- Approval Id
- 7604010d187c9734
- Drug Name
- Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial
- Product Name
- Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial
- Approval Number
- SIN17129P
- Approval Date
- 2024-10-30
- Registrant
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Licence Holder
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<img src="/TGIF/SpikevaxSingleDoseVial-Table2.png" alt="Spikevax Single Dose Vial Dosage Table 2" /><br><br>
<p><em>Paediatric population</em><br>
The safety and efficacy of Spikevax XBB.1.5 in children less than 6 months of age have not yet been established. No data are available.</p>
<p><em>Elderly population</em><br>
No dosage adjustment is required in elderly individuals ≥65 years of age.</p>
<p><u>Method of administration</u></p>
<p>The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.</p>
<p>Do not administer this vaccine intravascularly, subcutaneously or intradermally.</p>
<p>The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.</p>
<p>For precautions to be taken before administering the vaccine, see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 disease caused by SARS- CoV-2 in individuals 12 years of age and older (see sections 4.2 and 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The use of this vaccine should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- J07BN01
- Pharma Manufacturer Name
- MODERNA BIOTECH SINGAPORE PTE. LTD.
