Active Ingredient and Strength	(POWDER) RSV SUBGROUP A STABILIZED PREFUSION F PROTEIN - 0.06 MG/VIAL (POWDER) RSV SUBGROUP B STABILIZED PREFUSION F PROTEIN - 0.06 MG/VIAL
Dosage Form	INJECTION, POWDER, FOR SOLUTION
Manufacturer and Country	PFIZER MANUFACTURING BELGIUM NV - BELGIUM PFIZER MANUFACTURING BELGIUM NV (DILUENT) - BELGIUM
Registration Number	SIN17049P
Licence Holder	PFIZER PRIVATE LIMITED
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	J07BX05

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.

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 diluent provided to form ABRYSVO.

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.

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.

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].