-filled syringes contains no antimicrobial preservative. Each pre-filled syringe is for use in one patient on one occasion only. Discard any residue.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 THERAPEUTIC INDICATIONS</strong></p>
<p>AUDENZ® is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.</p>
<p>AUDENZ® should be used in accordance with official recommendations.</p>
<p>The available evidence was based on immunogenicity studies conducted in healthy subjects following administration of two doses of monovalent vaccine of different influenza subtypes. See also <strong>Section 5.1 Pharmacodynamic properties – Clinical trials</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></p>
- Contraindications
- <p><strong>4.3 CONTRAINDICATIONS</strong></p>
<p>AUDENZ® is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to:</p>
<ul>
<li><p>any component of the vaccine (refer to <strong>Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION & Section 6.1 LIST OF EXCIPIENTS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) or</p></li>
<li><p>a previous dose of an influenza vaccine.</p></li>
</ul>
