- Approval Id
- 75c2913782fd1e8d
- Drug Name
- PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL
- Product Name
- PANVAX® PANDEMIC INFLUENZA VACCINE (ADJUVANTED) 10ML SUSPENSION FOR INJECTION VIAL
- Approval Number
- SIN15801P
- Approval Date
- 2019-09-06
- Registrant
- SEQIRUS PTE. LTD.
- Licence Holder
- SEQIRUS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>Dosage and method of administration</strong></p>
<p><strong>Dose</strong></p>
<p>Two 0.5 mL doses, 21 days apart.</p>
<p><strong>Method of administration</strong></p>
<p>The vaccine should be administered by intramuscular injection.</p>
<p>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.</p>
<p>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.</p>
<p><strong>Instructions for use and handling</strong></p>
<p>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.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>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.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>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 <strong>Qualitative and Quantitative Composition</strong> and <strong>List of excipients</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) 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.</p>
- Atc Code
- J07BB02
- Atc Item Name
- influenza, inactivated, split virus or surface antigen
- Pharma Manufacturer Name
- SEQIRUS PTE. LTD.
- Company Detail Path
- /organization/seqirus-pte-ltd
