ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION [SIN17049P]

Product Info

ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

[SIN17049P]

Indication

2 INDICATIONS AND USAGE

2.1 Immunization of Pregnant Individuals

ABRYSVO is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

2.2 Immunization of Individuals 60 Years of Age and Older

ABRYSVO is a vaccine indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

2.3 Immunization of Individuals 18 through 59 Years of Age

ABRYSVO is a vaccine indicated for active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

Dosing

3 DOSAGE AND ADMINISTRATION

3.1 Dose and Schedule

Administer a single dose (approximately 0.5 mL) of ABRYSVO intramuscularly.

3.2 Preparation for Administration

The lyophilized vaccine (powder) must be reconstituted only with the solvent provided to form ABRYSVO.

For Use of Vial of RSV preF Vaccine, Pre-filled Syringe of Solvent and Vial Adapter

Step 1. Attach vial adapter

• Peel off the top cover from the vial adapter packaging and remove the flip off cap from the vial.

• While keeping the vial adapter in its packaging, center over the vial’s stopper and connect with a straight downward push. Do not push the vial adapter in at an angle as it may result in leaking. Remove the packaging.

Step 2. Reconstitute lyophilized vaccine component to form ABRYSVO

• For all syringe assembly steps, hold the syringe only by the Luer lock adapter. This will prevent the Luer lock adapter from detaching during use.

• Twist to remove the syringe cap, then twist to connect the syringe to the vial adapter. Stop turning when you feel resistance.

• Inject the entire contents of the syringe into the vial. Hold the plunger rod down and gently swirl the vial until the powder is completely dissolved. Do not shake.

Step 3. Withdraw reconstituted vaccine

• Invert the vial completely and slowly withdraw the entire contents into the syringe to ensure a 0.5 mL dose of ABRYSVO.

• Twist to disconnect the syringe from the vial adapter.

• Attach a sterile needle suitable for intramuscular injection.

For Use of Vial of RSV preF Vaccine and Vial of Solvent

1. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the solvent.

2. Inject the entire contents of the syringe into the vial containing the powder. Gently swirl the vial in a circular motion until the powder is completely dissolved. Do not shake. Withdraw 0.5 mL from the vial containing the reconstituted vaccine.

Reconstituted Vaccine for Administration

The prepared vaccine is a clear and colorless solution. Visually inspect the vaccine for large particulate matter and discoloration prior to administration. Do not use if large particulate matter or discoloration is found.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

3.3 Administration

For intramuscular injection only.

After reconstitution, administer ABRYSVO immediately or store at room temperature (15°C to 30°C) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

Contraindications

5 CONTRAINDICATIONS

Do not administer ABRYSVO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO [see Description (1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].