- Approval Id
- 1254539e112624bd
- Drug Name
- JYNNEOS SUSPENSION FOR INJECTION
- Product Name
- JYNNEOS SUSPENSION FOR INJECTION
- Approval Number
- SIN17067P
- Approval Date
- 2024-08-23
- Registrant
- AENON PHARMACEUTICALS SEA PTE. LTD.
- Licence Holder
- AENON PHARMACEUTICALS SEA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>For subcutaneous injection only.</strong></p>
<p><strong>2.1 Dose and Schedule</strong></p>
<p>Administer two doses (0.5 mL each) of JYNNEOS 4 weeks apart.</p>
<p><strong>2.2 Preparation and Administration</strong></p>
<p>Allow the vaccine to thaw and reach room temperature before use.<br>
Once thawed, the vaccine may be kept at +2°C to +8°C for 4 weeks. Do not refreeze.</p>
<p>When thawed, JYNNEOS is a milky, light yellow to pale white colored suspension.<br>
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br>
If either of these conditions exists, the vaccine should not be administered.</p>
<p>Swirl the vial gently before use for at least 30 seconds. Withdraw a dose of 0.5 mL into a sterile syringe for injection.</p>
<p>Administer JYNNEOS by subcutaneous injection, preferably into the upper arm.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients <em>[see Description (8)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em> or trace residues (chicken protein, benzonase, gentamicin and ciprofloxacin).</p>
- Atc Code
- J07BX01
- Pharma Manufacturer Name
- AENON PHARMACEUTICALS SEA PTE. LTD.
