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HSA Approval

PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL

SIN15801P

PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL

PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL

September 6, 2019

SEQIRUS PTE. LTD.

SEQIRUS PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSEQIRUS PTE. LTD.
Licence HolderSEQIRUS PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

**Dosage and method of administration** **Dose** Two 0.5 mL doses, 21 days apart. **Method of administration** The vaccine should be administered by intramuscular injection. The vaccine should be allowed to reach room temperature before use. Shake before use. The vaccine should appear as a homogeneous creamy/white opaque liquid suspension with no large clumps visible. Once opened, the vaccine is to be used immediately and within the one vaccination session, with any remaining contents discarded in accordance with local requirements. No additions should be made to the contents of the vial. **Instructions for use and handling** It is important that the contents of the container be shaken thoroughly immediately before use. The vaccine should appear as a homogenous creamy/white opaque liquid suspension with no large clumps visible.

INTRAMUSCULAR

Medical Information

**Therapeutic indications** Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with Singaporean Health Authorities’ recommendations, taking into account the recommendation of the World Health Organisation.

**Contraindications** History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (e.g. eggs, chicken protein refer to sections **Qualitative and Quantitative Composition** and **List of excipients** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) of this vaccine. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.

J07BB02

influenza, inactivated, split virus or surface antigen

Manufacturer Information

SEQIRUS PTE. LTD.

Seqirus Pty Ltd

Active Ingredients

Pandemic Influenza Virus Type A, inactivated and disrupted

30 mcg HA / 0.5 ml

Documents

Package Inserts

Panvax Pandemic Influenza Vaccine PI.pdf

Approved: March 9, 2023

Download

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PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL - HSA Approval | MedPath