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National Drug Formulary

AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE [SIN17377P]

Active ingredients: AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

View product's general information
Last updated 24 April 2026

Product Info

AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

[SIN17377P]

Product information

Active Ingredient and Strength

INFLUENZA VIRUS SURFACE ANTIGENS (HAEMAGGLUTININ AND NEURAMINIDASE) - 7.5 MICROGRAMS HA PER 0.5 ML DOSE

Dosage Form

INJECTION, SUSPENSION

Manufacturer and Country

SEQIRUS INC. - UNITED STATES

Registration Number

SIN17377P

Licence Holder

SEQIRUS PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07BB02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 THERAPEUTIC INDICATIONS

AUDENZ® is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.

AUDENZ® should be used in accordance with official recommendations.

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 Section 5.1 Pharmacodynamic properties – Clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

Dosing

4.2 DOSE AND METHOD OF ADMINISTRATION

Individuals 6 months of age and older: Administer two doses (0.5 mL each), at least 21 days apart.

Elderly: No dose adjustment is required in elderly individuals ≥ 65 years of age.

Booster dose: The need for a booster dose(s) following the primary vaccination schedule has not been established.

Method of administration

The vaccine should be administered by intramuscular injection.

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.

AUDENZ® must not be mixed with other products.

Instructions for Use and Handling

Gently shake before use. After shaking, the normal appearance of the vaccine is a milky-white suspension.

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.

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.

Contraindications

4.3 CONTRAINDICATIONS

AUDENZ® is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to:

  • any component of the vaccine (refer to Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION & Section 6.1 LIST OF EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or

  • a previous dose of an influenza vaccine.