AstraZeneca Pharmaceuticals LP (UNITED STATES)🇸🇬 Health Sciences Authority
Approval Date
Jul 31, 2025
Approval ID
48a94b714fddc432
Company
AstraZeneca Pharmaceuticals LP (UNITED STATES)
Type
Therapeutic
Approval Details
Approval Id
48a94b714fddc432
Drug Name
FLUMIST TRIVALENT INFLUENZA INTRANASAL VACCINE
Product Name
FLUMIST TRIVALENT INFLUENZA INTRANASAL VACCINE
Approval Number
SIN17298P
Approval Date
2025-07-31
Registrant
ASTRAZENECA SINGAPORE PTE LTD
Licence Holder
ASTRAZENECA SINGAPORE PTE LTD
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
SPRAY
Dosage
<p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>For intranasal use.</strong></p>
<p><strong>2.1 Dosing Information</strong><br>
Administer FluMist Trivalent according to the following schedule:</p>
<img src="/TGIF/FluMist-Table1.png" alt="FluMist Dosage Table 1" /><br><br>
<p><strong>2.2 Administration Instructions</strong><br>
Each sprayer contains a single dose (0.2 mL) of FluMist Trivalent; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril (each sprayer contains 0.2 mL of vaccine). Refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e.g., sharps container or biohazard container).</p>
<img src="/TGIF/FluMist-Figure1.png" alt="FluMist Dosage Figure 1" /><br><br>
Indication Info
<p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>FluMist® Trivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine <em>[see Description (11)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>FluMist Trivalent is approved for use in persons 2 through 49 years of age <em>[see Clinical Studies (14)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
Contraindications
<p><strong>4 CONTRAINDICATIONS</strong></p>
<p><strong>4.1 Severe Allergic Reactions</strong><br>
Do not administer FluMist Trivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine <em>[see Description (11)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em> including egg protein, or after a previous dose of any influenza vaccine.</p>
<p><strong>4.2 Concomitant Aspirin Therapy and Reye’s Syndrome in Children and Adolescents</strong><br>
Do not administer FluMist Trivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza infection <em>[see Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
