Source: FDA, National Drug Code (US) Revision Year: 2022
JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
For subcutaneous injection only.
Administer two doses (0.5 mL each) of JYNNEOS 4 weeks apart.
Allow the vaccine to thaw and reach room temperature before use. Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 12 hours. Do not refreeze.
When thawed, JYNNEOS is a milky, light yellow to pale white colored suspension.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Swirl the vial gently before use for at least 30 seconds. Withdraw a dose of 0.5 mL into a sterile syringe for injection.
Administer JYNNEOS by subcutaneous injection, preferably into the upper arm (deltoid).
Keep frozen at -25°C to -15°C (-13°F to +5°F).
Store in the original package to protect from light.
Do not re-freeze a vial once it has been thawed.
Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 12 hours.
Do not use the vaccine after the expiration date shown on the vial label.
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