JYNNEOS SUSPENSION FOR INJECTION [SIN17067P]

Product Info

JYNNEOS SUSPENSION FOR INJECTION

[SIN17067P]

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

For subcutaneous injection only.

2.1 Dose and Schedule

Administer two doses (0.5 mL each) of JYNNEOS 4 weeks apart.

2.2 Preparation and Administration

Allow the vaccine to thaw and reach room temperature before use.
Once thawed, the vaccine may be kept at +2°C to +8°C for 4 weeks. 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.

4 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients [see Description (8) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information] or trace residues (chicken protein, benzonase, gentamicin and ciprofloxacin).